Ear, Nose and Throat - 11.1.2 2020-04 / 167
Side effects: Dryn.& irrit.of nose & throat, unpleas. taste & smell, Special precautions: Concom.corticoster., transf. from syst.to topic. (S2) AQ.NAS.SPRAY, 33/21.5.1/0482
epistax., hypersens. reacts., nas.perforat.(rare), HPA-axis suppress.at corticoster., act./quiesc. TB, untreat.fung./bact./syst.vir.infects.or ocul. 716718-001: 50 µg/actuat., 60 met.spray, R87,73
dos. high.than recomm. Nasules also: rare glauc. & incr.IOP. H.simplex, recent nasal surg./trauma/ulc., avoid expos.to chicken pox/ 883261-007: 50 µg/actuat., 140 met.spray, R204,72
Special precautions: Treat nasal airway infects. appropriat., transf. measles., poss.hypoadrenal. infts.born.to mothers receiv.corticoster. Dosage: Prophylax. & treatm: Adults & adolesc: Recomm.dos: 2
of pts.from syst. steroid., poss.addit.ther.if heavy challenge of sum- dur.preg., poss.growth suppress.in childr. & teen, loc. Candida albicans sprays (100 µg) into each nostril once dly., reduc.to one spray/nostril
mer allergens. Nasules also: Unilat.polypos: diagn. to be confirm.by infects., syst.eff.with excess.dos once sympts.control. Incr.to 4 sprays (200 µg)/nostril once dly.if not
specialist, reg.use essent. for full therapeut.benef.but consid. alt. ther. NASONEX, MSD [P/S] adeq.control., reduc.dos.once sympts. control.
if no improvem.seen aft.4-6 wks.ther. Childr.2-11 yrs: Recomm.dos: 1 spray (50 µg) into each nostril
Mometasone furoate once dly.
FLOMIST, Cipla Medpro [P/S] Indications: Season.allerg.rhinit., perenn. allerg.rhinit. Contraindications: Pregn.& lactat., safety & effic. in childr.und.2
Fluticasone propionate. (S2) AQ.NAS.SPRAY, 32/21.5.1/0157 yrs.not est.
Indications: Prophylax.& treatm.of season.allerg. rhinit.inc. hayfever 883253-004: 50 µg/actuat., 140 met.spray, R296,64 Side effects: Common: Epistax., pharyngit., nas.burn.& irrit., nas.
in adults & childr.over 12 yrs.of age. Dosage: Prophylax. & treatm: Adults & adoles: Recomm.dos: 2 ulcerat., headache, Other: Dizzin., rhinit., sinusit., cough., skin rash,
(S2) AQUEOUS NAS.SPRAY. 37/21.5.1/0289. 50 µg/spray sprays (100 µg) into each nostril once dly., reduc.to one spray/nostril nas.sept. irrit., rhinorrh., conjunctivit., dry eyes, naus., taste & smell
704383-001: 120 met.dos./bottle, R75,05 once sympts.control. Incr.to 4 sprays (200 µg)/nostril once dly.if not disturbs., hypersens.reacts.incl.angioed.& anaphylax., blurr.vis. Rare:
Dosage: Admin.by intranasal route only. Ther.to be taken reg.even if adeq.control., reduc.dos.once sympts. control. Nas.sept.perforat./IOP.
asymptomat. Max.relief expect. 3-4 days aft.init.ther. Childr.2-11 yrs: Recomm.dos: 1 spray (50 µg) into each nostril Warnings and special precautions: In recent nas.surg./trauma
Prophylax.& treatm.of season.allerg.rhinit.: Adults & childr. once dly. use only once heal.occurr., act./ quiesc.TB, RTI’s, untreat. fung./bact./
over 12 yrs: 2 sprays in each nostril once a day pref.in morn.. Max: Contraindications: Pregn.& lactat., safety & effic. in childr.und.2 syst.vir. infects/ ocul.H. simplex., do not use in pres.of untreat. loc.in-
2 sprays 2xdly in each nostril. yrs.not est. fect.involv.nas.mucosa., discont.in fung. infect./persist.nasopharyng.
Contraindications: Pregn., safety in lactat.not est. Side effects: Common: Epistax., pharyngit., nas.burn.& irrit., head- irrit., when transf. from syst.to nasal inhal.ther., immunosuppress.
Side effects: Hypersens.reacts.incl.anaphylax.& bronchosp., head- ache, Other: Dizzin., rhinit., sinusit., cough., skin rash, taste pervers., risk expos.to infects.eg.chicken pox/ measles, refer.to opthalmolog.
ache, unpleas.taste & smell, dryn. & irrit.of nose & throat, epistax., nas.sept. irrit., nas.ulcer., rhinorrh., conjunctivit., dry eyes, naus., to eval.vis. disturbs. causes.
nas. perforat. (rare), HPA-axis suppress.at dos.high. than recomm., smell disturbs., hypersens.reacts.incl. angioed. & anaphylax., blurr. Interactions: CYP3A4 inhibit.poss.incr. corticoster. plasma conc.
vis. Rare: Nas.sept. perforat./IOP.
poss.system.corticoster.S/E, rarely unmask.of underly.eosinophil. Warnings and special precautions: In recent nas.surg./trauma
condits.(e.g. Churg Strauss syndr.) usual.assoc.with withdr./dos. re- use only once heal.occurr., act./ quiesc.TB, RTI’s, untreat.fung./bact./ SPEC BUDESONIDE, Specpharm [P/S]
duct.of oral corticoster.ther. syst.vir. infects/ ocul.H.simplex., do not use in pres.of untreat. loc. Budesonide
Special precautions: Transf.of pts.from syst. steroid., teratogen. nas.mucosa infect., discont.in fung. infect./persist.nasopharyng.ir- Indications: Season.& perennial allerg.rhinit. prophylax.
in anim.& cannot be excl.in humans, treat nasal airway infects.ap- rit., when transf.from syst.to nasal inhal.ther., immunosuppress.risk (S3) AQ.NAS.SPRAY. A40/21.5.1/0224
propriat., poss.addit.ther.(esp.eyes) if heavy challenge of summer expos. to infects.eg.chicken pox/measles., refer.to opthalmolog. to 712614-001: 100 µg/met.spray, 200 dos., R170,72
allergens, med.&surg.emerg. eval.vis.disturbs.causes. Dosage: Adults & childr.over 12 yrs: Two sprays in each nostr.
once a day or one spray in each nostr 2xdly.morn.& even. Maint:
Drug interactions: Incr.plasma conc.with P450 3A4 enzyme inhibit. Interactions: CYP3A4 inhibit.poss.incr.corticoster. plasma conc. One spray in each nostr.once a day. Max.dly.dos.not to exceed 400 µg
FLONASE, GSK [P/S] & NEXOMIST, Cipla Medpro [P/S] Contraindications: Act./quiesc.pulm.TB, fung./ vir.nose infects.,
Fluticasone propionate. Mometasone furoate safety & effic.in childr.not est, safety in pregn.& lactat.not est.
Indications: Short-term (<6 mnths) prophylax.& treatm. of allerg. Indications: Season.& perenn.allerg.rhinit. Side effects: Sneez., sore throat, dry nose, crust format., headache,
rhinit.(hayfev).in adults & childr. over 12yrs. (S2) AQ.NAS.SPRAY, A38/21.5.1/0341 poss.slight haemorrhag. secret.
(S2) AQUEOUS NAS.SPRAY. 36/21.5.1/0504. 50 µg/spray 713968-001: 50 µg/actuat., 140 met.spray, R195,84 Special precautions: Foet.abnormalit.in pregn. animals report.,
714595-001: 120 met.sprays/bottle, R79,43 Dosage: Commenc.prophylact.treatm.prior to start of pollen seas. poss.system.effs.at high dos.over prolong.per., discont.grad., treat
Dosage: Admin.by intranasal route only. For full therapeut.benef.reg. Prophylax. & treatm: Adults & adoles: Recomm. dos: 2 sprays poss.eye sympt. from allergy with concom.antihistamin.
use essent. Adults & childr. over 12 yrs: 2 sprays in each nostril (100 µg) into each nostril once dly., reduc.to one spray/nostril once TRIAMIST, Cipla Medpro [P/S]
once a day pref.in morn. sympts. control. Incr.to 4 sprays (200 µg)/nostril once dly. if not adeq. Triamcinolone acetonide
Contra-indications: Safety in pregn.& lactat. not est. control., reduc.dos.once sympts. control. Indications: Season.& perenn.allerg.rhinit.in adults & chil-
Side-effects: Hypersens.reacts., unpleas.taste & smell, epistax., Childr.2-11 yrs: Recomm.dos: 1 spray (50 µg) into each nostril once dly. dr.6 yrs.& old.
dryn.& irrit.of nose & throat, nas.sept.perforat.(rare), HPA-axis sup- Contraindications: Pregn.& lactat., safety & effic. in childr.und.2 (S3) NASAL SPRAY. 45/21.5.1/0676
press.at dos. high.than recomm. yrs.not est., untreat.loc. infect. involv.nas.mucosa. 721681-001: 55 µg/dos., 120 dos., R184,23
Special precautions: Corticoster.teratogen.in anim.& system.ab- Side effects: Epistax., pharyngit., dizzin., headache, taste pervers., Dosage: Adults & childr.over 12 yrs: Init.2 sprays per nostril
sorpt.poss., treat nasal airway infects. appropriat., transf.of pts.from conjunctivit., dry eyes, rhinit., sinusit., cough., nas.sept.irrit., rhinorrh., once a day.
syst. steroid., poss.addit.ther.if heavy challenge of summer allergens. nas.burn.& irrit., naus., rash, hypersens.reacts. incl. angioed. & ana- Maint: 1 spray per nostril as sngl.dly.dos. Childr.6-12 yrs: 1 spray in
MOMETASONE CLICKS NASAL SPRAY, (Unicorn) Sandoz [P/S] phylax., rarely nas.sept. perforat./IOP. each nostril dly.2 sprays in each nostril once dly. may be used with
Special precautions: Benzalkon.Cl.intol., aft. recent nas.surg./
Mometasone furoate trauma use only once heal. occurr., exam periodic.for nas.mucosa more sev.sympt. Maint.on low.effect.dos.once sympt.contr. Contin.
Indications: Season.allerg.rhinit., perenn. allerg. rhinit.in adults/ chang.with prolong. use, discont.in persist. nasopharyng. irrit., in use beyond 3 mnths in childr.und.12 yrs not recomm. Consid.alt.ther.
adolesc.& childr.2-11 yrs., prophylact. ther.recomm. in pts.with mod. case of fung.infects.treat./discont.ther., act. or quiesc.TB of resp. if adeq.relief.not obt. within 3 wks.
to sev. allerg. rhinit. sympt.hist. bef.poll.seas.start. tract., untreat.fung./ bact./ syst.vir.infects/ocul.H.simplex., when Contraindications: Childr.und.6 yrs., pregn., safety in lactat.not est.
(S2) NAS.SPRAY, 46/21.5.1/0490 transf. from syst.to nasal inhal.ther., unmask.of prev.allerg.condits. Side effects: Headache, ocul.hypertens., rhinit., pharyngit., burn./
3000396-001: 50 µg/met dos., 120 dos., R98,02 suppress.by system. corticoster., immunosuppress.risk expos.to in- dryn./other irrit./crust.in nose, epistax., sore throat, nas.mucosa ulc.,
Dosage: Prophylax. & treatm: Adults incl. elderly & adolesc: fects. eg.chicken pox/measles., consid.system. corticoster.cover dur. nas./ pharyng. candidias., nas.sept.perforat., sneez., sinus.congest.,
throat discomf., dry mucous membr.
Recomm.dos: 2 sprays (100 µg) into each nostril once dly., reduc.to one stress/elect.surg.if high. than recom.dos.given.
spray/ nostr.once sympts.contr. Max.4 sprays (200 µg) /nostril once Warnings and special precautions: Teratogen. in animals follow.
topic.applic., poss.growth suppress. in childr. & teen. esp.with high.oral
dly.if not adeq.control. Reduc. dos.once sympts.contr. Tot.dos: 400 µg. OMNAIR, AstraZeneca [P/S] corticoster. dos.over extend.per., act./quiesc.TB of resp.tract, untreat.
Childr.2-11 yrs: Recomm.dos: 1 spray (50 µg) into each nostril once Ciclesonide. fung./bact./syst.vir.infects.or ocul. H.simpl., inhibit.eff.on wound heal.,
dly. Tot.dos: 100 µg. Indications: Adults & childr.12 yrs.& over: Nas.sympts.of per- concom. corticoster., transf. from syst.to topic.corticoster., avoid expos.
Contraindications: Pregn.& lactat., safety & effic. in childr.und.2 yrs. enn.allerg.rhinit. Adults & childr.6 yrs.& old: Nas.sympts.of sea- to chicken pox/measles., discont. ther. in case of loc.Candida albicans
not est., untreat.loc.infect. involv. nas.mucosa, rec.nas.surg./trauma. son.allerg. rhinit. infects., recent nasal surg./trauma/ulc., syst.eff.with excess.dos., poss.
Side effects: Freq: Pharyngit., URTI, epistax., nas. burn./irrit./ul- (S3) NAS.SPRAY, 43/21.5.1/0008. hypoadrenal.in infts.born.to mothers receiv. corticoster. dur.pregn.
cerat./dryn., headache. Less freq: GI disords., taste/smell disturbs., 718730-001: 50 µg/spray.120 met.sprays, R200,49
vomit., throat irrit. Freq.unknown: Hypersens.incl. anaphylact.re- Dosage: Admin.by intranas.route only. Titrate to low.effect.dos.to ZILFONE NASAL SPRAY, (Sanofi) Sandoz [P/S]
acts., angioed., bronchosp., dyspn., psych./ CNS effs., dizzin., eye minimise syst.corticoster.advers. effs. Mometasone furoate
Season.allerg.rhinit: Adults & childr.6 yrs.& old: 200 µg/day
disturbs.incl.incr. IOP/ conjuctivit., benign IC hypertens., rhinit., sinusit., Indications: Season./perenn.allerg.rhinit.in adults/adolesc./childr.
cough., nas.sept.irrit., rhinorrh., naus., ac. pancreatit., skin reacts.incl. as 2 sprays in each nostril once a day. Max.tot.dly.dos: 200 µg/day. betw.2-11 yrs.
Perenn.allerg.rhinit: Adults & childr.12 yrs.& old: 200 µg/day
hyperhidros., avascul. bone necros., amenorrh. as 2 sprays in each nostril once a day. Max.tot.dly.dos: 200 µg/day. (S2) NAS.SPRAY, 46/21.5.1/0491.490
Warnings and special precautions: Immunosuppress. risk ex- Contraindications: Act.pulm.TB, no adeq.stud. in pregn., not known 724010-001: 50 µg/spray, 120 dos., R98,03
pos.to infects.eg.chicken pox/ measles., discont.in local.fung.infect./ if excret.in human milk but other corticoster.are. Dosage: Commenc.prophylact.treatm.prior to start of pollen seas.
persist. nasopharyng.irrit., act./quiesc.TB, RTI’s, untreat. fung./bact./ Side effects: Cough, pharyngit., epistax., nasopharyngit., sinusit., Adults incl.elderly & adolesc: Recomm.dos: 2 sprays (100 µg) into
syst.vir.infects/ocul.H.simpl., monit. growth in childr dur.longt.treatm., nas.dryn./-irrit., pharyngolaryngeal pain, rhinorrh., nas.septum dis- each nostril once dly., reduc. to one spray/nostril once sympts.con-
poss. Cushingoid sympt.with high corticotroph.dos., when transf. ord., throat irrit., headache, dysgeus., URTI, influenza, candidias., trol. Incr.to max. 4 sprays (200 µg)/nostril once dly.if inadeq. control.,
from longt.syst.to nasal inhal.ther., unmask. of prev.allerg. condits. rhinit., vomit., dry mouth, dyspeps. reduc.dos.once sympts.control.
suppress.by syst. corticoster. Special precautions: Transf.of pts.from syst. steroid.& monit.for Childr.2-11 yrs: Recomm.dos: 1 spray (50 µg) into each nostril once
Interactions: Incr.syst.S/E risk with cert.CYP3A inhib. incl.cobi- adren.insuffic.in respons.to stress, in clinic.condits.req.long-term dly. Tot.dos: 100 µg.
cistat-cont.meds. system. corticoster.rapid decr.of syst.corticoster.poss. exacerbat. Contraindications: Safety & effic. in pregn.& lactat./ childr.
NASACOR T, Sanofi Aventis [P/S] sympts., incr.infect.suscept.when immune syst.suppress., avoid ex- und.2 yrs.not est., untreat.loc.infect. involv. nas.mucosa, in recent
nas.surg./trauma use only once heal.occurr.
Triamcinolone acetonide. pos.to dis.pts.not immunis.against & consid.prophylax.if expos., rec. Side effects: Pharyngit., URTI, hypersens.incl. anaphylact.reacts.,
Indications: Season.& perenn.allerg.rhinit. nas.surg./-trauma or –sept.ulc.until heal., incr.IOP/glauc./cataracts or psych./CNS/eye disords., incr. IOP, epistax., nas.burn./dryn./irrit./ul-
(S3) NASAL SPRAY. 29/21.5.1/0715. changes in vis., grad. withdr., quiesc.TB, RTI, untreat.loc./syst.fung./ cer., rhinit., cough, rhinorrh., GI disturbs., ac.pancreatit., skin reacts.,
895149-004: 55 µg/actuat., 120 actuat., R318,65 bact./vir./parasit.infects., ocul.H.simplex, monit. poss.advers.eff.on hyperhidros., avasc.bone necros., amenorrh., headache.
nas.mucosa, monit.height in childr.weigh.risk vs benefits & titrat.to
Dosage: Adults & childr.over 12 yrs: Init.2 sprays per nostril once Warnings and special precautions: Immunosuppress. risk expos.
a day. Maint: 1 spray per nostril as sngl.dly.dos. Childr.6-12 yrs: low. effect.dos., concom.ketoconazole, monit.infts.born to mothers to infects.eg.chicken pox/ measles, act./quiesc.TB, untreat.fung./
receiv.corticoster.dur.pregn., other corticoster.cross sens., Candida
1 spray in each nostril dly. With more sev.sympts.2 sprays in each albicans superinfect. bact./ syst. vir. infects/ocul.H.simpl., discont.in fung. infect./per-
nostril once dly.poss. Once control.maint.on low.effect.dos. Contin. Drug interactions: Des-ciclesonide AUC incr.at steady state with sist.nasopharyng.irrit., per.exam.for nas. mucosa chang.with longt.
use beyond 3 mnths in childr. und.12 yrs not recomm. Consid.alt.ther. oral ketoconazole. use, regul.height monit. of childr.receiv.prolong.ther., when transf.
if adeq. relief.not obt.within 3 wks. from syst. to nasal inhal.ther., withdr.grad., unmask.of pre-exist. al-
Contraindications: Childr.und.6 yrs., pregn.& lactat. RINELON, MSD [P/S] lerg.condits.prev.suppress.by syst. corticoster., nasal sept.perforat.,
Side effects: Headache, rhinit., pharyngit., epistax., nasal irritat., Mometasone furoate adren.cortex hyperactiv.
dry mucous membr., naso sinus congest., throat discomf., sneez. Indications: Season.allerg.rhinit., perenn.allerg. rhinit. Interactions: Incr.syst.S/E risk with cert. CYP3A inhib.
168 / 2020-04 Ear, Nose and Throat - 11.1.3 / 11.1.4
alpha-& ß-block., poss.interacts.with guanethidine/reserpine /di- NAZOVIN, Actor [P/S]
11.1.3 Chromones goxin & alpha-methyldopa. Xylometazoline HCl.
Indications: Nas.congest.in colds, sinusit., otit.med. & to facilit.
No products listed ENT, AI Pharm Ltd [P/S] rhinoscop.
Phenylephrine HCl 62,5 mg, naphazoline nitrate 6,25 mg/25 ml. (S1) ADULT MET.SPRAY, [P/S] 46/16.1/0311
Indications: Nasal congest.due to colds/flu/ sinusit./rhinit.& hayfev. 723718-001: 1 mg/ml, 10 ml, R49,16
11.1.4 Decongestants (S1) NAS.DROPS, [P/S] H1505. Dosage: Adults & childr.over 12 yrs: 1 spray into each nostril.
723363-005: 25 ml, R45,13
ILIADIN (MDR Listing) Dosage: Insert 4 hrly if nec.with max.of 3xdly. Tot.of 3 applic./day usual.suffic. Do not exceed recomm.dos.esp.
childr.& elderly
ADCO-NAPHENSYL, AI Pharm Ltd [P/S] Adults: 2-3 drps. Childr. 3-12 yrs: 1-2 drps.in each nostril. (S1) PAED.NAS.DROPS, [P/S] 46/16.1/0854
(S1) NAS.SPRAY, [P/S] H1504.
Phenylephrine HCl. 723720-001: 0,5 mg/ml, 10 ml, R49,16
Indications: Mucos.congest.accompan.resp. condits., ac.allerg. Phenylephrine HCl 62,5 mg, naphazoline nitrate 5,64 mg/25 ml. Dosage: Childr.2-12 yrs: 1-2 drops into each nostril once or 2x dly.
723371-008: 25 ml, R49,61
rhinit.& coryza, sinusit. 2 applic./day not to be exceed.
(S1) 1% NOSE DROPS, [P/S] H1403. 100 mg/10 ml. Dosage: Insert 4 hrly if nec.with max.of 3xdly. Contraindications: Ischaem.heart dis., hyperthyroid., MAOIs, sta-
Adults: 2 sprays. Childr.3-12 yrs: 1-2 sprays in each nostril. Use
836133-005: 10 ml, R16,98 tus post sphenoid. hypophysect.or aft.transnas.-/oral surg.intervent.
Dosage: 2-3 drps. 4 hrly. spray spar.in childr. in which dura mater expos.
Contraindications: Sev.coron.dis., hypertens., CV dis., hyperthy-
(S1) 0,25% PAED NOSE DROPS, [P/S] H1596. 25 mg/10 ml. Side effects: Loc./ CNS effs., epistax., anosm., GI disords., palpitat.,
836141-008: 10 ml, R17,08 roid., MAOI, pregn., spray not for childr. und.2yrs., concom.TCA’s. skin/ allerg. reacts., vis.disturbs.
Side effects: CNS effs., GI disturbs., extreme hypertens.poss.lead.
Dosage: 2-3 drps.4 hrly. Warnings and special precautions: Absorb. through nas.mucosa,
Contraindications: Hyperthyroid., aneurysm, hypertens., arterio- to cerebr.haemorrh., CV effs. incl.ang.pain & hypotens., rebound avoid in childr.und.12 yrs., hypertens., phaeochromocyt., CV dis., narr.
scleros., CV disords., MAOI, TCA’s. congest., trans. irrit. angl. glauc., diab.mellit., prostat.hypertrophy, strong sympathomimet.
Special precautions: Hypertens., hyperthyroid., childr., CV disor-
Side effects: High BP, reflex bradycard., rebound congest.with freq./ react., rebound congest.with prolong./ excess.use, poss.atroph.rhinit.
prolong.applicat., loc.irrit., hypersens. ds., pts.receiv.guanethidine & simil. adrenerg.block.agents extrem. with chron. use, poss.porphyrinogen., topic.applic., pregn. & lactat.,
sens.to phenylephr.
Drug interactions: Extr.sens.to hypertens.eff. with guanethidine do not swall.if dripp. into throat.
& simil.adrenerg.neurone block., hypotens.eff.of reserpine & me- Drug interactions: Hypotens.eff.of reserpine & methyldopa.revers., Drug interactions: TCAs poss.potent.syst.effs., hypertens. cris.,
avoid in pts.receiv. TCA’s.
thyldopa revers. MAOIs.revers.act.of antihypertens. agents.
DRINASAL PAEDIATRIC, (Mylan) Xixia [P/S] ILIADIN, P&G SA Trading [P/S] & OTRIVIN, GSK Consum [P/S]
Oxymetazoline HCl.
Oxymetazoline HCl. Xylometazoline HCl.
Indications: Nas.congest.assoc.with common cold/sinusit./allerg. Indications: Short term treatm.(less than 5 days) of nas.congest. Indications: Nas.decongest.in colds & sinus infect., otit.med., &
assoc.with ac.rhinit.in infts.old.than 1 mnth.
rhinit.& hayfev., adjunct.in middle ear infect. to fac.rhinoscopy.
(S1) PAED DROPS, 27/16.1/0390. (S1) BABY NOSE DROPS, [P/S] 34/16.1/0366 (S1) ADULT DRPS, [P/S] H/16.1/1382. 1 mg/ml.
702618-003: 0,25 mg/ml, 10 ml, R35,43 708510-001: 0,100 mg/ml, 5 ml, R44,46 798991-003: 10 ml, R58,16
Dosage: Max.treatm.period x5 days Dosage: Do not exceed recomm.dos.or admin. long. than 5 days. Dosage: Adults & childr.over 12 yrs: 2-3 drps. in each nostril dly.
Childr.up to 6 yrs: 2-3 drps.in each nostr.2-3xdly. Meter.pipette supplied clearly mark. as reqd. 3xdly usual.suffic.
(S1) PAED.METER.SPRAY, 27/16.1/0390 Infts.1-12 mnths: 1-2 drps.in each nostril 2-3xdly. (S1) ADULT MET.SPRAY, [P/S] H/16.1/1382., 31/16.1/0319
702620-003: 0,25 mg/ml, 10 ml, R48,35 (S1) KIDS NOSE DROPS, [P/S] V/16.1/296. 1 mg/ml.
Indications: Nas.congest.due to common cold, sinusit., allerg.
Dosage: Max.treatm.period x5 days 821934-007: 10 ml, R75,09
Childr.up to 6 yrs: 2-3 sprays in each nostr. 2-3xdly. rhinit.& hay-fever. Adjunct.in otit. media. 703557-001: Menthol, 10 ml, R78,49
732281-008: 0,25 mg/ml, 10 ml, R55,94
Side effects: Loc.burn./sting., sneez., dry mouth/ throat, rebound Dosage: Adults & childr.over 12 yrs: One puff into each nostr.as
congest., drug induc.rhinit. Dosage: Childr.up to 6 yrs: 2-3 drps.in each nostr. 2-3xdly. reqd. 3xdly usual.suffic.
(S1) KIDS NOSE SPRAY, [P/S] V/16.1/296.
Special precautions: Card.dis., hypertens., hyperthyroid. (S1) PAED.DRPS, [P/S] H/16.1/1381. 0,5 mg/ml.
732338-018: 0,25 mg/ml, 10 ml, R75,12 799114-006: 10 ml, R58,16
DRISTAN LONG LASTING VAPOUR, (Pfizer) Pfizer Consum.[P/S] Dosage: Childr.up to 6 yrs: 2-3 sprays in each nostr. 2-3xdly. Dosage: Childr.2-11 yrs: 1-2 drps.in each nostril 1-2xdly. Max.2
Oxymetazoline HCl. (S1) NOSE DROPS, [P/S] H1400. applic/day.
Indications: Nas.congest., otitis med.treatm. adjunct 732257-018: 0,5 mg/ml, 10 ml, R51,71 (S1) PAED.MET.SPRAY, [P/S] H/16.1/1381. 0,5 mg/ml
(S1) NASAL SPRAY J/16.1/397. 0,5 mg/1 g Dosage: Adults & childr.over 6 yrs: 2-3 drps.in each nostr. 2-3xdly. 821942-018: 10 ml, R71,70
721387-004: 15 ml squeeze bot., R55,74 (S1) METER.NOSE SPRAY, [P/S] H1597. Dosage: Childr.2-11 yrs: One puff into each nostril 1-2xdly. Max.2
783870-019: 15 ml met.dos.pump , R55,74 732265-002: 0,5 mg/ml, 10 ml, R69,09 applic./day.
Dosage: Do not use for more than 5 days. Avoid eyes Dosage: 2-3 sprays in each nostr. 2-3xdly. Contraindications: Hyperthyroid., narr.angl. glauc.or predispos.to
Adults & childr.over 6 yrs: Admin. morn.& even.or if necess.at (S1) NOSE SPRAY, [P/S] H1597. it, diab.mellit., ischaem. heart dis./other heart dis.incl.ang.or hyper-
8-12 hrly interv. Childr.und.6 yrs: Not recomm. Indications: Nas.congest.due to common cold/ sinusit/allerg. rhinit tens., MAOI, status post-transsphen.hypophysec./aft. transnas.oral
Contraindications: Porphyr., MAOI’s, safety in pregn.& lactat.not & hay fev., adjunct treatm.in middle ear infect. surg.in which dura mater expos., not advis.in pregn.due to system.
est., not for use in childr.und.6 yrs. 732303-001: 0,5 mg/ml, 20 ml, R55,21 absorpt.potent., safety in lactat.not est.
Side effects: Burn., sting., trans.irritat., mouth & throat dryn., re- Dosage: 1 spray in each nostr. 2-3xdly. Side effects: Rebound congest., loc.sting.& irrit., dry nose, naus.,
bound congest., meds.induc.rhinit., CNS effs., psych.disords.incl.psy- Contraindications: Porphyr. headache, lightheadn., palpit., anosmia, epistax., dizzin., insomn.,
chot.state, palpits., N&V, weakn., blurr.vis., reduc.appetite. Side effects: Loc.burn./sting., sneez., dry mouth/ throat, rebound trans.vis. disturbs., skin rash, hypersens.reacts.incl.contact. dermatit.
Warnings and special precautions: Coron.art. dis., heart dis. congest., fast irreg.heartbeat, headache, light-headedn., nervousn., with menthol, poss.atroph.rhinit.with chron. use.
incl.angina & hypertens., narr.angle glauc., hyperthyroid., diab. trembl., trouble in sleep. Special precautions: Hypertens., CV dis., pts. who show strong
mellit., MAOI’s, prostat. enlargem., childr.und.6 yrs., do not use for Warnings and special precautions: Admin. more freq.than reacts.to sympathom., do not exceed recomm.dos.esp.childr.& el-
more than 5 days. recomm./prolong admin.without med.advice, MAOI ther., agents derly, prolong. use.
Drug interactions: Poss.hypertens.crisis with MAOI’s, vasopress. with potent.to incr.BP, incr.IOP esp.narr.-angle glauc., sev. cardvasc. Drug interactions: TCA’s may potent.syst.effs.
eff.of anlph1-agon.poss. enhanc. dis., phaeochromocyt., metabol.disords. eg.hypertens.& hyperthyroid.,
DRIXINE, Bayer Consum. [P/S] pregn.& lactat., childr. esp.prone to system.absorpt. SINUTAB NASAL SPRAY, J&J [P/S]
Xylometazoline HCl.
Oxymetazoline HCl. Drug interactions: Poss.hypertens.cris.with MAOI, maprotiline Indications: Nas.congest.due to common cold, sinusit., allerg.
Indications: Nas.congest.in colds, flu, hayfev., allerg.rhinit., other may potent.press.eff. rhinit.& hayfev.
upp.resp.allerg., post-nas.drip, & sinusit., See also MDR page 512. (S1) SOL. P/16.1/184.
(S1) NAS.SPRAY [P/S] H1376 NAZENE ADULT NASAL, AI Pharm [P/S] 702940-001: 1 mg/ml, 10 ml, R51,09
721441-009: Regular, 0,5 mg/ml, 20 ml, R47,12 Oxymetazoline HCl. Dosage: Adults & childr.over 12 yrs: 1 spray into each nostril
(S1) NAS.PUMP SPRAY, [P/S] H1376 Indications: Nas.congest.assoc.with common cold/sinusit./al- 2-3x/day as requir.Max.dly.dos: 3 sprays. Do not use for more than
814199-003: 0,5 mg/ml, 10 ml, R68,90 lerg.rhinit.& hay fev.. 3 days/exceed recomm.dos.
721976-001: 0,5 mg/ml, 20 ml, R88,39 (S1) METER.SPRAY, A39/16.1/0211 Contraindications: Childr.und.12 yrs.not recomm., prolong.use in
Dosage: Childr.und.6 yrs: not recomm. 715296-001: 0,50 mg/ml, 10 ml, R50,30 chron.rhinit., concom. adrenerg. neur.block.agents/MAOI’s.
Adults & childr.over 6 yrs: 1-2 sprays in each nostril morn.& even. Dosage: Do not admin.long.than 5 days. Side effects: Loc.sting., sneez., dry nose, headache, insomn., drow-
Not more often than 10-12 hrly. with max.2 applic./24 hrs. Max.5 days. Adults & childr.6 yrs.& over: 2-3 sprays in each nostr. 2-3xdly. sin., nausea, palpits.
Contraindications: Porphyr., extreme caut.in MAOI’s, safety in Contraindications: Porphyr., safety in pregn.& lactat.not est. Special precautions: Hypertens., hyperthyroid., rebound congest./
pregn.& lactat.not est., 0,05% in childr.und.6 yrs., narr.angle glauc., Side effects: Headache, light-headedn., nervousn., trembl., trouble chemic.rhinit.with prolong.use.
trans-sphenoidal hypophysect., inflamm.of skin & mucosa of nas. in sleep., blurr.vis., fast irreg.heartbeat, high BP, loc.burn./sting./ dryn.,
vestib.& rhinit.sicca, ac.CV dis., card.asthma, sev.hypertens. sneez., incr.nas.discharge, dry mouth/ throat, rebound congest., weakn. UNIVERSAL NASAL DROPS, Litha
Side effects: Loc.reacts., nas.burn./-sting./-discharge/-dryn., incr. Special precautions: Incr.IOP esp.narr.-angle glauc., sev.cardvasc. Phenylephrine HCl
nas.discharge, headache, light headedn., insomn., anx., restlessn., dis.eg.coron.heart dis./ hypertens., metabol.disords.eg.hyperthyroid./ Indications: Nas.congest.relief
trem., confus., irritabil., agitat., drowsin., hallucinat., convuls. (part. diab.mellit., childr.esp.prone to system.absorpt., insuffic.evid.to est. (S1) DROPS, H1542. 2,5 mg/ml
childr.), weakn., psychot.states, GI disturbs., vasoconstrict.with result. effic.& safety in infts.less than 1 mnth., consult Dr for long-term use. 773867-007: 15 ml, R18,42
hypertens./ cerebr.haemorrh.& pulm.oed., card.arrhythm., palpitat., Drug interactions: Maprotiline may potent. press. eff., incr.BP with Dosage: Adults & childr.6-12 yrs: 2-3 drps.in each nostril not
tachycard., card.arrest, hypotens., faint., flush., ang.precipitat., dif- MAOI/other sympathomimet. more oft.than 4 hrly.
fic.micturit., urin.retent., dyspn., alt.metabol., sweat., hypersalivat., Contra-indications: MAOI’s, safety in pregn.& lactat.not est.
blurr. vis., dry mouth, throat irrit., rebound congest., appet. reduct. NAZENE Z, (AI Consum) AI Pharm Ltd [P/S] Side-effects: Loc.irritat., anx., restlessn., trem., insomn., confus.,
Special precautions: Childr.esp.sens.to effs., not for use long. Oxymetazoline HCl 0,5 mg, Zn sulph. 0,015 mg/ml. irritabil., weakn., psychot.states, GI disturbs., vasoconstrict.with re-
than 5 days, CV dis., hypertens., signs of reduc.placent.perfus., Indications: Nas.congest.in ac.colds/allerg. rhinit. / sinusit./hay fev. sult.hypertens., ang.precipitat., hypotens., diffic.micturit., urin. retent.,
freq./prolong high dos.use may reduc.placent.perfus., hyperthyroid., (S1) NAS.SPRAY. H1501. dyspn., alt.metabol., sweat., hypersalivat., headache.
diab. mellit., clos.-angle glauc., prostat.hypertrophy, halog.anaesth., 746126-018: 20 ml, R38,57 Special precautions: Rebound congest.& rhinorrh. with prolong./
rebound congest. & rhinorrh.with prolong./excess.use, 0,05% to be Dosage: Adults: 1 spray in both nostrils 1-3xdly as reqd. excess.use, adult supervis. of childr.recomm., hypertens., hyperthy-
avoid.in phaechromocytoma Contraindications: Childr.und.6 yrs., porphyr. roid., ischaem. heart dis., arrhythm., tachycard., occlus. vasc.dis.,
Drug interactions: Press.effs.poss.potent.by TCA’s / maprotiline/ Side effects: Loc.burn./sting., sneez., dry throat & mouth., GI disturbs. arterioscleros., aneurysm, diab.mellit., clos.-angle glauc., prostat.
MAOI’s, incr.arrhythm.risk with concom.card.glycosid./quinidine or Special precautions: Rebound congest./drug induc.rhinit.with hypertrophy, halogen. anaesthes.
TCA’s, anti-hypertens.act. poss.revers., poss.hypertens. cris. with prolong.use. Drug interactions: Act.of anti-hypertens. poss.revers., complex.
Ear, Nose and Throat - 11.1.4 / 11.1.5 / 11.1.6 / 11.1.7 / 11.2 / 11.3 2020-04 / 169
reacts with alpha-& beta block.& poss.hypertens.crisis, ventric.fibril- Contraindications: Safety in pregn.& lactat.not est., embryotox.& CILODEX, Novartis [P/S] &
lat.with halogen.anaesth., interacts.poss.with guanithid./ reserpine/ teratog.eff.in mice & rats at high syst.dos. Ciprofloxacin 3 mg, dexamethasone 1 mg/ml.
maprotiline/TCA’s/digox.& alpha-methyldopa Side effects: Naus., fatig., pain, loc.irrit./pain/ dryn./ burn./discomf., Indications: Top.treatm.of ac.otit.med.with tympanotomy tubes,
VIBROCIL-S, GSK Consum. [P/S] sinusit., headache, somnol., dizzin., pharyngolaryng pain, epitax., ac.otit.externa caus.by suscept.bact.strains.
cough., nas. congest./discomf., palpitat., tachycard., eyelid-/ nas.
(S4) SUSP. A39/16.2/0544
Dimethindene mal. 25 mg, phenylephrine base 250 mg/100 g oed., malaise, anaphylax., hypersens., bronchosp., dyspn 710689-001: 5 ml, R252,60
or 100 ml. Warnings and special precautions: Ren. impairm., pass.into Dosage: Adults & childr: 4 drps.2x dly.x7 days.
Indications: Nas.& sinus congest., dry.nas. mucosa. breast milk, poss.sedat.theref. advis.to determine respons.bef.driv./ Contraindications: Other quinolone hypersens., pregn.
(S2) NASAL GEL, [P/S] G/16.1/227. peform. complicat. tasks. Side effects: Ear discomf.& pain, candidal infect., irritabil., cry., dys-
775959-006: 12 g, R51,99 Drug interactions: Poss.interact.with alcoh., absorpt. trans.re- geus., dizzin., ear prurit., tinnit., ear disord., medicat.residue, implant
Dosage: Adults & childr.over 6 yrs: Apply 4xdly, last applic.on retir. duc.by oxymetazol. migrat., tingl.in ear, cerumen impact., flush., skin rash.
(S2) SOL, [P/S] W/16.1/93. Special precautions: Eval.furth.to excl.underly. condit.if 2 or more
Indications: Nas.& sinus congest. episod.of otorrhea occur within 6 mnths./if otorrhea perists aft.full
794414-001: 15 ml, R85,41 course, superinfect., corticoster.teratogen., lactat.
Dosage: Adults & childr.over 6 yrs: 1 spray in each nostril 3-4xdly. 11.1.6 Mucolytics See also MDR page 125.
Contraindications: Atroph.rhinit., MAOI., safety in pregn.& lac-
tat.not est. No products listed COVANCAINE, AI Pharm Ltd [P/S]
Side effects: Burn., vestibulit., GI disturbs., poss. syst.absorpt.can Na-sulphacetamide 100 mg, phenazone 50 mg, benzocaine 10 mg,
raise BP, vasoconstrict.with result. hypertens., CV effs., diffic.mictu- urea 120 mg/ml.
rit., urin. retent., dyspn., alt.metabol., sweat., hypersalivat., prolong. 11.1.7 Others Indications: Ac./chron.otit.media & -externa.
use: skin sensitisat., excess use: rebound congest. No products listed. (S2) DROPS. H1474.
Special precautions: Hypertens., CV dis., diab. mellit., thyrotoxi- 716596-008: 20 ml, R50,59
cos., hyperthyroid., clos.angle glauc., prolong./excess.use, concom. Dosage: Fill ear every 1-4 hrs.
TCA’s & ß-adrenerg.block., card.glycoside/ quinidine, pregn., halo- 11.2 Ear drops and ointments Contraindications: Vir./fung.infects.
gen.anaesthes. Side effects: Irrit.to inflam.skin/exudat.les.
Drug interactions: Poss.interacts.with guanethidine, reserpine, CILODEX (MDR Listing)
digox., alpha-methyldopa, alpha & ß-block. ADCO-OTISED, AI Pharm Ltd [P/S] LOCACORTEN-VIOFORM, Pharmaco [P/S]
Flumethasone pivalate 0,2 mg, clioquinol 10 mg/ml
ZADIN, Sandoz [P/S] Phenazone 0,05 g, benzocaine 0,01 g, glycerine 1,185 g/ml Indications: Infect.corticoster.respons.ext.ear dermatit.
Oxymetazoline HCl. Indications: Ear infects.with intact eardrum. (S4) EAR DROPS, H1380
Indications: Tempor.relief of nas.congest.in colds & flu/hay fev./al- (S2) DROPS. H1418. 738840-009: 7,5 ml, R170,34
lerg.rhinit./other upp.resp.allerg./ post-nas.drip & sinusit. 751537-004: 15 ml, R11,74 Dosage: 2-3 drps.2xdly
(S1) NASAL DROPS 0,025%, [P/S] 44/16.1/0751 Dosage: 3-4 drps.in ear 4 hrly. Contraindications: Perforat.eardrum, syphilit. skin affs., skin TB/vir.
720641-001: 0,25 mg/ml, 10 ml, R42,62 Contraindications: Perforat.eardrum., infts. infects., eye applic./allerg., childr.und.2 yrs., thyroid defic.
Dosage: Childr.2-6 yrs: With adult supervis. 1-3 drps.in each nostr. Side effects: Allerg.reacts. Side effects: Loc.irrit., atroph.skin chang., syst. absorpt., HPA-axis
not more than 10-12 hrly. Do not exceed 2 applic./24 hrs. Special precautions: Pts with low plasma cholinesterase/an- depress., benign IC-press.
(S1) NASAL SPRAY 0,025%, [P/S] 44/16.1/0749 ticholinesterase Special precautions: Pregn.& lactat., prolong. admin.
720643-001: 0,25 mg/ml, 10 ml, R59,48 AURONE, (Aspen Pharmacare: Consum) Pharmacare [P/S]
Dosage: Childr.2-6 yrs: With adult supervis. 2-3 sprays.in each Phenazone. MAXIDEX, Novartis [P/S]
Dexamethasone.
nostr.not more than 10-12 hrly. Do not exceed 2 applic./24 hrs. Indications: Painf.ear inflamm.condits. Indications: Steroid respons.otic.inflamm.of extern.audit.meatus.
(S1) NASAL DROPS 0,05%, [P/S] 44/16.1/0752 (S2) DROPS, [P/S] H1389. 750 mg/15 ml. (S4) SUSP. H1143 (Act 101/1965) 1 mg/ml.
720642-001: 0,5 mg/ml, 10 ml, R42,63 705780-007: 15 ml, R59,82 740446-002: 5 ml, R177,16
Dosage: Adults & childr.over 6 yrs: 1-2 drps.in each nostr.not more Dosage: Instil. 5-10 drps. 2 hrly. Dosage: Otic: 3-4 drps. 2-4xdly.
than 10-12 hrly. Do not exceed 2 applic./24 hrs. (S2) FORTE DROPS, [P/S] H1390. Contraindications: Epithelial herpes.simplex keratit., vaccinia,
(S1) NASAL SPRAY 0,05%, [P/S] 44/16.1/0750 Phenazone 750 mg, benzocaine 150 mg, chlorbutol 150 mg/15 ml. varicella, fung.dis.
720644-001: 0,5 mg/ml, 10 ml, R56,27 Indications: Ac.otit.med., simple catarrhal otit., furunculos.& Side effects: Delay.wound heal., progress.of H.simplex infect., de-
Dosage: Adults & childr.over 6 yrs: 1-2 sprays in each nostr.not other ear infects. velopm.& spread of second.& fung.infects.
more than 10-12 hrly. Do not exceed 2 applic./24 hrs. 705799-018: 15 ml, R63,02
Contraindications: Atroph.nas.mucosa inflammat., MAOI/within Dosage: Instill. 5-10 drps. 2 hrly. UNIVERSAL EARACHE DROPS, Litha
14 days of stop.treatm., porphyr., sev.hypertens., phaeochromocyt., Contraindications: Porphyr. Phenazone 50 mg, procaine HCl 10 mg, K hydroxyquinoline sul-
safety in pregn. & lactat.not est. Side effects: Skin erupts., Forte also: methaemoglobaemia. ph.1 mg/g
Side effects: Alt.metabol.incl.gluc.metabol., anx., irritab., headache, in- Special precautions: Loc.anaesthet.: epilep., shock, myasth. Indications: Otit.med., ear infect.& inflammat.
somn., nervousn., trem., restlessn., confus., fear, pain, dizzin., ligheadedn., grav., imp.card.conduct., liv. damage, ear condits with discharge/ (S2) DROPS, H1544
cerebr. haemorrh., palpitat., tachycard., ventric. dysrhythm., ang.pain, card. perforat. tympan.membr. 773859-004: 15 ml, R21,63
arrest, bradycard., vasoconstrict.,hypertens., hypotens., sneez., pulm. oed., Dosage: 2-3 drps.in affect.ear 4 hrly.
incr.nas.discharge, dyspn., dry mouth & throat, naus., vomit., reduc.appet., BETNESOL, (Aspen Pharmacare: Pharma) Pharmacare [P/S] Special precautions: Med.attent.wherever poss. for childr.& if
thirst, incr. sweat., unusual palen., piloerect., diffic./painf. urinat., urin.re- Betamethasone sod.phosph. respons.not quick.
tent., flush., loc.sting., burn., hypersalivat., cold extremit., weakn., faint. Indications: Inflam.condit.of the ear WAXSOL, (Mylan) Meda Pharma, [P/S]
Special precautions: Do not exceed recomm.dos or use long.than (S4) EAR DROPS. H1257. 1 mg/ml. Docusate sodium
5 days, 0,05% not recomm.in childr. und.6 yrs., rebound congest.& 708267-009: 5 ml, R191,04 Indications: Ear wax remov.
rhinorrh.with prolong./ excess.applicat., CV disords.esp.card. dys- Dosage: 2-3 drps 2-3 hrly.until control achiev.then reduc. (S0) EAR DROPS, V/16.2/289. 0,05g/10 ml
rhythm./ ischaem.heart dis./hypertens., occlus. vasc. dis.at incr.periph. Contraindications: Vir., bact., fung., TB & purul. infects., pregn., 778567-001: 10 ml, R74,87
ischaem.risk, hyperthyroid., diabet., elderly, childr., thyroid hormon., ulcerat.condit., rosacea, H.simplex, vaccinia/varicella Dosage: Aural use only. Tilt head & fill ear canal (usually 10 drops)
clos.angle glauc., diff.urinat. Special precautions: Long term use in childr., infect.sympt.poss.mask.,
Drug interactions: Sev.hypertens.with MAOI’s, incr. card.effs.with incr.suscept.to infect., adren.suppress.esp.in infts., grad,withdr., HF, rec. on 2 consecut.nights. Plug ear with cottonwool leav.in ear overnight.
If aft.2 nights ear is still block.consult Dr.
meds.incr.myocard.sensitiv.to beta 1-agon., antihypertens.meds/ MI, hypertens., diab.mellit., epilep., glauc., hypothyroid., hepat.fail.,
meds.caus. hypotens. partic.thos involv.smypath.nerv.syst., poss. osteoporos., pept.ulcerat., psychos., sev.affect. disords., ren.impairm. Contraindications: Infect., tympan.perforat.
Side effects: Less freq: Applic.site reacts.incl. trans. Unknown:
hypertens.crisis with alpha-& beta-block., poss. hypertens.with Drug interactions: Corticoster.eff.reduc.by barbit./carbamazepine/
adrenerg.neurone block.eg reserpine & alpha-methyldopa, poss. phenytoin/primidone & rifampic., corticoster.plasma conc.incr.by OC’s Hypersens.reacts., allerg.skin reacts., contact dermatit., audit.can.
injur./ inflammat.
+
hypertens.& dysrhythm. with TCA’s, CNS stimul.effs.potent., vaso- & ritonavir, corticoster.with K + deplet.diuret.poss. caus. excess K loss
constrict. & vasopress.eff.of alpha agon. enhanc., incr.dysrhythm. & incr.hypokalaem.with amphotericin B/xanthines & ß2-agon., incr.
risk with inhalat. anaesthet. GI bleed. & ulcerat.with concom.NSAID’s, alt. respons. to anticoags.,
poss.incr.antidiab./ antihypertens. requirem., salicyl.ser.conc.decr., an-
timuscar. effs.in myasth.grav.poss.decr., poss. interacts with antivir./ 11.3 Mouth and throat
neuromusc.block.& fem. hormones.
11.1.5 Antihistamines BETNESOL-N, (Aspen Pharmacare: Pharma) Pharmacare [P/S] preparations
Betamethasone sod.phosph. 0,1 g, neomycin as sulph. 0,35 g/100 ml.
RHINOLAST, MEDA Pharma [P/S] Indications: Inflam.ear condits.with poss./pres. bact.infect. ANDOLEX, iNova [P/S]
Azelastine HCl (S4) EAR DROPS. H1258. Benzydamine HCl. Alcohol 10%v/v
Indications: Season & perenn.rhinit. 708291-007: 5 ml, R151,84 Indications: Symptomat.relief.of painful mouth & throat inflamm.
(S2) NASAL SPRAY, 27/5.7.1/0590 708429-009: 10 ml, R303,69 condit., traumat.condits.& dent.ops.
815527-004:, 0,14 mg/actuat., 10 ml, R70,82 Dosage: 2-3 drps 2-3 hrly.until control.achiev. then reduc. (S1) SOL, [P/S] Z/16/40. 22,5 mg/15 ml
Dosage: Adults & childr.old.than 6 yrs: 1 spray in each nos- Contraindications: Viral, fung., TB & purul. infects., perfor.eardrum, 810576-007: 200 ml, R103,16
tril 2xdly. neonates, pregn., lactat. Dosage: Rinse/ gargle with 15 ml undil.sol 1½-3 hrly. Can be dil.if
Contraindications: Childr.und.6 yrs. Side effects: Ac.sensitisat. sting./burn.sensat.occurs.
Side effects: Irrit./burn.of throat/nose, bitter taste. Special precautions: Should not be used until intact tympan.mem- (S1) SPRAY, [P/S] Z/16/40. 22,5 mg/15 ml
Special precautions: Pregn.& lactat. br.visualis., avoid unnecess./ prolong. use, adren.suppress.esp.in infts. 816167-001: 30 ml, R85,52
Drug interactions: Cimetidine incr.bld.lev. Dosage: 5-10 sprays on affect.area and swallow gently, rep.1½-
CERUMOL, Litha [P/S] 3 hrly.as necess.
SINUMAX ALLERGY NASAL SPRAY, Janssen Arachis oil 570 mg, paradichlorobenzene 20 mg, chlorbutol 50 mg/ml. Contraindications: Childr.und.12 yrs.
Pharmaceutica [P/S] Indications: Removal of cerumen. Side effects: Less.freq: Hypersens.reacts.incl. urticar./rash/la-
Levocabastine HCl equiv.to levocabastine. (S0) DROPS. H/16.2/1519. ryngosp & photodermatit., light headedn., oral tiss.numbn./sting.&
Indications: Short-term season.allerg.rhinit. treatm. 713430-001: 10 ml, R44,83 burn.sensat., taste disturbs. Freq.unknown: Ser.allerg.react. (ana-
(S2) NASAL SPRAY. X/5.7.1/230. 0,5 mg/ml (i.e. 50 µg/spray) Dosage: 5 drps into ear, soak 10-30 mins. bef.remov.cerumen. phylact.shock), N&V
839965-001: 15 ml, R109,74 Contra-indications: Otit.externa, seborrh. dermatit., eczema of Warnings and special precautions: Avoid eye contact, do not
Dosage: Adults & childr.over 5 yrs: 2 puffs/ nostril 2xdly.for up to ext.ear, perfor.ear drum. exceed 7 days uninterrupt. treatm., poss.delay.allerg.reacts., safety
8 wks. Childr.6 mnths.-5 yrs: 1 puff /nostril 2xdly.for up to 4 wks. Side-effects: Loc.irrit. in pregn.& lactat.not est.
170 / 2020-04 Ear, Nose and Throat - 11.3
LET
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HELP TAKE THE program
WEIGHT OFF
COMMITTED TO RESULTS
ANDOLEX-C, iNova [P/S] Dosage: Apply evenly aft.meals to affect.areas 3-4xdly depend.on (S0) LOLLIES, H1541 2020/01/16 14:06
12897L DUR MIMS Strip adverts 2020 R.indd 1
Benzydamine HCl 22,5 mg, chlorhexidine gluconate 18 mg/15 ml. sev.of infect.,cont. x2days aft.infect.clear. Retain in mouth for max. 770655-009: 3 mg, 10, R38,70
Alcohol 9%. time poss.for best results. Dosage: Suck 1 lolly 3 hrly.dissolv.slow.in mouth for max.eff.
Indications: Relief of min.infects.& painful mouth & throat inflamm. Fung.stomatit.(dentures): Apply to les.in even. & leave overnight. Special precautions: Infts.
condit., reduc.plaque developm. For oral candidos.remov.dental prosthes.at night & brush with gel
(S1) ORAL RINSE, 31/16.4/0143 Contraindications: Infts.< 6 mnths.whose swallow. reflex not ful- MEDI-KEEL A, AI Pharm Ltd [P/S]
827630-018: 200 ml, R108,15 ly develop., imp.liv.funct., concom.CYP3A4 metabolis., astemizole, Benzocaine 12 mg, cetylpyridinium chlor. 1,5 mg
(S1) SPRAY, 31/16.4/0143 bepridil, cisapride, dofetilide, halofantrine, mizolastine, pimozide, Indications: Sore throat.
710149-001: 30 ml, R89,80 quinidine, sertindole, ergot.alkaloids, HMG-CoA reductase inhibits., (S1) LOZ, T/16.3/223, 33/16.3/0496,0495
Dosage: Do not exceed 7 days treatm.except und. med. supervis. triazolam, midazolam., safety in pregn.not est., lactat. 741035-006: 16, R36,33
Adults: Rinse/ gargle with 15 ml undil.sol for 30 secs. every 1½-3 Side effects: Dysgeus., GI disturbs., diarrh., stomatit., taste abnor- 884225-004: 16 Honey & lemon, R36,33
hrs. Childr. 6-12 yrs: 5-15 ml every 3 hrs. mal., hypersens./angioed./ anaphylact. reacts., chok., tong.discol- 884233-007: 16 Blackcurrant, R36,33
Adults: 5-10 sprays onto affect.area then gently swallow. Rep. every our., hepatit., skin disords. incl tox.epiderm.necrolys./Stev.-Johns. Dosage: Diss.1 loz.slowly in mouth 2-3 hrly as reqd.
1½-3 hrs. as necess. syndr., urticar., rash. Contraindications: Low plasma-cholinesterase conc./ receiv.
(S1) LOZ, 31/16.4/0042 Special precautions: Avoid eye contact, ensure gel does not ob- anticholinesterases, safety in pregn. & lactat.not est., childr.und.6
Benzydamine HCl 3 mg, cetylpyridinium Cl 1,33 mg struct.throat.in infts.& young childr., do not apply to back of throat., yrs.not recomm.
Indications: Relief of min.infects.& painful mouth & throat condit. div.dos into small. portions, observ.for poss.chok., dos.reduc./ monit. Side effects: Syst.effs./toxic.incl.peri-oral & tong. numbn., CNS eff.
827622-007: 16, R55,37 plasma lev.of meds.CYP2C9 metabol: oral anticoags./hypoglycem./ incl.nystagm., blurr.vis., musc. twitch., convuls., N&V, resp.fail, coma.,
(S1) RASPBERRY LOZ, 31/16.4/0042 phenytoin also CYP3A4 metabol: HIV prot.inhibits./cert.antineo- myocard. depress., hypotens.& bradycard., arrythm., card.arrest, idi-
827622-007: 16, R55,37 plast./ cert. chann. blocks./immunosuppress.agents/ alfentanil/ osyncras., allerg.reacts.
(S1) HONEY & LEMON LOZ, [P/S] 35/16.4/0320 alprazolam/brotizolam/buspirone/ carbamazepine/ cilostasol/dis- Special precautions: Benzocaine sens., epilep., imp. card.conduct./
710036-001: 16, R55,37 opyramide/ebastine/ methylprednisolone/ midazolam/reboxetine/ respir.funct./hepat.damage, myasthen.grav.
(S1) ORANGE LOZ, [P/S] 36/16.4/0195 rifabutin/ sildenafil. (S1) THROAT GARGLE, [P/S] H/16.3/199.
710035-001: 16, R55,37 Drug interactions: Metabol.of meds.metabol.by the CYP3A4 & Dibucaine HCl 5 mg, benzocaine 30 mg, cetylpyridinium chlor.
Dosage: Do not chew. Do not exceed 7 days uninterrupt. treatm. CYP2C9 enzyme syst.inhibit.which can result in either incr./prolongat. 3,713 mg, benzyl alcoh. 60 mg/15 ml.
Suck 1 loz.slowly in mouth every 1-2 hrs.as reqd.to max.12 loz./day. of their effs.& S/E, poss.enhanc. eff.lead.to hypoglycaem.with cert. Indications: Sore & irrit.throat, minor mouth irrit.
(S1) ORAL GEL, 33/16.4/0285 oral hypoglycem.such as sulphonylur. 741043-018: 100 ml, R33,50
Benzydamine HCl 10 mg, cetylpyridinium Cl 1 mg/g DEQUADIN, (Aspen Pharmacare: Consum) Pharmacare [P/S] Dosage: 15-30 ml as gargle/rinse 3-4 hrly as nec.
Indications: Painf.inflam.mouth condits.incl. mouth/ dent.ulc., Dequalinium Cl 0,4 g, lignocaine base 1,75 g/100 ml. Special precautions: Sev.traumatis./sept.loc. mucosa.
sore gums. Indications: Infect.ulc.of mouth, gums, buccal membr.& throat, (S0) THROAT SPRAY, [P/S] T/16.4/ 184
705350-001: 10 g, R66,68 denture irritat. Phenol
Dosage: Do not eat/drink for 15 mins.aft. applicat. (S1) MOUTH PAINT,[P/S] C/16.4/217 Indications: Min.sore throat infects.
Gently massage 1 cm into affect.area every 2-3 hrs. upto max.12x/day. 718629-019: 10 ml, R71,99 805173-005: 0,5 g/100 ml,100 ml, R59,19.
Side effects: Most common: Oral numbn., sting./ burn.sensat., dry Dosage: Apply to affect.areas 2-3xdly. Dosage: Repeat 2 hrly if necessary. Adults & childr.over 12 yrs:
mouth., thirst, tingl., warm feel. in mouth, alter.taste. Freq.unknown: Special precautions: Avoid prolong.use Full strength 5 sprays. Childr.6-12 yrs: 3 sprays.
Ser. allerg. react.(anaphylact.shock) Side effects: Cert.pts.may become senitis.to phen., loc.irrit.
Warnings and special precautions: Childr.und. 6 yrs., safety DERMADINE ORAL ANTISEPTIC, Cipla Medpro [P/S] Special precautions: Consult dr.if sympts.sev.& persist., not to be
in pregn.& lactat.not est., if sore throat is caus./complic.by bact. Povidone iodine. admin.to childr.und.6 yrs.unless direct.by dr.
infect.appropr. antibact. ther.to be consid., laxat.eff.with excess Indications: Painful infect.& inflamm.mouth & throat, routine ORANIX, (Cipla) iNova [P/S]
loz. consumpt. mouthwash. Benzydamine HCl 22,5 mg, chlorhexidine gluconate 18 mg/15 ml.
(S0) LIQ. H1511. 1 g/100 ml. Alcohol 9%
CEPACOL, AI Pharm Ltd [P/S] 799688-002: 200 ml, R38,48
Cetylpyridinium chloride 1,47 mg, benzyl alcoh. 6,5 mg. Dosage: Mouthwash: Dil.1:2 parts water. Indications: Relief of min.infects.& painful mouth & throat inflamm.
Indications: Sore/irrit.throat, minor mouth infect., oral hygiene. Infect: Use full strength x30 secs.hrly. Childr. und. 3 yrs: Dil.1:3 condit., reduc.plaque developm.
(S0) LOZ (Reg) [P/S] H1388. parts water & paint mouth. (S1) ORAL RINSE, 34/16.4/0391.
713252-006: 24, R45,31 Contraindications: Pregn., lactat., non-toxic nodul.colloid.goi- 723607-001: 30 ml spray, R73,74
(S0) LOZ (Menthol) [P/S] H1388. tre, I-allergy. 723600-001: 200 ml, R87,83
713317-019: 24, R45,31 Side effects: Sensitisat. Dosage: Use as a gargle: Gargle with 15 ml for at least 30 secs.
(S0) LOZ (Honey & Lemon) [P/S] 33/16.4/0505 Repeat at 1½-3 hrly interv. as requir. Do not swall.
894854-006: 24, R45,31 DYNEXAN, AI Pharm Ltd [P/S] As a rinse for oral les: Rinse with 15 ml. Hold sol.in mouth &
(S0) LOZ (Blackcurrant) [P/S] 33/16.4/0492 Tetracaine HCl 50 mg, extr.of chamomile, arnica and salvia with Al- swirl around for at least 30 sec. Repeat at 1½-3 hrly interv.as reqd.
894850-008: 24, R45,31 triformate 1 g/10 g. Do not swall.
Dosage: Diss.one as reqd. Indications: Mucous membr./lips & gums anaesthet., cold sore, Childr. 6 yrs & old: 5-15 ml as a gargle if able otherw. oral rinse
Contraindications: Loz: Childr.und.3 yrs., diab. mouth ulc.relief, denture irrit. every 3 hrs.
Side effects: N&V, CNS depress., depolaris. musc. relax.propert. (S1) OINT. G2266. As a spray: 5-10 sprays direct.onto painf./ inflam.area. Repeat at
1½-3 hrly as reqd.
826391-001: 10 g, R35,63
CORYX THROAT, (Cipla Medpro) Mirren Dosage: Apply small quantity to affect.area 3xdly 5-7 hrly. Contraindications: Childr.und.6 yrs.
Benzocaine 267 mg, chlorhexidine glucon.sol.20% 1 ml/100 ml. Contraindications: Low plasma-cholinesterase conc./pts.receiv. Side effects: Hypersens.reacts., ser.allerg. react., GI disturbs., oral
Indications: Sore throat pain & discomf., minor mouth irrit. anticholinesterases numbn., sting./burn. sensat., dryn., thirst, revers.discol.of teeth &
(S1) SOL, W/16.3/58 Side effects: Allerg.reacts. tong., taste disturbs., oral desquamat., parotid gland swell.
717505-001: Gargle: 200 ml, R77,00 Special precautions: Epilep., myasth.grav., imp. card.conduct., Warnings and special precautions: Maybe dil.with water if
723270-001: Spray: 100 ml, R38,01 shock, imp.liv.funct., prolong. use/ extens.areas. burn./sting.occurs, avoid contact with eyes, do not exceed 7 days
Dosage: Gargle: Use undil/dil.with small quantity water. Do not Drug interactions: Sulphonamide act.may be antagon. uninterrupt. treatm., at least 30 min.interv. betw. toothpast.use,
swallow. Rinse mouth x1 min.3-4 hrly as need. safety in pregn.& lactat. not est.
Adults: 15-30 ml. Childr.6-12 yrs: 5-15 ml. ENDCOL, (Unicorn) Pharmacare [P/S] Drug interactions: Anion.agents in toothpast. incompat.with
Spray: Rinse mouth and back of throat without swallow.excess sol. Cetylpyridinium Cl. 0,866 mg, benzocaine 5,000 mg chlorhexid.
Rep.every 1½-3 hrly.as necess Indications: Sore/infect./irrit.throat.
Adults: 4-8 sprays directly onto affect.area. Max.32 sprays/day. Chil- (S1) THROAT LOZ, H1392. OROCHLOR, (Aspen Pharmacare: Consum) Pharmacare [P/S]
dr.6-12 yrs: 2-4 sprays directly onto affect.area. Max.16 sprays/day. 873977-009: 16, R24,69 Benzocaine 267 mg, chlorhexidine glucon.sol. 20% 1 ml/100 ml.
Side effects: Allerg.reacts.incl.nas.congest./ shortn. of breath/skin Dosage: Adults: Suck 1 loz.3 hrly.when necess. not exceed Indications: Sore throat, pain & discomf., minor mouth irrit.
rash/hives & fac.swell., conjunctiv.irrit., loc.skin sensitive.reacts., 8 loz./24 hrs. Childr.und.12 yrs: ½ loz. 3 hrly. (S1) SOL, [PWR] P/16.3/41
tooth/ tong.discolourat., large swell.in mouth/throat, muc.membr. Contraindications: Low plasma-cholinester. conc./ receiv.anticho- 751332-003: 100 ml, R48,51
irrit., tong.tip irrit., taste disturbs., tong.burn., tartar incr.on teeth, linester., concom. sulphonamid., myasth.grav. Dosage: 15-30 ml undilut./dil.in a little water rins.mouth/gargle x1
fac.& neck swoll.glands, Side-effects: N&V, CNS excitat./depress.eff., convuls., hypotens., min.3-4 hrly.as necess. Do not swallow.
Special precautions: Rins.mouth aft.use , may incr. bittern.& decr. resp.fail., coma, allerg.reacts., dyspn., cyanos., asphyx., vasovag.at- (S1) SPRAY SOL, [PWR] 28/16.3/0057.
eff., alter.taste of food x4 hrs. aft.use, do not admin.to pts.with phe- tack, dizzin., tinnit., nystagm., blurr.vis., trem., musc.twitch., syst. toxic. Benzocaine 267 mg, chlorhexidine glucon.sol. 20% 1 ml/100 ml.
nylketonur., safety in pregn.not est. incl.peri-oral & tong.numbn., myocard. depress., periph.vasodilat., 808563-009: 100 ml, R96,92
bradycard., arrythm., card. arrest, methaemoglobinaem. Dosage: Adults: 4-8 sprays 4 hrly.max. 32 sprays/day. Childr. 6-12
DAKTARIN, Janssen Pharmaceutica [P/S] Special precautions: Epilep., imp.card.conduct./ resp.funct., yrs: 2-4 sprays 4 hrly.max. 16 sprays/day.
Miconazole. liv.damage. Contraindications: Low plasma-cholinesterase conc., pts.receiv.
Indications: Fung.infects.of mouth, in fung stomatit.assoc.with anticholinesteras.
dentures. GOLDEX THROAT LOLLIES, Litha [P/S] Side effects: Loc.skin sens., tooth discol. (prolong.use), taste dis-
(S2) ORAL GEL. L/20.2.2/183. 20 mg/g. Cetylpyridinium Cl turbs., burn.sensat.of tong. imp. swallow.& incr.aspirat.risk, CNS &
835307-018: 30 g, R233,96 Indications: Relief of tonsillit., laryngit., cert. mouth & gum infects. CV eff. with syst.toxic.
Scheduling status: S5 Proprietary name (and dosage form): Duromine 15 mg and 30 mg Capsules. Composition: Sustained action ion-exchange resinate
granules, available as capsules containing phentermine 15 mg and 30 mg Pharmacological classification: A 11.3 Anorexigenics. Indications: Duromine is
an anorectic agent used in the management of obesity. Reference number: 15 mg: B657; 30 mg: B658 [Act 101/1965]. Name and business address of
applicant: iNova Pharmaceuticals (Pty) Limited. Co. Reg. No. 1952/001640/07, 15e Riley Road, Bedfordview. Tel. No. 011 087 0000. www.inovapharma.co.za.
For full prescribing information, refer to the package insert as approved by the SAHPRA (South African Health Products Regulatory Authority). Further information
is available on request from iNova Pharmaceuticals. IN3632/20
12897L DUR MIMS Strip adverts 2020 R.indd 2 2020/01/16 14:06
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COMMITTED TO RESULTS
Special precautions: Do not eat for 60 mins. aft.use, epilep., imp. Indications: Relief.of painful mouth & throat inflamm.condit., re- 2020/01/16 14:06
12897L DUR MIMS Strip adverts 2020 R.indd 1
card.conduct., shock, myasthen.grav., liv.dam. lief of minor infects. 12 GASTRO-INTESTINAL
PYRALVEX, (Mylan) Meda Pharma [P/S] (S1) ORAL RINSE, A40/16/0718. 22,5 mg/15 ml TRACT
722122-001: 30 ml spray, R70,63
Rhubarb extract 0,05 g, salicylic acid 0,01g/ml 712171-001: 200 ml, R87,43
Indications: Ac.& chron.bucc.mucosa & gingiv. inflammat. Dosage: Use as a gargle: Gargle with 15 ml for at least 30 sec.
(S0) SOL, H1494 (Act 101/1965) Repeat at 1½ -3 hrly interv.as requir. Do not swall.
758566-018: 10 ml, R68,71 As a rinse for oral lesions: Rinse with 15 ml. Hold sol.in mouth & 12.1 Digestants
Dosage: Do not rinse mouth, eat or drink immed. aft. Adults & swirl around for at least 30 sec. Repeat at 1½ -3 hrly interv.as reqd.
childr.over 12 yrs: Apply with suppl.brush to inflamm.areas 3-4xdly. CREON, Abbott [P/S]
Max. use: 14 days. May be dil. with water if neccess. Do not swall. Pancreatin. Enzyme activ.per cap amylase 8 000, lipase 10 000, pro-
Childr. 6-12 yrs: Use 5-15 ml as a gargle if able otherw.oral rinse
Contraindications: Childr.und.12 yrs. tease 600 Ph Eur units.
Side effects: V.common: Trans.loc.burn. Unknown: Allerg.reacts. 3 hrly. Do not swall. Indications: Supplementat.for pancreat.exocrine insuffic.in paed.
As a spray: 5-10 sprays direct.onto painf./inflam. area. Repeat
incl.rash & urticar. pts.& adults caus.by chron. pancreatit., cystic fibros., part.pan-
Warnings and special precautions: Safety in pregn.& lac- 1½ -3 hrly.as reqd. createctomy.
Contraindications: Childr.und 6 yrs., safety in pregn.& lactat.not est.
tat.not est. (S1) CAPS 10 000, 33/11.1/0340
Side effects: Adverse CNS eff. with high-/ overdos., oral numbn., 887162-003: 150 mg, 20, R152,32
SEPTADINE ORAL ANTISEPTIC, Ranbaxy [P/S] sting./burn.sensat., dry mouth, thirst, GI disturbs., alt.taste, revers. 887162-002: 150 mg, 100, R761,39
Povidone iodine. tooth/ tong. discolour. with prolong.use Dosage: Indiv. 1 cap 3x/day with meals. Dos.may be incr.if necess.
Indications: Antisept.mouthwash in min.throat infects. Special precautions: Do not exceed 7 days uninterrupt.treatm., al- Do not chew.
(S0) LIQ. 28/16.4/0650. 1 g/100 ml. low 30 mins.bef. toothpaste use, avoid cont.with eyes, mucos.irrit.in (S1) CAPS 25 000, 28/11.1/0645
819859-001: 200 ml, R13,69 case of ingest., poss.syst.toxic. Pancreatin. Enzyme activ.per cap amylase 18 000, lipase 25 000,
Dosage: Use full strength and rinse/gargle x30 secs. then spit out. protease 1 000 FIP units.
Repeat.hrly./as direct. THROFLAM-CO, (Aspen Pharmacare: Consumer) 822434-009: 300 mg, 20, R365,98
Contraindications: Pregn., lactat., non-tox.nodul. colloid. goi- Pharmacare [P/S] 822434-008: 300 mg, 100, R1 829,73
tre, I-allergy. Benzydamine HCl 22,5 mg, chlorhexidine gluconate 18 mg/15 ml Dosage: Admin.dur./aft.meals. Swallow whole/ open cap.& ad-
Side effects: Sensitisat. Indications: Relief of min.infects.& painful mouth & throat inflamm. min.pellets from spoon or add to soft food that does not req.chew.
condit., reduc.plaque developm.
STREPSILS, Reckitt Benckiser [P/S] (S1) ORAL RINSE, 41/16/0190 if swallow.diffic.
2,4-Dichlorobenzyl alcoh. 1,2 mg, amylmetacresol 0,6 mg, sugar 2,5 g 721415-001: 30 ml spray, R60,00 Indiv.accord.to dis.severity/steatorrh.contr.& maint. of nutrit.status.
Indications: Min.mouth & throat infect., coughs due to allergy 710371-001: 200 ml, R91,82 Weight bas.enzyme dos: Childr.<4 yrs: Init.with 1 000 lipase units/
& colds. Dosage: Use as a gargle: Gargle with 15 ml for at least 30 secs. kg/meal. Childr.>4 yrs: Init.with 500 lipase units/kg/meal.
(S0) SOOTH HONEY/LEMON & ORIGIN LOZ Repeat at 1½-3 hrly interv.as requir. Do not swall. Most pts.to remain below/not to exceed 10 000 lipase units/kg/
E/16.4/46, H1468. As a rinse for oral les: Rinse with 15 ml. Hold sol.in mouth & swirl day. Dos.ranges from 25 000- 80 000 Ph.Eur.units lipase/meal &
864994-028: 24, R39,96 around for at least 30 sec. Repeat at 1½-3 hrly interv.as reqd. May half indiv.dos. for snacks.
Dosage: Dissolv.1 loz.in mouth 2-3 hrly. be dil.with water if need. Do not swall. Contraindications: Early stages of ac-pancreatit., pig prot.hy-
(S0) ORANGE-WITH VIT.C LOZ. S/16.4/144. Childr. 6-12 yrs: 5-15 ml as a gargle if able otherw. oral rinse every persens.
Vit.C 100 mg, 2,4-dichlorobenzyl alcoh. 1,2 mg, amylmetacresol 3 hrs. Do not swall. Side effects: Abdom.pain, N&V, diarrh., constip., abdom.distent.,
0,6 mg, sugar (sucrose & gluc.) 2,5 g As a spray: 5-10 sprays direct.onto painf./ inflam.area. Repeat at abnorm.stool, peri-anal soren., allerg. skin reacts., prurit., urticar.,
Indications: Dry, irrit.sore throat, coughs due to allergy & colds. 1½-3 hrly as reqd. hyperuricosuria & hyperuricaem.with high dos., ileo-caecum & large
864994-028: 24, R39,96 Contraindications: Childr.und.6 yrs., safety in pregn.& lactat.not est. bowel strict.and colit.in cyst.fibros.pts.tak. high dos.
Special precautions: Hyperoxalur. Side effects: Oral numbn., sting./burn.sensat., dryn., thirst, GI dis- Warnings and special precautions: Childr.with cyst. fibros.tak.
(SO) EUCALYPTUS MENTH.LOZ. W/16.4/195. turbs., tingl., warm feel.in mouth, alt.taste, revers.discol.of teeth & in excess of 10 000 units of lipase/ kg/day may develop.colon dam-
Menthol 8 mg, 2,4-dichlorobenzyl alcoh. 1,2 mg, amylmetacresol tong. with prolong.use. age, excl.colon damage if unusual abdom.sympts./changes occur.,
0,6 mg, sugar 2,5 g Special precautions: Do not exceed 7 days uninterrupt.treatm., theoretic.risk of vir.dis.transmiss.& pres.of porcine vir.that may infect.
Indications: Dry, irrit.sore throat, coughs due to allergy & colds. at least 30 min.interv.betw. toothpast.use, avoid cont.with eyes, humans cannot be excl., safety in pregn.not est., not to be used in
864994-028: 24, R39,96 mucos.irrit. with ingest., poss.syst.toxic., adverse CNS effs. with lactat., ensure adeq.hydrat.
Dosage: Dissolv. 1 loz.in mouth 2-3 hrly. high-/overdos.
Special precautions: Poss.hypersens.reacts.due to menthol. Drug interactions: Anion.surfact. in toothpast. incompat.with
(S1) NUMBING LOZ, [P/S] 28/16.4/0647. chlorhexid. 12.2 Appetite suppressants
2,4-Dichlorobenzyl alcoh. 1,2 mg, amylmetacresol 0,6 mg, lignocaine
HCl 10 mg, sugar 2,5 g VARI MICONAZOLE 2% ORAL GEL, (Litha) Barrs Pharma. DUROMINE (MDR Listing)
Indications: Sore throat. Indus. [P/S]
820814-008: 16, R32,01 Miconazole. DUROMINE, iNova &
Dosage: Not recomm.for childr.und.12 yrs. Dissolv.1 loz.in mouth Indications: Fung.infects.of mouth, in fung stomatit.assoc.with Phentermine, sust.act.
2-3 hrly. Max 8 loz. x24 hrs. dentures. Indications: Short-term adjunct to weight reduct. in conjuct.with
Side-effects: Imp.swallow., incr.risk of aspirat. (S2) ORAL GEL. 36/20.2.2/0233. 20 mg/g. reduc.kj.intake where adeq. clinic. respons.not obt.
Special precautions: Epilepsy, imp.card. conduct., shock, liv.dam- 718641-001: 40 g, R149,13 (S5) CAPS, B657, B658
age, myasthen.grav., pregn., lactat., not recomm.for childr.und.12 yrs. Dosage: Apply even.aft.meals to affect.areas 3-4xdly depend.on 721786-006: 15 mg, 30, R277,11
721794-009: 30 mg, 30, R357,65
STREPSILS INTENSIVE, Reckitt Benckiser [P/S] sev.of infect., cont. x2days aft.infect.clear. Retain in mouth for max. Dosage: Adults & childr.over 12 yrs: 1 cap.dly. approx.7 am.
time poss.for best results.
Flurbiprofen 8,75 mg, sugar 2,3 g. Fung.stomatit.assoc.with dentur: Apply to les.in even. & leave Pts.req.med.review aft.defin.course which should ideally not ex-
Indications: Pain relief of sore throats overnight. For oral candidias. remov.dent.prosthes.at night & brush ceed 3 mnths.
(S1) LOZ, 35/16/0015. with gel. Contraindications: Pulm.artery/arter. hypertens., cerebro-vasc.dis.,
711738-001: 12, R37,92 Contraindications: Infts.< 6 mnths.or whose swallow. refl.not card.dis.incl. arrhythm., adv. arterioscleros., sympathomimet.drug hy-
Dosage: Adults & childr.>12 yrs: Suck/dissolv. 1 loz.in mouth fully devel., safety & effic.in pregn. & lactat.not est., concom.meds. persens., hyperthyroid., agitat.states, psychiatr.disord.hist. incl. ano-
slow.3-6 hrly.as req. Max 5 loz.x24 hrs. Limit use to 3 days. metabol.by CYP3A4: substrat.prolong.QT interv.incl. astemizole/ rex.nervosa & depress., glauc., hist.of drug/ alcoh.abuse/depend., ob-
Contraindications: Hypersens.to aspirin/other NSAIDs, exist./hist dofetilide/halofantrine/mizolastine/ pimozide/ quinidine/sertin- struct.uropathy, poorly contr. epilepsy, MAOI’s, pregn., avoid.in lactat.
pept.ulcerat./bronchosp./ rhinit./ urticar.assoc.with aspirin/other dole/terfenadine/ ergot. alkaloids/HMG-CoA reduct.inhibits./ tria- Side effects: CNS overstimulat., restlessn., nervousn., insomn.,
NSAIDs, pregn.& lactat, childr. und.12 yrs. trem., dizzin., headache, rare euphor. follow.by fatig.& depress.,
Side effects: Changes in taste sensat., paraesthes. in mouth, GI zolam/ midazolam. psychot. episod., hallucinate., exertion.dyspn.aggrav., tachycard.,
Side effects: Allerg.condits.incl.angioneurot. oed./ anaphylact.re-
disturbs.incl.GI haemorrh., mouth ulc., fluid retent., oed., urticar., an- palpitat., hypertens., precord.pain, stroke, angina, MI, CF, card.ar-
gioed., rash., jaund., thrombocytopen., aplast. anaem., agranulocy- acts., chok., GI disturbs., hepatit., skin reacts.incl.tox.epiderm.necro- rest, N&V, dry mouth, abdom.cramps, unpleas.taste, diarrh., consti-
lys./ Stev.-Johns.syndr.
tos., prolongs bleed.time. pat., mictur.disturbs., rash, impot., libido changes,, fac.oed., blurr.vis.
Special precautions: Move loz.around mouth to avoid irrit., revers. Warnings and special precautions: Avoid eye contact, ensure Special precautions: Concom.admin.of other weight-reduc.agents
gel does not obstruct.throat. in infts.& young childr., do not apply to
jaund., thrombocytopen on withdr., dimin.undesir.effs.by using min. not recomm., poss.card. valvul. dis.assoc.with select.serotonin re-up-
eff.dos.for short.poss.durat., bronchosp.precipit.in pts.with prev. hist. back of throat., div.dos into small.port., observ.for poss. chok., concom. take inhibit/ fenflur./dexfenflur., mild hypertens., kidn. impairm., dia-
of bronch.asthma, admin.und.medic advice to asthmat.& pts.allerg. oral anticoags./phenytoin/oral hypoglycaem./HIV prot.inhibits./cert. bet., grad.& control.weight loss in pts. at risk of vasc.dis., antihyper-
to other pain reliev., ren./card./hepat.impairm., hypertens., abnorm. antineoplast./ cert.Ca chann.blocks./ immunosuppress. agents/other tens.& psychotrop. treatm., epilep., concom. sympathomimet. agents.
bleed. potent., bleed.disords. meds.incl. alfentanil/ alprazolam/brotizolam/buspirone/ carbamaz- Drug interactions: Hypotens.eff.of adrenerg. neurone block.drugs
Drug interactions: Diuret.respon.to furosemide reduc., anticoag. epine/ cilostasol/disopyramide/ ebastine/ midazolam IV/reboxetine/ poss.decr., effs.of MAOI potent.
act.interfer.with, antihypertens. effs. dimin. methylprednisolone/ rifabutin/sildenafil./ trimetrexate. See also MDR page 392.
Drug interactions: Poss.enhanc.hypoglycaem. eff. with cert.oral
THROFLAM, (Aspen Pharmacare: Consumer) Pharmacare [P/S] hypoglycem., inhibit.metabol.of meds. metab.by the CYP3A4 & CY- OBESAN X, Le Basi Pharmaceuticals
Benzydamine HCl P2C9 enzym. syst. incr.eff. Phendimetrazine tartrate
Scheduling status: S5 Proprietary name (and dosage form): Duromine 15 mg and 30 mg Capsules. Composition: Sustained action ion-exchange resinate
granules, available as capsules containing phentermine 15 mg and 30 mg Pharmacological classification: A 11.3 Anorexigenics. Indications: Duromine is
an anorectic agent used in the management of obesity. Reference number: 15 mg: B657; 30 mg: B658 [Act 101/1965]. Name and business address of
applicant: iNova Pharmaceuticals (Pty) Limited. Co. Reg. No. 1952/001640/07, 15e Riley Road, Bedfordview. Tel. No. 011 087 0000. www.inovapharma.co.za.
For full prescribing information, refer to the package insert as approved by the SAHPRA (South African Health Products Regulatory Authority). Further information
is available on request from iNova Pharmaceuticals. IN3632/20
12897L DUR MIMS Strip adverts 2020 R.indd 2 2020/01/16 14:06
172 / 2020-04 Gastro-Intestinal Tract - 12.2 / 12.3
LET
SCIENCE www.ilivelite.co.za
HELP TAKE THE program
WEIGHT OFF
COMMITTED TO RESULTS
Indications: Obesity Dosage: 1 tab 3xdly.bef.meals, reduc.grad.once desir.eff.obtain. (S1) TABS. L/11.2/59. 2020/01/16 14:06
12897L DUR MIMS Strip adverts 2020 R.indd 1
(S6) TABS, C877 Contra-indications: Porphyr. 731951-026: 10 mg, 10, R37,43
750239-034: 35 mg, 30, R130,35 Side-effects: Depress., headache, diarrh., constip., dizz. 731951-027: 10 mg, 20, R74,85
Dosage: Adults: 1-2 tabs.2xdly.1 hr bef.breakf.& midday meal. Du- 731951-018: 10 mg, 100, R374,25
rat.not to exceed 6 wks. BUSCOPAN, Sanofi-Aventis [P/S] Dosage: Adults: 20 mg 4xdly. Childr.: 1 to 3 yrs: 5-10 mg. 3xdly.
Contra indications: MAOI’s, ephedrine, other sympathomimet. Hyoscine-N-butylbromide. 3-6 yrs: 10 mg 3xdly.6-12 yrs: 10-20 mg 3x dly.
agents, beta-block., childr., pregn., lactat. Indications: Condits.assoc.with GI spasm. Contraindications: Enlarg.prostate, clos.angle glauc./narr.angle
Side effects: Psychot.reacts., CNS effs., trem., GI disturbs., depend., (S1) TABS, [P/S] E501. betw.iris & cornea.
tol., diff.micturit., imp.ren. funct., sweat., alt.libido, impot., skin rash, 711276-005: 10 mg, 10, R53,51 Side effects: Dry mouth/skin, diffic.swallow., thirst, dilat.of pupils,
musc. damage with assoc.rhabdomyolys.& ren. complicat., aplast. 711276-014: 10 mg, 20, R102,38 loss of accommodat., photophob, incr.IOP, flush, brady-/tachycard.,
anaem., pancytopen., BP changes & CV effs., poss.hypersens.react. Dosage: Adults & childr.over 6 yrs: 1-2 tabs.3-4xdly. Childr.und. reduc. GIT tone, GI disturbs., skin rash, retrostern. pain.
Special precautions: Diab., anorex., drug/alcoh. abuse hist., per- 6 yrs: Use syrup. Warning: Porphyr.
sonality disords., psychiat.illn.hist., insom., hyperexicitabil./agitat., (S3) INJ, [P/S] E500. 20 mg/ml. Drug interactions: Concom.anti-cholinerg.incr. eff.
imp.ren.funct., CV dis., hypertens., arterioscleros., thyrotoxicos., narr. 711306-001: 5x1 ml, R113,40 (S1) SYRUP, A39/11.2/0353
angle glauc., prostat., extrapyramid.sympt., prolong. use, grad.with- Dosage: Admin.by slow IV IM or SC. Adults & adolesc.over 12 yrs: Hyoscine -N-butyl bromide.
dr., do not admin.within 14 days of discont.agents with similar act. 1 amp (20 mg) several xdly. Do not exceed max.dly.dos.of 100 mg/ Indications: GI spasm.
Drug interactions: Alcoh.incr.CNS eff.potent., poss. decr.eff.of an- day. Infts.& childr: Sev.cas: ¼ amp (5 mg) 3x/day. Do not exceed
tihypertens., poss.incr.CV effs. with amphetamin.& TCA’s, enhanc./ max.dly dos. of 1,5 mg/kg bm. 707213-001: 5 mg/5 ml, 100 ml, R40,83
Dosage: Admin.init.low.dos.for age group. Do not exceed max.dos.
prolong.eff.of amphetamin.with urin.alkalin., decr.eff.with urin. acidif. (S2) SYRUP, [P/S] Z/11.2/93. 5 mg/5 ml. for each age group. Admin.30 mins.-1 hr.bef.meals.
RELISLIM, Loock Pharm. 797413-006: 100 ml, R77,38 Babies >1 mnth-3 mnths: 2,5 ml 3xdly. Infts.>3 mnths.up to 1 yr:
d-Norpseudoephedr.HCl. Dosage: Init.dos.must be low.recomm.for age. Do not exceed 2,5 –5 ml 3xdly. Childr.>1 yr up to 3 yrs: 5-10 ml 3xdly. .>3 yrs up
Indications: Aid to mass reduct.with reduc.Kj intake. max.recomm.dos. to 6 yrs: 10 ml 3xdly. .>6 yrs up to 12 yrs: 10-20 ml 3xdly. .>12 yrs
(S6) TABS, 29/11.3/0316. 20 mg Infts.1-3 mnths: 2,5 ml 3xdly. 3 mnths.-1 yr: 2,5-5 ml 3xdly. Chil- & adults: 20 ml 4xdly.
853275-009: 30, R63,06 dr.1-3 yrs: 5-10 ml 3xdly. 3-6 yrs: 10 ml 3xdly. 6-12 yrs: 10-20 ml Contraindications: Clos.angle glauc./narr.angle betw.iris & cornea,
853275-017: 90, R189,28 3xdly. Adults & childr.over 12 yrs: 20 ml 4xdly. myasthen.grav., porphyr., fev., tachycard., megacolon, paralyt.ileus,
Dosage: Do.not exceed recomm.dos. Contraindications: Myasth. grav., porphyr., enlarg.prostat., clos. pylor.stenos., other mechanic.GI stenos./obstructs., pregn., lactat.
1-2 tabs.with breakf.follow by 1 tab at luncht. Do not use for long. angle glauc., paralyt.ileus, pylor.stenos., other mechanic. stenos./GIT Side effects: Reduc.GIT tone, GI disturbs., dilat.of pupils, loss of ac-
than 4 wks at a time. obstruct., fev., tachycard., megacolon, heredit. fructose intol., pregn.& commodat., photophobia, brady/ tachycard., palpitat., arrythm., diffic.
Contraindications: Pregn., coron.thrombos., hyperthyroid., clos.- lactat., IMI to pts.on anticoags.as IM haematoma poss. micturit., reduc. bronch.secret., flush, dry mouth/skin, dyshidros., diffic.
angle glauc., MAOI. Side effects: Anaphylact.reacts.incl.fatal outcome, dyspn., urticar., swallow./talk., thirst, hypersens.reacts.partic.of skin.
Side effects: CNS effs., N&V, sweat., thirst, tachycard., pre-cord. tachycard., bradycard. follow.by tachycard./palpitat, & arrhythm., dry Special precautions: High ambient temp.esp.in the case of childr,
pain, palpitat., dyspn., diffic. mictur., urin.retent., musc.weakn./trem., mouth, diff.swallow., thirst, reduc.GIT tone & motility.lead.to consti- Down’s syndr., spast.paralys./ brain damage in childr., elderly, debili-
psychot reacts., tol.with depend, hypertens., ang.pain, card. arrhythm. pat., vomit., retrostern.pain due to gastr.reflux, dyshidros., dry skin, tat., imp.liv./ kidn funct., urin.retent.incl.prostat.enlargem., tachycard.
Special precautions: Psychiatr.illn., organ.heart dis., card.decom- urin. retent., giddin., stagger., incr.IOP, pupil dilat. & loss of accomo- condits., HF, card.surg.ac.MI, hypertens.
pensat., ang.of effort in pts.receiv. digital., prostat.enlargm., not to be dat., photophob., flush., also decr. BP with inj. Drug interactions: Sedat.eff.enhanc.by other CNS depress.& al-
taken aft.16h00 due to stimul.eff., drug/alcoh.abuse hist., personal- Special precautions: Narrow-angl.glauc., suscept. to intest./urin.
ity disords., lack of evid.of long.term effic., CV dis.esp.coron.insuffic., outlet obstruct., inclin.to tachyarrhythm., imp.metabol./liv.or kidn. cohol, effs.enhanc.by other antimuscar. agents, MAOI inhibit.med.-
metabol. enzymes enhanc.effs., absorpt.of other meds. affect. by
hypertens., thyroidtoxic., narr.-angle glauc. funct., anaphylax.aft. parenter.admin.theref.monit.aft., no driv./operat.
Drug interactions: Use with halogen.anaesthes. not recomm., machin.aft.parenter.admin.as result of vis.accomodat.disturbs., seek reduc.gastric motility, parasympathomimet. may counteract eff.&
dimin.eff.of guanethidine, incr. arrhythm. in digitalis.pts., eff.en- ophthalmolog. advice if painful/red eyes with loss of vis.occur aft.inj. vice-versa, reduc.GIT motility enhanc.by dopamine antagon., tachy-
hanc./dimin. by TCA’s Interactions: Anticholinerg.eff.of TCA’s/ antihistamin./quinidine/ card.caus.by beta-adrenerg.poss enhanc.
XENICAL, Pharmaco Distribution (Pty) Ltd. amantadine/ disopyramide & other anticholinerg.enhanc., tachycard. LIBRAX, MEDA Pharma [P/S]
See Section 12.10 effs.of beta-adrenerg.agents enhanc., dopamine antagon. dimin.effs. Chlordiazepoxide 5 mg, clidinium bromide 2,5 mg
of both drugs on GIT., CNS depressants may enhanc.CNS depress., Indications: Adjunct.in short-term treatm.of non-ulcerat.irrit.bowel
syndr.assoc.with anx./tens./ apprehens.in adults, indic.only when dis-
BUSCOPAN COMPOSITUM, Sanofi-Aventis [P/S] ord.sev. /disabl.or subject.indiv.to extr.stress.
12.3 Anti-spasmodics Metamizole sod.monohydrate 250 mg, hyoscine butylbromide 10 mg. (S5) TABS, B994
(See also 1.8, 5.4, 12.4) Indications: Paroxysmal & colicky pain. 737984-007: 100, R615,09
(S4) TABS, [P/S] E/11.2/502.
Dosage: Init.low.recomm.dos.with treatm.durat. as short as poss.,
BENNETTS COLIC MIXTURE, Bennetts [PWR] 711292-019: 20, R151,60 gener.not long.than 8-12 wks incl. taper.-off per. Extens.beyond max.
Diphenhydramine HCl 3,125 mg, belladonna tinct. 0,125 ml, alco- 711292-027: 100, R758,25 per.may be necess. with pt.status re-evaluat.
hol 4,7%v/v/5 ml. Dosage: Admin.up to 3xdly. Adults: Indiv. Usual: 1 tab 3-4xdly.bef.meals & at bedt. Max.dly.dos.
Indications: Uncomplic.GI colic & spasms in babies of 1-4 mnths. Adults: 1-2 tabs. Courses long.than 10 days to be und.med.supervis. of 8 tabs.not to be exceed.
where organ.causes excl. (S4) INJ, [P/S] E/11.2/504. Elderly & debilit.pts: Limit to small.eff.dos. Init.1 tab.2x/day. Dos.
(S2) SYRUP, W/11.2/0130 Metamizole sod.monohydrate 2 500 mg, hyoscine butylbromide may be adjust.as need.& toler.
826162-004: 50 ml, R78,54 20 mg/5 ml Contraindications: Myasth.grav., glauc., benign bladd.neck ob-
826162-003: 100 ml, R157,07 711284-008: 3x5 ml, R158,84 struct., paralyt.ileus,, other benzodiazep. /belladonna alkaloids hyper-
Dosage: Safety & effic.in infts.weigh.less than 3 kg & admin.for Dosage: 1 amp slow IV over at least 5 mins. May be rep.2-3xdly sens., pregn. & lactat., not recomm.in childr., safety & effic. in treatm.
long.than 2 wks.not est. with a several hr.interv. May be admin. IM if necess. exceed.12 wks.not est., not recomm. for prim.treatm.of psychot.illn.,
Recomm.dos: 2,5-5 ml 5-10 mins.bef.feeds rep.if necess.aft.feeds. If Contraindications: Allerg.to pyrazole deriv., ac. intermitt.porphyr., not to be used alone treat.depress./anx.
weight known; 1 ml/kg bm upto max.8 ml/dos & max.5 dos./24 hrs. granulocytopen., congenit.G6PD defic., asthma, glauc., prostat.hyper- Side effects: Abuse/depend.potent.esp.with prolong.use/high
One half of indiv.dos.may be admin.5-10 mns.bef.feeds & remain.of trophy with urin.retent., GIT stenos., megacol., pronounc. tachycard., dos., drowsin., dry mouth, GI disords., vis.blurr., urin.hesit.in elderly,
dos.aft.feed. Not to be admin.more freq. than 4 hrly. aspir./NSAID cross-sens./where induc.asthma/rhinit/urticar., Inj also skin reacts., oed., menstr.irregul., extrapyramid.effs., libido chang.,
Contraindications: Angle clos.glauc., narr.angle betw.iris & corn, childr.und.12 mnths., SC admin. EEG pattern chang., bld.dyscras., jaund., hepat.dysfunct., paradox.
fev., condits.charact.by tachycard., hypertens., prem.infts., hepat./ Side effects: Dry mouth, diffic.swallow., thirst, pupil dilat., cyclopleg., reacts.in psych. pts.
ren. fail., suspect.bowel obstruct. photophob., flush./dry skin, trans. bradycard.follow.by tachycard./pal- Special precautions: Concom.alcoh./other CNS depress., antacids/
Side effects: CNS depress., paradoxic.stimulat., headache, anti- pitat. & arrhythm., urin.urgency/diffic.& retent., constip.due to reduc. meds.contain.kaolin or attapulgite to be taken 2-3 hrs.bef./aft.Librax,
muscar.effs., GI disturbs., palpitat., arrhythm., bld.dyscras., convuls., GIT tone, vomit., giddin., stagger., retrostern.pain due to incr.gastr. admin. at least 2 hrs.aft.ketoconazole, undiagn. glauc. poss.precipit.
sweat., extrapyramid. effs., paraesthes., trem., sleep disturbs., fatig., reflux, drowsin., sev.anaphylax., allerg.reacts. affect.skin, mucosa &
diplop., nervousn., tingl.& weakn. of hands. irritabil., tinnit., hypotens., granulopoet.syst., shock, Stev-Johns. & Lyell syndr. in elderly, alcoh./drug abuse hist., phys.depend., pt.to be inform.of
poss. rebound effs.with discont., withdr.grad., re-assess regul.& eval.
allerg. dermatit., drug fev., photosens., jaund., hair loss. Special precautions: Bld.cell format.disturbs., syst.BP bel.100 mg
Special precautions: Reduc.bronch.secret. assoc. with bronch.plug need for contin.treatm., concom.other psychotrop.meds.not recomm.
format., Down’s syndr. incr. & albinism reduc.suspectibil.to belladonna Hg, unstab.circulat., medic. supervis., cross.placent.barr., excret.in esp.MAOI/ phenothiazin., ren./hepat.funct.impairm., anx./ depress.
act., chron.bronchit., sev.CV disords., epilep., dur. ac. asthma attack. breast milk, eval.ability to drive/operate machin., med.supervis. in risk, card.dis., hiatus hern.with reflux oesophagit., intest.atony, GI/
exist.bld.cell format.disturbs.eg cytostat.treatm., systol.BP bel.100
GU tract obstruct., ulc.colit., urin.retent.
BEVISPAS, (Aspen Pharmacare: Consumer) Pharmacare [P/S] mm Hg, unstable circulat., discont.in pres.of agranulocytos., shock Drug interactions: Reduc.eff.with antacids/ meds.contain.kaolin
Mebeverine HCl. poss.up to 1 hr.aft.admin. or attapulgite, incr.effs.with other anticholinerg., poss.reduc.bld.lev.
Indications: Prim.irrit.colon charact.by persist. diarrh. /alternat. Interactions: Anti-cholinerg.eff.potent.by TCA’s/ quinidine & with ketoconazole, may incr.gastr./bowel superfic. ulcerat. with KCl,
constipat.& diarrh./abdom.pain & postprand.distens., second.irrit. amantadine., poss.aff.enzymat. bld. sugar assay by gluc.oxidase poss.bld.coagul.eff.with oral anticoags.
colon due to organ.les.eg.diverticulit./reg.enterit./specif.& non- meth.in diab.pts.
specif.GI inflamm.condits. PHARMA-Q HYOSCINE BUTYLBROMIDE INJECTION
(S2) TABS. 29/11.2/0255. HYOSPASMOL, (Aspen Pharmacare: Pharma) Pharmacare [P/S] 20 mg/1 ml, Pharma-Q [P/S]
822019-035: 135 mg, 20, R33,47 Hyoscine butylbromide. Hyoscine butylbromide
822019-019: 135 mg, 100, R167,39 Indications: GI spasm. Indications: GI spasm
Scheduling status: S5 Proprietary name (and dosage form): Duromine 15 mg and 30 mg Capsules. Composition: Sustained action ion-exchange resinate
granules, available as capsules containing phentermine 15 mg and 30 mg Pharmacological classification: A 11.3 Anorexigenics. Indications: Duromine is
an anorectic agent used in the management of obesity. Reference number: 15 mg: B657; 30 mg: B658 [Act 101/1965]. Name and business address of
applicant: iNova Pharmaceuticals (Pty) Limited. Co. Reg. No. 1952/001640/07, 15e Riley Road, Bedfordview. Tel. No. 011 087 0000. www.inovapharma.co.za.
For full prescribing information, refer to the package insert as approved by the SAHPRA (South African Health Products Regulatory Authority). Further information
is available on request from iNova Pharmaceuticals. IN3632/20
12897L DUR MIMS Strip adverts 2020 R.indd 2 2020/01/16 14:06
Gastro-Intestinal Tract - 12.3 / 12.4 / 12.4.1 / 12.4.2 2020-04 / 173
(S2) INJ, 32/11.2/0242. 20 mg/ml Dosage: Adults: 10-15 ml 1-3 hrs.aft.meals and at bedt. Dosage: Chew thoroughly aft.meals & at bedt.
701514-001: 10x1 ml, R45,91 Contraindications: Imp.ren.funct., safety in pregn.not est. Adults & childr.over 12 yrs: 1-2 tabs. Childr. 6-12 yrs: 1 tab. Childr.
Dosage: Adults & childr.over 12 yrs: 20 mg IM/ IV repeat. Side effects: GI disturbs., intest.obstruct.with large dos., osteoma- und 6: At discret.of physic.
aft.30 mins.if need. lac., encephalopathy & dement. in chron.ren.fail., hypermagnesaem. (S0) 250 PEPPERMINT TABS. A38/11.10/0446
Contraindications: Safety in pregn.& lactat.not est., porphyr., if ren. funct.imp.sympts.of which incl.flush.skin/thirst/ hypotens./ Na Alginate 250 mg, Na-bicarb. 133,5 mg, Ca carbon.80 mg
myasth.grav., prostat.enlargem., paralyt.ileus, pylor.stenos., fev., drowsin./confus./tend.reflex loss /musc. weakn./resp.depress./ar- Indications: Gastro-oesophag.reflux sympts. follow. meals /
enlarg.prostate. rhythm./coma/ card.arrest. dur.pregn.
Side effects: Dry mouth/skin, diffic.swallow., thirst, dilat.of pupils, Special precautions: Low phosph.diet., kidn.dis. 6, R15,95
loss of accommodat., photophob., incr.IOP, flush, brady-/tachycard. Drug interactions: Interfere.with absorpt.of other drugs, con- 12, R29,02
with palpitat. & arrhythm., urin.urgency with inabil.to do so, reduc. com.tetracycl. 20, R35,80
GIT tone & motility, GI disturbs., giddin., stagger., retrostern.pain, 60, R94,59
hypersens./ anaphylact. reacts. AMPHOJEL, (Aspen Pharmacare: Consum) Pharmacare [P/S] Dosage: Chew thoroughly aft.meals & at bedt.
Special precautions: Cross.placenta, elderly, imp. metabol./liv./ Al-hydroxide Adults & childr.over 12 yrs: 2-4 tabs. Childr. und.12 yrs: Not
ren.funct., condits.charact.by tachycard., card.insuffic.-fail., card.surg., Indications: Hyperacid., dyspeps., gastrit., heartburn. recomm.
ac.MI, hypertens., diarrrh., childr., clos.angle glauc./narr. angle betw. (SO) SUSP, E/11.4.1/1229. 300 mg/5 ml. (S0) ANISEED SUSP, [P/S] L/11.10/1.
iris & cornea, ulcerat.colit. 703168-029: 200 ml, R27,44 Na-alginate 500 mg, Na bicarb.267 mg/10 ml.
Drug interactions: Poss.enhanc.depress.eff.of other CNS depress., 703168-010: 500 ml, R51,57 728462-141: 150 ml, R44,12
antimuscar.eff.enhanc.by other meds.with antimuscar.propert. Dosage: Adults: 10 ml 5-6xdly betw.meals & at bedt. 837016-002: 300 ml, R86,83
PRO-BANTHINE, (Aspen Pharmacare: Pharma) Contraindications: Appendicit., hypophosphataem., concom. 728462-125: 600 ml, R126,22
tetracyl.
Pharmacare [P/S] Side effects: GI disturbs., hypophosphataem. with prolong.ad- (S0) PEPPERMINT SUSP, [P/S] 29/11.10/0641.
Propantheline bromide. min./large dos. Na Alginate in thicken.base
Indications: Adjunct.therapy of pept.ulc., ulcerat.colit., diverticulit., Special precautions: Ren.fail., low phosph. diets., interv.of 1-2 837016-011: 500 mg/10 ml, 150 ml, R44,12
cholecystit.& pancreatit., symptomat.treatm.of irrit.bowel syndr., hrs.betw.other meds. 837016-012: 500 mg/10 ml, 300 ml, R86,83
neurogen.bladder, enures., urin.incontin., ren.colic, hyperhidros., Drug interactions: Alt.rate &/extent of absorpt. of many other meds. Dosage: Admin.aft.meals & at bedt.
cert.GI diagnost.proced. Adults & childr.over 12 yrs: 10-20 ml. Childr.und.12 yrs: 10 ml.
(S2) TABS. E921. GELUSIL PEPPERMINT, iNova [P/S] Und.2 yrs: Consult doc. Max. 5 ml dose.
757136-028: 15 mg, 100, R499,12 Al-hydrox.dried gel 250 mg, Mg-trisil 500 mg. (S0) ADVANCE ANISEED SUSP, [P/S] 32/11.10/0207
Dosage: Pept.ulc: 1 tab 3xdly.30 mins.bef.meals, 2 at night (ie.75 mg Indications: Gastrit., hyperacid., pept.ulc. managem., heartburn, Na Alginate in thicken.base
dly.) Subseq.adjustm.accord.to indiv. respons.& tol. acid indigest. Indications: Gastric reflux, reflux oesophagit., heartburn incl.that of
Contrast radiology: 2 tabs 45 mins.bef.proced. (S0) TABS, Z/11.4.1/243. pregn., hiatus hern., flatul.assoc.with gastric reflux, epigastric & retro-
Other indicat: 1-2 tabs 4xdly. 812137-027: 24, R44,67 stern.distress where gastric reflux is underly.cause
Contraindications: Glauc., obstruct.GI & UT dis., intest.atony, sev. Dosage: Max.durat.of max.dos.is 2 wks. Chew/ suck 1-2 tabs up to 862282-004: 500 mg/5 ml, 500 ml, R160,36
ulc.colit., toxic megacolon, unstab. CV adjustm.in ac.haemorrh., 4-8x dly.pref.betw.meals as reqd. Max.dos: 16 tabs./24 hrs. 862282-013: 200 mg/5 ml, 200ml, R86,82
myasth.grav. Contraindications: Imp.ren.funct./-fail., sev. debilitat. Dosage: Adults & childr.over 12 yrs: 5-10 ml aft. meals & at bedt.
Side effects: Dry.of saliv.secret., mydrias., blurr. vis., cyclopleg., incr. Side effects: Less freq: Hypersens., prurit., urticar., angioed., ana- Childr.und.12 yrs: Not recomm. except on physic.advice
ocul.tens., heat stroke, CNS effs., tachycard., GI disturbs., urin.hesit.& phylact.reacts., osteomalac., hypermagnesaem., hyperaluminaem., (S0) ADVANCE PEPPERMINT SUSP, [P/S] A40/11.10/0049
retent., impot., allerg.reacts.incl.urticar.& anaphylax. hyperphosphataem., encephalopathy, dement., confus., drow- Na Alginate in thicken.base
Special precautions: Avoid in ileost./colostomy pts. with diarrh. sin., neuromusc.block., coma, card. dysrhytm., card.arrest, periph. Indications: Gastric reflux, reflux oesophagit., heartburn incl.that of
since it may indic.incompl.intest. obstruct., heart dis., poss.heat vasodilat., hypotens., resp. depress., N&V, diarrh., constip., intestin. pregn., hiatus hern., flatul.assoc.with gastric reflux, epigastric & retro-
prostrat.in high environm.temp., prostat.hypertrophy, auton. neu- obstruct., thirst, skin flush., loss of tendon reflex., musc. weakn., stern.distress where gastric reflux is underly.cause
ropathy, hepat./ren.dis., hyperthyroid., hiat. hern. assoc.with reflux ren.dysfunct./-fail. 862282-014: 500 mg/5 ml, 200 ml, R86,82
oesophagit., ulc.colit.since intest.motil.may be suppress.to point.of Warnings and special precautions: Poss. intestin. obstruct./ 862282-005: 500 mg/5 ml, 500 ml, R160,36
paralyt. ileus, elderly, lact.intol., cont.sucrose & sweetn. ileus trigger./aggravat.in ren. impair. or elderly, phosph.deplet.with Dosage: Adults & childr.over 12 yrs: 5-10 ml aft. meals & at bedt.
Drug interactions: Absorpt.of other concom. meds.delay., excess low phosph. diet, incr.Mg & Al plasma lev.in ren.impairm.lead. to Childr.und.12 yrs: Not recomm. except on physic.advice
cholinerg.block.with concom. belladonna alkaloids, synthet/semi- poss.dement./microcyt.anaem., haemodialys.in porphyr., fruct.in-
synthet. anticholinerg. agents, narcot.analges., type 1 antiarrhythm. tol./gluc.galact.malabsorpt./sucr. insuffic., diab.mellit., safety in Contraindications: Peppermint tabs: phenylketonuria, childr.
und.12 yrs.
drugs, antihistam., phenothiaz., TCA’s, other psychoact.drugs., sedat. pregn.& lactat.not est.
eff.of phenothiaz. potent., incr.IOP with corticoster., incr. ser. digox. Interactions: Other med.absorpt.poss.interfer. with if taken within Side effects: Hyperkalaem./alkalos., GI disturbs., hypercalcaem.,
lev.with slow-dissolv.digox.tabs. 1 hr., absorpt.of oral tetracycl./ rifampic./ciproflaxac./cefdinir/cefpo- hypersens.reacts., urticar., bronchosp. Peppermint tabs: Also gastric
hypersecret.& acid rebound with prolong.admin., milk-alkali syndr.
SCOPEX, AI Pharm Ltd [P/S] dox./ methenam./digoxin/quinidine/oral Fe-preps./ antichol. drugs/ from Ca carbon., poss.reduc.effic. with low gastric acid lev.
Hyoscine butylbromide. barbit./quinines/warfar./vits./H 2-recept. antagon./oral isoniaz./su- Special precautions: Restrict.salt intake, CHF, ren.impairm., liv.
Indications: GI spasm. cralfate./Na fluor./ ketoconazole/phenyt./phenothiaz./ hydroxychlo- cirrhos., hypertens., corticoster. therapy, metabol./resp.alkalos., hy-
(S2) INJ, [P/S] C688. 20 mg/ml. roquine/chloroquine/chlorpramaz/ levothyrox& rosuvastat.reduc., pocalcaem., hypochlorhydria. Tabs also diabet. Peppermint tabs.:
762733-004: 10x1 ml, R52,44 incr.Al lev.with ren.impairm. also hypercalcaem./nephrocalcinosis & recur.Ca contain.calculus.
Dosage: 20 mg IM/IV/SC.Repeat aft.30 mins.if necess. Drug interactions: Absorpt.of other drugs interfer. with by large dos.
(S2) TABS, [P/S] C674.
762725-001: 10 mg, 10, R28,11 GAVISCON PLUS, Reckitt Benckiser [P/S]
Dosage: 2 tabs 4xdly. 12.4.2 Antacids and Na alginate 500 mg, Na-bicarb. 213 mg, Ca carbon.325 mg/10 ml.
(S2) SYRUP, [P/S] 36/11.2/0327. 5 mg/5 ml Indications: Gastr.reflux, reflux.oesophagit., heartburn
703383-001: 100 ml, R43,36 combinations (S0) PEPPERMINT SUSP, A40/11.10/0480
Dosage: Init.dos.must be low.recomm.dos. Do not exceed 715428-001: 150 ml, R64,13
recomm.dos. ADCO-MEDIGEL, AI Pharm Ltd [P/S] 715428-002: 300 ml, R107,94
Babies old.than 1 mnth up to 3 mnths: 2,5 ml 3xdly. Infts.old Al-oxide 200 mg, light Mg oxide 200 mg, dicyclomine HCl 5 mg, Dosage: Not recomm.in childr.und.12 yrs.unless on med.advice. Re-
than 3 mnths up to 1 yr: 2,5 -5 ml 3xdly. Childr.old.1 yr up to 3 simethicone 40 mg/10 ml view condit.if no improvem.within 7 days.
yrs: 5-10 ml. 3xdly. Childr.old.than 3 yrs up to 6 yrs: 10 ml. 3xdly. Indications: Pept.ulcerat, gastrit., hyperacid., dyspeps., flatul. Adults & childr.over 12 yrs: 10-20 ml aft meals & at bedt.
Childr.old.than 6 yrs up to 12 yrs: 10-20 ml. 3xdly. Childr.old.than (S2) SUSP. E1246 (S0) TABS, A42/11.10/0263
12 yrs & adults: 20 ml 4xdly. 740683-020: 100 ml, R7,55 Na alginate 250 mg, Na-bicarb. 106,50 mg, Ca carbon.187,50 mg.
Contraindications: Prostat.enlargem., paralyt. ileus/pylor.stenos., 740683-039: 200 ml, R15,69 Indications: Gastro-oesophag.reflux sympts.
close./narrow angle glauc., high ambient temp. esp.childr., pregn.& 740683-012: 2,5 L, R188,96 8, R11,14
lactat., myasth.grav. Dosage: Adults: 10-20 ml 3-4xdly. Childr.2 -12 yrs: 5-10 ml 3xdly 24, R32,52
Side effects: Dry mouth, diffic.swallow./talk., thirst., CV effs., pu- or as prescr. Dosage: Not recomm.in childr.und.12 yrs. Chew tabs.thoroughly, do
pil dilatat., accomodat.loss, photophob., reduc.bronch.secret., GI Contraindications: Alkalos.& ren.insuff., prostat.hypertrophy, GIT not swallow whole. Admin. without water.
disturbs. incl.GI tract tone & motil.reduct., diffic.micturit., mydrias., obstruct.dis., paralyt. ileus, pylor.stenos., ulcerat.colit., myasthen. Adults & childr.over 12 yrs: 2-4 tabs.aft meals & at bedt. Review
cyclopeg.& dry/flush.skin., CNS effs., impot., incr.IOP, retrostern.pain. grav., clos.angl.glauc., narrow angl.betw.iris & cornea, fev. esp.childr., condit.if no improvem.within 7 days.
Special precautions: Fev., tachycard.condits. e.g. thyrotoxicos.& when ambient temp.is high, pregn. & lactat., infts.less than 6 mnths. Contraindications: Plus tabs: Phenylketonur., childr.young.
card.surg., ac.MI, diarrh., poss. lead.to ileus & megacol.in ulcerat.colit. Side effects: Dry mouth, diffic.swall./talk., thirst, blurr.vis., photo- than 12 yrs.
pts., pylor. stenos., reflux exacerb., prostat.enlargem., imp. ren./liv./ phob., flush.& dry skin, urin./ card./ CNS effs., GI disturbs., retrostern. Side effects: GI disturbs., hypersens.reacts., bronchosp., gastric.hy-
metab.funct., hypertens., childr., elderly. pain, phosph. defic.with risk of osteomalac., reduc.bronch.secret. with persecret.& acid rebound with high dos.& prolong.use of Ca carbon.,
Drug interactions: Eff.enhanc.by other medic. with antimuscarin. assoc.muc.plug format., ment.confus.esp.in elderly/brain damage. hypercalcaem./alkalos.esp.with imp.ren.funct.& high dos.Ca carbon.,
propert., CNS depress.enhanc. by other CNS depress., absorpt.of Special precautions: Low phosph.diets, imp.ren funct., diarrh., milk-alkali syndr.assoc.with Ca carbon.
other meds aff. due to reduc.GI motil. childr.& elderly, condits.charact.by tachycard. Special precautions: Observ.interv.of 2-3 hrs. betw.admin.of other
Drug interactions: Dimin.absorpt.of tetracycl./ digoxin/oral Fe meds.to avoid interact.due to poss.absorpt.interfer., restrict.salt in-
preps., enhanc.eff.with other antimuscarin.drugs./some antihista- take, hypercalaem., nephrocalcinos., recurr.Ca contain. ren. calculi,
12.4 Acid reducers min./ butyerophen./phenothiazine /TCA’s, absorpt.of other drugs CHF, ren.impairm., liv.cirrhos., hypertens., corticoster.ther., metabol./
from GIT alt. resp. alkalos., hypocalcaem., hypochlorhydria, Tabs.also: reduc. effic.
when gastric acid lev.very low.
12.4.1 Antacids GAVISCON, Reckitt Benckiser [P/S] Drug interactions: Absorpt.of other drugs interfer. with by large
Alginic acid 500 mg, Mg-trisil. 25 mg Al-hydrox. 100 mg, Na-bi-
dos., poss.hypercalcaem. with thiazide diuret./vit.D
carb. 170 mg.
ADCO-MAYOGEL, (Propan-Zurich) AI Pharm Ltd [P/S] Indications: Condits.assoc.with gastr.reflux, heartburn, heartburn GELACID, Cipla Medpro [P/S]
Al.oxide 282 mg, Mg oxide 120 mg/15 ml. of pregn., hiatus hernia. Alginic acid 500 mg, Mg-trisil.25 mg Al-hydrox. 100 mg, Na-bi-
Indications: Gastr.acidity, dyspeps., pept.ulc. (S0) TABS. J/11.4/201. carb.170 mg. Cont.sugar.
(S0) SUSP. E/11.4.1/1732. 862282-005: 6, R15,95 Indications: Gastroesophag.reflux, mild to mod. reflux oesophagit.,
740551-019: 100 ml, R6,09 862282-006: 12, R29,02 heartburn, heartburn of pregn., dyspeps.
740551-027: 200 ml, R12,05 728454-009: 20, R35,80 (S0) TABS, [P/S] 33/11.4/0383
740551-035: 2 500 ml, R86,05 728454-017: 60, R94,59 890350-002: 20, R30,70
174 / 2020-04 Gastro-Intestinal Tract - 12.4.2 / 12.4.3
Dosage: Chew thoroughly/break into pieces aft. meals & at bedt. Warnings and special precautions: Attent.to dos.to avoid poss. Indications: Duod.& gastric ulc., hypersecret. states, Zollinger-El-
Adults & childr.over 12 yrs: 1-2 tabs. Childr. 6-12 yrs: 1 tab. Childr. hypernatraem.risk with excess. amnt., assess pt.condit.within.3 lison syndr., reflux oesophagit., pts.at high risk of upper GIT haem-
und.6 yrs: As direct.by physic. days of init. treatm./ sooner if sympts.worsen, treat hypernatraem. orrh.due to hepat. fail.
Contraindications: Obstruct.GIT dis., imp.ren. funct., heart fail, hy- with oral fluid and electrol.monit. & treat.sev.cases with caut.use (S3) INJ. 29/11.4.3/0214. 200 mg/2 ml.
pertens., liv.cirrhos., safety in pregn. & lactat.not est. of hypo-osmot. sols. 838276-008: 10x2 ml amp, R98,66
Side effects: Hyperkalaem./metabol.acidos., GI disturbs., hyperma- Drug interactions: Poss over thicken.of stomach cont.if used with Dosage: Admin.by IV/IM route. Tot.dly.dos.not to exceed 2,4 g.
gnaem./Al encephalopathy & osteomalac.in imp.ren.funct., hypercal- thick.agents./inft.milk preps. contain.thick.agent. Usual dos: 200 mg 4-6 hrly. IV inj.dil in 0,9% NaCl to tot.vol.20 ml
ciuria., CHF from excess.Na absorpt. & admin.slow.over 2 mins. Intermitt. IV infus: 400 mg in 100 ml
Special precautions: Low phosph.diet, CHF, ren. impairm., oed., MUCAINE, (Aspen Pharmacare: Consum) Pharmacare [P/S] NaCl 0,9%/ Gluc.5% sol.admin. over 30-60 mins. 4-6 hrly. Contin.
hypertens., eclamps., aldosteronism, allow few hrs.betw.admin.& Oxethazaine 10 mg, Al-hydrox. 291 mg, Mg-hydrox. 98 mg/5 ml. IV infus: 50-100 mg/hr.
tetracycl. /digox.& oral Fe preps admin., med. supervis. of use in Indications: Antacid in dyspeps., hyperacid. assoc.with pept.ul- Childr: Limited exper: 20-40 mg/kg in div.dos. orally/ parenteral.
pregn., citrate cont.preps.in ren. fail. cerat., gastrit., oesophag.reflux with heartburn.& gastr.hyperacid. Contraindications: Pregn.& lactat., infts.und.1 yr., concom.an-
Drug interactions: Absorpt.of tetracycl./digox.& oral Fe preps decr., (S1) SUSP. E/11.4.3/1223. ticholin.agents.
ren.clear.of acid.drugs incr. 744751-020: 100 ml, 40,26 Side effects: Diarrh., dizzin., tiredn., headache, skin reacts., alopec.,
(S0) SUSP, [P/S] 33/11.10/0046 744751-039: 200 ml, R80,52 CNS effs., myopathy, neuropathy, gynaecomast., impot., reduc.sperm
Dosage: 5-10 ml 4xdly bef.meals & at bedt.
Na bicarb. 267 mg, Na-alginate 500 mg, Ca-carb.160 mg/10 ml. counts, breast tendern., hypersens.reacts., fev., arthralg., myalg., bld.
Indications: Gastr.reflux, mild to mod.reflux oesophagit., heartburn, Contraindications: Concom.tetracycl., sev.ren. funct.impairm., ap- disords., interstit.nephrit., hepatatox., arthrit.sympts., CV disords.,
pendicit.sympts., hypophosphataem., safety in pregn.& lactat.not est.
heartburn of pregn., hiatus hern. hepatit., pancreatit., candidal peritonit.
890357-010: 100 ml, R50,45 Side effects: Dizz., faintn., drowsin.with dos. exceed.60 ml/day, Special precautions: Excl.malign., imp.ren./ hepat.funct., CV dis.,
sens.reacts., GI disturbs., hypermagnesaem.in mild-mod.ren.im-
890357-002: 200 ml, R84,64 IV infus.recomm.in CV impairm., card.arrest & arrhythm & hypotens.
Dosage: Admin.aft.meals & at bedt. pairm./ hyperaluminaem.in chron.ren.fail., hypophosphataem. with follow. rapid IV bolus, admin.at end of dialys., monit.prothromb.time
Adults & childr.over 12 yrs: 10-20 ml. Max.dly. dos: 80 ml. Chil- prolong.admin./large dos. with concom.anticoags., caut.nifedipine titrat.advis., poss.defic.
dr.und.12 yrs: 10 ml. Max.dly.dos: 40 ml. Childr.und.2 yrs: Max. Special precautions: Mild to mod.ren.impairm., low phosph.diets, anaem. dur.long term ther., diabet., elderly.
dos.5 ml und.medic.supervis. poss.GI Ca in protract./recurr. indigest. Drug interactions: Clinic.signific.effs.with warfarin anticoags., Fe
Contraindications: Metabol./resp.alkalos., hypocalcaem, hy- Drug interactions: Alter.rate &/or extent of absorpt. of many absorpt.from GIT impair., assoc.with malabsorpt.of prot.bound.vit.
pochlorhydr. other medic., incr.in quinidine plasma lev.& poss.toxic.if alkalina- B12., incr. bld.lev.of cyclosp., lignoc., nifedip. phenytoin, suxameth.,
Side effects: GI disturbs., hypercalcaem.& alkalos. with high dos. sat.of urine occurs. theophyl., warf., propranol., diazep., chlordiazep.
Special precautions: CHF, oed., ren.impairm., Na restrict.diet., liv.
cirrhos., hypertens., HF, concon corticoster. LENAMET, (Aspen Pharmacare: Pharma) Pharmacare [P/S]
Drug interactions: Absorpt.of other meds.poss. interfer. with. 12.4.3 Histamine-2 receptor Cimetidine
GELUSIL PLUS, iNova [P/S] Indications: Benign gastr.& duod.ulc., reflux oesophagit., Zollinger-
Ellison syndr., condits. assoc. with gastr. hypersecret.states, at reduc.
Na alginate 500 mg, Na-bicarb.267 mg, Ca carbon.160 mg/10 ml antagonists dos. for recurr. duod.ulc.in select.pts.
Indications: Gastr.reflux, reflux oesophagit., heartburn (incl.dur. (S3) TABS, U/11.4.3/67, 66
pregn.), sympts.of hiat.hern., flatul.assoc.with gastr.reflux & all cas- ADCO-CIMETIDINE, AI Pharm Ltd [P/S] 736260-005: 400 mg, 56, R40,84
es of epigastr. & retrostern.distr.where underly.cause is gastr.reflux. Cimetidine 736260-013: 400 mg, 500, R364,64
(S0) SUSP, 43/11.10/1124 Indications: Duod.& gastr.ulc., reflux oesophagit., upper GI bleed., 736252-002: 200 mg, 60, R40,68
721954-001: 200 ml, R107,66 hypersecret.states assoc.with syst. mastocytos./basophil.leukaem. 736252-010: 200 mg, 150 R101,69
721954-002: 500 ml, R192,32 with hyperhistaminemia/Zollinger-Ellison syndr. Dosage: Max.tot.dly dos.2,4 g. Ther.cont.for at least 4 wks.
Dosage: Adults& childr. >12 yrs: 10-20 ml aft.meals & bef.bedtime. (S3) TABS, Y/11.4.3/426, 427. Duod.ulc: 400 mg 2xdly & at bedt.or 800 mg at bedt. Maint. 400 mg
Side effects: Less freq: Hypersens., urticar., bronchosp., anaphylact. 811459-004: 200 mg, 60, R34,35 at bedt.for recurr.duod.ulc.
reacts. Freq.unknown: Alkalos., milk-alkali syndr., hypercalcaem., 800252-004: 400 mg, 60, R51,39 Benign act.gastr.ulcerat: 200 mg 3xdly with meals & 400 mg at
stomach cramps, belch., flatul., constipat., Dosage: Childr: Use not recomm. bedt. Alt. 400 mg at breakf.& bedt. or 800 mg at bedt.
Warnings and special precautions: Highly restrict.salt diet, heart Duod.& gastr.ulc: 200 mg or 400 mg if necess. 3xdly.with meals & Gastr.hypersecret: Usual.200 mg 3xdly with meals & 400 mg at
fail./oed./liv.cirrhos./ hypertens./eclamps./aldosteronism, gastr. hy- 400 mg at bedt.or 400 mg 2xdly with meals & at bedt.or 800 mg at bedt. May be incr.to 400 mg 4xdly with meals and at night. Contin.
persecret./ acid rebound with prolong.use, do not admin.in metabol.-/ bedt.. Cont.for 4 wks.for duod.ulc.& x6 wks.for gastr.ulc. ther.for as long as need.
resp.alkalos/ hyperchlorhydr., monit. ser.electrol.conc.& acid-bas. stat. Maint.of duod.ulc: 400 mg at bedt.or 400 mg 2xdly.if reqd. Reflux oesophagit: 400 mg 4xdly with meals and at bedt for
freq.dur.treatm.of acidos., poss. hypercalcaem./ alkalos./nephrocalci- Zollinger-Ellison syndr.& upper GI bleed: Indiv.& cont.for as up to 12 wks.
nos.or recurr. Ca calculi esp.with ren.fail., milk-alkali syndr. assoc. with long as clinic.indicat. Usual. 200 mg or if necess.400 mg 3xdly.with
Ca carbon., reduc.effic.in pts.with very low gastr. acid levs., separat. meals & 400 mg at bedt. Contraindications: Fac.oed., laryngosp., prurit., rash, angioed.,
anaphylax., imp.ren.funct., pregn.& lactat., pts.with any other illn./
dos.by at least 3 hrs. from that of concom.meds., Ca crosses placen- Reflux oesophagit: 400 mg 4xdly.with meals & at bedt.for up
ta & distribut.in breast milk, not recomm.in childr.<12 yrs., re-eval.if to 12 wks. taking any other meds. unless prescrib.by dr., midd.-aged or old. pts.
GORD sympts.not improv.within 7 days. Contraindications: Pregn., lactat. with new or recent.chang. dyspept.sympt./ dyspeps. with unintend.
weight loss to seek med. advice.
Interactions: Alkalinisat.of urine poss.incr. ren. clear. of acid.meds. Side effects: Diarrh., dizzin., tiredn., headache, rashes, revers.
incl.salicylat./tetracycl.& barbiturat., enhanc.Li.excret., hypercalcaem. confus.states esp.in elderly/ seriously ill., gynaecomast., impot., Side effects: Comm: Diarrh., dizzin., tiredn., headache, rash., revers.
confus.esp.in elderly or ser. ill pts./gynaecomast.& impot.in men giv.
with concom. thiaz.diurets.,thiaz.diuret.decr.urin. excret., enhanc.con- allerg.reacts., arthralg., myalg., bld.disords., interstit.nephrit,. hepa-
com.digox.effs.on heart, digox. toxic. poss.precipit., reduc.absorpt.of totox., pancreatit. high dos. Less freq: Hypersens.reacts., fev., arthralg., myalg., bld.
bisphosphonates/ tyrox./H2-antag./Fe salts/ ketoconaz./neurolept../ Special precautions: Excl.malign., imp.ren. funct., elderly. disords., interstit.nephrit., hepatotoxic., CV disords.
beta-blocks./penicillam./ glucocorticoids/chloroq./fluoride/cert. fluo- Drug interactions: Accumulat.of other therapeut. agents egs.of Warning and special precautions: Excl.poss. malign. bef.init.
roquinol. & tetracyclines whose metabol.is affect incl.warfar./ phenytoin/theophyll./pheno- ther., imp.ren.funct.
Interactions: Hepat.metabol.of drugs inhibit.by bind. to cytochrome
GELUSIL-S, iNova [P/S] barbit./benzodiazep./ ß-block.& imipramine., lignocaine clear.slow. P450 eg.of clinic.signific. interacts. are phenytoin/theophyll./ligno-
Al hydroxide dried gel 200 mg, Mg hydroxide 200 mg, simethi- BIO CIMETIDINE, Biotech [P/S] caine/ other antiarrhythm./oral anticoags.
cone 20 mg. Cimetidine.
Indications: Hyperacid.& flatul.assoc.with heartb., gastrit., acid Indications: Duod.& benign gastr.ulcerat., pept. oesophagit., recurr. LENAMET-OTC, (Aspen Pharmacare: Consum) Pharmacare [P/S]
indigest., pept.ulc.adjunct. ulcerat., stom.ulcerat., condits. where reduc.gastr.acid secret.benefic., Cimetidine.
(S0) TABS, E/11.4.1/633. recurr. duod. ulcerat.maint.ther., high risk of upper GIT, haemorrh.due Indications: Short-term sympt.relief of heartburn, dyspeps.&
788465-007: 24, R54,42 to hepat.fail.& immuno-suppress. agent treatm.follow.kidn.transpl., hyperacid.
Dosage: Chew/suck 1-2 tabs.betw.meals up to 4 -8x dly. Max.dly. patholog. hypersecret. such as Zollinger-Ellison syndr., eros. gastro- (S2) TABS, 30/11.4.3/0412
dos: 16 tabs./24 hrs. oesophag.reflux dis.(GORD). 832901-008: 200 mg, 20, R12,98
Contraindications: Imp.ren.funct. (S3) TABS, 31/11.4.3/0679, 31/11.4.3/0680 Dosage: Adults & childr.over 16 yrs: 1 tab 3xdly.with meals & at
Side effects: GI disturbs., poss.intest.obstruct. with large dos., os- 886978-002: 200 mg, 60, R29,29 bedt. Max.dly.dos.800 mg.
teomalac./encephalopathy & dement. report.in chron.ren.fail.pts.on 886978-009: 200 mg, 150, R73,25 Contra-indications: Not recomm.for min.digest. complaints &
high dos.Al hydrox., hypermagnesaem. 887003-015: 400 mg, 14, R10,43 childr., imp.ren.funct., pregn. & lactat., in pres.of other illness./meds.
Special precautions: Ren.insuffic., low phosph. diet. 887003-016: 400 mg, 56, R41,56 unless prescrib. by physic.
Drug interactions: Absorpt.of oral tetracycl./ digoxin/oral Fe-preps./ Dosage: Admin.with meals & at bedt. Tot.dly.dos. by any route Side-effects: Diarrh., CNS effs., rash, prurit., hypersens.reacts.,
antichol.drugs/barbit./ quinines /quinidine/warfar./vits./H 2-recept. should not exceed 2,4 g. fev., arthralg., myalg., bld. dyscras., CV disords., revers.confus.states
antagon./oral isoniaz./sucralfate./Na fluor./ ketoconazole/phenyt./ Duod.& gastr.ulcerat: Sngl.dos.of 800 mg dly at bedt. for 4 wks & brainstem syndr.esp.in elderly/ser.ill e.g.ren.fail., gynaecomast.&
phenothiaz.& methenamine poss.reduc. (duod.ulc.) & 6 wks.(gastr.ulc.). Maint.400 mg at bedt.or 200 mg impot.with high dos.
Special precautions: Middle-aged & old.pts. with recent.chang.
INFANT GAVISCON ALUMINIUM FREE, Reckitt Benckiser [P/S] 2xdly for up to 1 yr. if necess. dyspept.sympts.& pts with dyspeps. & unintend.weight loss should
Oesophag.reflux: 400 mg 4x/day for 4-8 wks.
Na-alginate 225 mg, Mg-alginate 87,5 mg/sachet Zollinger-Ellison syndr: 400 mg 4x/day for 4-8 wks. May be incr. 1 consult a dr., imp.ren.funct.
st
Indications: Helps prevent gastric regurgitat.in infts & childr., gas- to max.2,4 g/day if necess. Drug interactions: Med.to high potent.antacids may decr.absorpt.,
tro-oesophag.reflux & reflux assoc.with hiatus hern.in infts & childr. Maint.treatm: Prophylax.of recurr.ulc: 400 mg at bedt. May be meds.reduc.GI transit time may reduc.bioavailabil., inhibit.of cyto-
(S4) ORAL POWD, 32/13.1/0335 incr.to 400 mg 2x/day up to 1 yr.if necess. chrome P-450 enzyme syst.incr.bld.conc.& delays eliminat.of cyclo-
728470-005: 30 dos., R245,78 Contra-indications: Safety in pregn.& lactat.not est. spor., lignocaine, nifedipine, phenytoin, suxamethon., theophylline,
Dosage: Not for use in infts.<3 mnths. Consult dr for infts over 3 Side-effects: Diarrh., dizz., tiredn., headache, rash, confus., gynae- warfarin, quinidine, phenobarbit, many benzodiazepines & TCA’s.
mnths & und.1 yr. Mix with water/ milk immed.bef.tak. Mix.powd. comast., impot., hypersens. reacts., fev., arthralg., myalgia, bld.dys-
with 5 ml cool. boil.water to smooth paste thereaft.add.addit. 10 ml cras., interstit. nephrit., hepatotoxic., CV disords. PHARMA-Q CIMETIDINE INJECTION 200 mg/2 ml,
& admin.aft.feed. Do not use more than stated amnt. Do not admin. Special precautions: Elderly, imp.ren.funct., Zollinger-Ellison syndr., Pharma-Q [P/S]
more than 4x/24 hrs. excl.poss.malign., childr., monit. prothromb.time if warfar.giv.concom. Cimetidine
Infts.3 mnths – 1 yr: 1 dos. Childr.over 1 yr: 2 dos. Drug interactions: Inhibit.activ.of cytochrome P450 in the liv.pro- Indications: Gastr.& duod.ulc., oesophag.reflux, Zollinger-Ellison
Contraindications: Intestin.obstruct., est.diarh., where excess. long.the half-life of cert.meds. e.g.cyclosporin, lignocaine, nifedipine, syndr.& other condits.assoc.with gastr.hypersecret.states, pts.at high
water loss likely, gastro-enterit. where rehydrat.with fluid replacem. phenytoin & theophylline. risk of upp.GIT haemorrh.due to hepat.fail.& immunosuppress. agent
approrpiate, imp.ren.funct. treatm.follow.kidn.transpl.
Side effects: Thick.of gastric cont., hypernatraem., intragastr CIMETIDINE ADCO, AI Crit.Care [P/S] (S3) INJ, 32/11.4.3/0196. 200 mg/2 ml
aggregate(mass). Cimetidine. 703601-001: 10x 2 ml vials, R90,77
Gastro-Intestinal Tract - 12.4.3 / 12.4.4 2020-04 / 175
Dosage: Admin IV/IM.Tot.dly.dos.not to exceed 2,4 g.Usual.dos: Special precautions: Excl.poss.malign.bef.ther., ren.impairm., pe- (S4) POWD.FOR SOL.FOR INJ, 44/11.4.3/0981. 40 mg
200 mg repeat.4-6 hrly. Admin.IVI slow.over 2 mins. IV infus.recomm. riod.exam.dur.longterm treatm., concom. NSAID esp.elderly, CV dis., 720385-002: 1x15 ml, R31,93
if larg.dos. reqd. or in CV impairm. Intermitt.IV infus: recomm. dos. is cross.placenta & pass.into breast milk, limit.exper.in childr., evid. in- 720385-001: 5x15 ml, R159,73
400 mg in 100 ml NaCl 0,9% sol.over 30-60 mins.& repeat.4-6 hrly if dic.protect.aginst NSAID assoc.ulcerat.in duodenum & not stomach. Dosage: Only for IV use for up to 7 days in pts. who cannot be treat.
necess. Recomm.rate for contin.IV infus: 50-100 mg/hr. Drug interactions: Poss.decr.absorpt.with antacids. oral. Replac.ther.by same oral dos.in compliance with approv.dos.
Childr: Only if benef.outweighs potent.risk. Limit. exper: 20-40 mg/ regim.as soon as poss. Once reconstit.admin.by direct.IV or dil. furth.
kg/day in div.dos. with 100 ml 0,9% NaCl or 5% gluc.only. Admin. over 2-15 mins.
CV impairm: IV infus.recomm. Duod.ulc: 40 mg once dly. Use in combinat.with appropr.antibiot.
Contraindications: Safety in pregn.& lactat.not est., infts.und.1 yr. 12.4.4 Proton pump inhibitors when assoc.with H.Pylori.
Side effects: Diarrh., dizzin., tiredn., headache, rash., confus.states Gastr.ulc: 40 mg once dly..
esp.in elderly/ser.ill pts.incl. ren.fail., gynaecomast., impot., hyper- TRUSTAN (MDR Listing) Reflux oesophagit: 40 mg once dly.
sens.reacts., fev., arthralg., myalg., bld.dycras., interstit. nephrit., ACCORD OMEPRAZOLE, Accord [P/S] Zollinger-Ellison syndr: Init.80 mg dly theraft. titrat.up/ down as
hepatotox., CV disords. Omeprazole need. Dos.above 80 mg to be div.& admin.2x dly.
Special precautions: Excl.poss.malign.bef.init. treatm., imp. Indications: Short term treatm.of duod.ulc./ gastr.ulc./reflux oe- If rapid acid contr.is req.a start.dos.of 2 x 80 mg is suffic.to man-
ren.funct., limit.exper.in childr., cross. placent.barrier & excret. sophagit. & Zollinger-Ellison syndr.when oral ther.inapprop/contra- age a decr.of acid output into target range (<10 mEq/h) within 1
into breast milk. indicat.for max.5 days. hr in maj.of pts.
Drug interactions: Poss.dos.reduct.of cyclospor./ lignocaine/nifedi- (S4) POWD.FOR SOL FOR INFUS, 41/11.4.3/0663 Mild to mod.liv.impairm: Do not exceed 20 mg dly.
pine/phenytoin/suxamethonium/ theophyll./warfarin. 715885-001: 40 mg, 1xvial, R42,24 Contraindications: Safety & effic.in pregn.& lactat. & in childr.not
R-LOC INJECTION, Zydus [P/S] Dosage: Reconstit.with 100 ml 5% gluc.& admin. as IV infus. est., sev.liv.funct.impairm., concom. atazanavir/nelfinavir.
Side effects: Bld.dyscras., tinnit., vertigo, blurr. vis., anter.ischaem.
Ranitidine HCl. over 20-30 mins. optic neuropathy, GI disturbs. incl. pancreatit./stomatit., fatig., throm-
Indications: Duod.ulc., benign gastr.ulc., reflux oesophagit., Recomm.dos: IV infus of 40 mg as dly dos. Indiv. dos.for Zollinger- bophlebit., asthen., sweat., malaise, sev.hepatocell.damage lead.
Zollinger-Ellison syndr., anaesthes. pre-med.to reduc. vol.& acid Ellison when high.dos.may be indicat. If dos.exceeds 60 mg dly.div. to jaund.with/without hepat.fail., incr.liv. enzym., hepatit., hepat.
content of gastr. secret.minimis.acid aspirat.syndr. dos.& admin. 2xdly.infus. encephalopathy, anaphylact. reacts., allerg.reacts.incl.prurit./skin
(S3) INJ, 37/11.4.3/0266. 50 mg/2 ml. Contraindications: Safety in pregn.& lactat.not est. rash/urticar./angioed., UTI, URTI, incr.triglycerid., incr. body temp.,
704786-001: 5x2 ml, R226,30 Side effects: Headache, CNS effs., paraesthes., depress., aggres- hyperglycaem., arthralg., myalg., rhabdomyolys., hyperton., headache,
Dosage: Admin.IV/IM. siven., hallucinat., vertigo, ment. confus., agitat., GI disturbs., dry paraesthes., dizzin., hypokines., speech disord., psych.disords. incl. de-
Adults: Slow IVI(over 2 mins.)of 50 mg dil.to vol.of 20 ml may be mouth, stomatit., candidias., taste disturbs., incr.liv.enzymes, hepatit. press./revers.confus.state/agitat./ hallucinat, interstit.nephrit., impot.,
rep. 6-8 hrly.or IV.infus.at rate of 25 mg/hr.x2 hrs. May be rep.at with/without jaund., hepat.fail., photosens., blurr.vis., taste disturbs., gynaecomast., sev.skin reacts.incl.Stev.Johns./erythema multiforme/
6-8 hrly.interv. skin rash incl.erythema multiforme/Stev.John.syndr.& tox. epiderm. tox.epiderm.necrolys., photosens., bullous erupt., alopec., periph.oed.
Anaesth.pre-med: 50 mg IMI or 50 mg dil.to vol.of 20 ml by slow necrolys., alopec., prurit., urticar., incr. sweat., gynaecomast., bld. Warnings and special precautions: Excl.poss. malign., discont.
IVI(over 2 mins) 45-60 mins prior to induct. dyscras., hypersens. reacts., angio-oed., fev., bronchosp., interstit. ther.if liv.enzym.elev., confirm reflux. oesophag.diagn.by endoscopy,
Contra-indications: Porphyr., pregn.& lactat., no exper.in child. nephrit., anaphylact.shock, blurr.vis., periph.oed., hyponatraem., ma- monit.for incr. INR/prothromb.time with warfarin.
Side-effects: Bld.dyscras., bradycard.& AV block, headache, diz- laise, arthralg.& mylag., musc. weakn., irrevers.vis. impairm.in critic. Drug interactions: Reduc./incr.absorpt.of pH-depend. meds.
zin., ment.confus., depress., hallucinat. (predom.elderly/sev.ill pts.), ill receiv.high dos. bolus inj. eg.ketoconazole,may prev. degradat. of acid-labile meds., poss.
involun. motor disturbs., gynaecomast.in men, GI disturbs., hepato- Special precautions: Excl.poss.malign., monit. concom. warfar.& interacts.with meds. also metabol.via cytochrome P450 enzyme
bil.effs.with/-out jaund., arthralg., myalg., skin rash incl.erythema phenytoin, not recomm.in childr. as exper.limit., incr.freq.of benign syst., decr.atazanavir/indinavir/nelfinavir conc., resp. to concom.
multiforme, alopec., anaphylactoid reacts. gastr.glandul. cysts with long-term treatm., poss.incr.GI infects. anticoags.poss.affect.
Special precautions: Excl.poss.malign., monit. anticoags.pro- due to decr.acidity,
thromb.time to prev.bleed.from anticoag. potent., incr.phenytoin Drug interactions: Ketoconazole & itraconazole absorpt.reduc., elim- ADCO-ROZNAL, AI Pharm [P/S]
bld.conc., incr. assoc. atax.risk, cross.placenta & into breast milk, in.of diazepam/warfar.& phenytoin prolong., plasma conc.of omepra- Lansoprazole
card.rhythm.disturbs., sev.ren.impairm., period. exam. pts.on pro- zole & clarithromycin incr.with concom.admin., digox. bioavailabil.incr. Indications: Short-term treatm.of gastric/duod. ulc. & reflux oe-
long.maint.treatm. ADCO-OMEPRAZOLE, AI Pharm Ltd [P/S] sophagit., in conjunct.with appropr. antibiot.as part of eradicat.pro-
Drug interactions: Eliminat.of meds.req.hepat. metabol.via cyto- Omeprazole. gram.for H.Pylori-posit.duod.ulc.
chrome P450 system.poss.decr., procainamide bld.conc.incr. Indications: Duod.ulc.incl.relap.prev., gastr.ulc., reflux oesophagit. (S4) CAPS, 37/11.4.3/0558
RANITIDINE 300 BIOTECH, Biotech [P/S] incl.long-term managem., Zollinger-Ellison syndr., symptomat.heart- 704668-001: 30 mg, 28, R153,57
Dosage:Take bef.meals.
Ranitidine HCl burn rel. in gastro-oesophag.reflux dis., short-term rel.of funct. dys- Gastr.ulc: 30 mg once dly.for upto 8 wks.
Indications: Duod.ulc., benign gastr.ulc.incl. prev. of duod.ulcerat. peps., duod.ulc.assoc.with H.pylori infect. in combinat.with appropr. Duod.ulc: 30 mg once dly.for upto 4 wks. As part of eradicat.pro-
assoc.with NSAID’s use, reflux oesophagit., Zollinger-Ellison syndr., antibiot., NSAID assoc. gastric/duod.ulc./eros.& reduc.risk of de- gram.with appropr.antibiot.for H.pylor posit.ulc.
acid aspirat. syndr. risk dur.gen.anaesthes. velop./ relapse of such assoc.ulc/eros., short term up to 3 mnths. Oesophagit.due to gastro-oesophag.reflux: 30 mg once dly.x4
(S3) TABS. 31/11.4.3/0674 treatm.of sev.ulcerat.reflux oesophagit.resist.to prev.treatm.in childr. wks., rep.course poss.necess. depend. on endoscop.results
718482-001: 300 mg, 30, R68,68 (S4) CAPS 37/11.4.3/0228 Contraindications: Pregn.& lactat., liv.impairm., safety & effic.
Dosage: Peptic ulcerat: 150 mg 2xdly.or 300 mg at bedt.init.x4 703543-001: 20 mg, 28, R157,03 in childr.not est.
wks. Ulc.not heal.within 4 wks.may need a furth.course. An 8-12 Dosage: Swallow whole in morn.with half glass water. Do not Side effects: Bld.dyscras., oed., CNS effs., GI disturbs.incl.ulcerat.
wk.treatm.poss. necess. for NSAID assoc.ulc chew/ crush. colit., gynaecomast., galactorrh., elev.hepat.enzymes, asthen., ar-
NSAID assoc.duod.ulc.prophylax: 150 mg 2xdly. dur NSAID ther. Duod.ulc: 20 mg dly x2-4 wks. Pts.refract.to other treatm.regim: thralg., myalg., blurr.vis., skin reacts., fev., incr.freq.of gastr. glandul.
Reflux oesophagit: 150 mg 2xdly./300 mg at bedt. for up to 8-12 40 mg once dly may be effect. cysts.dur long term treatm.& incr. gastric.bact.counts result.from in-
wks. May be incr.to 150 mg 4xdly.for upto 12 wks.in mod.to sev.cases. Relapse prev.& H.pylori posit.duod.ulc: 10 mg once dly.incr.to hibit.of gastr. acid secret.
Zollinger-Ellison syndr: Init: 150 mg 3xdly.incr.if necess.up to 20-40 mg dly.if necess. Also as part of eradicat.programme with ap- Special precautions: Excl.malign., confirm. diagnos. by endoscopy,
600-800 mg dly. propr.antibiot. for H.Pylori assoc.ulc. monit.concom.warfar.
Anaesthes: 300 mg 2 hrs pre-op or 150 mg 12 hrs. prior follow.by Gastr.ulc.& reflux oesophagit: 20 mg dly x4-8 wks. Pts.refract.to Drug interactions: CNS depress.eff.enhanc.by CNS depress.& al-
furth.150 mg 2 hrs. pre-op. other treatm.regimens: 40 mg once dly.may be effect. coh., poss.interacts.with drugs metabol. by cytochrome P450 syst.,
Maint.treatm: In hist.of recurr.ulc.admin.150 mg dly at bedt. Ad- Long term reflux oesophagit.treatm: 10 mg once dly incr.to 20- warfar.conc. poss.reduc.
dit.300 mg at bedt.to pts.unable to stop smok. 40 mg once dly.if need. If sev/ recurr.contin.with 20 mg dly.
Contraindications: Porphyr.hist., safety in pregn. & lactat.not est.. NSAID assoc.gastroduod.les: 20 mg once dly. with heal.gen.with- ALTOSEC, (Aspen Pharmacare: Pharma) Pharmacare [P/S] &
Side effects: Trans.&revers.liv.funct.changes, hepatit.without in 4 wks. If full heal.not achiev. aft.init.course contin.for furth.4 wks. Omeprazole
jaund., leucopen., thrombocytopen., agranulocytos., anaphylact. re- NSAID assoc.prophylax: 20 mg once dly. Indications: Duod.ulc.incl.relap.prev., gastr. ulc., reflux oeosphagit.
acts., bradycard., AV block, headache, dizzin., ment.confus./depress Symptomat.gastro-oesophag.reflux dis: 20 mg dly. Indiv.as some incl.long term managem., Zollinger-Ellison syndr., gastro-oesophag.
& hallucinat.main.in sev.ill/ elderly, GI disturbs., skin rash incl.ery- may respond to 10 mg dly. Investig.furth.if sympt.control not achiev. reflux dis. (GORD), 20 mg for H Pylori-pos.duod.ulc.in combin. with
thema multiforme, ac.pancreatit., arthralg., myalg., breast sympt.& aft.2 wks. on 20 mg dly. appropr.antibiot.
gynaecomast. in men. Zollinger-Ellison syndr: 60 mg once dly. Adjust indiv.& contin.as (S4) CAPS, 32/11.4.3/0703, 0087
Special precautions: Excl.poss.malign.bef.ther., ren.impairm., pe- long as indic. Dos.over 80 mg dly. admin.in 2 div.dos. 703988-001: 10 mg, 28, R184,40
riod.exam.dur.longterm treatm., concom. NSAID esp.elderly, Sev.ulcerat.reflux oesophagit.in childr.1 yr. & old: 10-20 kg: 703987-001: 20 mg, 28, R168,71
10 mg once dly. >20 kg: 20 mg once dly. If necess.incr.dos.to 20- Dosage: Adults:
ULTAK, Cipla Medpro [P/S] 40 mg respectiv. Duod.ulc: 20 mg dly.x2-4 wks. In pts.refract.to other treatm.regimes:
Ranitidine HCl Contraindications: Safety in pregn.& lactat.not est., longt.safety 40 mg dly.may be effect. Prev.of relapse: 10 mg once dly.if necess.
Indications: Duod.ulc., benign gastr.ulc.incl. prev.of duod.ulcerat. in ren./hepat.impairm.not est. incr.to 20-40 mg once dly. 20 mg caps are indic.for duod. ulc.assoc.
assoc.with NSAID’s use, Zollinger-Ellison syndr., reflux oesophagit., Side effects: GI disturbs., stomatit., candidias., bld.dyscras., pho- with H. Pylori infect.in combinat. with appropr.antibiot.
acid aspirat.syndr.risk dur.gen.anaesthes. tosens., skin rash incl.Stev. Johns. & tox.edpiderm.necrolys., hy- Gastric ulc.& reflux oesophagit: 20 mg dly. x4-8 wks. When re-
(S3) TABS. 32/11.4.3/0539,0540 ponatraem., bronchosp., headache, CNS effs., paraesthes., malaise, fract.to other treatm.regimens 40 mg once dly.may be effect. Long-
867934-018: 150 mg, 60, R99,06 fev., periph.oed., interstit.nephrit., gynaecomast., blurr.vis., hepatit. term reflux oesophagit. mangem: 10 mg once dly.incr.to 20-40 mg
867942-002: 300 mg, 30, R82,02 with/without jaund., hepat.encephalopathy, asthen., arthral.& my- once dly.if necess. In sev./symptomat. recurr. reflux oesophagit.
Dosage: Duod/gastr.ulc: 300 mg at bedt./ 150 mg 2xdly.init.x4 wks. alg., hypersens.reacts.incl.anaphylax., taste disturbs., incr.sweat., contin.with 20 mg dly.
Incr.dos.if necess.to max.300 mg 2xdly. Maint: 150 mg dly at bedt. benign revers.gastr.glandul. cysts with long-term treatm., incr GI bact. Symptomat.gastro-oesophag.reflux dis: Indiv. 10-20 mg once dly.
Cont.for furth.4 wks. if not heal. Special precautions: Cont.sucrose, excl.poss. malign., imp.hepat. Investig.furth.if sympt. contr.not achiev.aft.4 wks.treatm.
Reflux oesophagit: 150 mg 2xdly./300 mg at bedt.for up to 8-12 wks. funct., limit.exper.in childr., monit. of INR/phenyt.serum lev., incr.GI Zollinger-Ellison syndr: Init.60 mg dly. Indiv.& contin. as long as
Zollinger-Ellison syndr: Init: 150 mg 2-3xdly. incr.if necess.up to Salmonella & Campylobacter.infect. risk. clinic.reqd. Effect.sev.dis. control. on 20-120 mg dly. Admin.dos.over
600-800 mg dly.in div.dos. Drug interactions: CNS depress.eff.enhanc.by CNS depress.& al- 80 mg dly.in 2 div.dos.
Anaesthes: 300 mg 2 hrs pre-op or 150 mg 12 hrs.prior follow.by coh., poss.interacts.with meds. also metabol.via cytochrome P450 Contraindications: Safety in pregn.not est.
furth.150 mg 2 hrs. pre-op. enzyme syst., poss.prolongs diazepam, warfarin & phenytoin elimi- Side effects: Skin rash incl.erythema multiforme/ bull.erupt., pru-
NSAID assoc.duod.ulc.prophylax: 150 mg 2xdly.dur NSAID ther. nat., may incr.digox.bioavail. rit., urticar., photosens., angio-oed., alopec., headache, GI disturbs.,
Contraindications: Porphyr., ac.porphyr.hist., safety in pregn.& stomatit., candidias., benign revers. gastr. glandul.cysts, bld.dyscras.,
lactat.not est.. ADCO-PANTOPRAZOLE IV, AI Crit.Care [P/S] CNS effs., revers. ment.confus., agitat., hallucinat., paraesthes., de-
Side effects: CNS effs., GI disturbs., skin reacts. incl.erythema mul- Pantoprazole press., periph.oed., interstit. nephrit., gynaecomast., blurr.vis., taste
tiforme, alopec., hepatit., jaund., bld. dyscras., anaphylactoid reacts. Indications: Short-term treatm.of duod.& gastr. ulc. & reflux oe- disturb., hepat. encephalopathy, hepatit.with/without jaund., hepat.
incl.anaphylact. shock, bradycard., AV block, ac.pancreatit., arthralg., sophagit., duod.ulc.assoc.with H.pylori infect.in combinat.with ap- fail., incr.liv.enzymes, myalg., incr. sweat., malaise, fev., bronchosp.,
myalg., breast sympt., impot., gynaecomast. in men. propr.antibiot., Zollinger-Ellison syndr. arthritic sympts.
176 / 2020-04 Gastro-Intestinal Tract - 12.4.4
Warnings and special precautions: Safety & effic. in childr.not (S4) TABS, 41/11.4.3/1115, 1116 (S4) TABS, [P/S] 34/11.4.3/0006, 29/11.4.3/0123
est., hepat.impairm., long-term safety in ren.& hepat.impairm.not 715312-001: 20 mg, 30, R126,43 892291-005: 20 mg, 28, R227,86
est., excl.poss. malign.if gastr.ulc.suspect., monit.concom. warfar.& 715313-001: 40 mg, 30, R200,61 812153-006: 40 mg, 14, R169,52
phenytoin, lact.intol., contains mannitol Dosage: Take dly.dos.in the morn. 812153-014: 40 mg, 28, R339,05
Interactions: Poss.interact.with drugs metabol. via cytochrome Duod.ulc: 40 mg once dly. x2-4 wks. (S4) IV INJ, [P/S] 33/11.4.3/0519
P450 enzyme syst., elimin.of diazepam/warfar.& phenytoin prolong., Gastr.ulc.& reflux oesophagit: 40 mg once dly. x4-8 wks. 707420-001: 40 mg/vial, 5 vials, R536,96
digox. bioavail.incr., plasma conc.of omeprazole & clarithromycin incr. Zollinger-Ellison syndr: Init.80 mg dly.thereaft. titrat.as necess. Dosage: Inj.for IV use only over 2-15 mins.max. x7 days transf.then
with concom.admin. Admin.dly.dos above 80 mg in 2 div.dos. to oral ther. Take dly.oral dos. in the morn.
Mild GORD: 20 mg/day x4-8 wks. Duod.ulc: 40 mg once dly. x2-4 wks. Use in combinat. with appropr.
ASPEN PANTOPRAZOLE, (Aspen Pharmacare: Pharma) Long term/GORD relapse prevent: Recomm. maint: 20 mg/day antibiot.when assoc.with H.Pylori.
Pharmacare [P/S] incr. to 40 mg/day in case of relapse. Reduc.to 20 mg dly aft.heal. Gastr.ulc.& reflux oesophagit: 40 mg once dly. x4-8 wks.
Pantoprazole NSAID induc.gastro-duod.les.& dyspept. sympt. prev: Zollinger-Ellison syndr: Init.80 mg dly. thereaft. titrat.as necess.
Indications: Short-term treatm.of duod.& gastr. ulc.& reflux oe- 20 mg/day Admin.dly.dos above 80 mg in 2 div.dos. If rapid acid control reqd.
sophagit., duod.ulc.assoc.with H.pylori infect.in combinat.with ap- Contraindications: Pregn.& lactat.& safety & effic.in childr.not est., admin init. 2x80 mg IV then transf.to oral ther as soon as clinic. justif.
propr.antibiot., Zollinger-Ellison syndr. sev.liv.funct.impairm., concom.atazanavir or nelfinavir Mild gastro-oesophag.reflux dis: 20 mg/day x4 wks. An addit.4
(S4) IV INJ, 42/11.4.3/0313 Side effects: Bld.dyscras., anaphylact.reacts.incl. anaphylact.shock, wks.will usually achieve heal. if heal.insuffic.
717247-001: 40 mg, 5x10 ml vials, R158,20 incr.liv.enzymes, elev. triglycerides, incr.body temp., depress., head- Recurr.sympts.of heal.reflux dis: 20 mg once dly as on de-
Dosage: IV use in pts.who cannot be treat.oral. Admin. over 2-15 aches, dizzin., vis. disturbs., GI disturbs., jaund.with/ without hepat. mand regim.
mins. Once reconstit.admin.by direct.IV or dil.furth.with 100 ml 0,9% fail., allerg.reacts.incl.sev.skin reacts., photosens., arthralg., myalg., Long term managem.& relapse prev.in gastro-oesophag.re-
NaCl or 5% gluc. only. rhabdomyolys., bone fract., malaise, asthen., gynaecomast., impot., flux dis: Recomm.dos: 20 mg/day incr.to 40 mg/day if relapse oc-
Duod.ulc: 40 mg once dly.x2-4 wks.incl.of oral use. Use in combinat. Clostrid.diffic.assoc.diarrh., interstit. nephrit. curs. Reduc.again to 20 mg when relapse heal.
with appropr.antibiot.when assoc.with H.Pylori. Warnings and special precautions: Excl.poss. malign., not to Prev.of NSAID induc.gastroduod.les.& dyspept.sympts:
Gastr.ulc.& reflux oesophagit: 40 mg once dly. x4-8 wks. exceed 20 mg dly in mild-mod.sev. liv.impairm., monit.liv.funct.in Recomm.dos: 20 mg/day
Zollinger-Ellison syndr: Init.80 mg dly theraft. titrat.up/ down as pres.of impairm.& discont. if elev., restrict use for NSAID induc.effs. Contraindications: Safety in pregn.& lactat.& safety & effic.in childr.
need. Dos.above 80 mg to be div.& admin.2x dly. For rapid acid contr. to pts.on cont. ther.& at incr.risk, not indicat.for mild GI complaints, not est., sev.liv.funct. impairm., concom.atazanavir.
start.dos.of 2 x 80 mg suffic. to decr.acid output to target range within incr.risk of Clostrid.diffic. assoc. diarrh., confirm reflux oesophag.di- Side effects: Leucopen., thrombocytopen., hypersens.reacts. incl.an-
1 hr. Tfd.to oral formulat.as soon as clinic.justif. agn.by endoscopy, incr.risk of SCLE and bone fract., poss. cyanoco- aphylax.& sev.skin reacts., hyperlipidaem., lipid incr., weight changes,
(S4) TABS, [P/S] 43/11.4.3/0545 balam malabsorpt.with prolong.treatm. (ie.>3 yrs.), hypomagnesaem. sleep disords., depress., disorientat., headache, dizzin., vis.disturbs.,
Indications: Symptomat.improvem.& heal.of mild GORD, long term with prolong.treatm. GI disturbs., dry mouth, rash, exanthema, erupt., prurit., urticar., an-
managem.& prev.of GORD relapse. Drug interactions: Poss.changes in absorpt.of pH-depend.meds. gioed., arthralg., myalg.,asthen., fatig., malaise, incr.body temp., pe-
717376-001: 20 mg, 30, R129,01 eg.ketoconazole, diazepam/ phenytoin & warfar.elimin.prolong., poss. riph.oed., inj.site thrombophlebit., incr.liv enzym., hepatocellul. injur.,
Dosage: Swallow whole. Recomm.dly.dos.in morn.bef./dur.breakf. hypomagnesaem.with prolong.concom.digox.& tacrolim., jaund., hepatocell.fail., hallucinat., confus. esp.in pre-dispos./with
Mild GORD: 20 mg/day.x4 wks.& if not suffic. heal. usuall.achiev. pre-exist.sympts., interstit. nephrit., Stev.-John.syndr., Lyell syndr.,
within furth.4 wks. CORPOCID 20 mg, Activo [P/S] erythema multiforme, photosens., C difficile assoc. diarrh.
Long term managem.& prev.of GORD relapse: 20 mg/day incr.to Omeprazole Special precautions: Not indicat.for mild GI complaints.,furth.in-
40 mg/day if relaps.occurs reduc. back to 20 mg/day aft.relaps.heal. Indications: Duod.ulc.incl.relaps.prevent., gastr. ulc., reflux oe- vestigat.if sympts.persist. despite adeq.treatm., not to exceed 40 mg
(S4) TABS, [P/S] 43/11.4.3/0546 sophagit., Zollinger-Ellison syndr., NSAID-assoc.gastr./duod.ulc., dly in elderly/ren.funct.impairm., poss.incr.risk of C difficile-assoc.di-
Indications: Short-term treatm.of duod.& gastr. ulc.& reflux oe- H.pylori posit.duod. ulc.as part of eradic.program with appropr. arrh.partic.in hospit.pts., monit. concom.anticoag.ther., excl.poss.ma-
sophagit., duod.ulc.assoc.with H.pylori infect.in combinat.with ap- antibiot. lign., insuffic. clinic.data for long-term admin., not to exceed 20 mg dly
propr.antibiot., Zollinger-Ellison syndr. (S4) TABS, A 43/11.4.3/0502 in mild-mod.liv.impairm., monit. liv.funct. in pres.of sev.impairm./long
717377-001: 40 mg, 30, R206,91 720358-001: 20 mg, 30, R166,00 term treatm. & discont. if elev., restrict.to pts.requir. contin. NSAID
Dosage: Swallow whole. Recomm.dly dos.in morn. bef./dur.breakf. Dosage: Admin.in morn. Swall.whole without chew./crush. treatm.for prev.of NSAID induc. les., poss. cyanocobalam malabsorpt.
Duod.ulc: 40 mg once dly. Total per.with IV & oral treatm: 2-4 wks. Duod.ulc: 20 mg dly.x2-4 wks. In pts.refract.to other treatm: 40 mg with prolong. treatm. (ie.>3 yrs.).
Use in combinat.with appropr. antibiot.when assoc.with H.Pylori. dly.may be effect. H pylori-posit. duod.ulc: Indic.as part of eradicat. Drug interactions: Poss.interact.with other meds. also metabol.
Gastr.ulc.& reflux oesophagit: 40 mg once dly. x4-8 wks. program. with appropr.antibiot. by cytochrome P450 enzyme syst., poss.changes in absorpt.of pH-
Zollinger-Ellison Syndr: Init.80 mg dly.thereaft. titrat. up/down as Gastric ulc.& reflux oesophagit: 20 mg dly.x4-8 wks. When re- depend. meds. eg.ketoconazole, atazanavir bioavail. substant. reduc.
necess. Admin.dly.dos above 80 mg in 2 div.dos. fract.to other treatm.regimens 40 mg once dly.may be effect. May LANCAP, Pharma Dynamics [P/S]
Contraindications: Safety & effic.in pregn.& lactat.& in childr.not be contin.with 20 mg once dly in case of sev.or symptom.recurr. Lansoprazole
est., sev.liv.funct.impairm., concom. atazanavir. reflux oesophagit. Indications: (S4) 30 mg: Short-term treatm.of gastric/ duod. ulc. &
Side effects: Bld.dyscras., GI disturbs., thrombophlebit.(IV), periph. Zollinger-Ellison syndr: Init.60 mg dly. Indiv.& contin. as long reflux oesophagit. 15 mg: Short-term managem.of mild funct.dys-
oed., jaund.with/ without hepat.fail., anaphylax., incr.liv.enzym./ as clinic.reqd. Sev.dis.maint: Usual. 20-120 mg dly. Div.dos. & peps., gastro-oesophag. reflux relapse prophylax. In conjunct.with ap-
triglycer., incr.body temp., arthralg., myalg., headache, dizzin., vis. admin.2xdly if above 80 mg dly. propr. antibiot.as part of eradicat. program.for H.Pylori-posit.duod.ulc.
disturbs., ment.depress., interstit. nephrit., allerg.reacts., sev.skin NSAID-assoc.gastr. & duod.ulc: 20 mg once dly. x4wks. Contin. (S2) 15 mg: Short term symptomat.heartburn & hyperacidity at
reacts. incl.Stev. Johns./Lyell syndr./erythema multiforme, photosens. for furth.4 wks.if heal.not compl. max.15 mg dly dos.for max. 14 days.
Special precautions: Concom.anticoags., not to exceed 20 mg dly Contraindications: Safety in pregn./lactat.not est., concom. nelfi- (S4) & (S2) CAPS, 40/11.4.3/0247, 0248
in mild-mod.liv.impairm., monit. liv. funct. reg.in pres.of sev.impairm. navir/atazanavir./indinavir. 715812-001: 15 mg, 14, R55,17
esp.dur. longt.ther.& discont.if elev., not indicat.for min.GI compl., excl. Side effects: Headache, dizzin., CNS effs., vertigo, depress., hal- 708052-001: 15 mg, 30, R118,22
poss.malign., confirm reflux. oesophag. diagn.by endoscopy, poss. cy- lucinat., GI /taste disturbs., stomatit., GI candidias., incr.liv.enzym., 708053-001: 30 mg, 30, R166,15
anocobalam malabsorpt.with prolong.treatm. (ie.>3 yrs.), long-term encephalopathy with pre-exist.sev.liv.dis., hepatit., hepat.fail., skin Dosage: Take bef.meals. Admin.low.dos.& short. durat.appropr.
treatm.exper.limit., IVI & tabs.cont.mannitol reacts.incl.erythema multiforme/ Stev.-Johns. syndr./tox.epiderm. to condit.treat.
Drug interactions: Reduc./incr.absorpt.of pH-depend.meds.eg. ke- necrolys., alopec., bld. dyscras., platel./bleed.& clott.disords., gy- Heartburn & hyperacidity: 15 mg dly.for up to max.14 days.
toconazole, poss.interacts. with meds.also metabol.via cytochrome naecomast., arthralg., myalg., musc.weakn., arthrit., UTI, interstit. Gastr.ulc: 30 mg once dly.for up to 8 wks.
P450 enzyme syst. nephrit., malaise, incr.sweat., periph. oed., back/chest pain, hy- Duod.ulc: 30 mg once dly.for up to 4 wks. As part of eradicat.pro-
persens., angioed., fev., bronchosp., anaphylact.shock, URTI, blurr. gram.with appropr. antibiot.for H.pylori posit.ulc.
BURNLOC, AI Pharm [P/S] vis., hyponatraem., proteinur., hypomagnesaem., hypocalcaem., Oesophagit.due to gastro-oesophag.reflux: 30 mg once dly.x4
Lansoprazole hypokalaem. wks., rep.4 wk.course poss. necess.
Indications: Short-term managem.of mild funct. dyspeps.& gastro- Warnings and special precautions: Not indic. for mild GI com- Gastro-oesophageal reflux prevent: Maint: 15 mg once dly.
oesophag.reflux relapse prophylax. pl.such as nerv.dyspeps., excl.poss. malign., cons.risk vs.benef.in for max.1 yr.
(S4) CAPS, A39/11.4.3/0116 chron.hepat.dis.or hist. thereof, lact.intol., concom.warfar./ pheny- Funct.dyspeps: Adults: 15-30 mg once dly.x2-4 wks.
707192-003: 15 mg, 7, R27,46 toin/ digoxin/indinavir, sev.hepat.impairm., excret. in breast milk, Elderly: Max.dly.dos: 30 mg.
707192-001: 15 mg, 14, R54,91 gastr.glandul.cysts dur. longt.ther., incr.osteoporos.-relat.fract.risk, Contraindications: Pregn.& lactat., liv. impairm., safety & effic.in
Dosage: Admin.bef.meals. Paed.use not studied. hypergastrinaem.may be high.in pts.with H.pylori infect., incr.GI childr.not est., lact. intol.
Gastro-oesophag.reflux maint.prophylax: 15 mg once dly. Salmonella/Campylobacter/ Shigella/ Clostrid.diffic.infect.risk, cya- Side effects: CNS effs., bld.dyscras., oed., headache, dizzin., tremor,
x1 yr.max. nocobalamin absorpt. reduct., potent.vit.defic.risk with longt.t her., GI disturbs. incl. ulcerat. colit., gynaecomast., galactorrh., elev. hepat.
Funct.dyspeps: 15-30 mg dly.x2-4 wks. fat malabsorpt., limit.exper.in childr., longt. safety in pts.with ren.& enzym., asthen., arthralg., myalg., blurr. vis., skin reacts., alopec., fev.,
Contraindications: Pregn.& lactat., liv.impairm., safety & effic. hepat.impairm.not est., cirrhos., gastr.polyps with dly.ther.for 1 yr., incr.freq.of gastr. glandul.cysts.dur long term treatm.& incr.gastr. bact.
in childr.not est. elderly pts. receiv.high dos. counts result.from inhib.of gastr.acid secret. incr.GIT infects.risk.
Side effects: Bld.dyscras., oed., CNS effs., GI disturbs.incl.ulcerat. Drug interactions: Alter.absorpt.of some meds., poss. prolong. Special precautions: Pass.into milk of rats, tumorigen.effs.in anim.,
colit., gynaecomast., galactorrh., elev.hepat.enzymes, asthen., ar- eliminat.of diazepam/warfar.or other Vit. K antagon./ phenytoin/ excl.malign., incr. Clostrid. diffic.assoc.diarrh.risk, monit. concom. war-
thralg., myalg., blurr.vis., skin reacts., fev., incr.freq.of gastr. glandul. meds.metabol.by oxidat. in liv., plasma conc.of both meds.incr.with far., confirm reflux.oesophagit.diagnos.by endoscopy.
cysts.dur long term treatm.& incr. gastric.bact.counts result.from in- voriconazole, decr.atazanavir/indinavir/nelfinavir, incr. expos.with Drug interactions: Sedat.eff.potent.by CNS depress. & alcoh.,
hibit.of gastr. acid secret. flovoxamine, clopidogrel antiplatel. eff.reduc.in pts.tak.clopidogrel & poss.interacts.with drugs metabol. by cytochrome P450 syst., war-
Special precautions: Excl.malign., confirm. diagnos. by endoscopy, aspir. or clopidogrel alone, poss.interacts.with meds.also metabol. via far.conc. poss.reduc.
monit.concom.warfar. cytochrome P450 enzyme syst., concom. clarithromycin poss.incr.plas-
Drug interactions: CNS depress.eff.enhanc.by CNS depress.& al- ma conc.of both drugs., digox.bioavailabil.incr., diet.Vit.C bioavail. imp. LANSOLOC, Cipla Medpro [P/S]
coh., poss.interacts.with drugs metabol. by cytochrome P450 syst., Lansoprazole.
warfar.conc. poss.reduc. GASTRIWIN, (Zentiva) Takeda [P/S] Indications: Short-term treatm.duod., gastr.ulc., & reflux oe-
Pantoprazole. sophagit., with appropr.antibiotics in H.Pylori positive duod.ulc.
CONORAN, Ranbaxy [P/S] Indications: 40 & IV: Short-term treatm.of duod.& gastr. ulc., re- (S4) CAPS. 37/11.4.3/0155
Pantoprazole. flux oesophagit., duod.ulc. assoc.with H.pylori infect.in combinat. 704754-001: 30 mg, 30, R261,55
Indications: 40 mg tabs: Short-term treatm.of duod./gastr.ulc.& with appropr.antibiot., Zollinger-Ellison syndr. Inj: Also when oral Dosage: Admin.bef.meals. Use in childr.not studied.
reflux oesophagit., use in combinat. with appropr.antibiot., Zollinger- ther.not suitable. Gastr.ulc: 30 mg dly x8 wks.
Ellison syndr. 20: Symptomat.improvem.& heal.of mild gastro-oesophag.reflux Duod.ulc: 30 mg dly upto 4 wks. May be used as part of eradi-
20 mg tabs: Mild gastro-oesophag.reflux dis (GORD) & the long term dis., on demand regimen for recur. sympts.of heal.reflux dis., long cat.programm.with appropr.antibiot. in H Pylori positive duod.ulc.
managem.& relapse prevent. thereof, prevent.of gastroduod.les.& term managem. & prev.relapse in gastro-oesophag. reflux dis., prev. Oesophagit.due to gastro-oesophag.reflux: 30 mg dly x4 wks.,
dyspept.sympts.induc.by NSAID’s. of NSAID induc.gastroduod.les.& dyspept.sympts.in at risk pts. rep.for furth.4 wks.depend.on endoscopic results.
Gastro-Intestinal Tract - 12.4.4 2020-04 / 177
Maint.for prevent of gastro-oesophag.reflux: 15 mg dly for (S4) CAPS, 36/11.4.3/0446 NSAID assoc.prophylax: 20 mg once dly.
up to 1 yr. 705466-001: 20 mg, 30, R175,32 Symptomat.gastro-oesophag.reflux dis: 20 mg dly. Indiv.as some
Function.dyspeps: 15 –30 mg dly for 2-4 wks. Dosage: Swallow whole. may respond to 10 mg dly. Investigate further if sympt.control not
(S2) OTC CAPS, 37/11.4.3/0238 Adults: achiev. within 4 wks.on 20 mg dly.
Indications: Short-term relief of heartburn & hyperacid. Duod.ulc: 20 mg dly.x2-4 wks. In pts.refract.to other treatm: 40 mg Funct.dyspeps: 20 mg once dly. Consid.10 mg dly.as start.dos.as
704752-001: 15 mg, 7, R31,10 dly.may be effect. Prev.of relapse: 10 mg once dly.if necess.incr.to adeq.respons.report. Investig. furth.if sympt.contr.not achiev.aft.2
Dosage: . Swall.whole without crush./chew. 20-40 mg once dly. Above recomm.regim.are incl.of H.Pylori assoc. wks.at 20 mg dly.
Admin.1x dly.bef.meals. Max.dly.dos: 15 mg for durat.max.14 days duod.ulc.with suit.antibiot. Zollinger-Ellison syndr: Init. 60 mg dly. Adjust indiv., av.maint.betw.
Contraindications: Pregn., lactat., liv.impairm., safety & effic.in Gastric.ulc.& reflux oesophagit: 20 mg dly. x4-8 wks. When 20-120 mg dly. Doses over 80 mg admin.in 2 div.doses.
childr.not est., concom. atazanavir., OTC Caps.not suit.in fruct.intol./ refract.to other treatm.regimens 40 mg once dly.may be effect. Contraindications: Safety in pregn.not est., excret. in breast milk.
gluc.-galact. malabsorpt.syndr./sucr.isomalt.defic. Long-term reflux oesophagit.mangem: 20-40 mg once dly.if necess. Side effects: GI disturbs., stomatit., candidias., CNS effs., paraes-
Side effects: Headache, dizzin., fatig., malaise, candidias., oral In sev./symptomat. recurr. reflux oesophagit.contin.with 20 mg dly. thes., malaise, skin disords.incl. Stev. Johns./tox.epiderm.necrolys.&
monilias., pneumon., URTI, UTI, Ca, laryng. neoplasma, bld.dyscras., NSAID-assoc.gastroduod.les.with/without contin.NSAID erythema multiforme, fev., photosens., angio-oed., alopec., arthrit.
lymphadenopathy, bruis., petechiae, allerg./hypersens.react.incl. treatm: 20 mg once dly.x4wks. If heal.not compl.contin.xfurth.4 wks. & myalg.sympts., musc.weakn., blurr.vis., aggress., periph.oed., hy-
angioed./ wheez./fev./anaphylax., diab.mellit., goitre, hypothyroid., NSAID-assoc.gastroduod.les.&dyspept. sympt. prophylax.: ponatraem., incr.sweat., gynaecomast., bronchosp., bld.dyscras., hy-
GI disturbs.incl.ulcerat.colit./ haemorrh., stomatit., tenesm., bezoar, 20 mg once dly. persens. reacts. incl.anaphylax., encephalopathy with sev. pre-exist.
glossit., thirst, gout, dehydrat., hyper-/hypoglycaem., weight chang., Symptomat.gastro-oesophag.reflux dis: 20 mg dly. Investig.furth. liv.dis., hepatit.with/without jaund., hepat. fail., incr.freq.of gastr.glan-
hyponatream., CNS effs., CV accid., cerebr.infarct., psych.disords.incl. if sympt. contr.not achiev.aft.2 wks.treatm.at 20 mg dly. dul.cysts with long-term treatm., incr.liv.enzymes.
hallucinat., libido chang., migraine, convuls., hemipleg., hyperkines., Zollinger-Ellison syndr: Init.60 mg dly. Indiv.& contin. as long as Special precautions: Not indic.for mild GI complaints, limit.paed.
hyper-paraesthes., tremor, parosm., vis.disturbs. incl. retin.degenerat./ clinic.reqd. Admin.dos.over 80 mg dly.in 2 div.dos. exper., excl.poss.malign., imp. hepat.funct., monit.pts.on warfar./
vis.field defect, eye/ oesophag./ musculoskelet./back/chest/neck/ Childr.1 yr & old.: (Limit.exper.) phenytoin ther., incr.GI Salmonella & Campylobacter.infect. risk
pelv./ kidn./ urethr./breast pain, conjunctivit., vertigo, deafn., otit.med., Sev.ulcerat.reflux oesophagit: Over 20 kg: 20 mg once dly.incr. Drug interactions: Poss.interacts.with meds.also metabol.via cy-
tinnit., card.disords.incl.MI, dysrhythm., palpitat., oed., hypo-/hyper- to 40 mg once dly.if necess. tochrome P450 enzyme syst., ketoconazole & itraconazole absorpt.
tens., shock, asthma, bronchit., dyspn., epistax., haemoptys., pleur. Contraindications: Other benzimidaz. hypersens., concom.nelfina- decr., prolongs diazepam, warfarin & phenytoin eliminat., plasma
disord., stridor, incr.hepat. enzym., cholelithias., hepatit., hepat.fail./ vir/atazanavir & clopidogrel conc.of omeprazole & clarithromycin incr. with concom.admin.,
encephalopathy, skin reacts.incl.erythema multiforme/ Stev.Johns. Side effects: Bld.dyscras., hypersens.reacts. incl. anaphylax., hy- incr.digox.bioavail.
syndr./tox.epiderm. necrolys., alopec., photosens., arthralg., myalg., ponatraem., hypomagnesaem., hypocalcaem., hypokalaem., in-
arthrit., bone/joint disord., myasthen., sinovit., gynaecomast., galact- somn., agitat., revers.ment.confus., aggress., hallucinat., depress., MYLAN PANTOPRAZOLE, (Mylan) Xixia [P/S]
orrh., asthen., ren./urin. disords., interstit.nephrit.with poss.progress. CNS effs., paraesthes., malaise, fev., blurr. vis., vertigo, tinnit., pe- Pantoprazole., sodium sesquihydrate (equiv.to pantoprazole)
to ren.fail., menstr./penis/testis disord., vaginit., impot., dysmenorrh., riph. oed., angina, tachy-/ bradycard., bronchosp., cough, GI disturbs., Indications: 40 mg tabs: Short-term treatm.of duod.& gastr. ulc.,
breast tendern./enlargem., chills, flu syndr., gastric.gland.cysts dur. gastr.glandul.cysts, acid regurgitat., incr. GI bact., pancreatit., incr.liv. reflux oesophagit., duod.ulc. assoc.with H.pylori infect.in combinat.
long term treatm., incr. GI infect.risk due to incr.norm.GIT bact. counts. enzymes, hepatit.with/-out jaund., hepat. encephalopathy, hepat.ne- with appropr. antibiot., Zolling.-Ellison syndr.
Special precautions: Pass.into milk of rats & caus.tumorigen.effs.in cros., skin reacts.incl. erythema multiforme, prurit., photosens., tox. 20 mg tabs: Mild gastro-esophageal reflux dis (GERD) & the long
anim., excl.malign.bef.init. ther.esp.in old.pts.with new/recent.chang. epiderm. necrolys.& Stev.John.syndr., alopec., asthen., arthralg.& term managem.& relapse prevent. thereof, prevent.of NSAID-induc.
dyspept. sympt., concom. theophyll./OC’s/carbamazepine, admin.at myalg., musc.weakn., hip/ wrist or spine fract., interstit.nephrit., gastro-duod.les.& dyspept.sympt.in pts.at risk & need. contin.treatm.
least 30 mins.bef.sucralfate, antacids not to be giv.with.1 hr of ther., gynaecomast., incr.sweat. (S4) TABS, 44/11.4.3/0843, 0844
reflex oesophagit.diagn.to be confirm.by endoscopy, monit.concom. Warnings and special precautions: Not indicat. for min.GI 717420-001: 20 mg, 30, R118,90
warfar.as min.warfar.conc. reduct. poss., discont.ther.if persist. diarrh. complaints, limit.exper.in childr., excl. poss. malign., monit.pts.on 717421-001: 40 mg, 30, R185,08
devel., OTC Caps.not for mild GI compl. long-term treatm.(ie >1 yr), Vit B12 absorpt.reduc. theref. consid.in Dosage: Admin.recomm.dos.in the morn.bef./dur. breakf.
Drug interactions: Incr.theophyll.clear., reduc. bioavail.with ant- pts.with reduc.body stores/risk fact. for reduc.absorpt., consid.poss. Duod.ulc: 40 mg once dly. x2-4 wks. Use in combinat. with appropr.
acids, atazanavir expos.reduct., as weak induc.of cytochrome P450 interacts. with other meds.metabol.through CP2C19, monit. for poss. antibiot.when assoc.with H.Pylori.
enzyme syst. interacts. with drugs metabol.by this syst.poss., delay. effs.of hypomagnesaem./concom.meds. caus. hypomagnesaem., incr. Gastr.ulc.& reflux oesophagit: 40 mg once dly. x4-8 wks.
absorpt.with sucralphate, poss.interfer.with absorpt.of meds.where risk of hip/wrist & spine fract.with long term high dos.ther.in elderly Zolling.Ellison syndr: Init.80 mg/day, thereaft. titrat.up/down
gastr.pH is determin.of bioavailabil., conc.of both meds. incr.with or in pres.of other recogn.risk fact., osteoporos. risk pts., incr.risk of accord.to gastric acid secret. Dly. dos. above 80 mg/day to be ad-
voriconazole, drowsin.aggrav.by alcoh.& CNS depress. GI infects.due to decr.acid. incr. gastr.bact.counts, imp.hepat.funct., min.in 2 div.dos.
LANSOPRAZOLE UNICORN, Unicorn [P/S] incr. freq.of gastric glandul.cysts report.with long term use, eval. Mild GERD: 20 mg/day x4-8 wks. Recurr.sympt. contr. by 20 mg
once dly on demand.
Lansoprazole poss.S/E on driv.ability & hazard. machine operat., diab., sucrose Longt./GERD relapse prev: Recomm.maint. 20 mg/day incr.to
Indications: (S4) 30 mg: Short-term treatm.of gastric/ duod. ulc. & and lact. intol., high dos.ther.in elderly on digox.when monit. advis.,
reflux oesophagit. 15 mg: Short-term managem.of mild funct.dys- monit.concom.INR/phenytoin lev., consid. withdr. ther.with high-dos. 40 mg/day in case of relapse reduc.to 20 mg/day aft.heal.
NSAID induc.gastro-duod.les.& dyspeps. sympt: Recomm.
peps., gastro-oesophag.reflux relapse prophylax. In conjunct.with ap- methotrex. admin., safety in pregn./lactat.not est., long term use in
propr. antibiot.as part of eradicat. program.for H.Pylori-posit.duod.ulc. ren./ hepat.impairm.not est. dos.20 mg once dly.
Contraindications: Safety & effic.in childr.not est., sev.liv.funct.im-
(S2) 15 mg: Short term symptomat.heartburn & hyperacidity at Interactions: Incr./decr.absorpt.of meds with gastric PH depend.
max.15 mg dly dos.for max.14 days. absorpt., nelfinavir & atazanavir plasma lev.decr., digox.bioavailabil. pairm., concom.atazanavir, safety in pregn.& lactat.not est.
Side effects: Bld.dyscras., GI disturbs., periph. oed., sev.hepatocel-
(S4) & (S2) CAPS, 40/11.4.3/0249, 0250 incr., expos.to clopidogrel act.metabol.decr., absorpt. of posconazole/
715079-002: 15 mg, 14, R57,31 dasatinib/erlotinib/ ketoconaz. & itraconaz.signif.reduc.imp.clinic. ef- lul.damage lead.to jaund.with/ without liv.fail., anaphylact.reacts.
715079-001: 15 mg, 30, R122,82 fic., metabol.of other meds.metabol.by hepat. P450 cytochrome en- incl.shock, incr. liv.enzym., elev.triglycerid., incr.body temp., arthralg.,
715080-001: 30 mg, 30, R158,88 zyme poss.affect., prolong. elimin. of diazepam/warfar/other vit.K myalg., headache, dizzin., blurr.vis., depress., interstit.nephrit., allerg.
Dosage: Take pref.bef.meals using low.dos.& short.durat. antagon./ cilostazol & phenytoin, fluvoxam.incr.expos.in extens. me- reacts.incl.sev. skin reacts.such as Stev.-John./ Lyell’s syndr./ erythem.
Gastr.ulc: 30 mg once dly.for upto 8 wks. tabolis., saquinavir/ritonavir/ tacrolimus plasma lev.incr., methotrex. multiforme, photosens.
Duod.ulc: 30 mg once dly.for upto 4 wks. As part of eradicat.pro- lev.incr., subst. known to inhib.CYP2C19/CYP3A4 may incr. Lokit ser. Special precautions: 40 mg Tabs.cont. tartrazine, aspir.cross-sens.,
gram.with appropr.antibiot.for H.pylor posit.ulc. lev.while induc.will decr.Lokit ser. lev, with concom.voriconaz.expos. excl.poss.malign., not to exceed 20 mg dly in mild-mod.liv.impairm.,
Oesophagit.due to gastro-oesophag.reflux: 30 mg once dly.x4 to both meds. incr.theref.dos.adjustm.poss.necess.in sev. hepat. im- monit. liv.enzym.reg.in sev.impairm.esp.dur.longt. use & discont.
wks., rep.4 wk.course poss. necess. pairm./long term ther., plasma conc. incr. with clarithromycin, absorpt. if elev., not indic.for mild GI compl., may allev. malign.ulc.sympt.&
Gastro-oesophageal reflux prevent: Maint: 15 mg once dly. of Vit.B 12 reduc., concom. CNS depress.& alcoh.may potent.any CNS delay diagn., confirm reflux oesophag.diagn.by endoscopy, poss.
for max.1 yr. eff., elimin.of diazepam/warfar.& phenytoin prolong. cyanocobalam. malabsorpt.with prolong.treatm. (ie.>3 yrs.), monit.
Funct.dyspeps: Adults: 15-30 mg once dly.x2-4 wks. Elderly: Max. LOSEC, AstraZeneca [P/S] prothromb.time/INH esp.when ther. init./discont./admin.irreg., exper.
dly dos: 30 mg. Omeprazole. in longt. admin.limit., cont.NSAID treatm.in risk pts.
Heartburn & hyperacidity: 15 mg dly.for up to max.14 days. Con- Indications: Adults: Duod.ulc.incl.relap.prev., gastr.ulc., reflux oe- Drug interactions: Poss.changes in absorpt.of pH-depend.meds.
sult practit.should sympt.persist / get worse/cont.dur.or aft.treatm. sophagit.incl.long-term managem., Zollinger-Ellison syndr., symp- eg. ketoconazole/ampicill. esters/ Fe salts, poss.interacts.with oth-
Contra-indications: Pregn.& lactat., liv.impairm., safety & effic. tomat. heartburn rel., gastro-oesophag.reflux dis., short-term rel. er meds. metab.by hepat.cytochrome P450-enzyme syst., anticoag.
in childr.not est., heredit.probl./ galact. intol.hist., Lapp lact.defic., of funct. dyspeps., duod.ulc.assoc.with H.pylori infect.in combinat. respons.poss.affect.
gluc.-galact. malabsorpt. with appropr.antibiot., NSAID assoc. gastric and/duod.ulc./reduc. NECTIZOLE, (Activo) Abex [P/S]
Side effects: Bld.dyscras., oed., CNS effs., headache, dizzin., tremor, the assoc. risk of develop.such ulc.& reduc.the poss.of relapse of Esomeprazole magnes.dihydr.equiv.to esomeprazole
GI disturbs.incl. ulcerat.colit., dry mouth, glossit., gynaecomast., ga- such assoc.ulc. Indications: Eros.reflux oesophagit., relapse prophylax. in heal.
lactorrh., elev.hepat.enzym., asthen., arthralg., myalg., blurr.vis., skin Childr: Short term treatm.of sev.ulcerat.reflux oesophagit. oesophagit., symptomat.treatm. of GORD, prevent.of gastr.& duod.
reacts., alopec., fev., incr. freq.of gastr.glandul.cysts.dur long term (S4) MUPS TABS. 32/11.4.3/0222, 0223 ulc.assoc.with NSAID ther., in combin.with appropr.antibiot.in duod.
treatm.& incr.gastric.bact.counts result.from inhibit.of gastr. acid se- 849383-005: 10 mg, 28, R420,12 ulc.heal.& relapse prevent.of pept.ulc. assoc. with H.pylori infect.,
cret.incr.risk of GIT infects. 849391-016: 20 mg, 28, R701,41 patholog.hypersecret. condits.incl.Zollinger-Ellison syndr.& idi-
Special precautions: Excl.malign.bef.init.ther.as treatm. poss.al- Dosage: Swallow whole in morn., do not chew or crush. Disperse opath. hypersecret.
lev.sympt.& delay diagn., monit. concom.warfar., distrib.into milk of in water/fruit juice and take within 30 mins. (S4) GASTRO-RESIST.TABS. 48/11.4.3/0438, 0439
lactat.rats, poss.tumorigen.effs.in animals, confirm.reflux. oesophagit. 721061-001: 20 mg, 30, R220,54
diagnos. by endoscopy, incr.clostrid. diffic.assoc.diarrh.risk. Duod.ulc: 20 mg dly x2-4 wks. 721062-001: 40 mg, 30, R329,30
Relapse prev: 10 mg once dly.if need.incr.dose to 20-40 mg dly.
Drug interactions: Sedat.eff.potent.by CNS depress. & alcoh., Dosage: Admin.at least 30 mins. bef.meals. Do not chew/crush.
poss.interacts.with drugs metabol. by cytochrome P450 syst., war- H.pylori posit.duod.ulc: Losec as part of the eradicat. programme May be dispers.in non-carbon. water if diffic.swall. Admin.low.dos.&
with appropr.antibiot.
far.conc. poss.reduc.
Gastr.ulc.& reflux oesophagit: 20 mg dly x4-8 wks. for short. treatm. durat.
LOKIT, (Cipla) Pharmascript [P/S] Gastr.ulc.& reflux oesophagit: Refract.to other treatm.regimens: Adults & adolesc.from 12 yrs:
Omeprazole 40 mg once dly.may be effect. Eros.reflux oesphagit: 40 mg once dly.x4 wks. Addit.4 wks.recomm.
Indications: Adults: Duod.ulc.incl.prev.of relapse, gastr.ulc., reflux Reflux oesophagit.long-term treatm: 10 mg once dly incr.to 20- if not heal./sympts.persist.
oeosphagit., Zollinger-Ellison syndr., gastro-oesophag.reflux dis. 40 mg once dly.if need. Longt.relapse prevent.of heal.oesophagit: 20 mg once dly.
(GORD), funct. dyspeps., duod.ulc.assoc.with H Pylor infect.in combi- Sev/recurr.reflux oesophagit: contin.with 20 mg dly. Symptomat.GORD: Without oesophagit.admin. 20 mg once dly.
nat.with suit.antibiot., treatm. of NSAID’s assoc.gastr.&/or duod.ulc.& Sev.ulcerat.reflux oesophagit.in childr.1 yr. & old: 10-20 kg: Furth.investig.if sympt.contr.not achiev. aft.4 wks. Admin.20 mg once
eros., reduc.risk of develop.gastric and/or duod. ulc. /eros.,reduc.risk 10 mg once dly. >20 kg: 20 mg once dly. If necess.incr.dos.to 20 mg dly.if necess. when sympt.resolv.
of relapse of prev.heal. gastr. &/or duod.ulc.& eros.in pts.on NSAID & 40 mg respectiv. Gastric/duod.ulc.prevent with NSAID ther: 20-40 mg once dly.
ther. Childr>20 kg: Short term treatm.(up to 3 mnths) of sev. ulcerat. NSAID assoc.gastroduod.les: 20 mg once dly. with heal.gen.with- H.Pylori assoc.ulc.& relapse prevent.of such ulc: 20 mg in com-
reflux oesophagit.resist.to prev. med. treatm. in 4 wks. If full heal.not achiev. aft.init.course contin.for furth.4 wks. binat.with amoxicillin 1 g and clarithromycin 500 mg 2xdly x7 days.
178 / 2020-04 Gastro-Intestinal Tract - 12.4.4
Pathol.hypersecret.condits.incl.Zollinger-Ellison syndr. & Eros.reflux oesphagit: 40 mg once dly.x4 wks. If not heal./sympts. ulc.prev.in at risk pts., duod.ulc.& prevent.of relapse of pept. ulc.as-
idiopath.hypersecret: Init. dos. 40 mg 2xdly.then indiv.adjust.for persist contin.for addit.4 wks. soc.with H.pylori infect.,
as long as need. Up to 120 mg 2xdly has been giv. Relapse prevent.of heal.oesophagit: 20 mg once dly. (S4) GASTRO-RESIST.TABS. 45/11.4.3/0125, 0126
Contraindications: Substit.benzimidazol. hypersens., concom. Symptomat.GORD: If oesophagit.not pres admin. 20 mg once dly. 720753-001: 20 mg, 30, R244,15
atazanavir/nelfinavir. Subseq.sympt.contr.can be achiev. on a demand regimen of 20 mg 720754-001: 40 mg, 30, R376,60
Side effects: C.diffic.assoc.diarrh., GI disturbs. incl. candidias., resp. once dly. If sympt. contr.not achiev.aft.4 wks.investig.furth. Dosage:.Do not chew/crush. For pts.unable to swall.disperse in non-
infect., sinusit., pancreatit., bld. dyscras., hypersens.reacts.incl.angi- Contin.NSAID ther: 20-40 mg once dly. carbon.water and drink liq.with pellets.
oed.& anaphylax., oed., hyponatraem., hypomagnesaem., psych./ H.Pylori assoc.ulc.& relapse prevent.of such ulc: 20 mg 2xdly Eros.reflux oesphagit: 40 mg once dly.x4 wks. Addit.4 wks.recomm.
ren./urin.disords., CNS effs., headache, dizzin., paraesthes., fatig., x7 days in combinat.with amoxicillin 1 g and clarithromycin 500 if not heal./sympts persist.
blurr.vis., vertigo, taste disturbs., bronchosp., dry mouth, stomatit., mg at same interv. Relapse prevent.of heal.oesophagit: 20 mg once dly.
incr. liv. enzym., hepatit.with/without jaund., hepat.fail., skin reacts. (S4) GRAN, 42/11.4.3/1003 Symptomat.GORD: If oesophagit.not pres admin. 20 mg once dly.
incl.erythem.multiforme/ Stev. -John. syndr./tox.epiderm.necrolys., Indications: Eros.reflux oesophagit., relapse prophylax. in heal. Once sympt.resolv.20 mg once dly.when necess. If sympt.contr.not
alopec., photosens., arthralg., myalg., musc.weakn., hip/ spine/ wrist oesophagit., symptomat. treatm. of GORD, prev.gastric & duod.ulc. achiev. aft.4 wks.investig.furth.
fract., gynaecomast., incr.sweat., malaise. assoc. with NSAID ther.in risk pts., duod.ulc.& prevent. of relapse of Gastric/duod.ulc.prevent with NSAID ther: 20-40 mg once dly.
Warnings and special precautions: Not for mild GI complaints, such ulc.assoc.with H.pylori infect. in combinat.with appropr.anti- H.pylori assoc.ulc.& relapse prevent.of such ulc: 20 mg in com-
excl.poss.malign.& gastr.ulc., incr. risk of GI infects. incl.C.diffic., monit. biot., pathologic. hypersecret. condit.incl.Zollinger-Ellison syndr.& binat. with amoxicillin 1 g and clarithromycin 500 mg2xdly x7 days
longt. ther., safety in pregn.& lactat.not est., no data for childr. bel. idiopath.hypersecret. (S4) POWD.FOR SOL.FOR INJ./INFUS. 46/11.4.3/0606
12 yrs., sev.ren.insuff./liv.impairm., monit. concom.phenytoin init.& 715868-001: 10 mg/sachet, 28, R401,52 Indications: Alternat.to oral ther.for short.poss. durat.in eros.reflux
when withdr., concom. anticoags., avoid concom.clopidogrel, concom. Dosage: Disolv.sach.contents in 15 ml water and leave to thicken and oesophagit., relapse prophylax. in heal.oesophagit., sev.reflux dis.
high-dos.methotrex.ther., incr.wrist/hip/ spine fract. with prolong.use/ admin.within 30 mins. Admin. orally or by nasogastr.tube. sympts., haemostas. maint.& prev.of rebleed.follow. therapeut. en-
high dos., elderly, adeq. Vit.D & Ca intake where osteoporos.risk, sev. Eros.reflux oesphagit: Adults & adolesc.12-18 yrs: 40 mg doscopy for ac.bleed.gastr./duod.ulc.
hypomagnesaem., monit.mg.lev.bef.init./ dur. ther.if prolong./with once dly.x4 wks. If not heal./sympts. persist contin.for addit.4 wks. 723472-001: 40 mg, 10x5 ml vials, R699,20
concom.digox./meds. caus. hypomagnesaem., concom.voriconazole Childr.1-11 yrs: <20 kg: 10 mg once dly.x8 wks. >20 kg: 10-20 mg Dosage: Discont.IV ther.& cont.with oral ther. when poss./ap-
esp. where sev. hepat.impairm.& long.ther.indic. once dly.x8 wks. propr. May be admin.for up to 7 days as part of full treatm.per.for
Interactions: Dasatinib absorpt.reduc., incr. plasma conc.of meds.me- Relapse prevent.of heal.oesophagit: Adults & adolesc.12-18 specif.indicat.
tabol.by CYP2C19 enzym., elimin. half-life of cisapride prolong.but not yrs: 20 mg once dly. Childr.1-11 yrs: 10 mg once dly. Eros.reflux.oesophagit: 40 mg once dly.x4 wks. Addit.4 wks.
signif. incr. in peak plasma lev., elev.INH with warfar., antiplatel. eff. Symptomat.GORD: Adults & adolesc.12-18 yrs: If oesophagit.not recomm.when oesophgit.not heal./ sympts.persist.
of clopidogrel poss.reduc., incr. digoxin bioavailabil., absorpt.of oral.- pres admin. 20 mg once dly. Subseq. sympt.contr.can be achiev.on a Relapse prophylax. in heal.oesophagit. & sev, reflux dis.
admin.ion salts decr., methotrex.ser.conc.elev., bioavail.of any meds. demand regimen of 20 mg once dly. If sympt.contr.not achiev. aft.4 sympts: 20 mg once dly.
with pH depend.absorpt.potent.affect. such as prot.inhibits./antifung. wks.investig.furth. Childr.1-11 yrs: 10 mg once dly.for upto 8 wks. Haemostas.maint.& prev.of rebleed.of gastr./ duod.ulc: 80 mg
agents, decr. atazanavir/ nelfinavir conc., metab.of other meds. me- Contin.NSAID ther: Adults: 20-40 mg once dly. as bolus infus.x30 mins.follow.by contin.IV infus.of 8 mg/hr x3 days.
tabol. via cytochrome P450 enzym.syst.poss. affect., protease inhib.ab- H.Pylori assoc.ulc.& relapse prevent.of such ulc: Adults: Follow with 40 mg orally once dly.x4 wks.
sorpt.poss.chang.by incr. gastr. pH, incr.plasma lev.with clarithromycin, 20 mg 2xdly x7 days in combinat.with amoxicillin 1 g and clarithro- Contraindications: Substit.benzimidazol. hypersens., concom.
decr. ser. lev.with meds.known to induce CYP2C19/ CYP23A4 or both mycin 500 mg at same interv. atazanavir/nelfinavir & clopidogrel
eg.St John’s Wort/ rifampicin, both esomeprazole & voriconazole plas- Patholog.hypersecret.condits: Adults: Init. 40 mg 2xdly.thereaft. Side effects: C.difficile assoc.diarrh., bld. dyscras., hypersens.re-
ma conc. poss.incr., ketoconazole & itraconazole absorpt. poss.decr. indiv.and cont.as indicat. Dos. of upto 120 mg 2xdly.have been admin. acts., headache, dizzin., somnol., paraesthes., insomn., confus., ag-
NESOPRAM, (Cipla Medpro) Ranbaxy[P/S] (S4) GRAN, 44/11.4.3/0208, 0209 gress., agitat., hallucinat., depress., blurr.vis., eye disords., vertigo,
Esomeprazole magnes.equiv.to esomeprazole Indications: Reduc.intra-oesophag.pH by reduc. gastric reflux tinnit., angina, tachycard., bradycard., bronchosp., cough., periph.
Indications: Eros.reflux oesophagit., relapse prophylax. in heal.oe- acidity in neonates & infts, gastro-oesophag.reflux dis.confirmby oed., hyponatraem., GI disturbs., dry mouth, stomat., candidias.,
sophagit., symptomat.treatm. of GORD, prevent.of gastric & duod. pH probe/ endoscopy. pancreatit., microscop.colit., taste disturbs., incr.liv.enzym., hepatit.
ulc.assoc.with NSAID ther., duod.ulc.& prevent.of relapse of pept. 720048-001: 2,5 mg/sachet, 28, R401,52 with/without jaund., hepat.fail., hepat.encephalopathy, skin rash.
ulc.assoc.with H.pylori infect. 720053-001: 5 mg/sachet, 28, R401,52 incl.erythem.multiforme/Stev.-John.syndr./ tox. epiderm.necrolys.,
(S4) GASTRO-RESIST.TABS. 45/11.4.3/0123, 0124 Dosage: Disolv.sach.contents in 5 ml water and leave to thicken prurit., urticar., photosens., arthralg., myalg., musc. weakn., back
721089-001: 20 mg, 30, R238,89 and admin.within 30 mins. Admin. orally or by nasogastr.tube flush. pain, interstit. nephrit., urin. disords., impot., gynaecomast., fatig.,
721090-001: 40 mg, 30, R367,47 nasogastric tube aft.admin. Dos.over 1,33 mg/kg/ day not stud. hyperhidros., malaise, admin. site reacts.for parenter.admin., sev.
Dosage: Do not chew/crush. Maybe dispers.in non-carbon.water GORD: Childr.0-1 yrs (1-11 mnths): 3-5 kg: 2,5 mg once dly.for up hypomagnesaem., subac.cutan.lupus erythematos(SCLE), hip/wrist/
swallow.liq.with pellets. Admin. low.dos.& for short.treatm.durat. to 6 wks. >5-7,5 kg: 5 mg once dly.for up to 6 wks. >7,5-12 kg: 10 spine fract.predom. in elderly/those with risk fact.with high dos. pro-
for treat.condit. mg once dly.for up to 6 wks. long. treatm., incr.CgA lev.
Eros.reflux oesphagit: 40 mg once dly.x4 wks. Addit.4 wks.recomm. (S4) IV INJ/INFUS, A38/11.4.3/0384 Warnings and special precautions: Tabs.not for mild GI compl.,
if not heal./sympts persist. 704470-002: 40 mg/vial, 10x5 ml, R810,89 excl.poss.malign., monit.long-term ther., monit.concom.warfar., incr.
Relapse prevent.of heal.oesophagit: 20 mg once dly. Indications: Gastroesophageal reflux dis.where oral ther.not appro- ser.gastrin in respons.to decr.acid secret., incr.GI infects.poss. due to
Symptomat.GORD: Without oesophagit.admin. 20 mg once dly. pr., eros.reflux oesophagit., long-term managem.of heal.oesophagit. incr.gastr.bact.counts, poss.Vit.B absorpt. reduct.to be consid.in pts.
Once sympt.resolv.admin.20 mg once dly.when necess. If sympt. to prev. relapse, short term haemostas.maint.& prevent. of rebleed. with reduc.body stores/ risk fact.for reduc.vit.B12 absorpt., monit.Mg
contr.not achiev. aft.4 wks.investig.furth. follow.therapeut.endoscopy for ac. bleed. gastric/duod.ulc. lev. bef. init./dur.prolong.ther./with concom.digox/ meds.caus.hy-
Gastric/duod.ulc.prevent with NSAID ther: 20-40 mg once dly. Dosage: Admin.for short.poss.time. May be giv. x7 days. Tfd.to oral pomagnesaem., seek med.assist.& poss.discont.if SCLE les.appear
H.Pylori assoc.ulc.& relapse prevent.of such ulc: 20 mg in com- ther.ASAP. Reconstit.only with 0,9% NaCl for IV use. Admin.IV inj. esp.in sun-expos. skin areas, incr.risk of SCLE if exper.aft.prev.PPI
binat. with amoxicillin 1 g and clarithromycin 500 mg 2xdly x7 days over 3 mins. & IV infus.over 10-30 mins. treatm., incr.fract.risk, adeq.vit.D & Ca intake in pts. at osteoporos.
Contra-indications: Substit.benzimidazol. hypersens., concom. Eros.reflux oesophagit: 40 mg once dly.x4 wks.. Addit.4 wks. risk, incr.CV events.with concom. clopidogrel theref.to be avoid., poss.
atazanavir/nelfinavir, recomm.where oesophagit.not heal./if sympts.persist. interfer.with neuroendocr.tumour investig.theref. discont.5 days bef.
Side-effects: C.diffic.assoc.diarrh., bld.dyscras., hypersens.reacts. Long term managem.of heal.oesophagit.to prev. relapse: CgA meas., no exper.in childr., sev. ren.insuff., max.20 mg/day in sev.
incl.angioed.& anaphylax., headache, dizzin., paraesthes., somnol., 20 mg once dly. liv.impairm., consid. C.difficile diagnos.for diarrh.not improv., monit.
psych. disords.incl.revers.confus.state, blurr.vis., vertigo, periph. Sev.reflux dis.sympts: 20 mg once dly. concom. phenytoin/warfar or other coumar. derivat. plasma conc.,
oed., GI disturbs., abdom.pain, dry mouth, stomat., taste disturbs., Haemostas.maint.& prevent.of rebleed.of gastric /duod.ulc: safety in pregn.& lactat.not est.
incr.liv.enzym., hepatit. with/without jaund., hepat.encephalopathy, 80 mg as bolus infus.over 30 mins. follow.by contin.IV infus.8 mg/ Drug interactions: Absorpt.any med.whose absorpt. is pH depend.
skin reacts.incl.erythem. multiforme/Stev.-John.syndr./ tox.epiderm. hr over 3 days. Follow parenter.treatm.with acid suppress.ther of potent.affect., ketoconazole & itraconazole absorpt.reduc., poss.decr.
necrolys., photosens., arthralg., myalg., interstit.nephrit., impot., gy- Nexiam 40 mg once dly.x4 wks. clear.of meds. metabol.by CYP2C19 enzyme eg diazepam/ citalopram/
naecomast., fatig., incr.sweat., malaise. Contraindications: No paed.exper.for MUPS tabs. /inj., sachets in imipramine/clomipramine/warfar & phenytoin, eliminat.half-life of
Warnings and special precautions: Not for mild GI complaints, childr.und.1 yr., safety in pregn. & lactat.not est., hypersens.to substit. cisapride prolong., pharmacokinet./pharmacodynam.cardiovasc.event
excl.poss.malign.& gastric ulc., monit.long-term ther., concom.clopi- benzimidazoles, concom.atazanavir & nelfinavir interact. with clopidogrel, atazanavir & nelfinavir conc. decr., CYP3A4
dogrel to be avoid., safety in pregn.& lactat.not est., no exper. with Side effects: Headache, dizzin., paraesthes., somnol., taste dis- inhibit.clarithromyc.doubl.AUC expos., incr.methotrex./tacrolimus lev.,
childr., sev.ren.insuffic., max.dly.dos.of 20 mg in sev.hepat.impairm., turbs., GI disturbs., abdom.pain, dry mouth, stomatit., GI candidias., digox. absorpt. incr., cilostazol AUC incr.
incr.risk of GI infects. incl.C.diffic., skin reacts., alopec., photosens., bld.dyscras., rare hypersens. re- NEXMEZOL, Sandoz [P/S]
Drug interactions: Absorpt.of any med.whose absorpt.mechan.is acts.incl.erythem.multiforme/Stev.-John.& tox. epiderm.necrolys., Esomeprazole
influenc.by gastric acid., poss.decr.clear.of meds.metabol.by CYP2C19 periph.oed., hyponatraem., insomn., psych.disturbs., blurr.vis., verti- Indications: Eros.reflux oesophagit., relapse prophylax. in heal.oe-
enzyme, phenytoin & warfar.R-isomer trough plasma lev.incr., elimi- go, bronchosp., incr.liv.enzymes, hepatit.with/without jaund., hepat. sophagit., symptomat.treatm. of GORD, duod.ulc.& prevent.of relapse
nat.half-life of cisapride prolong.but not signific.incr.in peak plasma encephalopathy/fail., arthralg., myalg., gynaecomast., malaise, hy- of pept. ulc.assoc.with H.pylori infect.
lev., antiplatelet.eff.of clopidogrel poss.reduc., atazanavir & nelfinavir perhidros., musc. weakn., interstit.nephrit., gastr.glandul. cysts with (S4) TABS. 44/11.4.3/0335, 0336
conc.decr., metabol.by CYP3A4 & concom admin.of CYP3A4 inhibit long term.oral treatm.due to acid secret. inhibit, loc.reacts.with high 718879-001: 20 mg, 14, R119,10
clarithromyc.doubl.esomeprazole AUC expos. dos.IV expos.x3 days 718879-002: 20 mg, 28, R238,21
Special precautions: Not for mild GI complaints, excl.poss.malign.,
NEXIAM, AstraZeneca [P/S] monit.long-term ther., investig. GORD further if sympt.control not 718880-001: 40 mg, 14, R180,28
Esomeprazole. acheiv.aft.4 wks., sev.ren.insuffic., sev.imp.hepat.funct., close monit. 718880-002: 40 mg, 28, R360,66
Indications: Eros.reflux oesophagit., relapse prophylax. in heal. with concom.warfar./other coumar. anticoags., do not mix./co-admin. Dosage: Swallow with liq.without crush./chew.
oesophagit., symptomat.treatm. of GORD, prev.gastric & duod.ulc. inj.with any other drug/ in same infus.set., incr.GI infect.(eg Salmo- Eros.reflux oesphagit: 40 mg once dly.x4 wks. Addit.4 wks.
assoc.with NSAID ther.in risk pts., duod.ulc.& prevent. of relapse nella & Campylobacter.) risk due to decr. gastric. acid.incr.bact.counts recomm.if not heal.
of such ulc.assoc.with H.pylori infect.in combinat. with appropr. Drug interactions: Poss.incr./decr.absorpt.of drugs whose absorpt. Relapse prevent.of heal.oesophagit: 20 mg once dly.
antibiot., patholog. hypersecret. condit.incl.Zollinger-Ellison syndr.& is influenc.by gastric acid., ketoconazole & itraconazole absorpt.decr., Symptomat.GORD: If oesophagit.not pres admin. 20 mg once dly.
idiopath. hypersecret. poss. incr. plasma conc.of meds.metabol.by CYP2C19 enzyme, diaz- Once sympt.resolv.20 mg once dly.when necess. If sympt.contr.not
(S4) MUPS TABS. 35/11.4.3/0263, 0264 epam clear.decr., incr.phenytoin plasma conc., elev.INR with warfar., achiev. aft.4 wks.investig.furth.
897132-009: 20 mg, 14, R210,40 atazanavir & nelfinavir ser.lev.decr., CYP2C19&/CYP3A4 inhibit. incr. H.Pylori assoc.ulc.& relapse prevent.of such ulc: 20 mg in com-
897132-017: 20 mg, 28, R420,80 esomepraz.expos., CYP2C19&/CYP3A4 induc. decr. ser.lev. binat. with amoxicillin 1 g and clarithromycin 500 mg2xdly x7 days
897125-002: 40 mg, 14, R324,48 Contraindications: Substit.benzimidazol. hypersens., concom.
897125-009: 40 mg, 28, R648,96 NEXIPRAZ, Ranbaxy [P/S] atazanavir/nelfinavir, safety in pregn.& lactat. not est., safety & ef-
Dosage: Swallow whole with liq., do not chew or crush. May Esomeprazole magnes.equiv.to esomeprazole fic.in childr.not est.
be dispers.in non-carbon.water stir. until tabs disintergrate, drink. Indications: Eros.reflux oesophagit., relapse prophylax. in heal.oe- Side effects: Skin reacts.incl.erythem. multiforme/ Stev.-John.syndr./
liq.with pellets. sophagit., symptomat.treatm. of GORD, assoc.NSAID gastr.& duod. tox.epiderm. necrolys., arthralg., myalg., myopathy, headache, dizzin.,
Gastro-Intestinal Tract - 12.4.4 2020-04 / 179
dry mouth, GI disturbs., dyspeps., pancreatit., incr.liv.enzym., hepatit. OMEZ, Dr Reddy’s Laboratories [P/S] with appropr. antibiot., Zollinger-Ellison syndr.
with/ without jaund., sinusit., resp.infect., angioed., anaphylact. reacts. Omeprazole 20 mg tabs: Mild gastro-oesophageal reflux dis (GERD) & the long-
Special precautions: Excl.poss.malign., monit. long-term ther., not Indications: Adults: Duod.ulc.incl.relap.prev.of gastr. ulc.& reflux term managem.& relapse prevent. thereof., prev.of NSAID induc.
for mild GI compl., sev.ren. insuff./sev.liv.impairm., not for use with oeosphagit., long term managem. reflux oeosphagit.& Zollinger-El- gastro-duod.les.& dyspept.sympts.
gluc.-galact. malabsorpt.syndr./fruct.intol.& sucr.-isomaltase defic. lison syndr., heartburn relief in gastro-oesophag. reflux dis. (GORD), Inj: Above 40 mg tab.indicat.when oral ther.not suitable.
Drug interactions: Poss.incr.plasma conc.of meds. metabol.by short term funct.dyspeps., H Pylor posit. duod.ulc.in combinat.with (S4) TABS, [P/S] 34/11.4.3/0005, 28/11.4.3/0407.
CYP2C19 enzyme eg diazepam/ citalopram/warfar & phenytoin, appropr. antibiot., treatm.of & risk reduct.of NSAID assoc. gastric &/ 881589-004: 20 mg, 28, R305,86
incr.clear.of imipramine/sev.antipsychot./tacrine & theophyll., plas- duod.ulc.& reduc.relapse risk of prev. heal.ulc./eros. 811793-001: 40 mg, 14, R288,47
ma conc.of both meds.incr.with concom. voriconazole, bioavailabil.of Childr: Short term (3 mnths) treatm.of sev. ulcerat. reflux oesophagit. 811793-028: 40 mg, 28, R577,06
any med.whose absorpt. is pH depend.potent.affect., ketoconazole & resist.to prev.med. treatm. (S4) IV INJ, [P/S] 33/11.4.3/0041
itraconazole absorpt.reduc., esomeprazole & 14-hydroxyclarithromyc. (S4) CAPS, 34/11.4.3/0299, 0300, 0301 878197-001: 40 mg/vial, 5 vials, R763,52
plasma lev.incr., atazanavir & nelfinavir conc.decr. 703461-001: 10 mg, 30, R190,85 Dosage: Inj.for IV use only over 2-15 mins.max. x7 days transf.then
NEXOMEP, (Unicorn) Sandoz [P/S] 703459-001: 20 mg, 30, R180,75 to oral ther. Take dly.oral dos.in the morn.
Duod.ulc: 40 mg once dly. x2-4 wks. Use in combinat. with appropr.
706688-001: 40 mg, 14, R162,75
Esomeprazole magnes.dihydrate equiv.to esomeprazole 706688-003: 40 mg, 30, R348,80 antibiot.when assoc.with H.Pylori.
Indications: Eros.reflux oesophagit., relapse prophylax. in heal. Dosage: Swallow whole. Do not chew/crush. Gastr.ulc.& reflux oesophagit: 40 mg once dly. x4-8 wks.
oesophagit., symptomat.treatm. of GORD, as adjunct.ther.in duod. Adults: Zollinger-Ellison syndr: Init.80 mg dly.thereaft. titrat.as necess.
ulc.assoc.with H. Pylori infect./ risk reduct.of pept.ulc recurr.in Duod.ulc: 20 mg dly.x2-4 wks. In pts.refract.to other treatm: 40 mg Admin.dly.dos above 80 mg in 2 div.dos. If rapid acid control reqd.
H.Pylori assoc.ulc. dly.may be effect. Prev.of relapse: 10 mg once dly.if necess.incr.to admin init.2x80 mg IV then transf.to oral ther as soon as clinic. justif.
(S4) TABS. 44/11.4.3/0337, 0338 20-40 mg once dly. Above recomm.regimen incl.ofH Pylori infect.in Mild GERD: 20 mg/day x4-8 wks. Reoccurr. sympts.control.by 20
721578-001: 20 mg, 28, R238,22 combinat.with appropr.antibiot. mg once dly on demand.
721579-001: 40 mg, 28, R360,66 Gastric ulc.& reflux oesophagit: 20 mg dly. x4-8 wks. When re- Long-term/GERD relapse prevent: Recomm. maint: 20 mg/day
Dosage: Do not chew/crush. Swall.with liq. fract.to other treatm.regimens 40 mg once dly.may be effect. Long- incr. to 40 mg/day in case of relapse reduc.to 20 mg dly aft.heal.
Eros.reflux oesphagit: 40 mg once dly.x4 wks. Addit.4 wks.recomm. term reflux oesophagit. mangem: 20 mg once dly.incr.to 20 or 40 mg NSAID induc.gastro-duod.les.& dyspept. sympts.prev:
if not heal./sympts persist. once dly.if necess. In sev./symptomat. recurr. reflux oesophagit. Recomm.dos: 20 mg once dly.
Relapse prevent.of heal.oesophagit: 20 mg once dly. contin.with 20 mg dly. Contraindications: Safety in pregn.& lactat.& safety & effic.in
Symptomat.GORD without oesophagit: 20 mg once dly. Once NSAID-assoc.gastroduod.les.with./-out cont. NSAID treatm: childr.not est., sev.liv.funct. impairm. Inj. Not recomm.for min com-
sympt.resolv.admin.20 mg once dly.when necess. If sympt.contr.not 20 mg once dly. If not heal. within 4 wks.contin.treatm.for furth.4 wks. plaints.or long term treatm.as clinic.data insuffic., concom. atazanavir
achiev. aft.4 wks.investig.furth. NSAID-assoc.gastroduod.les.& dyspept. sympt. prophylax: Side effects: Bld..dyscras., allerg.reacts. incl. anaphylax.& sev.skin
H.Pylori assoc.duod.ulc.& assoc.pept.ulc.risk reduct: 20 mg 20 mg once dly. reacts., hyperlipidaem., weight changes, sleep disords., depress., dis-
in combinat. with amoxicillin 1 g and clarithromycin 500 mg 2xdly Symptomat.gastro-oesophag.reflux dis: Indiv. 10-20 mg once dly. orientat., headache, dizzin., taste disturbs., vis. disturbs., GI disturbs.,
x7 days. Investig.furth.if sympt. contr.not achiev.aft.2 wks.treatm.at 20 mg dly. dry mouth, incr.bilirub., arthralg., myalg., asthen., fatig., malaise, incr.
Contraindications: Substit.benzimidazol. hypersens., concom. Zollinger-Ellison syndr: Init.60 mg dly. Indiv.& contin. as long as body temp., periph.oed., inj.site thrombophlebit., incr. liv. enzymes.
atazanavir/nelfinavir. clinic.reqd. Admin.dos.over 80 mg dly.in 2 div.dos. Special precautions: Monit.concom.anticoag. ther., excl.poss.
Side effects: Skin reacts.incl.erythem. multiforme/Stev.-John. Sev.ulcerat.reflux oesophagit.childr: 1 yr & old: 10-20 kg: malign., not to exceed 20 mg dly in mild-mod.liv.impairm., monit.liv.
syndr./tox.epiderm. necrolys., myalg., arthralg., myopathy, CNS 10 mg once dly.incr.to 20 mg dly if necess. >20 kg: 20 mg once dly. funct.in pres.of impairm.discont.if elev., not to exceed 40 mg in el-
effs., headache, dizzin., dry mouth, GI disturbs., pancreatit., hepatit. incr.to 40 mg dly if necess. derly/ imp.ren.funct., confirm reflux oesophag. diagn. by endoscopy,
with/without jaund., incr.liv. enzym., sinusit., resp.infect., angioed., Contraindications: Safety in pregn./lactat.not est. restrict.gastroduod.NSAID induc. ulc.prophylax.to those at incr.risk,
anaphylact. reacts. Side effects: Bld.dyscras., gynaecomast., hyponatraem., revers. poss. cyanocobalam malabsorpt.with prolong.treatm. (ie.>3 yrs.).
Warnings and special precautions: Safety in pregn.& lactat.not ment.confus./agitat./ aggress./ depress.& hallucinat., CNS effs., par- Drug interactions: Poss.changes in absorpt.of pH-depend.meds.
est., safety & effic.in childr.not est., sev.ren.insuff./liv.impairm., excl. aesthes., blurr.vis., periph.oed., bronchosp., GI disturbs., dry mouth, eg. ketoconazole, methotrex. ser. lev.elev.& prolong
poss.malign. & gastric ulc., poss.mask sympt./delay diagn., monit. stomatit., oesophag. candidias., taste disturbs., hepatit.with/without
long-term ther., not for mild GI complaints., lact.intol., contains sucrose. jaund., hepat.encephalopathy, skin rash, urticar., prurit., photosens., PANTOPRAZOLE UNICORN, (Unicorn) Sandoz [P/S]
Drug interactions: Poss.decr.clear.of meds metabol. by CYP2619 tox.epiderm.necrolys., Stev. John. syndr., alopec., erythema multi- Pantoprazole
enzym.e.g.diazepam/ citalopram/ warfarin/clomipramine/phenytoin, forme, arthralg. & mylag., malaise, hypersens.reacts. incl. angio- Indications: 40 mg tabs: Short-term treatm.of duod. & gastr.ulc.,
incr. clear.of imipramine/some antipsychot.meds./ tacrine/ theophyl- oed.& fev., incr.freq.of gastr.glandul. cysts with long-term treatm. reflux oesophagit., duod.ulc. assoc. with H.pylori infect.in combinat.
line, plasma conc.of both voriconazole & esomeprazole poss.incr., re- Special precautions: Excl.poss.malign., imp. hepat. funct., limit. with appropr. antibiot., Zolling.-Ellison syndr.
duc. absorpt. of ketoconazole/itraconazole, bioavailabil. of any meds. exper.in childr., long term. safety in ren./hepat. impairm.not est., 20 mg tabs: Mild gastro-oesophageal reflux dis. (GORD) & longt.
whose absorpt.is Ph-depend.potent. affect., esomeprazole & 14-hy- monit.INR & phenytoin ser.lev., incr.risk of GI infects.as gastr. bact. managem.& relapse prevent. thereof.
droxyclarithromycin plasma lev.incr., decr.atazanavir & nelfinavir conc. counts incr. (S4) TABS, 43/11.4.3/0485, 0486
NOZER, Ascendis Pharma (Dezzo) [P/S] Drug interactions: CNS depress.& alcohol.may aggrav.drowsin.& 721270-002: 20 mg, 14, R60,19
721270-001: 20 mg, 28, R120,39
Omeprazole imp.conc., metabol.of meds. metabol.by hepat.P450 cytochrome en- 721273-001: 40 mg, 28, R193,11
Indications: Adults: Duod.ulc.incl.relap.prev., gastr.ulc., reflux oe- zymes affect., digox. bioavailabil.incr. Dosage: Admin.once dly.dos.in the morn.bef./dur. breakf.
osphagit.incl.long term managem., Zollinger-Ellison syndr., gastro- PANTOCID, Ranbaxy [P/S] Duod.ulc: 40 mg once dly x2-4 wks. Use in combinat. with appropr.
oesophag. reflux dis. (GORD), duod.ulc.assoc. with H Pylor infect. in Pantoprazole. antibiot.when assoc.with H.Pylori.
combinat.with appropr. antibiot., treatm.of & risk reduct.of NSAID Indications: Symptomat.improvem.& heal.of mild GERD, long term Gastr.ulc.& reflux oesophagit: 40 mg once dly. x4-8 wks.
assoc. gastric &/duod.ulc.& eros.& relaps.risk reduct. Childr: Short managem.& prev.of GERD relapse. Zolling.Ellison syndr: Init.80 mg/day, thereaft. titrat. up/down
term (3 mnths) treatm.of sev. ulcerat. reflux oesophagit.resist.to (S4) TABS, [P/S] 41/11.4.3/0787 accord.to gastric acid secret. Dly. dos. above 80 mg/day to be ad-
prev.med. treatm. 715610-001: 20 mg, 30, R118,76 min.in 2 div.dos.
(S4) CAPS, 36/11.4.3/0420 Dosage: Swallow whole. Recomm.dly dos.in morn. bef./dur.breakf. Mild GORD: 20 mg/day x4-8 wks.
704629-002: 20 mg, 28, R163,04 Mild GERD: 20 mg/day. 4 wk.period normal.reqd. for heal.& if not Long-term managem./GORD relapse prevent: Recomm.
704629-001: 20 mg, 30, R174,71 suffic.heal.usuall.achiev.within furth.4 wks. maint: 20 mg/day incr.to 40 mg/day in case of relapse reduc.to
Dosage: Adults: Long term managem.& prev.of GERD relapse: 20 mg/day incr.to 20 mg dly aft.heal.
Duod.ulc: 20 mg dly.x2-4 wks. In pts.refract.to other treatm: 40 mg 40 mg/day if relaps.occurs reduc.back to 20 mg/day aft.relaps.heals. Gastro-duod.les. prev./ dyspept.sympt.induc. by NSAIDs
dly.may be effect. Prev.of relapse: 10 mg once dly.if necess.incr.to 20- (S4) TABS, [P/S] A40/11/.4.3/0482 in risk pts. need.contin. NSAID treatm: 20 mg/day recomm.
40 mg once dly. Above regimen.recomm.for duod. ulc.assoc. with H Indications: Short-term treatm.of duod.& gastr. ulc.& reflux oe- Contraindications: Safety & effic.in childr.not est., concom.ataza-
Pylori infect.in combinat.with appropr.antibiot. sophagit., duod.ulc. assoc.with H.pylori infect.in combinat.with ap- navir, sev.liv.funct.impairm.
Gastric ulc.& reflux oesophagit: 20 mg dly. x4-8 wks. When re- propr. antibiot., Zollinger-Ellison Syndr. Side effects: Freq: Upp.abdom.pain, diarrh., constip., flatul., head-
fract.to other treatm.regimens 40 mg once dly.may be effect. Long- 708031-001: 40 mg, 30, R190,23 ache. Less freq: Leucopen., thrombocytopen., GI disords., periph.
term reflux oesophagit. mangem: 10 mg once dly.incr.to 20-40 mg Dosage: Swallow whole. Recomm.dly dos.in morn. bef./dur.breakf. oed., sev. hepatocell. damage lead.to jaund.with/without hepat.
once dly.if necess. In sev./symptomat. recurr. reflux oesophagit. Duod.ulc: 40 mg once dly. x2-4 wks.incl.of oral use. Use in combinat. fail., anaphylact.reacts.incl.shock, incr.liv. enzym., elev.triglycerid., incr.
contin.with 20 mg dly. with appropr.antibiot.when assoc.with H.Pylori. body temp., arthralg., myalg., dizzin., vis.disturbs., depress., interstit.
NSAID-assoc.gastroduod.les.with./-out cont. NSAID treatm: Gastr.ulc.& reflux oesophagit: 40 mg once dly. x4-8 wks. nephrit., allerg./skin reacts., angioed., Stev. Johns. syndr., erythema
20 mg once dly. If not heal. within 4 wks.contin.treatm.for furth.4 wks. Zollinger-Ellison Syndr: Init.80 mg dly.thereaft. titrat.as necess. multiforme, tox.epiderm. necrolys., photosens.
NSAID-assoc.gastroduod.les.& dyspept. sympt. prophylax: Admin.dly.dos above 80 mg in 2 div.dos. Special precautions: Safety in pregn.& lactat. not est., mild-mod.
20 mg once dly. Contraindications: Safety in pregn.& lactat.& safety & effic.in childr. sev.liv.impairm., monit.liv. funct.in pres.of impairm.esp.longt.& dis-
Symptomat.gastro-oesophag.reflux dis: Indiv. 10-20 mg once dly. not est., sev.liv.funct. impairm., concom.atazanavir cont.if elev., not indic.for mild GI disturbs., excl.poss. malign. bef.init.
Investig.furth.if sympt. contr. not achiev.aft.2 wks.treatm.at 20 mg dly. Side effects: Bld.dyscras., GI disturbs., thrombophlebit. & periph. ther., confirm reflux oesophag. diagn. by endoscopy, poss.cyanocobal-
Zollinger-Ellison syndr: Init.60 mg dly. Indiv.& contin. as long as oed., jaund.with/without hepat.fail., anaphylax., incr.liv.enzym./tri- am. malabsorpt. with prolong.treatm., limit.exper.with longt. admin.
clinic.reqd. Admin.dos.over 80 mg dly.in 2 div.dos. glycer., incr.body tem., arthralg., myalg., headache, dizzin., vis. dis- Interactions: Reduc./incr.absorpt.of pH-depend. meds.
Childr: 1 yr & old: (short term upto 3 mnths treatm) turbs., ment.depress., interstit.nephrit., allerg. reacts., sev.skin reacts. eg.ketoconazole, reduc.atazanavir bioavailabil., poss.interact.with
Sev.ulcerat.reflux oesophagit: 10-20 kg: 10 mg once dly.incr.to 20 incl.Stev. John.& Lyell Syndr., photosens. meds.also metab. via cytochrome P450 enzyme syst., respons.to
mg dly if necess. >20 kg: 20 mg once dly.incr.to 40 mg dly if necess. Special precautions: Not to exceed 20 mg dly in mild-mod.liv. anticoags. poss.affect.theref.monit.PT/INR.
Contraindications: Safety in pregn./lactat.not est. impairm., monit.liv.funct.reg.in pres. of sev.impairm.partic.on long
Side effects: GI disturbs., CNS effs., skin rash incl. erythema multi- term ther.& discont. if elev., not indicat.for min.GI complaints., excl. PARIET, Janssen Pharmaceutica [P/S]
forme, prurit., photosens., periph.oed., blurr.vis., incr.sweat., incr.freq. poss. malign., confirm reflux oesophag.diagn.by endoscopy, poss. Rabeprazole.
benign revers.gastr.glandul.cysts dur.long term treatm., arthralg.& cyanocobalam malabsorpt.with prolong.treatm. (ie.>3 yrs.), long- Indications: Act.duod.& benign gastr.ulc., symptomat.eros./ulcer-
mylag., malaise, oesophag. candidias., acid regurgitat., incr GI bact., term treatm. exper. limit. at.gastro-oesophag. reflux dis, maint.ther.of heal.erosive/ulcerat.
bld. dyscras., alopec., hyponatraem., bronchosp., interstit.nephrit., gy- Drug interactions: Reduc./incr.absorpt.of pH-depend.meds.eg. ke- GORD, symptomat.ther.of gastro-oesophag.reflux dis., Zollinger-
naecomast., hepatit.with/ without jaund., hepat.encephalopathy, hy- toconazole, poss.interacts.with meds.also metabol.via cytochrome Ellison Syndr.& other hypersecret. condits., H.Pylori posit.duod.ulc.
persens. reacts., angioed., tox.epiderm. necrolys., Stev.John.syndr., fev. P450 enzyme syst. with appropr. antibiot.
Special precautions: Limit.exper.in childr., excl.poss.malign., ren./ (S4) TABS. 33/11.4.3/0206, 32/11.4.3/0614.
hepat.impairm., monit. concom.warfar.& phenytoin PANTOLOC, Takeda P/S] 863106-005: 10 mg, 28, R220,38
Drug interactions: CNS depress.enhanc.sedat. eff., metabol.of oth- Pantoprazole. 863114-016: 20 mg, 28, R440,68
er meds.metabol.via cytochrome P450 enzyme syst.poss.affect., elim- Indications: 40 mg tabs: Short-term treatm.of duod.& gastr. ulc., Dosage: Admin.in morn.bef.eating. Swallow whole without
in. of diazepam/warfar.& phenytoin prolong., digox.bioavailabil.incr. reflux oesophagit., duod.ulc. assoc.with H.pylori infect.in combinat. crush./chew.
180 / 2020-04 Gastro-Intestinal Tract - 12.4.4
Adults incl.elderly: Act.duod.& benign gastr. ulc: 20 mg dly in Dosage: Take once dly.oral dos.in the morn. Swall. whole. Admin. Duod.ulc: 40 mg once dly. Use in combinat. with appropr.antibiot.
morn.gener.4-6 wks. Addit.4-6 wks.may be requir. Some with act. low.dos.& short.durat. appropr. to condit.treat. when assoc.with H.Pylori.
duod.ulc.may respond to 10 mg once dly. Duod.ulc: 40 mg once dly. Tot.treatm.IV & oral should be 2-4 wks. Gastr.ulc.& reflux oesophagit: 40 mg once dly.
Eros./ulcerat.GORD: 20 mg once dly.x 4-8 wks. GORD maint: 10- Use in combinat. with appropr.antibiot.when assoc.with H.Pylori. Zolling.Ellison syndr: Init.80 mg/day, thereaft. titrat.up/down
20 mg dly.for max.12 mnths. Symptomat.GORD: 10 mg once dly.in Gastr.ulc.& reflux oesophagit: 40 mg once dly. x4-8 wks. Tot. accord.to gastric acid secret. Dly. dos. above 80 mg/day to be ad-
pts.without oesophagit. Investig.furth.if control.not achiev. aft.4 wks. treatm.IV & oral should be for 4-8 wks. min.in 2 div.dos.
Once sympts.resolv.admin.10 mg once dly.when necess. Zollinger-Ellison syndr: Init.80 mg once dly. thereaft.titr.as necess. If rapid acid contr.requir. a start.dos of 2 x 80 mg Prazoloc 40 IV is
Zollinger-Ellison Syndr.& other patholog. hypersecret. con- Admin.dly.dos.above 80 mg in 2 div.dos. suffic.to manage a decr.of acid output into targ.range (< 10 mEq/h)
dits: Recomm.60 mg once dly. titrat.upwards to 120 mg/day bas.on in- Mild GORD: 20 mg/day x4-8 wks. within 1 hr in majority of pts.
div.needs. Dos.upto 100 mg may be admin.as sngl.dly.dos. Dos. of 120 Long term/GORD relapse prevent: Recomm. maint: 20 mg/day Contraindications: Sev.liv.funct.impairm., safety & effic.in childr.
mg to be div.into 60 mg 2xdly. Contin. treatm. as long as clinic.indicat. incr. to 40 mg/day in case of relapse reduc.to 20 mg dly aft.heal. not est., concom.atazanavir & nelfinavir
H.Pylori eradicat: Part of the eradicat.program. with appropr.antibiot. NSAID induc.gastro-duod.les.& dyspept. sympts.prev: Side effects: Freq: Asthen., fatig., diarrh.., headache. Less freq:
Contraindications: Safety in pregn.& lactat.not est., no exper. Recomm.dos: 20 mg once dly. Agranulocytos., anaphylact. reacts.incl. angioed. & anaphylact.shock.,
in use in childr. Contraindications: Safety in pregn.& lactat.& safety & effic.in anx., agitat., hallucin., somnol., arthralg., back/neck/ chest pain., blurr.
Side effects: Headache, GI disturbs.incl.gastr. glandul.cyst, asthen., childr.not est., sev.liv.funct. impairm., concom.atazanavir., not for vis., anter.ischaem.optic neuropathy, dizzin., speech disord., confus.,
rash, dry mouth, infect., bld.dyscras., leucocytos., hypersens., anorex., mild GI compl. hyperton., hypokines., migraine, paraesthes., dyspn., bronchit., incr.
hypomagnesaem., hyponatraem., psych. disords. incl.confus., dizzin., Side effects: Bld.dyscras., blurr.vis., GI disturbs. incl.diarrh., asthen., cough., pharyngit., rhinit., sinusit., URTI, erythema multiforme, rash,
somnol., vis.disturbs., periph. oed., cough, rhinit., pharyngit., bronchit., fatig., malaise, periph oed., sev.hepatocell.damage with jaund.with/ prurit., toxic epiderm.necrolys., Stev.-Johns.syndr., alopec., bullous
sinusit., eruct., stomatit., hepatit., jaund., hepat. encephalopathy with without hepat. fail./incr.liv.enzym., anaphylact.reacts. incl.shock/an- erupts., hypoglycaem., impot., gynaecomast., infect., flu-like syndr.,
underly.cirrhos., skin reacts. incl. erythema multiforme/tox.epiderm. gioed., triglycerid.elev., incr. body temp., hyperlipidaem., arthralg., inj.site thrombophlebit., incr.sweat., malaise., N&V, abdom.pain,
necrolys./ Stev. Johns.syndr., sweat., chest/non spec.back pain, my- myalg., headache, dizzin., psych.disords., interstit.nephrit., sev.skin constip., flatul., gastroenterit., pancreatit., belch., dyspeps., rect.dis-
alg., leg cramps., arthralg., UTI, interstit. nephrit., chills, fev., gynae- reacts. incl.erythema multiforme/Stev.Johns. syndr./ tox.epiderm. ords., incr. salivat., taste disturbs., periph.oed., tinnit., vertigo, UTI,
comast., flu-like syndr., weight gain, bone fract. necrolys., photosens. sev.hepatocellul. damage lead.to jaund.with/-out hepat.fail., incr.liv.
Warnings and special precautions: Effic.for maint.treatm.of heal. Special precautions: Elderly, ren.funct./ mild-mod. liv.impairm., enzym., hepatit., hepat. encephalopathy. Freq unknown: Allerg.re-
eros./ulcer.GORD not est.for per.exceed. 12 mnths., pass.through rat monit.concom.anticoag.ther., excl. poss.malign., confirm reflux oe- acts. incl. skin rash & prurit., depress., insomn., dry mouth, incr.body
placenta, excret.in rat mamar. secret., excl.malign.first, sev. hepat.dys- sophag.diagn. by endoscopy, monit.liv.funct.in pres.of impairm.& temp., elev.triglycerides, interstit. nephrit., myalg., thrombocytopen.,
funct.esp. when init.ther., osteoporos.-relat.fract.of hip/wrist/spine discont. if elev., poss.Vit.B12 malabsorpt.with prolong. treatm.(ie.>3 leucopen., urticar., photosens.
with high-dos./long-term ther., atazanavir co-admin.not recomm., yrs.), incr.Clostridium difficile risk, restrict.gastro duod.NSAID induc. Warnings and special precautions: Not indicat. for mild GI
poss. incr.GI infects. risk incl.Clostridium diffic., poss. methotrex. tox- ulc. prophylax. to those at incr.risk. complaints., not recomm.in pregn. & lactat.as safety & effic.not est.,
ic., concom.ketoconazole/ itraconazole/ digoxin, concom.meds.poss. Drug interactions: Poss.coagulat.fact.eff.with warfar., poss.chang. with concom. anticoags.monit.prothromb.time/INH esp. when ther.
caus. hypomagnesaem./ prolong.ther., discont.ther.& init.magnes.re- in absorpt.of pH-depend. meds. eg. ketoconazole, reduc.atanavir init./discont./admin.irreg., excl.poss. malign. as malign.ulc.sympt.
placem.in hypomagnesaem. bioavailab., poss.interacts.with meds.also metab.via cytochrome poss.allev.delay. diagn., dos.not to exceed 20 mg dly in mild-mod.
Drug interactions: Ser.lev.of concom. methotrex.poss.elev.& pro- P450 enzyme syst. liv. impairm., poss.cyanocobalam.malabsorpt.with prolong. treatm.
long., ketoconazole/ itraconazole lev. decr., digoxin lev.incr., low (ie.>3 yrs.), discont.if liv.enzym. elev., confirm reflux oesophag.diagn.
interact.potent.with ciclospor., reduc.atazanavir expos.with other PEPLOC OTC, Pharma Dynamics [P/S] by endoscopy, restrict to where contin.NSAID treatm.reqd.& incr. GI
proton pump inhibit. Pantoprazole. complicat.risk exist
Interactions: Atazanavir & nelfinavir conc.decr., poss. interacts.
Indications: Tempor.short-term heartburn & hyperacidity relief
PENTOZ, Dr Reddy’s [P/S] for max.14 days. with other meds.metab.by hepat. cytochrome P450-enzyme syst.,
Pantoprazole sodium sesquihydrate equiv.to pantoprazole (S2) TABS, A43/11.4.3/0344 anticoag.respons. poss. affect., poss.changes in absorpt.of pH-de-
Indications: 40 mg tabs: Short-term treatm.of duod./gastr. ulc.& 722787-001: 20 mg, 14, R41,83 pend. meds.eg.ketoconazole
reflux oesophagit., duod.ulc. assoc.with H.pylori infect.in combinat. Dosage: Take in the morn.
with appropr. antibiot., Zollinger-Ellison syndr. Recomm.dos: 20 mg/day PRAZOLOC OTC, Cipla [P/S]
Pantoprazole.
20 mg tabs: Mild gastro-oesophageal reflux dis. (GORD) & the long Contraindications: Safety & effic.in childr.not est., sev.liv.funct.
term managem.& relapse prevent. thereof. impairm., concom.atazanavir. Indications: Tempor.short-term heartburn & hyperacidity relief.
(S2) TABS, 43/11.4.3/1145
(S4) TABS, 41/11.4.3/0641, 0642 Side effects: Bld.dyscras., anaphylact.reacts. incl. shock/angioed.,
714674-001: 20 mg, 30, R123,28 incr.bilirub., triglycerid.elev., incr. body temp., hyperlipidaem., psych. 723826-001: 20 mg, 10, R31,24
Dosage: Take pref.in the morn. Swall.whole. Max.dly dos: 20 mg/
714675-001: 40 mg, 30, R198,00 disords., headache, dizzin., blurr.vis., GI disturbs.incl. diarrh., dry
Dosage: Admin.in morn. mouth, sev.hepatocell.damage with jaund.with/without hepat.fail., day. Treatm.per: 14 days.
Contraindications: Safety & effic.in childr.not est., sev.liv.funct.
Duod.ulc: 40 mg once dly. x2-4 wks. Use in combinat. with appropr. prurit., skin rash, urticar., sev.skin reacts.eg.erythema multiforme/
antibiot.when assoc.with H.Pylori. Stev. Johns. syndr./tox.epiderm.necrolys., photosens., arthralg., impairm., concom. atazanavir/ nelfinavir.
Side effects: Dizzin., vis.disturbs., somnol., vertigo, GI disturbs.
Gastr.ulc.& reflux oesophagit: 40 mg once dly. x4-8 wks. myalg., hyponatraem., hypomagnesaem., interstit.nephrit., gynae- incl.infects., bld.dyscras., anaphylact. reacts.incl. shock/angioed.,
Zollinger-Ellison syndr: Init.80 mg dly.thereaft. titrat.as necess. comast., asthen., fatig., malaise, periph oed. triglycerid.elev., incr.body temp., psych./CNS disords., headache,
Admin.dly.dos above 80 mg in 2 div.dos. Warnings and special precautions: Safety in pregn.& lactat.not paraesthes., anter.ischaem. opt. neuropathy, tinnit., periph.oed.,
Mild GORD: 20 mg/day x4-8 wks. est., monit.concom. anticoag. ther., excl.poss.malign., confirm reflux dyspn., bronchosp., stomatit., sev.hepatocell.damage lead.to jaund.
Long term/GORD relapse prevent: Recomm. maint: 20 mg/day oesophag. diagn. by endoscopy, incr.Clostridium difficile risk, low. with/without hepat.fail., incr.liv. enzym., hepat.encephalopathy, sev.
incr. to 40 mg/day in case of relapse reduc.to 20 mg dly aft.heal. Long dos.& short.durat.for condit., poss.assoc. hypomagnesaem.incr.risk of skin reacts.incl. erythema multiforme/Stev.Johns.syndr./tox. epiderm.
term.admin.exper.limit. fract.of hip/wrist/ spine, monit.liv.funct.in pres.of impairm.& discont. necrolys., photosens., arthralg., myalg., urin. syst.disords., interstit.
(S2) OTC DELAY REL.TABS, 45/11.4.3/0592 if elev., do not use for mild GI complaints, poss. Vit.B12 malabsorpt. nephrit., impot., gynaecomast., incr.sweat., malaise.
Indications: Tempor.short term relief of heartburn & hyperacid. with prolong.treatm.(ie.>3 yrs.), Na restrict.diet, Warnings and special precautions: Not indic. for mild GI compl.,
718886-001: 20 mg, 7, R28,08 Drug interactions: Poss.coagulat.fact.eff.with warfar., poss.reduc./ excl.poss.malign., poss. Vit.B12 malabsorpt. with prolong.treatm.
718886-002: 20 mg, 14, R56,17 incr.absorpt.of pH-depend. meds.eg. ketoconazole, reduc.atanavir (ie.>3 yrs.), discont. if liv.enzym.rise, confirm reflux oesophag. diagn.
Dosage: Admin.bef./dur.breakf. Consult dr if no sympt.relief obt. bioavailab., poss.interacts.with meds.also metab.via cytochrome by endoscopy, safety & effic.in pregn.& lactat. not est., monit.con-
within 2 wks.of continuous treatm. P450 enzyme syst. com.anticoag.ther., mild to mod.liv.impairm.
Max.dos.20 mg/day for a max.of 14 days. Interactions: Decr.atazanavir/nelfinavir conc., poss. interacts.with
Contraindications: Safety & effic.in childr.not est., sev.liv.funct.im- PRAZOLOC, Cipla Medpro [P/S] meds.also metab.via cytochrome P450 enzyme syst., poss.coagulat.
pairm., safety in pregn.& lactat. not est., concom.atazanavir & nelfinavir. Pantoprazole sodium sesquihydrate (equiv.to pantoprazole) fact. eff.with warfar., poss.reduc./incr.absorpt.of pH-depend. meds.
Side effects: Bld..dyscras., GI disturbs., allerg. reacts. incl.anaphy- Indications: 20 mg tabs: Mild gastro-oesophag. reflux dis (GORD) eg. ketoconazole.
lax.& sev.skin reacts.eg.Stev. John.syndr./erythema multiforme/Ly- & the long term managem.& relapse prevent.thereof, on-demand
ell’s sndr., photosens., jaund.with/without hepat.fail., incr. body temp., regimen to control recurr.sympts.of heal.reflux dis., prevent.of PROBITOR 20, (Unicorn) Sandoz [P/S]
arthralg., myalg., headache, dizzin., blurr. vis., ment.depress., sleep NSAID-induc.gastro-duod.les.& dyspept.sympt.in pts.at risk & need. Omeprazole
disords., hallucinat., confus., disorientat., interstit.nephrit. contin.NSAID treatm. Indications: Adults: Duod.ulc., gastr.ulc., reflux oesophagit.incl.
Special precautions: Excl.poss.malign., not to exceed 20 mg dly 40 mg tabs: Short-term treatm.of duod.& gastr. ulc., reflux oe- long-term managem., Zollinger-Ellison syndr., symptomat.heartburn
in mild-mod.liv.impairm., monit. liv. funct.in sev.liv.impairm.partic. sophagit., Zolling.-Ellison syndr. rel. in gastro-oesophag.reflux dis., short-term rel.of funct. dyspeps.,
with long term ther. & discont.if enzymes elev., not indicat.for mild (S4) TABS, 43/11.4.3/1147, 1148 duod.ulc.assoc.with H.pylori infect.in combinat.with appropr.antibiot.,
GI complaints, confirm reflux oesophag.diagn. by endoscopy, poss. 722767-001: 20 mg, 10, R31,24 NSAID assoc. gastric /duod.ulc.& reduc.risk of develop./relapse of
cyanocobalam malabsorpt.with prolong.treatm. (ie.>3 yrs.), contin. 722767-002: 20 mg, 30, R93,74 such assoc.ulc. Childr>20 kg: Short term treatm. (upto 3 mnths) of
self medicat.x4 wks./more to contr.sympts., incr.risk of bact.GI in- 722768-001: 40 mg, 30, R130,76 sev.ulcerat.reflux oesophagit.resist.to prev.treatm.
fects., prothrombin time incr., Dosage: Admin.recomm.dos.in the morn.with/ without food. (S4) CAPS, 43/11.4.3/0458
Drug interactions: Reduc./incr.absorpt.of pH-depend. meds.eg. Duod.ulc: 40 mg once dly.x2-4 wks. Use in combinat. with appropr. 720812-001: 20 mg, 28, R162,69
ketoconazole/dasatinib/ampicill. esters/Fe salts/digox., atazanavir antibiot.when assoc.with H.Pylori. 720812-002: 20 mg, 30, R174,31
& nelfinavir plasma conc.decr., interacts with other meds. metabol. Gastr.ulc.& reflux oesophagit: 40 mg once dly. x4-8 wks. Dosage: Swallow whole in morn.
by P450 enzyme syst.cannot be excl., incr. expos. to both meds.with Zolling.Ellison syndr: Init.80 mg/day, thereaft. titrat.up/down Adults:
concom.voriconazole, diazepam & phenyt.eliminat.prolong. accord.to gastric acid secret. Dly. dos. above 80 mg/day to be ad- Duod.ulc: 20 mg dly.x2-4 wks. In pts.refract.to other treatm: 40
min.in 2 div.dos.
mg dly.may be effect.
PEPLOC, Pharma Dynamics [P/S] Mild GORD: 20 mg/day x4-8 wks. Recurr.sympt. contr. by 20 mg Gastric ulc.& reflux oesophagit: 20 mg dly. x4-8 wks. When re-
Pantoprazole. once dly on demand. fract.to other treatm.regimens 40 mg once dly.may be effect.
Indications: 40 mg tabs: Short-term treatm.of duod. & gastr.ulc., Longt./GORD relapse prev: Recomm.maint. 20 mg/day incr.to NSAID-assoc.gastroduod.les.with/without contin.NSAID
reflux oesophagit., duod.ulc. assoc.with H.pylori infect.in combinat. 40 mg/day in case of relapse reduc.to 20 mg/day aft.heal. treatm: 20 mg once dly.x4wks. If heal.not compl.contin.xfurth.4 wks.
with appropr. antibiot., Zollinger-Ellison syndr. NSAID induc.gastro-duod.les.& dyspeps. sympt: Recomm. NSAID-assoc.gastroduod.les.& dyspept. sympt. prophylax:
20 mg tabs: Mild gastro-oesophageal reflux dis (GORD) & the dos.20 mg once dly. 20 mg once dly.
longt.managem.& relapse prevent. thereof., prev.of NSAID induc. (S4) SOL FOR INJ. 44/11.4.3/0305 Symptomat.gastro-oesophag.reflux dis: Indiv. 20 mg once dly.
gastro-duod.les.& dyspept.sympts.in pts.at risk & need.cont.treatm. Indications: Short-term treatm.of duod.& gastr. ulc./ reflux oe- Investig.furth.if sympt.contr.not achiev.aft.2 wks.treatm.at 20 mg dly.
(S4) TABS, [P/S] 42/11.4.3/0056, 42/11.4.3/0057. sophagit./ Zolling.-Ellison syndr.in pts who cannot be treated orally Zollinger-Ellison syndr: Init.60 mg dly. Indiv.& contin. as long as
715306-001: 20 mg, 28, R71,88 720716-001: 40 mg/10 ml, 1 vial, R25,82 clinic.reqd. Admin.dos.over 80 mg dly.in 2 div.dos.
715306-002: 20 mg, 30, R77,00 Dosage: For IV inj.only. Childr.: (Limit.exper.)
715307-001: 40 mg, 28, R184,81 Recomm.dos: 1 vial dly. for up to 7 days. Transit. to oral formulat. Sev.ulcerat.reflux oesophagit: Childr.>20 kg: 20 mg once dly.incr.
715307-002: 40 mg, 30, R99,87 as soon as clinic.justif. to 40 mg once dly.if necess.
Gastro-Intestinal Tract - 12.4.4 2020-04 / 181
Contraindications: Safety in pregn./lactat. not est., concom.St epiderm.necrolys., Stev.John. syndr., alopec., erythema multiforme, Indications: Short-term treatm.of duod.& gastr. ulc.& reflux oe-
John’s Wort/nelfinavir & atazanavir. urticar., photosens., angio-oed., asthen., arthralg.& mylag.,interstit. sophagit.for IV admin.to pts.unable to be treat.oral., duod.ulc.assoc.
Side effects: GI disturbs., taste disturbs., CNS effs., headache, nephrit., gynaecomast. with H.pylori infect.in combinat.with appropr.antibiot., Zollinger-
vetigo, dizzin., somnol., insomn., photosens., rash incl. erythema Warnings and special precautions: Excl.poss. gastric ulc./ma- Ellison syndr.
multiforme, prurit., periph.oed., blurr.vis., incr.sweat., benign revers. lign., imp.hepat. funct., limit.exper. in childr., where diarrh.does not (S4) IV INJ, 42/11.4.3/0345
gastr. glandul.cysts, revers.ment.confus., aggress., hallucinat., ma- improve consid. poss.C.diffic.assoc., incr.risk of GI infects.as gastr. 717406-001: 40 mg/10 ml, 5 vials, R365,22
laise, paraesthes., asthen., arthralg. & mylag., oesophag.candidias., bact.counts incr., contains sucrose, monit.INR & phenytoin ser.lev., Dosage: IV admin.only. Admin.40 mg once/dly. over 2-15 mins. Aft.
acid regurgitat., incr. GI bact., bld.dyscras., urticar., angio-oed., tox. long term.safety in ren./hepat. impairm.not est. reconstit.admin.by direct.IV or dil.furth.with 100 ml NaCl or 5% dextr.
epiderm.necrolys.& Stev.John.syndr., alopec., hyponatraem., hy- Interactions: CNS depress.& alcohol.may aggrav. drowsin.& imp. only. IV admin. for up to 7 days. Oral ther.as soon as poss. Dly. dos.
pomagnesaem., hypocalcaem., impot., bronchosp., interstit.nephrit., conc., metabol.of meds. metabol.by hepat.P450 cytochrome en- not to be exceed.esp.elderly/imp.ren. funct.
gynaecomast., hepatit.with/without jaund., hepat. encephalopathy, zymes affect., diazepam /warfar. & phenyt.elimin.poss.prolong., Duod.ulc: 40 mg once dly. x2-4 wks.incl.of oral use. Use in combinat.
hypersens.reacts.incl.anaphylax., fev., pancytopen., thrombocyto- digox. bioavailabil.incr. with appropr.antibiot.when assoc.with H.Pylori.
pen., agranulocytos., leucopen., hypomagnesaem., rais.liv.enzym. Gastr.ulc.& reflux oesophagit: 40 mg once dly. x4-8 wks.
Warnings and special precautions: Limit. exper. in childr., excl. ROZNAL OTC, AI Pharm [P/S] Zollinger-Ellison syndr: Init.80 mg dly.theraft. titrat. up/down as
Lansoprazole
poss. malign., imp.hepat. funct., monit.concom.INR/phenytoin lev., need. Dos.above 80 mg to be div. & admin.2x dly. For rapid acid contr.
incr.risk of GI infects.due to decr.acid. incr.gastr.bact. counts., incr. Indications: Short-term symptomat.relief of heartburn & acid start.dos. of 2 x 80 mg suffic.to decr.acid output to target range within
dyspeps.
GI Salmonella/Campylobacter/ Clostrid.diffic.infect. risk, consid. 1 hr. Tfd.to oral formulat.as soon as clinic. justif.
diagnos,of CDAD with diarrh.that does not improve., monit.Mg.lev (S2) CAPS, A40/11.4.3/0154 (S4) TABS, 43/11.4.3/0484, 0483
716841-001: 15 mg, 7, R29,75
bef.& periodic.dur.prolong.treatm/treatm.with concom.digoxin/ Dosage: Admin.bef.meals. Indications: 40 mg: Short-term treatm.of duod.& gastr. ulc.& reflux
hypomagnesaem.-caus.meds., Vit.B12 absorpt.reduc.due to hypo- Heartburn & dyspeps.: One cap dly for up to 14 days oesophagit., duod.ulc.assoc. with H.pylori infect.in combinat.with ap-
hydr./ achlorhydr., cosid.temp.withdraw.with high.dos. methotrexate, Contraindications: Pregn.& lactat., liv.impairm. propr. antibiot., Zollinger-Ellison syndr.
avoid concom.clopidrogel as interact. observ., hepat.impairm., long- Side effects: Bld.dyscras., oed., CNS effs.incl. somnol.& dizzin., GI 20 mg: Symptomat.improvem.& heal.of mild GERD, long-term man-
term use in ren./hepat.impairm, poss.incr.fract.risk in elderly/ pres.of disturbs.incl.ulcerat.colit., dry mouth, taste abnormalit., gynaecomast., agem.& prev.of relapse in GERD.
recognis.risk.facts, pts.at risk of osteoporos., lact.intol. galactorrh., elev.hepat.enzymes, asthen., arthralg., myalg., blurr.vis., 721183-001: 20 mg, 28, R154,81
Drug interactions: Concom.CNS depress.& alcoh. may potent.any skin reacts., alopec., fev., incr. freq.of gastr. glandul.cysts.dur long term 721184-001: 40 mg, 28, R230,20
CNS eff., poss.interacts. with meds.also metabol.via cytochrome treatm.& incr. gastric.bact.counts result.from inhibit.of gastr. acid secret. Dosage: Admin.once dly.dos.in the morn.
P450 enzyme syst., poss.prolongs diazepam/warfarin & phenytoin Special precautions: Pt to consult.dr.if sympts. persist aft.2 wks., Duod.ulc: 40 mg once dly.x2-4 wks. If in assoc. with H Pylori infect.
elimin., concom.clarithromyc.poss.incr. plasma conc.of both drugs., safety & effic.in childr.not est., excl.malign., monit.concom.warfar., use in combinat.with appropr. antibiot.
digox. bioavailabil. incr., absorpt.of posaconazole/ erlotinib/ keto- distrib.in milk of rats, tumorigen.effs.in anim., confirm.reflux oe- Gastric ulc: 40 mg once dly.x4-8 wks.
conaz. & itraconaz.reduc., saquinavir lev.poss. incr.with concom. sophagit. by endoscopy, incr.risk of GI infects. Reflux oesophagit: 40 mg once dly.x4-8 wks
saquinair/ritonavir, vorinconazole incr.lev., rifampicin/St.Johns Wort Drug interactions: CNS depress.eff.enhanc.by CNS depress.& al- Zollinger-Ellison Syndr: Init.80 mg once dly. thereaft.titrat.up/
reduc.plasma ser.lev., tacrolimus ser.lev.incr., methotrex ser.lev. incr., coh., poss.interacts.with drugs metabol. by cytochrome P450 syst., down using gastric acid secret.as guide. Dos.above 80 mg dly to
cilostazol AUC and C max incr. warfar.conc. poss.reduc. be given in 2 div. dos.
RABEMED, Sandoz [P/S] SANDOZ OMEPRAZOLE 20, Sandoz [P/S] Mild GERD: 20 mg dly.x4 wks. If reqd.a furth.4 wks. may be admin.
Rabeprazole Omeprazole Long-term GERD managem.& relap.prev: Maint.20 mg dly.incr.to
Indications: Act.duod.& benign gastr.ulc., symptomat.eros./ulcerat. Indications: Adults: Duod.ulc.incl.relap.prev., gastr.ulc., reflux oe- 40 mg if relapse occurs reduc.back to 20 mg dos.once relapse heal.
gastro-oesophag.reflux dis, maint.ther.of heal.erosive/ulcerat.GORD, sophagit.incl.long-term managem., Zollinger-Ellison syndr., symp- For prev.of NSAID induc.gastro-duod.ulc.& dyspept. sympts.in at risk
symptomat.ther.of gastro-oesophag.reflux dis., Zollinger-Ellison Syn- tomat. heartburn rel. in gastro-oesophag.reflux dis., short-term rel. pts: 20 mg dly.recomm.
dr.& other patholog. hypersecret. condits., H.Pylori positive duod.ulc. of funct.dyspeps., duod.ulc.assoc. with H.pylori infect.in combinat. Contraindications: Safety & effic.in pregn.& lactat.& in childr.not
with appropr. antibiot. with appropr. antibiot., NSAID assoc.gastric /duod.ulc.& reduc. risk est., sev.liv.funct.impairm., concom. atazanavir.
(S4) TABS. 44/11.4.3/0597, 0598 of develop./relapse of such assoc.ulc. Childr: Short term treatm. Side effects: Bld.dyscras., GI disturbs., dry mouth, thrombophlebit.,
718384-001: 10 mg, 28, R162,66 (upto 3 mnths) of sev.ulcerat. reflux oesophagit.resist.to prev.treatm. periph.oed., jaund.with/ without hepat.fail., anaphylax., incr.liv. en-
718385-001: 20 mg, 14, R163,23 (S4) CAPS, 36/11.4.3/0430 zym./triglycer., incr.body temp., arthralg., myalg., headache, dizzin.,
718385-002: 20 mg, 28, R326,57 703534-001: 20 mg, 30, R174,31 vis.disturbs., ment. depress., interstit.nephrit., allerg.reacts., sev.skin
Dosage: Admin.in the morn.bef.eating. Swallow whole. Do not Dosage: Swallow whole with half glass liq.in morn. reacts. incl.Stev.Johns./ Lyell syndr./erythema multiforme, photosens.
crush/ chew. Adults incl elderly: Adults: Special precautions: Concom.anticoags.theref. PT/ INR monit.
Act.duod.ulc./ act.benign gastr.ulc: 20 mg once dly. in morn.gen.x Duod.ulc: 20 mg dly.x2-4 wks. In pts.refract.to other treatm: 40 advis., excl.poss.malign., not to exceed 20 mg dly in mild-mod.liv.
4-6 wks.but some pts.may req.an addit.4 wks-6 wks.to achieve heal. mg dly.may be effect. impairm., monit.liv.funct.reg.in pres.of sev.impairm.& discont. if elev.,
Eros./ulcerat.GORD: 20 mg once dly.x 4-8 wks. Relapse prev.& H.pylori posit.duod.ulc.: 10 mg once dly.if necess. not indicat.for min.GI compl., confirm reflux oesophag.diagn.by en-
GORD maint: 10-20 mg dly.for max.12 mnths. depend.on respons. incr.to 20-40 mg once dly. Above recomm.regim.are incl.of H.Pylori doscopy, poss.cyanocobalam malabsorpt.with prolong. treatm. (ie.>3
Effic.not est.for per.exceed. 12 mnths. assoc. duod.ulc. tog.with suit.antibiot. yrs.), long-term treatm.exper.limit, cyanocobalamin defic.
Symptomat.GORD: 10 mg once dly.in pts.without oesophagit. In- Gastric ulc.& reflux oesophagit: 20 mg dly. x4-8 wks. When re- Drug interactions: Reduc./incr.absorpt.of pH-depend. meds.eg. ke-
vestig.furth.if control.not achiev. aft.4 wks. Once sympts.resolv.ad- fract.to other treatm.regimens 40 mg once dly.may be effect. Long- toconazole, poss.interacts. with meds.also metabol.via cytochrome
min.10 mg once dly.when necess. term reflux oesophagit.mangem: 10 mg once dly.incr.to 20-40 mg P450 enzyme syst., respons.to anticoags.poss.be affect.
Zollinger-Ellison Syndr.& other hypersecret. condits: 60 mg once dly.if necess. In sev./symptomat. recurr. reflux oesophagit. TOPZOLE, (AI Pharm.& Takeda) Takeda [P/S]
once dly.titrat.upwards to 120 mg/ day bas.on indiv.needs. Dos.up contin.with 20 mg dly. Pantoprazole., sodium sesquihydrate (equiv.to pantoprazole)
to 100 mg may be admin.as sngl.dos. Dos.of 120 mg to be div.into NSAID-assoc.gastroduod.les.with/without contin.NSAID Indications: 40 mg tabs: Short-term treatm.of duod.& gastr. ulc.,
60 mg 2xdly. Contin.treatm.as long as clinic. indicat. treatm: 20 mg once dly.x4wks. If heal.not compl.contin.xfurth.4 wks. reflux oesophagit., duod.ulc. assoc.with H.pylori infect.in combinat.
H.Pylori eradicat: Part of the eradicat.program. with appropr.anti- NSAID-assoc.gastroduod.les.& dyspept. sympt. prophylax: with appropr. antibiot., Zolling.-Ellison syndr.
biot. Recomm.combinat.all admin. 2xdly x7 days: Rabemed 20 mg + 20 mg once dly. 20 mg tabs: Mild gastro-esophageal reflux dis (GERD) & the long-
clarithromycin 500 mg & amoxicillin 1 g Symptomat.gastro-oesophag.reflux dis: Indiv. 10-20 mg once dly. term managem.& relapse prevent. thereof.
Contraindications: Pregn.& lactat., use in childr. not studied. Investig.furth.if sympt. contr.not achiev.aft.2 wks.treatm.at 20 mg dly. (S4) TABS, 38/11.4.3/0061, 38/11.4.3/0060.
Side effects: Infect., bld.dyscras., headache, dizzin., hypotens., par- Zollinger-Ellison syndr: Init.60 mg dly. Indiv.& contin. as long as 705368-001: 20 mg, 28, R228,94
aesthes., psych.disords.incl. anx./attent.defic., skin reacts.incl.tox. clinic.reqd. Admin.dos.over 80 mg dly.in 2 div.dos. 705369-001: 40 mg, 28, R340,33
epiderm. necrolys./ Stev.John.syndr./bullous react., fac. swell., alo- Childr.1 yr & old.: (Limit.exper.) Dosage: Admin.recomm.dos.in the morn.
pec., hypersens.reacts.incl.bronchosp./ anaphylax., anorex., weight Sev.ulcerat.reflux oesophagit: 10-20 kg: 10 mg once dly.incr. Duod.ulc: 40 mg once dly. x2-4 wks. Use in combinat. with appropr.
incr., hepatit., jaund., hepat. encephalopathy, incr.hepat.enzym., gy- to 20 mg once dly.if necess. Over 20 kg: 20 mg once dly.incr.to 40 antibiot.when assoc.with H.Pylori.
naecomast., impot., asthen., flu-like illn., chest pain, chills, pyrex., mg once dly.if necess. Gastr.ulc.& reflux oesophagit: 40 mg once dly. x4-8 wks.
incr.sweat., malaise, GI disturbs. incl.dyspeps./eructat./stomatit., Contraindications: Safety in pregn./lactat.not est., concom.St Zolling.Ellison syndr: Init.80 mg/day, thereaft. titrat.up/down
vis. disturbs., ant.ischaem. opt.neuropathy, vertigo, tinnit., cough, John’s Wort/nelfinavir & atazanavir. accord.to gastric acid secret. Dly.dos.above 80 mg/day to be ad-
pharyngit., rhinit., dyspn., bronchit., sinusit., non-specif./chest pain, Side effects: GI disturbs., taste disturbs., CNS effs., headache, min.in 2 div. dos.
myalg., leg cramps., arthralg., myopathy, rhabdomyolys., UTI, inter- vetigo, dizzin., somnol., insomn., photosens., rash incl. erythema Mild GERD: 20 mg/day x4-8 wks. Maint: 20 mg/ day incr. to 40
stit.nephrit., periph.oed. multiforme, prurit., periph.oed., blurr.vis., incr.sweat., benign revers. mg/day in case of relapse reduc.to 20 mg dly aft.heal. Exper.in long
Special precautions: Longt.treatm., concom. ketoconazole/ itra- gastr.glandul.cysts, revers.ment.confus., aggress., hallucinat., ma- term admin. limit.
conazole, excret.in rat mammary secret., sev.hepat.dysfunct.esp. laise, paraesthes., asthen., arthralg. & mylag., oesophag.candidias., Long-term/GERD relapse prevent: Recomm. maint: 20 mg/day
when init.ther., excl. malign.first. acid regurgitat., incr.GI bact., bld.dyscras., urticar., angio-oed., tox. incr. to 40 mg/day in case of relapse reduc.to 20 mg dly aft.heal.
Drug interactions: Poss.interact.where med absorpt. pH depend., epiderm.necrolys.& Stev. John.syndr., alopec., hyponatraem., hy- (S2) OTC TABS, 43/11.4.3/1001
ketoconazole/itraconazole lev. decr., digoxin lev.incr. pomagnesaem., bronchosp., interstit.nephrit., gynaecomast., hep- Indications: Gastric acid reflux sympts.
RAPACID, AI Pharm [P/S] atit.with/without jaund., hepat. encephalopathy, hypersens.reacts. 718142-001: 20 mg, 7, R54,57
incl. anaphylax., fev., pancytopen., thrombocytopen., agranulocytos.,
Omeprazole leucopen., hypomagnesaem., rais. liv.enzym. Dosage: 1 tab./day taken bef./dur.breakf.
Indications: Tempor.short-term heartburn relief. Special precautions: Limit.exper.in childr., excl. poss. malign., Consult dr if no sympt.relief obt.within 2 wks. contin.treatm. Treatm.
(S2) CAPS, A39/11.4.3/0466 imp.hepat.funct., monit. concom.INR/ phenytoin lev., incr.risk of GI not to exceed 4 wks. without consult.dr.
3000170-001: 10 mg, 14., R54,05 infects. due to decr. acid. incr.gastr.bact.counts., incr.GI Salmonella Contraindications: Safety in pregn.& lactat.& safety & effic.in childr.
Dosage: Take in morn. Swallow whole. Do not chew/ crush. & Campylobacter.infect.risk, Vit.B12 absorpt.reduc.due to hypohydr./ not est., sev.liv.funct. impairm., concom.atazanavir.
Recomm.dos: 1-2 caps.dly. Max.dly.dos: 20 mg. Max.treatm. achlorhydr., avoid concom.clopidrogel as interact. observ. Side effects: Agranulocytos./leucopen./ pancytopen.& thrombocyto-
per: 14 days. Investig.furth.if sympt. contr.aft.2wks.with 20 mg dly. Drug interactions: Concom.CNS depress.& alcoh. may potent.any pen., allerg.reacts. incl. anaphylax. & sev.skin reacts., hyperlipidaem.,
Contraindications: Safety in pregn./lactat.not est. CNS eff., poss.interacts. with meds.also metabol.via cytochrome weight changes, sleep disords., depress., disorientat., hallucinat.
Side effects: C.diffic.assoc.diarrh., bld.dyscras., hypersens.reacts. P450 enzyme syst., poss.prolongs diazepam, warfarin & phenytoin confus., headache, dizzin., vis.disturbs., GI disturbs., incr. bilirub.&
with anaphylax., hyponatraem., headache sev.enough to discont.in eliminat., digox.bioavailabil.incr., absorpt. of posaconazole/erlotin- liv.enzym., hepatocellul.injury, jaund., photosens., arthralg., myalg.,
cases, dizzin., vertigo., somnol., insomn., revers.ment.confus./ agitat./ ib/ketoconaz.& itraconaz.reduc., saquinavir & ritonavir plasma lev. interstit. nephrit., asthen., fatig., malaise, incr.body temp., periph.
aggress.& hallucinat., malaise, paraesthes., fev., depress., blurr.vis., poss.incr., vorinconazole incr.lev., rifampicin reduc. plasma ser.lev., oed., clostrid.diffic.assoc.diarrh.
periph.oed., bronchosp., abdom.pain, colic, GI disturbs., acid regur- tacrolimus ser.lev.incr. Special precautions: Monit.concom.anticoag. ther., excl.poss.ma-
gitat., stomatit., taste disturbs., benign revers. gastr.glandul.cysts, lign., not to exceed 20 mg dly in mild-mod.liv.impairm., monit.liv.funct.
dry mouth, oesophag. candidias., incr.GI bact., hepatit.with/without TOPRAFLUX, Sandoz [P/S] in pres. of impairm.discont.if elev., not indic.for mild GI complaints,
jaund., hepat.encephalopathy, skin rash, prurit., incr. sweat., tox. Pantoprazole confirm reflux oesophag. diagn.by endoscopy, incr.bact.count pres.in
182 / 2020-04 Gastro-Intestinal Tract - 12.4.4 / 12.4.5 / 12.4.6 / 12.5 / 12.6
upp. GIT, incr.risk of bact.GI infects., poss. cyanocobalam malabsorpt. where dehydrat.poss.danger., gastr.malign., condits.where hypotens. Dosage: Adults & childr.over 12 yrs: 5-10 ml aft. meals & at bedt.
with prolong.treatm. (ie.>3 yrs.). may precipit. sev.complicat., GI ulcerat. in absence of GI sympt., Childr.und.12 yrs: Not recomm. except on physic.advice
Drug interactions: Poss.interact.with other drugs metabol.by P450 avoid Mg contain.antacids, safety & effic.in childr.und.18 yrs.not est. Side effects: GI disturbs., hypersens.reacts., urticar., bronchosp.,
enzyme syst., poss. changes in absorpt.of pH-depend.meds.eg. keto- DENOL, Astellas [P/S] abdom.distent.& cramps, hyperkalaem.in ren.fail.
conazole, methotrex.ser.lev.elev.& prolong. Special precautions: Restrict.salt intake, CHF, ren.impairm., liv.
Bismuth trioxide. cirrhos., hypertens., corticoster. ther., hypercalcaem./alkalos., hy-
TRUSTAN, (Aspen Pharmacare:Pharma) AstraZeneca [P/S] & Indications: Duod.& gastr.ulc., adjunct.treatm.of gastrit.assoc. perkalaem., hypochlorhydria.
Esomeprazole with H.pylori. Drug interactions: Absorpt.of other drugs interfer. with by large dos.
Indications: Eros.reflux oesophagit., relapse prophylax. in heal. (S2) SWALLOW TABS, T/11.10/188
oesophagit., symptomat.treatm. of GORD, prev.gastric & duod.ulc. 781274-028: 120 mg, 40, R224,04
assoc.with NSAID ther.in risk pts., duod.ulc.& prevent.of relapse of Dosage: Swallow whole. No liq./food/fruit/fruit juices & antacids
such ulc.assoc.with H.pylori infect.in combinat.with antibact.therap. ½ hr.bef./aft.dos. 12.5 Motility enhancers
regim., patholog. hypersecret.condits.incl.Zollinger-Ellison syndr./ idi- Duod.& gastr.ulc: 2 tabs 2-3xdly on empty stomach ½ hr. bef.
opath.hypersecret. meals for 4-8 wks. ADCO-CONTROMET, Adcock-Ingram Healthcare (Pty) Ltd
(S4)GASTRIC RESIST.TABS. 45/11.4.3/0777, 0778 Adjunct.to H.pylori gastrit: 1 tab.4xdly. x7 days in combin.with ap- See Section 1.8
720215-001: 20 mg, 14, R114,16 propr.ther. Check PI’s of meds. used in triple/quadruple ther.
+
720215-002: 20 mg, 28, R228,30 Contraindications: Hypersens., low K diet, ren. impairm., pregn.& BIO METOCLOPRAMIDE, Biotech Laboratories (Pty) Ltd
720217-001: 40 mg, 14, R174,96 lactat., colost./ileostom. See Section 1.8
720217-002: 40 mg, 28, R350,00 Side effects: Stool/tong.blacken., N&V, constip., diarrh., GI pain,
Dosage: Swallow whole with liq., without crush./ chew. May be rash, prurit., anaphylact.react. CLOPAMON, Aspen Pharmacare (Pty) Ltd
+
+
dispers.in non-carbon.water stir. until tabs disintergr., drink.liq.with Special precautions: Control. K diet/imp.kidn funct. due to K con- See Section 1.8
pellets immed./ within 30 mins. tent, avoid concom.alcoh., maint. ther.not recomm.but treatm.may be
Adults & adolesc.12-18 yrs: resum. aft.1 mnth.free interv., discount.x3/4 days if GI sympts. devel.,
Eros.reflux oesphagit: 40 mg once dly.x4 wks. Contin.for addit.4 bismuth encephalopathy with high dos./ prolong.ther., do not admin. 12.6 Laxatives
wks.if not heal./sympts.persist. at high dos./over prolong. per.
Relapse prevent.of heal.oesophagit: 20 mg once dly. Drug interactions: Tetracycl.absorpt.poss.reduc., antacids/milk/fuit NORMACOL (MDR Listing)
Symptomat.GORD: If oesophagit.not pres admin. 20 mg once dly. & fruit juices poss.interfer.with act. PICOLAX (MDR Listing)
Subseq.sympt.contr.can be achiev. und.medic.supervis on a regimen Warning: Poss.neurotoxic.aft.prolong./excess. use.
of 20 mg once dly. If sympt.contr.not achiev.aft.4 wks.investig. furth. ULSANIC, (Aspen Pharmacare: Consum) Pharmacare [P/S] ADCO FOSENEMA, (AI Crit.Care) AI Ltd [P/S]
Adults: Sucralfate. Monosod.phosph. 24 g, disod.phosph.9 g/150 ml.
Contin.NSAID ther: 20 or 40 mg once dly. Indications: Gastr./duod.ulc., chron.gastrit., reflux oesophagit., relief Indications: Pre-op.low.bowel cleans.
H.Pylori assoc.ulc.& relapse prevent.of such ulc: 20 mg in com- of pept.ulc.subj.sympts., maint.aft.rec.duod.heal. (S3) ENEMA, F/11.5/54.
727202-006: 150 ml, 1, R21,45
binat. with amoxicillin 1 g and clarithromycin 500 mg all 2xdly x7 days. (S0) TABS, [P/S] Q/11.4.3/147.
Patholog.hypersecret.condits.incl.Zollinger-Ellison syndr.& 773417-028: 1 g, 20, R73,19 Dosage: For rect.admin.only. Adults: Contents of one container rec-
tally. Childr.over 2 yrs: Admin. only 64 ml.
idiopath.hypersecret: Recomm. init.dos:40 mg 2xdly. Adjust in- 773417-001: 1 g, 120, R427,60
div.& cont. treatm.as long as clinic.indic. Dos.up to 120 mg 2x/ day (S0) EFFERVESC.TABS, [P/S] 31/11.4.3/0119. Contraindications: Abdom.pain., N&V, Hirschprung’s dis., childr.
und.2 yrs.
have been admin. 837156-009: 1 g, 10, R54,05
Contraindications: Hypersens.to benzimidazol./ other compon. 837156-017: 1 g, 20, R92,26 Side effects: Excess.Na absorpt.
Special precautions: Ac.ren.fail., prolong. enema retent.esp.
of formulat., concom.atazanavir/ nelfinavir, gluc.-glact.malabsorpt. (S0) SUSP, [P/S] V/11.4.3/315. 1 g/5 ml.
syndr., fruct. intol., sucr.isomalt.defic., safety in pregn.& lactat. not 773441-034: 100 ml, R80,83 in colon.dis.pts.
est., no data for use in childr.und.12 yrs. 773441-042: 250 ml, R232,47 AGIOBULK, Takeda [P/S]
Side effects: Dizzin., blurr.vis., headache, paraesthes., somnol., 773441-026: 600 ml, R460,07 Seeds of Plantago ovata 3,25 g, Ispaghula husk 0,11 g/5 g.
taste disturbs., GI disturbs. incl.GI candidias./microscop.colit./sev. Dosage: Dissolv.effervesc.tab.in a glass of water Indications: Regulat.bowel funct.in cases of constipat., less wa-
debilit. diarrh., stomatit., skin reacts.incl.erythem. multiforme/Stev.- Duod.ulc: Usual adult dos: 1 g 3-4xdly.betw. meals & at bedt. Also tery stools in diarrh., alternat. diarrrh.& constip., in irritable bowel
John.syndr./tox.epiderm. necrolys., alopec., photosens., bld.dys- shown to be effect.is 2 g 2xdly. syndrome & in diverticulos.
cras., hypersens. reacts.incl.angioed., periph.oed., hyponatraem., Reflux oesophagit: 1 g 4xdly.betw.meals & at bedt. (S0) GRAN. Q/11.5/303.
hypomagnesaem., hypocalcaem., hypokalaem., psych.disturbs.incl. Maint.aft.duod.ulc.heal: 1 g 2xdly.½ hr.bef. breakf. &.supp. 834750-015: 250 g, R227,79
hallucinat., vertigo, bronchosp., incr.liv.enzym., hepatit.with/ with- x12 mnths. Dosage: Swall.whole with adeq.liq.
out jaund., hepat.encephalopathy, arthralg., myalg., musc.weakn., Contraindications: Safety & effic.in pregn.& lactat.not est. Constip: 2 heap.medic.meas. (10 g) at night. aft. meals at least
gynaecomast., malaise, hyperhidros., interstit.nephrit., digox.toxic. Side effects: Constip.& other GI disturbs., skin rash, prurit., dizzin., 1 hr bef.bedt.& 1 heap.medic.meas. (5 g) bef.breakf.when necess.
Special precautions: Not for mild GI compl., excl. poss.malign., drowsin, vertigo, back pain, bezoar format. Diarrh: Init. 2 heap.medic.meas.(10 g) 3xdly x1-3 days, then 1 heap.
monit.long-term ther., Clostrid. diffic. risk esp.in hospit.pts., sev.ren. Special precautions: Imp.ren.funct./dialys. treatm., poss.Al ac- medic.meas. (5 g) 3xdly when necess.
insuff./imp. hepat. funct., avoid concom.clopidogrel, incr.GI infect. (eg cumulat./toxic.with ren. impairm., absorpt.of other meds.poss.inter- Childr: ½ adult dose.
Salmonella & Campylobacter.) risk, elderly esp.high dos., monit.digox. fer. with theref.observ.2 hr.interv.with concom.non-antacid meds., Contraindications: Unexplain.abdom.pain, S&S of ileus, stenos.&
lev., close monit. with concom.warfar., concom.high-dos. methotrex- recomm.interv.with other antacids is 30 mins., bezoar format.in sev.ill GI obstruct.esp.oesophag.area, concom.swell.& antiperistalt.agents
ate, concom.tipranavir not recomm., monit.with some antiretrovir. in ICU/prem.infts.& with concom.enter.feeds theref.observ.1 hr.interv. against diarrh., poorly control.diab.
Drug interactions: Poss.incr./decr.absorpt.of drugs whose absorpt. betw.admin., not known if excret.in breast milk, addit.short term an- Side effects: Flatul., fullness init.
influenc.by gastr.acid., ketoconazole/ itraconazole/erlotinib absorpt. alges.& spasmolyt.agents may be benefic.with sev.epigastrium pain Special precautions: Electrol.& fluid bal., diabet. (contains sucrose).
decr., decr. expos.to act.clopidogrel metabolite, incr. digoxin absorpt., of pept.ulc, safety & effic.of maint.treatm.exceed.12 mnths not est.,
poss.incr.plasma conc.of meds. metabol. by CYP2C19 enzyme, diaz- phosph.defic.as Al inhibits.its GI absorpt., not recomm.in prem.infts., AGIOLAX, (Mylan) Takeda [P/S]
epam clear. decr., incr.phenytoin plasma conc., incr. methotrexate delay.gastric empty., elderly, lact.intol. Seeds of Plantago ovata 2,60 g, Ispaghula husk 0,11 g, Tinnevelly
lev., elev.INR with warfar., atazanavir & nelfinavir ser.lev.decr., poss. senna pods 0,34 - 0,66 g equiv.to sennoside B 15 mg/5 g
decr. conc. with tipranavir, CYP2C19 inhibit., incr. cisapride AUC/ Indications: Constip.
half-life prolong., decr.ser.lev.with St John’s Wort/rifampicin, more (S0) GRAN. E/11.5/0988
than triple expos. with concom.combin.inhib.of CYP2C19/CYP3A4 12.4.6 Anti-reflux agents 834769-018: 100 g, R83,92
e.g.voriconazole. 834769-026: 250 g, R195,81
See also MDR page 196. GAVISCON, Reckitt Benckiser [P/S] 834769-034: 1 000 g, R644,91
Na Alginate in thicken.base 703123-001: sachets, 4x10 g, R34,96
Indications: Gastric reflux, reflux oesophagit., heartburn incl.that of Dosage: Swallow whole with adeq.liq. Adults & childr.12 yrs.&
old: 1-2 heap.medic.meas.aft. even. meal & if necess.morn.bef.food.
12.4.5 Cytoprotective agents pregn., hiatus hern., flatul. assoc.with gastric reflux, epigastric & retro- Contraindications: Intest.obstruct./condits. poss.lead. to intest.
stern. distress where gastric reflux is underly.cause
(S0) PEPPERMINT SUSP, 29/11.10/0641. obstruct., undiagn.abdom. sympt., N&V.
CYTOTEC, Pfizer [P/S] 837016-011: 500 mg/10 ml, 150 ml, R44,12 Side effects: Cramps, flatul., swell., colic, diarrh. with excess.wa-
+
ter & electrol.loss esp.K dur. prolong. use, aton.colon, urine discol-
Misoprostol 837016-012: 500 mg/10 ml, 300 ml, R86,83 our., melanos.coli.
Indications: Co-admin.with NSAID’s for prophylax. of gastr.& duod. Dosage: Admin.aft.meals & at bedt. Special precautions: Discont.use in case of rect.bleed./fail.to have
ulc./haemorrh.les.& eros. induc.by NSAID. Adults & childr.over 12 yrs: 10-20 ml. Childr. und. 12 yrs: 10 ml.
(S4) TABS, S/11.10/392. 200 µg Und.2 yrs: Consult doc. Max. 5 ml dose. bowel movem.aft.use, inadeq.fluid intake poss.cause obstruct., dia-
bet. (contains sucrose), inflamm.bowel dis.
782416-020: 60, R385,57 Side effects: Stomach cramps, flatul., hypersens. reacts., urti-
782416-039: 120, R771,15 car., bronchosp. COLO-PREP, (Cipla) Anmaraté [P/S]
Dosage: Gastr.ulc., haemorrh.les. & eros prophylax: 1 tab Special precautions: Restrict.salt intake, CHF, ren.impairm., liv. Monobasic sod.phosph.anhydr.15 g, dibasic sod.phosph.anhydr.10
2xdly with food tog.with prescr. NSAID. May be incr.to 1 tab 3xdly cirrhos., hypertens., corticoster. ther., metabol./resp.alkalos., hypoc- g/sachet.
with max. 1 tab 4xdly. alcaem., hypochlorhydria. Indications: Bowel prep.prior to surg./radiolog./ endoscop.proced.
Drug interactions: Absorpt.of other drugs interfer. with by large dos.
Duod.ulc.prophylax: 4 tabs/day in div.dos.with meals. Al-contain. (S3) POWD. 32/11.5/0618
antacids may be giv.for pain if neccess. GAVISCON ADVANCE, Reckitt Benckiser [P/S] 865443-009: 2x sachets, R145,00
Contraindications: Prostaglandins.hypersens., pregn. & lactat., Na Alginate in thicken.base Dosage: Dissolv.sachet contents in 50 ml luke warm water.
imp.ren.funct. Indications: Gastric reflux, reflux oesophagit., heartburn incl.that of Add.200 ml cool water/clear cool drink. Sip slow.over 10-30 mins.
Side effects: Very common: Diarrh. Common: headache, dizzin., pregn., hiatus hern., flatul. assoc.with gastric reflux, epigastric & retro- Contin.fluid intake betw.dos.
abdom.pain, constip., dyspeps., flatul., N&V. Uncommon: Men- stern. distress where gastric reflux is underly.cause For morn.proced. take both dos.on the day bef. with 1 dos.at 12h00
st
str.disords.incl. vag.bleed.also post menopaus., uter.cramp., Rare: (S0) ANISEED SUSP, [P/S] 32/11.10/0207 & 2 betw.16 &17h00. For aftern.proced. take 1 dos.betw.16 &
nd
st
Menorrhag., dysmennorh. Postmarket: Anaphylact./skin react., 862282-013: 500 mg/5 ml, 200ml, R86,82 17h00 on day bef. & 2 dos.on day of proced.not less than 3 hrs.
nd
abnorm.uter.contract., amniot. fluid embol., foet.death, incompl. 862282-004: 500 mg/5 ml, 500 ml, R160,36 bef.sched.time.
abort., prem. birth, retain.placenta, uter.perforat./-rupt./-haemorrh., Dosage: Adults & childr.over 12 yrs: 5-10 ml aft. meals & at bedt. Contraindications: Appendicit.sympt., undiagn. rect.bleed., CCF,
birth defects, chills, pyrex. Childr.und.12 yrs: Not recomm. except on physic.advice hypertens., diab.mellit., GI obstruct., oral saline lax.hypersens.,
Warnigns and special precautions: Teratogenicity in animals, (S0) PEPPERMINT SUSP, [P/S] A40/11.10/0049 dehydrat., imp.ren.funct., colost./ileostomy, K-spar.diurets., K sup-
treatm.not to be start. bef.pregn.excl., adeq.contracept.in women.of 862282-014: 500 mg/5 ml, 200 ml, R86,82 plem., pregn., use in childr.und.5 yrs.not recomm., hyperphospha-
childbear. potent., excret. in breast milk, condits. predispos.to diarrh., 862282-005: 500 mg/5 ml, 500 ml, R160,36 taem., megacolon.
Gastro-Intstinal Tract - 12.6 2020-04 / 183
Side effects: Electrol.imbal., GI disturbs. Contraindications: Imp.ren.funct., megacolon, abd.pain, N&V, (SO) PAED.ENEMA, [P/S] E/11.5/1982.
Special precautions: Poss.laxat.depend., N&V, abdom.pain., childr.und.12 yrs.not recomm. Na-phos. 60 mg, Na-acid phosph. 160 mg/ml.
ac.phosphate nephropathy. Special precautions: Rect.bleed./fail.to have a bowel movem.aft. 726435-007: 64 ml, R30,73
DULCOLAX, Sanofi-Aventis [P/S] lax.use may indic.a ser.condit., low salt diet, kidn.dis., hypertens., Dosage: Contents of 1 contain.
sod.retent. poss. leads to extracell.fluid accumulat., CCF, periph./
Contraindications: Sev.imp.ren.funct., hyperphosphataem., mega-
Bisacodyl. pulm.oed., pre-ecclamps. colon, N&V, abd.pain, childr.und.2 yrs.unless prescrib.
Indications: Occas.constip. Side effects: GI disturbs., hyperphosphataem.& hypocalcaem.in
(S0) TABS, [P/S] E/11.5/531 FYBOGEL ORANGE, Reckitt Benckiser [P/S] childr., hypernatraem., fluid & Na retent.lead.to oed., depend.with
721549-013: 5 mg, 10, R27,75 Ispaghula husk. freq./prolong. use.
721549-004: 5 mg, 30, R74,62 Indications: Constip., irrit.bowel syndr., diverticul.dis. Special precautions: Card.fail., hypertens., imp.ren.funct., periph.&
721549-000: 5 mg, 60, R112,20 (S0) POWD. M/11.5/1. pulm.oed., toxaem.of pregn.
721549-012: 5 mg, 200, R354,51 727857-002: 3,5 g, 10 sachets, R60,83
Dosage: Admin.at night as sngl.dly.dos. 727857-010: 3,5 g, 30 sachets, R135,72 MOVICOL, Aspen Pharmacare [P/S]
Adults & childr. 12 yrs.& over: 1-3 tabs. Childr. 6-und.12 yrs: 1 tab. Dosage: Stir in water & take immed., pref.aft. meals morn.& even. Macrogol (PEG) 3350 13,125 g, Na bicarbonate 178,5 mg, NaCl
(S0) SUPPOS, [P/S] E/11.5/532 Adults & childr.over 12 yrs: 1 sachet. Childr. und.12 yrs: ½-1 level 350,7 mg, KCl 46,6 mg/13,8108 g sachet.
721522-009: 10 mg 10, R119,64 5 ml med.meas.depend on size & age. Indications: Chron.constipat.
Dosage: Adults & childr. 12 yrs.& over: 1 suppos.as sngl.dly.dos. Contra-indications: Salt restrict.diet., sympt.of appendicit., intest. (S0) POWD. 31/11.5/0123.
(S0) PAED.SUPPOS, [P/S] E/11.5/534 obstruct./abdom.pain of unknown cause., naus.& vomit. 828165-009: 20 sachets, R112,21
721530-001: 5 mg, 10, R101,70 Side-effects: Flatul., abdom.distent. Dosage: Constit.each sachet with 125 ml water.
Dosage: Child.1-12 yrs: 1 suppos.as sngl.dly.dos. Special precautions: Laxat.depend., inadeq. fluid intake may cause Adults: 1-3 sachets dly.in div.dos. Elderly: 1 sachet dly. Course nor-
Contraindications: Ileus, intest.obstruct., undiagn. abdom.sympts., faecal impact.& oesophag. obstruct. mally 2 wks. Rep.if reqd. accord. to indiv.response. Extended use:
ac.surg.abdom.condits., ac. inflamm. bowel dis., sev.dehydrat., safety Drug interactions: Lower.transit time through gut may lead to in- 1-2 sach. dly.in div.dos.
in pregn. & lactat.not est. terfer.with absorpt.of other medic. Contraindications: Intest.perforat., intest. obstruct.due to structur./
Side effects: Diarrh., abdom.cramps & pain, allerg. reacts. incl.angio- funct.disord., gastric retent., pept.ulc., sev.GIT inflamm.condit., childr.
oed.& anaphylact.reacts., dizzin.& syncope, diarrh & excess.water & KLEAN-PREP, (Aspen Pharmacare: Pharma) Pharmacare [P/S] und.12 yrs., safety in pregn.not est.
electrol. loss with prolong.use, poss.aton.non-funct.colon with pro- Sod.sulph.anhydr. 5,685 g, sod.bicarbon. 1,685 g, sod. chlor. 1,465 g, Side effects: Abdom.distent.& cramps, pain, N&V, borborygmi, mild
long.use. Supp: loc.irrit., proctit., epithelium slough.with repeat use. pot.chlor.0,7425 g, macrogol 3350 59 g/68,96 g sachet. diarrh., anal irrit., urticar., allerg.reacts.incl.anaphylax.
Special precautions: Tabs: Contain.sugar, childr. und.6 yrs./inabil. Indications: Bowel prep.prior to colonoscopy, colon.surg., radiolog. Special precautions: Do not use in pres.of abdom. pain/N&V, de-
to swall.without chew., do not take within 1 hr.of antacid/milk., in- examin.& relat.proced. pend.& loss of norm.bowel funct. with freq./prolong.use of laxat.,
flamm.bowel dis. Supp: rect.fiss./ulcer.haemorrhoids, medic. advice (S3) POWD. Z/11.5/340. stop.ther. immed. & meas.electrol.if shift in fluid/ electrol. observ.,
in childr., alert dr.if laxat.need.dly., sudd. bowel habit chang.persist. 796808-007: 4 sachets, R174,57 rect.bleed.& fail.to have bowel movem. may indic.a serious condit.,
for long.than 2 wks. Dosage: Dissolv.contents of each sachet in 1 L water. Drink 250 ml extend.use poss.reqd. in sev.chron./resist.constipat./second.to mul-
Interactions: Excess.dos.incr.risk of electrol. imbal.with concom.diuret./ every 10-15 mins, drink sol.from all 4 sachets within 4-6 hours. tiple sclerosis/ Parkinson’s dis./induc.by reg.constipat. meds. partic.
adreno-cortico-steroids, electrol.imbal.incr.sensit.to card. glycosides. Contraindications: GI obstruct./perforat., ileus, gastr. retent., opiods & antimuscarin., cont.sweetn.
Warning: Do not use in presen.of abdom.pain/ N&V., depend./ ac.intestin./gastr.ulc., toxic.colit., megacolon, pts.with body mass
loss of norm.bowel funct.with prolong./freq.use, discont.& seek und.20 kg, childr. und. 12 yrs., safety in pregn.not est. MOVIPREP, Aspen Pharmacare: Pharma [P/S]
med.advice if rect.bleed./fail.to have bowel movem.aft.use, not to Side effects: GI disturbs., urticar., anal irrit. Sachet A: Macrogol (PEG) 3350 100,000 g, sod.sulph.anhydr. 7,500 g,
use long.than 1 wk. Special precautions: Imp.gag reflex, reflux oesophagit., dimin.lev. NaCl 2,691 g, KCl 1,015 g
Sachet B: Ascorbic acid 4,700 g, sod.ascorbate 5,900 g
EUCARBON, (Austell) Camox [P/S] of consciousn., ulc.colit., admin. all oral medic.at least 1 hr.prior, reduc. Indications: Bowel cleans.prior to clinic.proced. requir. clean bowel.
rate of admin./stop temporar.in case of distent./pain, cont.aspartame
Charcoal wood 180 mg, dry rhubarb extr.25 mg, senna powd.105 mg. (S3) POWD. 42/11.5/0407.
Indications: Constipat. LACSON (Aspen Pharmacare: Consum) Pharmacare [P/S] 716697-001: 2 sachets/box, R175,73
TABS, Z/11.6/393 Lactulose Dosage: Adults incl.elderly: Cont.of one sach. A & one sach.B dis-
705468-001: 10, R26,57 Indications: Constipat., chron.portal hypertens., hepat.encepha- solv.togeth.in 1 lit.of water. This reconstit. solut.should be taken over
705468-002: 30, R53,13 lopathy. a per.of 1-2 hrs & repeat.with 2 lit. of Moviprep. May admin. div.as
nd
Dosage: Adults & elderly: 1-2 tabs.aft.meals. For strong.eff.ad- (S0) SYRUP, Z/11.5/55. 3,3 g/5 ml 1 lit. Moviprep in even.bef.& 1 lit. early morn.on day of proced. OR
min.even.dos.of 3-4 tabs. 797723-005: 150 ml, R25,36 in even.bef. proced. Must be at least 1 hr betw. end of fluid intake &
Contraindications: Intestin.obstruct., undiagn. abdom.symts. 797723-013: 500 ml, R72,92 colonoscopy start. Recomm.one lit.clear liq. incl.water/clear soup/
Side effects: GI disturbs., urine/faeces discol. 797723-021: 2 500 ml, R346,28 fruit juice without pulp/ soft drinks/tea & coff.without milk taken ad-
Special precautions: Inflamm.bowel dis., depend. with freq./ Dosage: Adults: Init.15-30 ml dly.in sngl./2 div.dos. Maint: 10- dit. dur. course of treatm.
lprolong.use, discont.aft.1 wk. use with no eff & seek med.advice. 15 ml dly. Childr: 6-12 yrs: Init.20 ml dly. 1-5 yrs: Init.10 ml dly. Contraindications: GI obstruct./perforat., gastr. empty.disords.,
FORLAX, (Litha) Ingelheim Pharma [P/S] Und.1 yr: 5 ml dly. ileus, phenylketonur., gluc.-6-phosph. dehydrogenase defic., tox.
Chron portal.hypertens.& hepat. encephalopathy: Usual maint:
Macrogol 4000 megacol. complicat. sev.inflamm.intest.tract condits.incl. Chron’s
Indications: Chron.constipat.as adjunct.to diet & lifestyle in adults 30-45 ml 3-4xdly, adjust dos.to achieve 2-3 soft stools dly.of pH 5-5,5. dis./ulc.colit., unconsc.pts., not recomm. in childr.bel.18 yrs.as no
Init.with 30-45 ml hrly if indicat.
& childr.8 yrs.& old. studies in paed.pts.
(S0) POWD. 45/11.5/1129 Contraindications: Galactosaem., galact.-free diet, intest.obstruct. Side effects: Diarrh., N&V, bloat., abdom.pain, anal irrit., sleep
723690-001: 10 g/sach., 20 sach., R138,00 Side effects: Abdom.discomf., N&V, diarrh.& electrol. imbal.partic. disturbs., allerg.reacts.incl.skin reacts./ oed./anaphylax., hunger.,
+
Dosage: Adults: 1-2 sachets dissolv.in water dly.pref.as sngl.dos. K with prolong./overdos. hypophosphataem., dizzin., headache, dyspeps., dysphag., thirst,
in morn. Admin.accord.to clinic. outcom.rang.from 1 sach.every 2 nd Special precautions: Lact.intol., diabet., no other concurr.laxat.in malaise, rigors, alter.bld.tests incl.hypercalcaem.
portal hypertens.& encephalopathy, proper faecal pH maint.essent.
day (esp.childr.) up to 2 sach./day. Eff.within 24-48 hrs.aft.admin. Special precautions: Do not take oral meds. within 1 hr of Movi-
Contraindications: Sev.inflamm.bowel dis., tox.megacol., digest. LAXETTE, Cipla Medpro [P/S] prep admin., therapeut.eff.of drugs with narr.therap.index./short half-
perforat./risk thereof, ileus, susp.intest.obstruct., painf.abd.syndr. Lactulose life poss. aff., use in pregn.& lactat.only if essent.as no data, debilit./
without establ.cause. Indications: Constip.esp.in assoc.with laxat. habituat./post-surg./ fragile pts./electrol.imbal.risk, pts. with imp.gag refl./aspirat./regurg.
Side effects: GI disturbs., faec.incont.in adults, hypersens. reacts., obstet.pts. & childr., hyperammonaem.in chron.hepat.encephalopa- tend., sev.ren. insuffic., card.impairm., sev.ac.inflamm.bowel dis., corr.
anaphylax., perian.soren.in childr. thy incl.coma/pre-coma stages. dehydrat.bef.Moviprep use, semi-consc pts./pts.prone to aspirat/
Special precautions: Rule out organ.disord.bef. init.ther., safety (S0) SOL. 29/11.5/0609. 3,3 g/5 ml. regurgit.to be clos. observ. dur.admin.esp.via NG tube, electrol.to be
in pregn.not est., not for gluc.intol. indiv., liq./diet.fibr.to be incr., 817309-004: 150 ml, R46,07 meas./ appropr.ther.if any sympt.developm. indicat. fluid/electrol.
appropr.phys.activ., meas. electrol. if shift in fluid/electrol.observ., 817309-012: 500 ml, R126,34 shifts, slow down/temp. stop taking Moviprep in case of sev.bloat./
3 mnth. ther.reassessm., ther.not to exceed 3 mnths. in childr.due Dosage: Constip: Admin.as sngl.dly.dos. Init.dos: Admin x3 days.: abdom. distent./ pain/diffic.to contin., cont. sweetn.& aspartame
to lack of clinic.data. Adults: 30 ml. Childr. 6-14 yrs: 15 ml. 1-5 yrs: 10 ml. Infts: 5 ml. NORMACOL, (Aspen Pharmacare: Pharma) Pharmacare [P/S]
FRESHEN BISACODYL LAXATIVE, AI Pharm Ltd [P/S] Maint: Adults: 15-30 ml. Childr. 6-14 yrs: 10-15 ml. 1-5 yrs: 5-10 ml. Sterculia.
Bisacodyl. Infts: 2,5-5 ml. Indications: Constip.incl.dur.pregn.& lactat., sympt.relief in irrit.
Indications: Occas.constip., bowel evacuat.prior to surg./radi- Portal system.encephalopathy: Init: 30-50 ml 3xdly, then adjust bowel syndr.& divertic.dis.
olog.exam. dos.to produc. 2-3 soft stools dly. (S0) GRAN, E1974. 6,2 g/10 g.
(S0) TABS. E/11.5/1668 (S0) DRY POWD, 36/11.5/0240. 10 g/sachet 834815-001: 500 g, R140,44
715545-001: 5 mg, 12, R7,91 700167-002: 10 sachets, R62,77 Dosage: Adults: 1-2 heap.5 ml meas.1-2xdly aft. meals. Upto 14 g
Dosage: Do not chew. Admin.as sngl.dly.dos. Dosage: Admin.with a full glass of liq.with each dos. dly.in div.dos. May reduc.dos.in colost.& ileos.managem.
Adults & childr.over 12yrs: 1-3 tabs. Childr: 6-12 yrs: 1 tab. Constip: Adults: Init.10-30 g dly.as sngl.dos.or 2 div.dos.for 3 days. Contraindications: Intest.obstruct., faecal impact., tot.colon ato-
Contraindications: Undiagn.abdom.sympt., intest. obstruct., safety Maint.dos: As need. Dos.may be incr.to 40 g. Childr: 7-14 yrs: 10 g ny, other condits.where intest. evacuant inadvis., childr.und.12 yrs.
in pregn.& lactat.not est., childr.und.6 yrs., within 1 hr.of antacids/milk. 1-6 yrs: 5-10 g. Adjust accord.to indiv.respons. not recomm.
Side effects: GI disturbs., excess.water loss/ electrol.imbal.& poss. Port.system.encephalopathy: Init: 60-120 g dly. in 3 or 4 div.dos. Side effects: Allerg.reacts., urticar., flatul., distent.
aton.non-funct.colon with prolong.use. Maint: adjust accord.to response. Special precautions: Depend.with freq.& prolong. use,adeq.liq.
Special precautions: Depend.with prolong.use, not to be used for Contraindications: Intest.obstruct., appendicit., undiagn.rect.bleed., to prev.faec.impact./ oesophag. obstruct., poss.interfer.with ab-
long.than 1 wk.unless dir.by dr., inflamm.bowel dis., do not use in pres. CHF, hypertens., low galact. diet, colost./ileost.pts. sorpt.of other substancs., do not admin.bef.retir.esp.in elderly, ul-
of abdom. pain /N&V, seek medic.advice in case of rect. bleed./no Side effects: GI disturbs., hepat.encephalopathy exacerbat. cerat.colit., cont.sucrose
bowel movem.aft.use. Special precautions: Lact.intol., diab., childr. und.6 yrs., diarrh.& Warning: Do not use in pres.of abdom.pain, N&V.
FRESHEN SODIUM SULPHATE LAXATIVE, electrol.disturb.with prolong. use/excess.dos., do not take within 2 See also MDR page 201.
hrs.of other meds.
AI Pharm Ltd.[P/S] Drug interactions: Reduc.K conc., aff.K-retain. eff. of K-spar.diurets. NORMACOL PLUS, (Aspen Pharmacare: Pharma) Phar-
Sod.sulph.anhydr. macare [P/S]
Indications: Occas.constip. LENOLAX, (Aspen Pharmacare: Consum) Pharmacare [P/S] Sterculia 6,2 g, frangula 0,8 g/10 g.
(S0) POWD, E/11.5/1799 Na-phos.heptahydr.60 mg, Na-acid phosph. monohydr.160 mg/ml. Indications: Constip., aft.ano-rect.surg., colon diverticul.dis.
715563-001: 8,5 g/sachet, 72, R80,42 Indications: Occas.constip., pre-op.bowel empty. (S0) GRAN, E1483.
715564-001: 200 g jar, 1, R9,82 (SO) DISPOS.ENEMA, [P/S] E/11.5/819. 834807-009: 200 g, R64,48
Dosage: Adults & childr.12 yrs and over: 8,5 g (one med.meas.) 726443-018: 135 ml, R30,73 834807-017: 500 g, R136,76
dly dissolv.in glass warm water. Dosage: Contents of 1 contain. Dosage: Adults: 1-2 heap.5 ml meas.1-2xdly aft. meals.
184 / 2020-04 Gastro-Intestinal Tract - 12.6 / 12.7
Contraindications: Undiagn.abdom.sympts., intest. obstruct., faecal sciousn., regurgitat./aspirat.risk, adeq.fluid intake., CHF, Ca chann.
impact., tot.colon atony, condits. likely to lead to intestin.obstruct., block/diuret.use, meds. affect. electrol.lev., kidn.dis., imp.ren.funct., 12.7 Antidiarrhoeals
childr. und. 12 yrs.not recomm., safety in pregn.& lactat. not est. pre-exist. electrol.disturbs., elderly.
Side effects: Allerg.reacts., urticar., GI disturbs. Drug interactions: Incr.electrol.disturb.risk with diuret./adreno-cor- KANTREXIL (MDR Listing)
Special precautions: Depend.with freq.& prolong. use, adeq.liq.to ticoster., anticoag./digital. glycosid. & phenothiaz.effs.reduc., cipro- ADCO-ENTEROLYTE, AI Pharm Ltd [P/S]
prev.faec.impactat./ oesophag./ intestin.obstruct., poss.interfer.with floxacin & etidronate absorpt.reduc., format.of nonabsorb. complex. Kaolin 6 000,0 mg, Pectin 120,0 mg, K.chlor. 41,4 mg, Na
absorpt. of other substancs., inflam.bowel dis./ ulcerat. colit., do not with oral tetracycl., sev.system.alkalos. with Na polystyrene sulfon. chlor.78,9 mg, Na lact.86,4 mg/30 ml.
admin.bef.retir.esp.in elderly, cont. sucrose PURGOLENE, Cipla [P/S] Indications: Mild to mod.ac.diarrh.
Warning: Do not use in pres.of abdom.pain, N&V.
Macrogol (PEG) 3350 13,125 g, sod.bicarb. 178,5 mg, NaCl 350,7 mg, (S0) SUSP. E/11.9/1688
PEGICOL PLAIN, Aspen Pharmacare [P/S] KCl 46,6 mg/13,8 g sachet. 723428-018: 100 ml, R7,90
Macrogol 3350 6,563 g, Na bicarbonate 89,3 mg, NaCl 175,4 mg, Indications: Chron.constipat. Dosage: Admin.3-4 xdly. Adults: 60-80 ml Childr.12 yrs.& over:
KCl 25,1 mg/6,9 g sachet. (S0) POWD. 42/11.5/0412. 60 ml. 6-und.12 yrs: 30-40 ml. 3-und.6 yrs: 15-20 ml.
Indications: Chron.constipat. 723629-002: 8 sachets, R55,20 Contraindications: Intest.obstruct., pregn.& lactat., not recomm.
(S0) POWD. A39/11.5/0385. 723629-001: 20 sachets, R108,05 for childr.und.3 yrs.
707942-001: 20 sachets, R146,60 Dosage: Adults: Dissolv.powd.in 125 ml water. 1-3 sachets dly. in Side effects: GI disturbs., constipat.
Dosage: Do not use contin. Reconstit.each sachet with 62,5 ml water. div.dos.accord.to indiv.respons. Elderly: Init 1 sach./day recomm. Special precautions: Not for fluid replacem. ther., reduc.absorpt.of
May be prepar in advanc.& kept refrigerat.x24 hrs. Treatm.per.usual.not exceed.2 wks. May be repeat. if reqd. Dos.ad- other concom.agents, maint.hydrat., admin.K-salts in well-dilut.sols.,
Chron.constipat.: Childr: 2-6 yrs: Init.1 sachet dly. 7-11 yrs: justm.to 1-2 sachets dly in case of extend.use. ren./adren.insuff., ac.dehydrat., heat cramps, CHF, periph.& pulm.oed.,
Init.2 sach. dly. Adjust dos.as reqd.to prod.reg.soft stools. Max.dos. Contraindications: GI obstruct./perforat.due to struct.or funct.gut pre-eclampsia, if sympts. persist long.than 48 hrs./pt.condit.deterior.
not norm.exceed. 4 sach./day. wall disord./ileus/gastr.retent./ pept. ulc./sev.intest.tract inflamm. ther.to be discont.& Dr consult.
Contraindications: Suspect.intest.perforat./ intest. obstruct.due to condits, safety in pregn.not est., not recomm.in childr.und.12 yrs. ADCO-LOPERAMIDE, Adcock Ingram Ltd [P/S]
struct./funct.disord., sev.GIT inflamm. condits. Side effects: Allerg.reacts.incl.skin reacts./ anaphylax., GI disturbs. Loperamide HCl.
Side effects: Very common: Abdom.pain, borborygmi, diarrh. incl. borborygmi/anal irrit. Indications: Adults & childr.over 6 yrs: Ac.& chron. non-specif.
Common: N&V, abdom. distent., flatul., perian. inflammat./sore- Warnings and special precautions: Safety dur. lactat.not est., el- diarrh., peristals.inhibit.& slow. of intestin.transit.time in ileost.,
ness. Rare: Allerg.reacts.incl.anaphylax. derly, extend.use poss.if sev. chron./ resist.constip.second.to multip. colost.& other intest.resect. Childr.2-5 yrs: Peristals.inhibit.& slow.
Warnings and special precautions: Do not use in pres.of ab- scleros./ Parkinson’s dis.or induc.by reg.constip.meds. esp. opioids/ intest.trans.time.
dom. pain/N&V, depend.& loss of norm.bowel funct. with freq./ antimuscarin., not for use in pres.of N&V/ abdom. pain, freq./prolong. (S2) TABS, [P/S] Y/11.9/5.
prolong.use of laxat., stop.ther. immed. & meas. electrol.if shift in use, discont.ther./ monit. electrol./appropr.ther.init.in case of fluid / 792071-115: 2 mg, 6, R9,37
fluid/electrol. observ., seek med.advice if sudd. bowel habit chang. electrol. imbal.sympt., alert dr.if sudd.bowel habit chang. persist.long. Dosage: Peristalsis inhibit.& slow.intestin. trans.time: Chil-
for per.long.than 2 wks./ rect. bleed.or no bowel movem.aft.use, than 2 wks., discont.ther.if rect. bleed./bowel movem.fail.aft. use. dr.2-5 yrs: ½ tab.8 hrly.
safety in pregn.not est., childr. und. 2 yrs.not recomm., no data avail. Interactions: Solubil.of meds.solub.in alcoh.& insol. in water rais. Ac.diarrh: Adults: Init. 2 tabs.follow.by 1 tab.aft. each loose stool.
in CV-/ ren.funct.impairm. theref.poss.reduc.absorpt.of such prod. Childr. 6 yrs.& older: Init.1 tab follow.by 1 tab aft.each loose stool.
Interactions: Absorpt.of meds.poss.alter. PURGOPED, Cipla [P/S] Chron.diarrh: Adults: Init. 2 tabs dly. Childr.6 yrs. & older:
PICOLAX, Ferring [P/S] & Macrogol 6,563 g, Na bicarb.89,3 mg, Na Cl 175,4 mg, K Cl Init.1 tab dly. Adjust init.dos.till solid stools obt., usual.achiev on
Sod.picosulph. 10 mg, Mg oxide light 3,5 g, citric acid 12,0 g/sachet. 23,3 mg/6,9 g sach. maint.dos.of 1-6 tabs.
Indications: Bowel empty.& cleans.prior GI examinat. (eg.colonos- Indications: In childr.with chron.constip.with/ without faec.impact., Max. 4-6 tabs/day.
copy, Ba enema X-ray), IVP, surg & sev.constipat. faec.impact.recurr. (S2) SYRUP, [P/S] 28/11.9/0003.
(S3) POWD.FOR ORAL SOL. A39/11.5/0058 (S3) POWD.FOR ORAL SOL. 42/11.5/0413 811467-007: 1 mg/5 ml, 50 ml, R25,01
717080-001: 2 sachets, R125,20 3000271-001: 20 sachets, R118,12 Dosage: Peristalsis inhibit.& slow.of intestin. transit time:
Dosage: Dissolv.contents of sachet in 150 ml cold water stir.2-3 mins Dosage: Dissolv.each sach.in ¼ glass water. The correct number of Childr.2-5 yrs: 5 ml/12,5 kg bm.8 hrly.
& drink. Take adeq.fluid (6-8 glass. liq./ day). sach.may be dissolv.in advance & kept refridgerat. Ac.diarrh: Adults & childr.6 yrs.&old: 5 ml/ 12,5 kg bm follow.
Adults: Drink reconstit.sol.of 1 sachet by 8 am on day prior to exami- Chron.constipat.& faec. re-impact.prev: Childr: 2-6 yrs: by 2,5 ml/12,5 kg bm aft.each loose stool. Dly.dos.not to exceed
nd
nat.and 2 sach.6-8 hrs.lat. Init.1 sach.dly. 7-11 yrs: 2 sach. dly. Dos.adjust.up or down as reqd. 15 ml/12,5 kg bm.
Childr.over 9 yrs: Adult dos. 4-9 yrs: 1 sach.in morn.and half sach. with max.dos. usual. not exceed.4 sach.dly. Chron.diarrh: Adults & childr.6 yrs.& old: With indiv.adjustm.
in the aftern. 2-4 yrs: Half sach. in morn.and half sach.in the aftern. Faec.impact: Admin.foll.numb.of sach.per day: Childr.2-4 yrs: Day dos.poss.to obt.virtual.norm.bowel movem. Init.dos 5 ml/12,5 kg
Contraindications: Bisacodyl & oral saline laxat.hypersens., GI ob- 1: 2. Day 2&3: 4. Day 4&5: 6. Day 6&7: 8. Childr.5-11 yrs: Day 1: 4. bm dly.for childr. Adjust dos.until 1-2 solid stools/day obtain. Usual
struct./perforat., gastr. retent., toxic.colit./megacolon, ileus, pts.with Day 2: 6. Day 3: 8. Day 4: 10. Day 5, 6&7: 12. Sachets to be taken in maint.dos: 2,5-10 ml dly.
stoma, appendicit./sympts.thereof, undiagn.rect. bleed., diab.mellit., div.dos. & within 12 hr per. Regim.to be stopp.once disempact.occurs. Contraindications: Colit., diarrh.assoc.with pseudomembr.co-
CHF, hypertens., ren. impairm., dehydrat., childr.und.2 yrs., safety in Contraindications: Suspect.intest.obstruct.from funct./struct.GI lit., childr.und.2 yrs., safety in pregn.& lactat.not est., prim.ther.
pregn.& lactat.not est., lact.intol. wall disords., sev. inflamm.intest. tract condits.eg. Chron’s dis./tox. in ac.dysentery
Side effects: Electrol.imbal., Mg.accumulat.in imp.ren.funct., megacol./ ulcerat. colit. Side effects: Abdom.pain & GI disturbs., dry mouth, dizzin., fatig.,
hyponatraem., hypokalaem., N&V, abdom.fulln.& bloat., abdom. Side effects: Allerg.reacts.incl.anaphylax., GI disturbs., perian.in- skin rash.
Special precautions: Where constip.to be avoid., hepat.dysfunct.,
cramps, diarrh., incr. thirst, belch., gastr.irrit., hypersens.reacts. incl. flamm./soren.in childr.
anaphylact.react., angioed. Warnings and special precautions: Low salt diet, kidn.dis., hyper- caref.observat.of pts.with inflamm.bowel dis.for signs of toxic mega-
col., ORT essent.where fluid & electrol.deplet.poss.esp. childr., medic.
Warnings and special precautions: Do not use in sudd.change of tens., not recomm. in imp.CV/ ren. funct., not for use in pres.of abdom.
bowel habits persist. long.than 2 wks./rect.bleed./fail to have bowel pain/N&V, depend./loss of bowel funct.with prolong./contin. use, dis- supervis.for use in childr.und.6 yrs., only for peristals.& intest.transit
movem. aft.laxat.use/abdom.pain N&V/rec.GI surg., med.supervis.in cont.ther./meas.electrol.if sympt.indic.shift in fluid/ electrol. observ., time slow.in childr. 2-5 yrs.
low salt diet/kidn.dis./ hypertens., depend.risk with prolong./freq.use, sudd.bowel habit chang. persist.for long.than 2 wks., discont.if rect. ADCO-PRODIUM, AI Pharm Ltd [P/S]
1-2 hr. interv.bef.admin.oral tetracycl., avoid concom. Na polystyrene bleed./ bowel movem. fail.aft.use, meds.in solid dos.form eg.tabs. Loperamide HCl.
sulfon., adeq.fluid intake., imp.gag reflex, dimin.lev.of consciousn., may be flush.from GI tract if taken within 1 hr.of large Purgoped vol., Indications: Adults & childr over 6 yrs: Ac.& chron.non specif.
regurgitat. /aspirat.risk, CHF, elderly, driv./ operat. mach.if dizzin./ not recomm.in childr. und. 2 yrs., appropr.bowel managem.program diarrh., peristals.inhibit.& slow. intestin.transit time in ileostom.,
light-headedn./confus. exper. recomm. aft.disimpact., safety in pregn.& lactat. not est. colostom./other intestin.resect. Childr. 2-5 yrs: Peristals.inhibit.&
Drug interactions: As GI transit rate incr. absorpt. of oral meds.poss Drug interactions: Absorpt.of meds.solub.in alcoh./ insolub.in slow.intest.trans.time.
water may be alter.
modif.(eg.anti-epilept/ OC’s/anti-diabet & antibiot.), anticoag./ digox (S2) TABS. X/11.9/303.
& phenothiaz.reduc.effectiven., meds. affect. water & electrol.bal., SENOKOT, Reckitt Benckiser [P/S] 791768-112: 2 mg, 500, R228,27
incr.sens.to card. glycos.with electrol.imbal., ciprofloxacin & etidro- Sennosides B. Dosage: Ac.diarrh: Adults & childr.6 yrs.& old: Init: 2 tabs for
nate absorpt.reduc., format.of nonabsorb. complex.with oral tetra- Indications: Occass.constip. adults & 1 tab for childr.then 1 tab. aft.each subseq.loose stool. Max.
cycl., sev.system.alkalos. with Na polystyrene sulfon. (S0) TABS. E/11.5/671. dos. 8 tabs/day for adults & 4-6 tabs/day for childr.
See also MDR page 343. 763225-029: 7,5 mg, 200, R179,23 Chron.diarrh: Adults & childr.6 yrs.& old: Init: 2 tabs. dly.for adults
PICOPREP, Beta [P/S] Dosage: Adults and childr.over 12 yrs: 2-4 tabs once dly. Chil- & 1 tab dly for childr.of 6 yrs.& old., adjust dos.to obt. 1-2 solid stools
Sod.picosulph. 10 mg, Mg oxide 3,5 g, citric acid 12,0 g/sachet. dr: 6-12 yrs: 1-2 tabs.once dly. 2-6 yrs: ½-1 tab.once dly. Und. 2 /day. Usual maint.dos: 1-6 tabs.dly. Childr.2-5 yrs: Peristals.inhibit.&
yrs: Not recomm.
slow.of intest.trans.time: ½ tab.8hrly.
Indications: Bowel empty.& cleans.prior to colonoscopy, Ba enema,
X-ray examin., IVP, surg & sev.constipat.. Contra-indications: Undiagn.ac./persist. abdom. sympt. Contraindications: Where inhibit.of peristals. must be avoid., liv.
Side-effects: GI disturbs., excess.water/ electrol. loss/ poss.aton.
impairm., infts.und.2 yrs., safety in pregn.& lactat.not est.
(S3) POWD. A38/11.5/0389.
700493-005: 3x15,5 g sachets, R116,12. colon with prolong.use, urine discolourat. Side effects: Abdom.pain & GI disturbs., CNS effs., dry mouth,
skin rash
Special precautions: Laxat.depend.(prolong. use), inflamm.
Dosage: Dissolv.contents of sachet in 250 ml hot water, stir un- bowel dis. Special precautions: Caref.observat.of pts.with inflamm.bowel dis.
til clear & chill. for signs of tox.megacolon, hepat. dysfunct., young childr., discont.if
Adults: 24 hrs prior to examinat.drink reconstit. sol.of 1 sachet & SOFLAX, Cipla Medpro [P/S] constip. occurs, medic.supervis.for use in childr.und.6 yrs., in childr.2-5
another glass water & rep.6 hrly. prior to examinat./as direct.by Dr. Senna Extract equiv.to 13,5 mg Sennosides A and B as Ca salts yrs.only for peristals.& intestin.trans. time slow.
Childr.over 9 yrs: Adult dos. 4-9 yrs: Half adult dos. 2-4 yrs: Quar- Indications: Constip.
ter adult dos. (S0) TABS. 32/11.5/0607 BETAPERAMIDE, AI Pharm Ltd [P/S]
Nasogastric intubat: Infus.20-30 ml/min. 868078-034: 13,5 mg, 20, R27,06 Loperamide HCl.
Contraindications: GI obstruct./perforat., gastr. retent., toxic.co- 868078-042: 13,5 mg, 60, R64,00 Indications: Adults & childr.over 6 yrs: Ac.& chron.non specif.
lit./megacolon, ileus, pts.with stoma, appendicit./sympts.thereof, 868078-026: 13,5 mg, 200, R155,81 diarrh., peristals.inhibit.& slow.intestin.transit. time in ileostom.,
undiagn.rect. bleed., CHF, hypertens., diab.mellit., oral saline laxat. Dosage: Adults: Recomm.dos: 1-2 tabs.1x dly. Start with low. colostom./ other intest.resect. Childr.2-5 yrs: Peristals. inhibit. &
hypersens., dehydrat., ren.impairm., safety in pregn.& lactat.not est. dos. incr.dly.if necess.for max. 3 days. Childr.over 6 yrs: Admin. slow.intest.trans.time.
Side effects: Electrol.imbal., Mg.accumulat.in imp.ren.funct., ½ adult dos. (S2) TABS. Z/11.9/113.
N&V, abdom.fulln.& bloat., abdom. cramps, diarrh., incr.thirst, trans. Contraindications: Intestin.obstruct., undiagn. abdom.sympt., rect. 792691-008: 2 mg, 10, R25,09
hypovolaem. bleed., CCF, childr.und.6 yrs. not recomm. Dosage: Ac.diarrh: Adults & childr.over 6 yrs: Init: 2 tabs for
Special precautions: Phenylketonur.as contains aspartame, low Side effects: GI disturbs., electrol.disturbs., skin reacts., urine & adults & 1 tab for childr.then 1 tab aft.each subseq.loose stool. Max.
salt diet, kidn.dis., hypertens., depend. risk with prolong./freq.use, oral faeces discolourat. dos. 8 tabs/day for adults & 4-6 tabs/day for childr.
med. taken within 1 hr.of admin.flush.from GI tract, 1-2 hr. interv.bef. Special precautions: Inflamm.bowel dis., prolong. use, atonic colon Chron.diarrh: Adults & childr.over 6 yrs: Init: 2 tabs dly for adults
admin.oral tetracycl., avoid concom. Na polystyrene sulfon., childr. with lax.abuse syndr., reduc.K + conc.aff.K-retain.eff.of K-spar.diurets., & 1 tab dly.for childr., adjust dos.to obt. 1-2 solid stools/day. Usual
und.4 yrs.on physic. advice only, imp.gag reflex, dimin.lev.of con- rect.bleed.& fail.to have bowel movem. aft.use. maint.dos: 1-6 tabs dly.
Gastro-Intestinal Tract - 12.7 / 12.8 2020-04 / 185
Peristals.inhibit.& slow.intest.trans.time: 4 caps. (8 mg); 34 kg: 5 caps (10 mg); 40 kg: 6 caps (12 mg); 47 kg: LOMOTIL, J&J [P/S]
Childr.2-5 yrs: ½ tab.8 hrly. 7 caps (14 mg); 54 kg: 8 caps (16 mg). Stop ther.as soon as diarrh. Diphenoxylate HCl 2,5 mg, atropine sulph. 0,025 mg
Contraindications: Where inhibit.of peristals. must be avoid., liv. und. contr. Indications: Mild to mod.diarrh.
impairm., infts.und.2 yrs., safety in pregn.& lactat. not est. Chron.non-spec.diarrh: Init: 2 caps. (4 mg)dly. for adults & 1 cap (S2) TABS, E/11.9/0918
Side effects: Abdom.pain & GI disturbs., dry mouth, dizzin., fatig., (2 mg) dly for childr.6 yrs & old. Adjust init.dos.unt.1-2 solid stools/ 738980-056: 10, R19,94
skin rash. day, usuall. achiev. on maint.dos.of 1-6 caps (2-12 mg)dly. Decr. dos. Dosage: Ac.diarrh: Adults: Init. 4 tabs., follow. by 2 tabs.6 hrly. Max:
Special precautions: Hepat.dysfunct., young childr., caref.obser- if constip.occurs. 25 mg dly. Childr: 4-8 yrs:(20-27 kg): 1 tab 3xdly, 9-12 yrs:(27-36 kg):
vat.of pts.with inflamm.bowel dis.for signs of tox.megacolon., medic. Do not exceed max.dly dos. Max.dos.in ac.& chron. diarrh: Adults: 8 1 tab. 4xdly, 13 yrs & above: 2 tabs 4xdly.
supervis.for childr.und.6 yrs., only for peristals.& intestin. transit time caps.dly. Childr.relat.to bw: 3 caps /20 kg Contraindications: Childr.und.4 yrs., diarrh. assoc.with antibiot.
slow.in childr.2-5 yrs. Contraindications: Infts.und.24 mnths., prim. ther. in ac.dysentry/ induc.pseudomembr. enterocolit., fev., prostat.enlargem., para-
ac.ulcerat.colit./bact. enterocolit. caus.by invas.organ.incl.Salmonel-
CIPLA LOPERAMIDE, Cipla Medpro [P/S] la, Shigella & Campylobact., pseudomembr. colit. assoc with broad- lyt. ileus/pylor.stenos., ulc.colit., clos.angle glauc., lactat., safety
in pregn.not est.
Loperamide HCl. spect antibiot., bact.enterocolit., where peristals.inhib.undesir., ileus Side effects: CNS eff., paraesthes., insomn., numb. of extremet.,
Indications: Adults & childr.over 6 yrs: Ac.& chron. non-specif.diarrh., irrespect.of cause, safety in pregn.& lactat.not est., allerg./anaphylact.reacts., GI disturbs., pancreatit., urin.urgency, dif-
peristals.inhibit.& slow. of intestin.transit.time in ileost./colost.& oth- Side effects: Constip., flatul., headache, naus., dizzin., abdom. fic.& retent., flush.of skin, dry mouth, thirst, pupil dilat., photophob.,
er intest.resect. Childr.young.than 6 yrs.und.medic. supervis: Peristals. pain/distent./discomf., dry mouth, vomit., rash, hypersens.reacts. dry skin, trans.bradycard.follow.by tachycard.with palpitat.& ar-
inhibit.& slow.intest.trans.time. incl.anaphylax.& anaphylact.react., co-ordinat.abnormal., depress./ rhythm., retrostern. pain.
(S2) TABS, A39/11.9/0407 loss of consciousn., hyperton., stupor, miosis, ileus, megacolon incl. Special precautions: Inflamm.bowel dis., hyperthyroid., adreno-
707342-001: 2 mg, 8, R12,74. tox.megacolon, angioed., Stev. Johns.., erythema multiforme, tox. cort.insuff., imp.kidn./liv. funct., prostat.hypertrophy, shock, obstruct.
Dosage: Discont.ther.immed.diarrh.is und.control. epiderm. necrolys., urticar., prurit., urin.retent., fatig. bowel disords., myasthen.grav., ac.bronch.asthma attack, HF second.
Ac.non-specif.diarrh: Adults: Init. 2 tabs.follow. by 1 tab.aft.each Warnings and special precautions: Do not use when peristal.in- to lung dis., resp.depress.esp.in pres.of ac. alcohol., cyanos.& excess.
loose stool. Childr. 6 yrs.& older: Init. 1 tab follow.by 1 tab aft.each hibit.is to be avoid., discont.if constip./ abdom.distent./ileus develop, bronch.secret., rais. IC-press., maint.hydrat.
loose stool. Do not exceed follow.max.dly dos: 14-19 kg: 2 tabs. 20- lact.intol., determin. & treat.underly.etiology, oral rehydrat. ther. where Drug interactions: Addit.eff.on CNS depress., MAOI’s.
26 kg: 3 tabs. 27-33 kg: 4 tabs. 34-39 kg: 5 tabs. 40-46 kg: 6 tabs. necess.esp.childr., not suitable for childr. und.6 yrs., discont.ther.in
47-53 kg: 7 tabs. > 54 kg: 8 tabs. AIDS pts.if abdom. distens.occurs as tox.megacol.report., hepat. im- LOPERASTAT, (Ranbaxy) Be-Tabs [P/S]
Chron. non-specif.diarrh: Und.med.supervis. Decr.dos.if con- pairm., monit.pts.with hepat.dysfunct.for S&S of CNS toxic., appears Loperamide HCl.
stip.occurs. Adults: Init. 2 tabs dly. Childr. 6 yrs.& older: Init. 1 tab in breast milk, seek medic. advic.with chron.non specif.diarrh./if no Indications: Ac.& chron.non-specif.diarrh., intestin.transit time con-
dly. Adjust init. dos. till 1-2 solid stools obt., usual.achiev on maint. clin. improvem.observ.with.48 hrs. in ac.diarrh. trol.with ileostom., colostom./other intest.resect.
dos.of 1-6 tabs. Drug interactions: Incr.plasma lev.with quinidine ritonavir/ itracona- Childr.und.6 yrs: Peristals.inhibit.& slow.of intest.transit time.
Contraindications: Infts.und.2 yrs., ac. dysentery, ac.ulcerat.colit., zole/gemfibrozil & ketoconazole, oral desmopress.plasma conc.incr., (S2) SYRUP. 28/11.9/0649. 1 mg/5 ml.
bact.enterocolit., pseudomembr. colit., avoid where inhibit.of peri- meds. accelerat. GI transit.decr.effs. 820563-005: 50 ml, R31,59
stals. could incr.risk of signific.sequelae incl. ileus/megacolon & tox. IMODIUM, J&J [P/S] Dosage: Ac.diarrh: 5 ml/12,5 kg bm follow.by 2,5 ml/12,5 kg bm
megacol., lactat., safety in pregn.not est. Loperamide HCl. aft.each subseq.loose stool. Dly.dos.not to exceed 15 ml/12,5 kg bm.
Side effects: Skin rash, allerg.reacts.incl. anaphylax. & Stev.Johns. Indications: Adults & childr.over 6 yrs: Ac.& chron. non-specif. Chron.diarrrh: Indiv. Childr: Init. 5 ml/12,5 kg bm dly. Adjust dos.until
syndr./erythema mutiforme, GI disturbs., ileus, tox.megacol., urin. re- diarrh., peristals.inhibit.& slow. of intest.transit time in ileostom., 1-2 solid stools/day obtain. Usual maint: 2,5-10 ml dly.
tent., dizzin., drowsin. colostom. & other intest.resect. Childr.und.6 yrs: Tabs./ syrup: Peri- Contraindications: Childr.und. 2 yrs, prim.ther. in ac.dysentery,
Special precautions: Specif.treatm.of underly. aetiology recomm., stals.inhibit.& slow.of intest.transit time. ac.ulcerat./pseudomembr.colit., where inhibit.of peristal.is to be
medic.supervis.for use in childr. und. 6 yrs., discont.at earl.signs of (S2) TABS, [P/S] H/11.9/152. avoid., safety in pregn.& lactat.not est.
abdom. distens.in AIDS assoc.diarrh.as tox.megacol. report., appears 732486-009: 2 mg, 6, R40,53 Side effects: Revers.paralyt.ileus, dry mouth, abdom. pain, other GI
in human breast milk, hepat. impairm., ORT essent.where fluid & (S2) MELT TABS, [P/S] 29/11.9/0213. 2 mg disturbs., hypersens.reacts., skin rash, dizzin., fatig.
electrol. deplet. poss.esp.childr. 703518-001: 6, R40,53 Special precautions: Discont.if constipat./ abdom. distent./subi-
Drug interactions: Plasma conc.rais.with quinidine & resp.sup- Dosage: Adults: leus develop, may precipit. toxic megacolon in pts.with inflamm.
press.may result. Acute: 2 tabs stat.then 1 aft.each loose stool. Max.dly.dos.: From bowel dis., ORT essent.where fluid & electrol.deplet.poss. esp.
childr., not to be admin.to infts.without medic. supervis., seek.med.
GASTRON, (Aspen Pharmacare: Pharma) Pharmacare [P/S] 14 kg: 4 mg; 20 kg: 6 mg; 27 kg: 8 mg; 34 kg: 10 mg; 40 kg: 12 mg; advice if no clinic.improvem. observ.within 48 hrs., monit.hepat.dys-
47 kg: 14 mg; 54 kg: 16 mg.
Loperamide HCl. funct.pts.for CNS toxic.
Indications: Ac.& chron.diarrh., slow intestin. transit.time with il- Chron: 2 tabs.dly.then adjust till 1-2 solid stools/ day. Maint. 1-6 tabs.
dly. Decr.dos.if constip. occurs.
eostom., colostom./other intest. resect. PECTROLYTE, AI Pharm Ltd
(S2) TABS., [P/S] V/11.9/213. Childr.over 6 yrs: Chlorodyne 2 ml, kaolin 20 g, pectin 0,4 g, Na-lact. 0,29 g, KCl 0,14 g,
Acute: Init.1 tab.then 1 tab.aft.each loose stool. Max.depend.on bm.
810916-002: 2 mg, 6, R7,69 Chron: 1 tab.dly.then adjust till 1-2 solid stools/ day. Decr.dos.if con- NaCl 0,26 g/100 ml.
810916-010: 2 mg, 300, R383,93 stip.occurs. Max.depend.on bm. Indications: Mild to mod.ac.diarrh., as adjunct.to electr.contain.
Dosage: Adults: (S2) SYRUP, [P/S] J/11.9/166. 0,2 mg/ml. fluids, rest & appropr.diet.
Ac.diarrh: Init: 2 tabs then 1 tab aft.each subseq. loose stool. Max. 732478-006: 50 ml, R82,75 (S2) SUSP. E935.
dos.8 tabs/day. Dosage: Acute: 5 ml/12,5 kg bm foll.by 2,5 ml/12,5 kg bm.aft.each 753246-007: 150 ml, R47,23
Chron.diarrh: Init: 2 tabs for adults & 1 tab aft.each loose stool. loose stool. Dly. dos. not exceed.15 ml/12,5 kg bm. Dosage: Admin.4 hrly.with water. Adults: 20-40 ml. Childr: 3-6 yrs:
Usual maint.dos: 2-4 tabs in div.dos.. Chron: Childr: 5 ml/12,5 kg bm dly. Maint: 2,5-10 ml dly. 5-10 ml. 6-12 yrs: 10-20 ml.
(S2) SYRUP, [P/S] V/11.9/214. 1 mg/5 ml. Contraindications: Infts.und.24 mnths.for syrup, prim.ther.in Contraindications: Safety in pregn.& lactat.not est., childr.und.3
810908-018: 50 ml, R29,18 ac.dysentry, ac.ulcerat./ pseudomembr. colit.assoc with broad- yrs.not recomm.
Dosage: Ac.diarrh: spect antibiot., bact. enterocolit., where peristals.inhib. undesir., Side effects: Constip., GI disturbs., hepatotoxic., CNS effs., urin.
Childr.2-5 yrs.(13-20 kg body mass): 5 ml 3x/day x1st day, follow. lactat., safety in pregn.not est., tabs.& melt tabs.in childr.und.6 yrs. retent., uter.& bil.spasm, antidiuret. eff., dry mouth, sweat., flush.,
by 5 ml/10 kg bm.aft.each loose stool. Tot.dly.dos.not to exceed 15 ml Side effects: GI disturbs.incl.toxic megacolon, skin reacts.incl.Stev. vertigo, CV effs., hypotherm., skin reacts., mios., rais.IC press., musc.
Childr.5-8 yrs.(20-30 kg body mass): 5 ml 4x/day x1st day, follow.by Johnson.& tox.epiderm. necrolys., hypersens.reacts.incl.anaphylax., rigid., restlessn., mood chang., euphor.
5 ml/10 kg bm.aft.each loose stool. Tot.dly.dos.not to exceed 20 ml. urin. retent., CNS effs. Special precautions: Not for fluid replacem. ther., reduc.absorpt.
Childr.8-12 yrs.(over 30 kg): 10 ml 3-4x/day x1st day, follow.by Special precautions: Discont.if constipat./ abdom. distent./ileus of other agents if used concom.
5 ml/10 kg bm.aft.each loose stool. Tot.dly.dos.not to exceed 40 ml develop, determin.& treat. underly. etiology, seek physic.advic.with
Contraindications: Ac.infect.diarrh., where inhib. of peristals.must chron. non specif.diarrh., hepat.impairm., oral rehydrat. ther. esp.
be avoid.partic.in constip.& inflamm. bowel dis., hepat.dysfunct., infts., rout.use in childr.und.6 yrs.not recomm., discont.ther.in AIDS 12.8 Liver, gall bladder
tabs.childr. und.5 yrs., syrup childr.und.2 yrs., safety in pregn. not est. pts.if abdom. distens. occurs, damage to tabs and melt tabs. occurs
Side effects: GI disturbs., abdom.pain, dry mouth, dizzin., fatig., skin if press.through blister pack. and bile
rash, revers.paralyt.ileus at high dos.
Special precautions: Caref.observat.of pts.with inflamm.bowel KANTREXIL, Opus [P/S] &
dis.for signs of toxic megacolon., discont.if constip./abdom.distent./ Kanamyc.sulph.equiv.to kanamyc.100 mg, aminopentamide LEGALON 70, (Mylan) Xixia [P/S]
ileus develops, tabs cont.mannitol, syrup cont.sweetn. 0,033 mg, pectin 25 mg, bism.subcarbon. 250 mg, act.attapulgite Silymarin.
500 mg/5 ml & tab.
Indications: Alcoh.induc.liv.dis.
GASTROPECT, (Aspen Pharmacare: Pharma) Pharmacare [P/S] Indications: Specif.& non-specif.gastroenterit. (S0) TABS. R/7.4/172.
Kaolin 1 g, pectin 0,05 g/5 ml. (S4) SUSP, [P/S] A E/11.9.1/793. 785849-009: 70 mg, 40, R87,22
Indications: Mild to mod.ac.diarrh. 734802-005: 100 ml, R136,15 785849-017: 70 mg, 100, R197,01
(SO) SUSP. E/11.9/1546. Dosage: Admin.4-6 hrly. Dosage: 2 tabs 3xdly. Maint: 1 tab 3xdly.
728284-006: 100 ml, R9,40 Adults & childr.over 12 yrs: 15 ml. Childr. 6-12 yrs: 10 ml. (S3) FORTE CAPS, 45/7.4/1132
Dosage: Admin.3-4x/day. 1-6 yrs: 5 ml. 3000442-002: 140 mg, 30, R113,06
Adults: 25-50 ml. Childr. 12 yrs.& over: 25 ml. 6-12 yrs: 12,5-25 ml. (S4) TABS, [P/S] A E/11.9.1/802. 3000442-001: 140 mg, 100, R376,92
3-6 yrs: 5-12,5 ml. 734810-008: 20, R139,39 Dosage: 1 cap 3xdly (ie 420 mg dly). Not recomm. for childr.<12 yrs.
Contraindications: Intest.obstruct., spast.bowel condit. 734810-016: 100, R696,92 Side effects: Rare: mild laxat.eff. V.rare: dyspn., hypersens.re-
Side effects: Constip., flatul., distent. Dosage: Adults: 3 tabs 6 hrly. Sev.cases: Init admin. 4 hrly. acts., rash.
Special precautions: Maint.of fluid & electrol. bal., cont.su- Contraindications: Other aminoglycos.antibiot. hypersens., glauc., Warnings and special precautions: Not a substit. for abstain.
crose & sweetn. prostat.hypertrophy, myasth. grav. from liv.damage cause, consult Dr if icterus/yell.discolourat.of eye
Side effects: Dry mouth, dimm.vis., cerebr. excitat., superinfect., white occurs, safety & effic.in pregn.& lactat.not est.
IMODIUM, Janssen Pharmaceutica [P/S] ototoxic., nephrotoxic., hypomagnesaem./hypocalcaem.& hy-
Loperamide HCl. poklaem.with prolong.use, anaem., purpura, convuls., vis. disturbs., URSOFALK, (Cipla Medpro) Orphan SA [P/S]
Indications: Adults & childr.6 yrs.& old: Ac.& chron.non-specif. headache, paraesthes., kanamycin resist. organ. overgrowth, revrs. Ursodeoxycholic.acid
diarrh., peristals.inhibit.& slow. of intest.transit time in ileostom., encephalopathy, bone & joint disords., faeces discolourat., neurotox. Indications: Prim.bil.cirrhos.treatm., provid.no decompens.hepat.
colostom.& other intest. resect. (prolong./ excess. use). cirrhos.
(S2) CAPS, U/11.9/213. Special precautions: Keep young childr.well hydrat., contains (S3) CAPS, 43/11.10/0442
807761-001: 2 mg, 6, R41,79 tartrazine, withdr.if ototoxic. sympts./superinfect.occur, ren.fail., con- 716334-001: 250 mg, 100, R1 045,95
Dosage: Ac.non-spec.diarrh: Adults & childr. 6 yrs.& old: com. neuromusc. block./ototox or nephrotox.meds., antiemet. poss. Dosage: Swall.whole. Dly.dos.depend.on bm, approx.10-15 mg/kg
Init.2 caps (4 mg)for adults or 1 cap. (2 mg) for childr. foll.by 1 cap. mask ototox.sympts., admin. separately from concom.betalactams bm.34-50 kg: 1 cap morn.& even. 51-65 kg: 1 cap 3x/day. 66-85 kg:
(2 mg) aft.each subseq.loose stool. Max.dly.dos.: From 27 kg: See also MDR page 589. 1 cap morn., 1 cap midd.& 2 caps in even.86-110 kg: 1 cap.in morn.,
186 / 2020-04 Gastro-Intestinal Tract- 12.8 / 12.9 / 12.10
2 caps midd.& 2 caps in even. Over 100 kg: 2 caps 3x/day. If clinic. Dosage: 2 g at night per rectum. persens.pneumonit., tachycard., hypo-/hypertens., pharyngolaryng.
sympt.worsen.at begin.of treatm., cont.ther.with 1 cap dly.dos.& then (S3) SUPPS. [P/S] Z/11.10/206. pain, pancreatit., abnorm. LFT, skin reacts.incl.prurigo, Stev.Johns.
incr.grad.by one cap.dly each wk until.dos.in regim.reach. Indications: Mild to mod.proctit.& proctosigmoidit. in ulcerat.colit. syndr., alopec., arthralg., back-/abdom.pain, asthen., fatig., pyrex.,
Contraindications: Ac.gall-bladd./bil.tract inflamm., common bile/ 824135-008: 500 mg, 20, R396,24 fac.oed., bld.dyscras., neuropathy, pericardit., myocardit., allerg.al-
cyst.duct occlus., pept.ulc. dis., freq.bil.colic episod., non-funct.gall- Dosage: One supp.per rectum up to 3x/day.aft. defaecat. Reduc. veolit., bronchosp., cholelithias., hepatit., angioed., SLE-like syndr.,
bladd., radio-opaq./ calcif.gallston., safety in pregn.& lactat.not est. as condit.improves. myalg., interstit.nephrit., nephrot. syndr., ren.impairm./-fail., bloody
Side effects: Pasty stool, diarrh., sev.(R) side upp.abdom.pain, gallst. Contraindications: Salicyl.sens., sev.ren. impairm., liv.impairm., diarrh., cramp., card.hypersens.reacts.
calcificat., poss. decompensat. of hepat.cirrhos.in PBC, urticar, prurit. gastric & duod.ulc., bleed. tendenc., safety & effic.pregn.& lactat. Warnings and special precautions Excret.in breast milk, elderly,
st
Special precautions: Dur.1 3 mnths liv.funct. test.to be monit. not est., lact.intol.for tabs. mild to mod.ren.impairm., ren. funct. eval.bef. nit.& at least 2x/yr dur.
every 4 wks, thereaft.3 mnthly., concom.ciclosporin, adeq.contra- Side effects: Anaem., headache, dizzin., tinnit., paraesthes., vom- ther., chron. lung funct.impairm.esp.asthma, hepat.impairm., concom.
cept.in women of childbear.age, pregn. exclud.bef.init.treatm., con- it., naus., dyspeps., abdom.pain, diarrh., flatul., rash., prurit., urticar., known nephrotox.agents incl.NSAID’s/ azathioprine, concom.6-
com. agents metabol.via cytochrome P450 3A enzyme, poss.clinic. arthralg., myalg., fev., bld.dyscras., periph.neuropathy, vertigo, peri- mercaptopurine, prothromb. time/INH monit.with coumar. antico-
sympt.worsen.at beg.ther. cardit., myocardit., dyspn., pneumon., interstit.-/eosinophil.pneumon., ags., sulphasalazine cross-sens., organ./ funct. upp.GI obstruct.,
Drug interactions: Reduc.absorpt.with concom. cholestyramine/ lung disord., chest pain, cough, bronchosp., alveolit., pulm. eosino- poss.ther.-induc. nephrotoxic., discont.ther.if ser.bld.dyscras.devel./
colestipol/Al contain.antacids (admin.at least 2 hrs bef./aft.), ciclo- phil., lung infiltrat., colit.sympt.exacerbat., pancreatit., LF paramet. ac.intol.syndr.susp., condits.predispos.to myo-/pericardit.developm.
sporin absorpt. incr. from intest., poss.reduc.ciprofloxacin absorpt., re- changes, hepatit., alopec., Stev.John.syndr., erythema multiforme, Drug interactions: Thiopurine methyltransferase inhib., poss.decr.
duc.peak plasma conc.and AUC of nitrendipine, induc.drug-metabolis. bulbous skin reacts., rash, lupus-like syndr.with pericardit.& pleu- anticoag.activ.with coumar. anticoags., consid.alternat.select.assay
enzyme cyto chromosome P450 3A4. ropericardit.as promin.sympts as well as rash & arthralg., imp.ren. when meas.urin.normetanephr.by liq.chromatography with elctro-
URSOTAN, Sanofi-Aventis [P/S] funct., interstit. nephrit., ren.fail., nephrot.syndr., hypersens. reacts., chemic.detect.as spuriously elev.test results record.
Ursodeoxycholic.acid revers.oligosperm. Enema & supps also: anal irrit. See also MDR page 94.
Indications: Dissolut.radiolucent cholestrol gallstones in funct. Warnings and special precautions Ren. impairm., rais.bld.urea/ PENTASA, Ferring [P/S] &
gallbladders. proteinur., consid.induc. nephrotox. if ren.impairm.develops dur.ther., Mesalazine
(S3) TABS, N/34/203 monit. ren.funct.bef.& 4 wkly x12 wks.dur.ther. extend. to every 6 Indications: Treatm of mild to mod ulcerat. colit. & maint.of it’s remiss.
774243-007:100 mg, 180, R1 445,15 mnths & then annually every 5 yrs. in absence of ac.allerg.ren.re- (S3) TABS, [P/S] 33/11/0088
Dosage: Treatm.durat.accord.to size & dissolut. rate of gallstones. spons., complete bld count bef.& 4 wkly x12 wks.dur. ther. & then 890775-004: 500 mg, 100, R641,35
6 tabs.dly.in 3 div.dos.aft.meals. quarterly if results norm., discont.if ren. impairm./ bld.dyscras.evid., Dosage: Do not chew/halve. May be dispers.in 50 ml cold water.
Contraindications: Bile acid allergy, pept.ulc.dis., chron.liv.dis., pulm.dis.in partic. asthma, myo-/pericardit.of allerg. background, Ulcerat.colit: Adults: Ac.treatm: Indiv. Up to 4 g/day admin.once
inflamm.small intest.& colon dis., bile duct obstruct., radio-opaq/ do not re-introduc.in case of mesalazine-induc. card.hypersens., dly.or in 4 div.dos. Recomm. maint: Indiv.2 g once dly or in 4 div.dos.
calcif./bile pigment stones/ non funct.gallballers, other gallstone sulphasalazine hypersens.hist., elderly, limit. documentat.for eff.in Childr.6 yrs & old: Indiv. Start with 30-50 mg/ kg/ day in div.dos. Max:
complicat., pregn. childr.6-18 yrs., concurr. preps. which lower stool pH., INR monit.with 75 mg/kg/day in div.dos. Tot.dos.not to exceed 4 g/day. Recomm.
Side effects: GI disords., dyspeps., calcificat.of cholesterol stones, concom. warfar, poss.life threat.infect.with concom. azathioprine/6- maint: Indiv. Start with 15-30 mg/kg/day in div.dos. Tot. dos.not to ex-
dose-relat.diarrh., prurit. mercaptopurine & thioguanine, poss.incr.ren.react.risk with known ceed 2 g/day. In childr.it’s gen. recomm. to give half adult dos to those
Special precautions: Monit.serum enzyme levels & perform nephrotox.agents eg NSAID’s/azathioprine with body weight up to 40 kg and norm.adult dos.for those over 40 kg.
liv.funct.test. Drug interactions: Prep.low.stool pH prev.act. ingred. rel., poss. (S3) SUPPS, [P/S] A40/11/0374
Drug interactions: Concurr.oestrog.hormones/ OC./antihyper- decr.anticoag.eff.of warfar., immunosuppress. effs.of azathioprine/6- Indications: Mild to mod.ulcerat.proctit.where les.within 30 cm
lipidem./neomycin progestins decr. ability to dissolve cholestr.gall- mercaptopurine & thioguanine incr., reduc. uricosur. acitiv.of sulfin- of anal verge
stones., bile acid bind.drugs decr.absorpt. pyrazone & diuret.eff.of furosemide 714134-001: 1 g, 28, R1 101,17
Warnings: Sulfation defic.congenit./acquir.poss. predispose pt.to ENTOCORD, Equity [N/P/S in C] Dosage: Ulcerat.proctit: Ac.treatm: 1 supp dly. Maint.treatm:
lithocholate-induc.liv.damage. Budesonide. 1 supp.3x/wk.on non-consecut. days
Indications: Ulcerat.colit.involv.rectum & sigmoid colon. (S3) ENEMA, [P/S] 44/11/0888. 1 g/100 ml.
(S4) ENEMA (DISPERS.TABS.& VEHICLE). [N/P/S in C] Indications: Treatm.of ulcerat.proctosigmoidit.& left-side colit.
12.9 Suppositories and anal 29/11.8/0638. 0,02 mg/ml 721267-001: 7x100 ml, R519,90
Dosage: 1 enema rectally at bedt.
824593-006: 2,3 mg, 7 tabs.+7 bott.of vehicle, R499,97
ointments Dosage: Adults: 1 enema nightly for 4 wks.just bef.bedt. Full eff. (S3) SACHETS (PROLONG.REL.GRAN.), [P/S] 43/11/0013, 0014
Indications: Adults & childr.6 yrs & over: Mild to mod.ulc.colit.
observ.in 2-4 wks.. If remiss.not achiev.within 4 wks.prolong treatm.
SCHERIPROCT (MDR Listing) to 8 wks. Prepare just bef.use. treatm.& remiss.maint., mild to mod.Chron’s dis.
(S4) CAPS. [N/P/S in C] 31/21.5.1/0215. 722335-001: 1 g, 120, R1 539,84
SCHERIPROCT, (Adcock Ingra) Bayer [N/P/S in C] & Indications: Induct.of remiss.in pts.with mild to mod.Crohn’s dis. 722336-001: 2 g, 60, R1 539,84
Prednisolone caproate 1,9 mg, cinchocaine HCl 5 mg/g. involv.ileum & or ascend.colon. Dosage: Empty cont. on tong.& swall.with water/ juice without
Indications: Short-term sympt.relief in haemorrh., anal fiss., 838896-006: 3 mg, 100, R1 127,73 chew.grans.
prurit.ani. Dosage: Act.dis: Take in morn.& do not chew caps. Recomm.dly. Ulc.colit: Ac.treatm. Adults: Indiv. Up to 4 g once dly/div.dos.
(S4) OINT, [N/P/S in C] E/11.8/0667. dos.is 9 mg once dly for up to 8 wks. Full effect achiev.within 2-4 wks. Childr.6 yrs & old: Indiv. start. with 30-50 mg/kg/day in div.dos.
762660-007: 15 g, R158,07 Taper off bef.cessat. Limit.exper.in elderly. Max.75 mg/kg/ day in div.dos.with tot.dos.not exceed.4 g/day. Maint:
762660-015: 30 g, R316,20 Contraindications: Loc.& syst. bact., fung.& vir.infects., safety & Adults: Recomm.2 g once dly/div.dos. Childr.6 yrs.& old: Indiv.
Dosage: Apply 2xdly., up to 4x dly.on 1st day. Max.7days. effic.not est.in childr. Init.15-30 mg/kg/day in div.dos.with tot.dos.not exceed.2 g/day. Chil-
(S4) SUPPS, [N/P/S in C] E/11.8/0668 Side effects: GI disturbs., skin & subcut.tiss. reacts., psych.disords., dr. with bm up to 40 kg: Half adult dos. & norm.adult dos.above 40 kg.
Prednisolone caproate 1,3 mg, cinchocaine HCl 1 mg/supp. endocr.disords., musc. cramps, trem., S/E typic.of syst.glucocorticos- Chron’s dis: Act.& maint.treatm: Adults: Indiv. Up to 4 g dly.in div.
875384-005: 12, R194,37 ter., caps also: palpitat., nervousn., blurr.vis., menstr. disords., hypoka- dos. Childr.6 yrs.& old: Act. dis.treatm: Indiv. Init.30-50 mg/kg/day
Dosage: Insert 1 supp.high PR dly. If sympts.sev. insert 1 supp.2- laem., growth.veloc.reduc., Cushingoid features in div. dos.. Max: 75 mg/kg/day in div.dos. Tot.dos.not exceed.4 g/
st
3 xdly for 1 day. Warnings and special precautions: Pregn.& lactat., pts. transfer. day. Maint: Indiv. Init.15-30 mg/kg/ day in div.dos. Tot.dly.dos.not ex-
Contraindications: Loc.vir, bact./fung.infects., second. untreat. from syst. steroids. Caps also: TB, system./loc.infects., hypertens., ceed.4 g/day. Half adult dos.in childr.with bm of up to 40 kg & norm.
skin infects., pregn. diab.mellit., osteoporos., pept.ulc., glauc., cataracts, family hist.of adult dos. above 40 kg.
Side effects: Adren.suppress., skin atrophy risk, syst.absorpt., Contraindications: Salicyl.sens., childr., sev. liv./ren.impairm., safety
allerg.reacts. diab./glauc., other condits.where glucocorticoster.may have unwant. in pregn.& lactat.not est.
effs., in stress situat.supplem.syst. glucocorticoster. recomm., chicken
Special precautions: Addit.ther.in fung./ second. infect., bleed., Side effects: Bld.dyscras., myocardit., pericardit., GI disturbs.incl.
infts., occlus.dress. pox & measles may have a more ser. course in pts on oral budesonide aggravat.of ulcerat. colit./cheilit & melaena, headache, dizzin., rash,
so avoid expos.& immune globulin may be indicat., allerg.unmask. dur.
See also MDR page 254. hypersens. & allerg.reacts., periph.neuropathy incl.Guillain-Barre
withdraw.phase.if syst.glucocortic.treatm. replac., HPA axis response
to stress reduc., comprom.hepat.funct.reduc.eliminat. syndr., incr.amylase, pancreatit., revers.alopec., cardiomyopathy,
Drug interactions: Incr. system.expos. with concom.ketoconazole.& allerg & fibrot.lung reacts., incr.liv.enzymes & bilirubin, hepatotox.,
12.10 Others grapefruit juice, oestrog./ OC’s enhanc.effs. myalg., arthralg., urticar., lupus erythematosus-like reacts., imp.ren.
funct., loc. reacts.follow.rect.admin., drug fev., pancolit., oligosperm.
MEZAVANT (MDR Listing) INTEFLORA, Dr Reddys [P/S] Warnings and special precautions Ren. damage, proteinur., reg.
PENTASA (MDR Listing) Saccharomyces boulardii CNCM 1-745 ren funct.monit.esp.dur. init.treatm.phase, suspect induc.nephrotoxic.
REVELLEX (MDR Listing) Indications: Prophpylax.& treatm.of intest.& muco-cutan.S/E induc. if ren.dysfunct.develops dur.treatm., discont. treatm. if myocardit./
by antibiot.ther., non-specif. diarrh., colit.,enterocolit., diarrh.prevent.
pericardit.suspect./in case of ac.intol.sympt., concurr.preps.which
ASACOL, Equity [P/S] dur.contin. enteral feed. low.stool pH., cross.placent.barr.& excret.in breast milk, elderly, imp.
Mesalazine (5-aminosalicylic acid). (S0) CAPS. T 194 liv.funct., determ.liv.funct.& differential bld.counts prior to & at reg.
Indications: Treatm.& maint.of remiss.in ulcerat. colit. 700485-003: 250 mg, 10, R61,99 interv. dur.treatm., sulfasalazine sens., monit.pulm.dis. esp. asthma.
(S3) TABS. [P/S] S/11.10/171 700485-005: 250 mg, 20, R123,97 Drug interactions: Prep.low.stool pH prev. release of act. ingred.,
783668-007: 400 mg, 90, R650,59 Dosage: Adults, elderly, infts.& childr: 1cap 2xdly or as prescrib. incr.ren.react.risk with other concom.nephrotox.agents, incr bld.
Dosage: Adjust dos.accord.to respons. Adults: dycras. risk with concom.azathioprine/6-mercaptopurine, poss.
Induct.of remiss: 2,4 g (6 tabs.)once dly or in div.dos.2-3xdly. If MEZAVANT, AI Pharm Ltd [P/S] & decr.warfar.eff.
necess.may be incr.to 4,8 g(12 tabs.)in div.dos.2-3xdly. Mesalazine See also MDR page 337-342.
Maint of remiss: 1,6-2,4 g (4-6 tabs.)once dly or in div.dos.2-3xdly. Indications: Treatm.& maint.of remiss.in ulcerat. colit.
(S3) TABS. [P/S] 37/11.10/0629. (S3) PR TABS. 45/11/0463 REVELLEX, Janssen [P/S] &
709076-001: 800 mg, 60, R867,61 720355-001: 1 200 mg, 60, R1 148,65 Infliximab.
Dosage: Adjust dos.accord.to respons. Max.dos not to exceed Dosage: Admin.tabs without crush./chew.once dly.with/-out food. Indications: Mod.to sev.act.adult/paed.Crohn’s dis.when respons.
6 tabs/day and not to exceed 3 tabs taken at any one time. Adults incl.elderly (>65 yrs): Remiss.induct: 2,4-4,8 g once dly. to convent.ther.inadeq., reduct.in the numb.of drain. enterocutan.&
Adults: Treatm.eval.at 8 wks when max. 4,8 g/day is used. rectovagin.fistula and maint.of fistula clos.in fistulis.Crohn’s dis., act.
Mild ac.dis: 2,4 g (3 tabs.)once dly or in div.dos.2-3xdly.with concom. Maint.remiss: 2,4 g once dly. ulcerat.colit. in adults & paeds.where respons.to convent.ther.inadeq.
corticoster.if clinic.indicat. Contraindications: Salicyl.sens., sev.ren./hepat. impairm., (S4) POWD.FOR INFUS, 33/30.1/0531
Mod ac.dis: 2,4-4,8 g (3-6 tabs.) in div.dos.2-3xdly.with concom.corti- safety in porphyr./pregn.& lactat.not est., safety & effic. in childr. 707507-001: 100 mg, R5 569,07
coster.if clinic.indicat. Dos.of 2,4 g may be taken once dly or in div.dos. bel.18 yrs.not est. Dosage: See product lit.for prep.& admin.techniq. Safety & effic.be-
Maint.ther.: 1,6-2,4 g (2-3 tabs.)once dly or in div. dos.2-3xdly. Side effects: Hypersens., anaphylact.react., drug reacts.with eosino- yond recomm.durat.not est. Admin. by exper.physic.only. Observ.for
(S3) ENEMA. [P/S] Z/11.10/205. 2 g/50 ml phil.& system.sympts.(DRESS), GI disturbs.incl.flatul./naus., abdom. 1-2 hrs. post infus. Facilit.for treat.anaphylax.to be avail.
824127-005: Sngl.enema, R181,99 distent./-pain, colit., dyspeps., vomit., headache, dizzin., somnol., hy- Mod to sev.Chron’s dis: Re-admin.not recomm. aft. 16 wk.med.
Gastro-Intestinal Tract / Anthelmintics - 12.10 / 13 2020-04 / 187
free period due to delay. hypersens. react. Adults: 5 mg/kg as sngl. hypothyroid., stomatit., parotit., hypoglycaem.eff.with high dos., gen. Giardiasis in childr.over 2 yrs: 400 mg as sngl.dly.dos.x5 days.
IV infus. over 2 hr.period as induct.regimen at 0, 2 & 6 wks. follow.by hypersens./ hepatotox.react., ser.sickn., eosinophil.infiltrat., hepat.fail.& Contraindications: Pregn./women who are likely to become pregn.
maint.5 mg/kg regim.every 8 wks. thereaft. Consid.adjust.dos.upto fulmin.hepatit., trans.liv.enzym.elev., CV effs., anaphylax., vertigo, inter- dur./shortly aft.treatm.
10 mg/kg for those with incomplete respons.dur.maint.treatm. Alter- stit.lung dis., leucopen. follow.bone marr.depress.and red cell abnormalit. Side effects: GI disturbs., headache, allerg. reacts., alopec., bone
nat.admin.init.5 mg/kg IV infus.over 2 hrs. follow. by rep.5 mg/kg infus. Warnings and special precautions: Adeq.fluid intake, crystallur. marr.depress.
when S&S of dis. recur. but data limit.on dos.interv.beyond 16 wks. risk, discont.if ser.tox./ hypersens. reacts. occur, period.bld.counts & Special precautions: Leucopen.if used long. than recomm.
Paed: Not stud.in childr.less than 6 yrs.of age. IV infus.of 5 mg/kg urine analys, G6PD defic., great incid.of adverse eff.in AIDS pts., pts. Drug interactions Plasma lev.of metabol.incr.by praziquantel.
st
follow.by addit.5 mg/kg infus.dos. at 2 & 6 wks. aft.1 infus.then with slow acetylat.phenotype are more likely to show adverse eff., ren BILTRICIDE, Bayer [P/S]
every 8 wks. thereaft. Consid.adjust.dos.upto 10 mg/kg for those impairm., poss. ser.-sickn.-like react.in childr.with syst.-onset rheum.
with incomplete respons. Admin.with concom. immunomodulat. arthrit., folic acid defic.poss.result.in ser. haematolog. toxic./terato- Praziquantel.
Indications: Bilharz., Schistosoma haematobium & mansoni.
Fistulis.Chron’s dis: Re-admin.not recomm.aft. 16 wk.med.free genic., pts.with sev. allergy/ bronch.asthma, pass.into breastmilk, (S4) TABS. P/12/23.
period due to delay.hypersens. react. Init.5 mg/kg as IV infus.over 2 prem./ G6PD defic. infts.if breastfed, bld.dyscras. 708607-004: 600 mg, 10, R448,82
st
hrs.,follow.by addit.5 mg/kg dos.at wks 2 & 6 aft.1 infus. If no re- Interactions: Bld sugar reduc.eff of sulphonylureas enhanc., poss.in- Dosage: Swallow whole aft.even.meal. Do not chew. 1 dose: 40 mg/
spons. aft.these 3 dos.do not admin.addit.treatm. Cont.treatm.strateg. teracts.with coumarins, methotrex., probenecid, rifampic., sulfinpyra- kg bm or 2 doses of 20 mg/kg bm within 4-6 hrs.
are addit.5 mg/kg infus.every 8 wks.or re-admin.if S&S recur.follow. zone, spironolact., furosemide & potent. of undesir.glucocortic.eff.on Contraindications: 1st trim.of pregn., ocul. cysticercos., strong
by 5 mg/kg infus.every 8 wks. stomach, Fe chelat.& absorpt. interfer.with, PABA & deriv.compnds. cytochrome P450 induc.
Adult/Paed.Ulcerat.colit: IV infus.of 5 mg/kg over 2 hrs. follow. by may antagon. act., acetylat incr.by paraldehyde, reduc. folate & digox. Side effects: Allerg.reacts., polyserosit., eosinophilia, headache, diz-
addit.5 mg/kg infus.dos.at 2 & 6 wks. aft. 1 infus.then every 8 wks. absorpt., alter.pt.respons.with concom. antibiot., eff.of oral coagul, zin., vertigo, somnol. incl.drowsin., seiz., unspecif.arrhythm., GI & ab-
st
thereaft. Data support. re-admin.other than every 8 wks.not avail. methotrex.& phenytoin potent., incr.risk of crystallur.with compnds. dom. pains, N&V, anorex., diarrh., prurit., myalg., asthen., feel.unwell.
In careful.select.adult pts. who have tolerat.at least 3 init.2-hr Revellex that acidify urine, folic acid absorpt./ metabol. inhibit.poss.caus.folic Special precautions: Stop breastfeed.on day & subseq.24 hrs.,
infus. & are receiv. maint.ther.consid. admin.subseq.infus.over a pe- acid defic., bone marr. suppress./leukopen.with concom.thiopurine imp.ren.funct., uncompensat.liv. insuffic.& hepatosplen.schistoso-
riod of not less than 1 hr. Shorten.infus.at dos. > 6 mg/kg not studied. 6-mercaptopurine/azathioprine. mias., card. irregularit., epilep.hist., signs of CNS involvem., safety
Contraindications: TB & other sev.infects.eg. sepsis/abscess/op- in childr.und.4 yrs.not est., simultan. schistosomias.& CNS cyst-
portunist.infects., mod.to sev.HF (NYHA class III/IV), concom.anakinra SALOFALK, (Cipla Medpro) Orphan SA [P/S] icercos.infect.poss.
not recomm., safety in pregn.& lactat. not est., safety & effectiven. Mesalazine Drug interactions: Plasma lev.reduc.by drugs incr. activ. of drug me-
not est.in juven.rheumat.arthrit. Indications: Treatm of ac.episod.& remiss. maint.of mild to mod. tabol.liv.enzym.& incr.by drugs decr.activ.of drug metabol.liv.enzym.,
Side-effects: Human antichimeric antibody (HACA) posit.pts.more ulcerat.colit. therapeut. effect.plasma lev.not achiev.with strong cytochrome P450
likely to exper.infus.reacts., infus.relat.ac.or delay.hypersens.reacts. (S3) GRANS., 43/11.10/0196 induc., chloroquine low.bld.conc.
incl. anaphylax., developm.of anti-dsDNA antibod., lupus-like syndr., 716333-001: 1000 mg/sach., 100, R932,67
vir./bact.& other opportunist. infects., bld.dyscras., ser.sickn.& lupus- Dosage: Adults & elderly: Swall.grans.without chew. Admin.reg. CIPEX, Cipla Medpro [P/S]
like reacts., resp.tract allerg.reacts., psych.disords., headache, vertigo, to achieve desir.therapeut.eff. Mebendazole.
dizzin., exacerbat.of demyelin.dis.suggest. MS, meningit., conjunctivit., Ac ulcerat.colit: 1,5- 3,0 g dly.as sngl.dos.or in 2-3 div.dos. Indications: Sngl./mix.infestat.of Ascariasis, intestin.Capillariasis,
endophthalmit., keratoconjunctivit., periorbit.oed., syncope, bradycard., Remiss.maint: 1,5 g as dly dos.giv.as sngl.dos.or in 2-3 div.dos. Enterobiasis, Trichuriasis, threadworm, hookworm, Taenia species,
palpitat., cyanos., arrhythm., worsen. HF, tachycard., flush., ecchymos., Contraindications: Salicyl.sens., sev.liv./ren. impairm., pre-exist./ Ternidens deminutus, Moniliformis.
haematoma., hyper-/hypotens., petech., thrombophlebit., vasosp., pe- pres.gastr./duod.ulc., haemorrh. diathes., safety in pregn.& lactat.not (S1) SUSP. 30/12/0245. 100 mg/5 ml.
riph.ischaem., circulat.fail., system.& cutan.vasculit., psorias.(incl.new est., safety & effic.in childr.not est., childr.bel.6 yrs. 828297-002: 30 ml, R20,78
onset& pustul, pericard.& pleur.effus., U&LRTI, dyspn., sinusit., epistax., Side effects: GI disturbs., headache, dizzin., periph. neuropathy, (S1) TABS, 32/12/0538. 100 mg
bronchosp., pleurisy, GI disords.incl. intestin. perforat./stenos.& haem- ren.funct. impairm.incl.ac./ chron.interstit.nephrit., allerg.xanthema, 878227-008: 6, R15,28
orrh., abnorm. hepat.funct., cholecystit., hepatit., skin reacts. incl.fung. meds. fev., bronchosp., peri-& myocardit., ac.pancreatit., allerg.al- Dosage: Dos.same adults & childr.over 2 yrs. If helminth is not sus-
dermatit./onychomycos./abnorm. skin pigmentat.& alopec., myalgia, veolit., LE syndr., pancolit., myalg., arthralg., bld.dyscras., hepatit., cept.treat for longer or at high. dos.
arthralg., back pain, UTI, pyelonephrit., vaginit., fatig., chest pain, inj. cholestat.hepatit., alopec., oligosperm. All worms except tapeworm, threadworm & Capillaria
loc.reacts., imp.heal., granulomat.les., elev. hepat.transaminas., auto- Special precautions Limit.document.in childr.6-18 yrs., hepat. philippinensis: 5 ml/1 tab.2xdly x3 days. Rep.course aft.3-4 wks.
antibod., complem.fact. abnorm., periph.myelinat.disords., neuropath., impairm., mesalazine-induc.toxic., monit.pulm. dis.pts.esp.asthma, if pt.not cured.
numbness., tingl., seiz., transvers.myelit., pancytopen., haemolyt. monit.pts.with react.hist.to preps.contain.sulfasalazine esp.init., Tapeworm: 5 ml/1 tab.2xdly x6 days.
anaem., idiopath. thrombocyt. purp., thrombot. thrombocyt. purp., discont.treatm.immed.if sev.reacts., phenylketonur., concom.warfa- Threadworm: Adults: 10 ml/2 tabs.2xdly x3 days. Childr: ½ adult
Stev.-Johns.syndr., tox.epiderm.necrolys., eryth. multif., agranulocytos., rin, concurr.preps. low.stool pH., bld.monit.prior to & reg.dur.treatm. dos. Rep.aft. 3-4 wks.if necess.
hepatocellul.damage, hepatit.B reactivat., jaund., autoimmune hepatit., Drug interactions: Potent.wafar.anticoag.eff., incr.gastr.eff.with Capillaria philippinensis: Adults & childr. over 12 years:
liv.fail., pancreatit., interstit. pneumonit., rare type hepatosplen.T-cell glucocortic., poss.incr.in sulphonylur.bld.gluc.lower.eff., poss.meth- 10 ml/2 tabs.2xdly x 20 days.
lymphoma in adolesc.& young adult Crohn’s dis.pts., trans.vis.loss, myo- otrex. tox. potential incr., attenuat.uricosur.eff.of probenecid, poss. Contraindications: Pregn., lactat.
card. ischaem./MI within 2 hrs of infus., interstit.lung dis. incr.diuret.eff.of spirinolact./ furosemide, tuberculost.eff.of rifampicin Side effects: GI disturbs., alopec./bone marr. suppress.& allerg.re-
Warnings and special precautions: Eval.TB incl.latent TB & other attentuat., incr bld.dycras.risk with concom. azathioprine/6-mercap- acts.with high dos., agranulocytos.
opportunist.infect.risk bef. init.ther., treat. clinic.manifest.infects.prior topurine, preps.low.stool pH prev. release of act.ingred. Special precautions: Admin.to childr.und.2 yrs. only if worm infect.
to ther. & monit.closely, prophylact.anti-TB ther.if latent TB diagn. XENICAL, Pharmaco, [P/S] interfer.signific.with nutrit. status & physic.developm., if GI transit
prior to init.ther.& consid.benefit/risk bal., pts.to rep.sympts.sug- Orlistat. time acceler.rep.dos.at more freq.interv.dly.
gest.of TB dur./aft. treatm., norm.immune respons.poss.aff., HF of Indications: Managem.of obesity in conjunct. with reduc.K.j.diet, CYSTICIDE, (Biopharma Div) Merck [P/S]
NYHA class I/II, antibody format.reduc.with concom. methotrex.& recomm.for obese pts.with BMI >30 kg/m & overweight pts.with Praziquantel.
2
other immunomodulat.in rheumat.& psoriat.arthrit.& Chron’s dis. BMI >27 kg /m in pres. of other risk fact. Indications: Neurocysticercos., Schistoma infects.
2
pts., new onset HF without pre-exist. CV dis., poss.delay. hypersens. (S3) CAPS. 32/11.3.1/0475. (S4) TABS. S/12/154.
reacts.in pts.re-challeng.follow.period without treatm., concom im- 852627-010: 120 mg, 42, R538,28 717169-006: 500 mg, 100, R2 868,59
munosuppress.agents appear to reduc.infus.relat.reacts.freq., new/ 852627-009: 120 mg, 84, R1 076,55 Dosage: Eval.usefuln.of addit.corticoster.(4-16 mg dexamethasone
recurr. malign.report., lymphoma incid.high.than expect.in gen.pop- Dosage: Admin.dur./up to 1 hr.aft.meal. Discont. aft.12 wks.only dly). Inpt.bas.treatm.recomm. Monit. for neurologic./neurosurg.events
ulat., host defence against infect.comprom., sympts.of infect.poss. if pts.unable to lose at least 5 % of weight as meas.at start of & treat accord. Admin.anti-convuls.as appropr. Admin.with meals.
masked, chron. infect./recurr.infect.hist., excl.source of infect. specif. ther. Adults: 1 cap.with each main meal. Omit dos.if meal miss./ Neurocysticercosis: Adults & childr.over 4 yrs: Recomm.dos:
absecess.in fistulis.Chron’s dis.with ac. suppurat.fistul., safety exper. contains no fat. 50 mg/kg bm/day, div.into 3 dly doses for 14 days. Do not exceed
of surg.proced. limit., concom.live vacc.not recomm., discont.if sev. Contraindications: Chron.malabsorpt.syndr., cholestas., lactat., eat. dos.& durat.of treatm.
hypersens.reacts.develops, discont.if sympts. suggest.of lupus-like disords.other than obesity, not recomm.for childr.und.12 yrs.of age, Schistosomiasis: S haematobium: 1x40 mg/kg bm as 1 day treatm.
syndr.develop, pre-exist./ recent onset CNS demyelinat.disords., concom. cyclosporine/acarbose & amiodarone, pregn., eff.in hepat./ S.mansoni & S.intercalatum: 1x40 mg or 2x20 mg/kg bm as 1 day treatm.
malign.hist. / pts.develop.malign., discont.if jaund./ALT lev.>5 times ren.impairm.& childr./elderly not est. S.japonicum & S.mekongi: 1x60 mg or 2x30 mg/kg bm as 1 day treatm.
ULN develop & investig., no studies in liv./ ren.dis., adeq.contracept. Side effects: GI disturbs.incl.diverticulit., abdom distens., rect.pain/ Contraindications: Intraocul.cysticercos., concom. rifampic.
in child bear.women x6 mnths.aft.last treatm. discomf., tooth /gingival disord., flu, hypoglycaem., anx., headache, Side effects: Common: Loss of appetite, headache, dizzin., light-
See also MDR page 417. U & LRTI, UTI, menstr.irregul., fatig., hypersens., cholelithias., hep- headedn., abdom.pain & distress, N&V, urticar., weakn., tiredn., incr.
SALAZOPYRIN, Pfizer [P/S] atit., bullous erupts. body temp., Uncomm: Meningism, confus. Post-market: Incr.eosin-
Sulphasalazine. Special precautions: Monit.INR values if used in combinat.with ophil & tot.WBC count, amblyop., anorex., hyperglycaem., psychomot.
Indications: Ac.ulcerat.colit.& maint.of remiss.in ulcerat.colit., ac warfar.or other anticoags., see dos. & direct.of use for diet guide- agitat., ment.disturbs., drowsin., diarrh., prurit.
Warnings and special precautions: Consid. short-term addit.cor-
Crohn’s dis.& maint.of remiss. lin., multivit.supplem. to be taken 2 hrs.aft.Xenical if consid.necess.,
(S4) TABS, [P/S] E/20.2.1/909. monit. bld.gluc.lev.in type II diab.mellit.& oral hypoglycaem.agents., ticoster.admin.as tempor. exacerbat. of sympt.poss.(eg.intracran.hy-
pertens.), which may poss.be delay., anti convuls.treatm. poss.reqd.for
762008-008: 500 mg, 100, R437,90 S/E incid.incr.the high.the diet fat content, monit.epilept.as convuls.
(S4) EN TABS, [P/S] E/20.2.1/910. report. with concom.antiepilept.meds. convuls., in decompens.hepat. insuffic./ hepatosplen.schistosomias.
when high. ser.conc. & prolong.half-life exper.in-pt.treatm. recomm.,
762016-019: 500 mg, 100, R437,90 Drug interactions: Ciclosporin & amiodarone plasma lev.decr., fat
Dosage: Indiv.accord.to respon.& tol. sol.vits.absorpt.imp., convuls. report. with concom.antiepilept.meds., imp.kidn.func., monit.ther.in card. dysrrhythm., ability to drive/operat.
machin., safety in pregn.& lactat.not est., passes into breast milk,
Ac.attacks: Adults: 2-4 tabs 6 hrly.with max. 12 g dly. Remiss: incr. GI S/E with atorvastat.& phentermine.
Reduc.to 2 g dly. Childr: 40-60 mg/kg bm dly.in 3-6 div.dos. Re- Interactions: Plasma lev.reduc.by cytochrome P450 induc., plasma
lev.doubl.by cytochrome P450 inhibit., grapefruit/-juice incr.lev., digi-
miss: 20-30 mg/kg bm. tal. antagonis. eff.seen in anim.stud.
Contraindications: Gastr.& duod.ulc., sulphon./ salicyl.hypersens.,
porphyr., haemorrhag.diathes., sev.ren./hepat.fail., pregn.& lactat., 13 ANTHELMINTICS VERMOX, J&J, [P/S]
infts.& childr. und.2 yrs, childr.with syst.-onset juven.rheum. arthrit. Mebendazole.
Side effects: Headache, fev., GI disturbs., loss of appetite, bld. BENDEX-400, Cipla Medpro [P/S] Indications: Sngl.& mixed helminth infestat. caus. by nematodes,
dyscras., skin reacts.incl.urticar., erythema, prurit., exanthema, revers. Albendazole. cestodes, moniliformis.
oligosperm.& infert.in men, orange-yell.col.urine, CNS eff., periorbit. Indications: Sngl./mix.intestin.parasites.incl. Taenia spp., giardia (S1) TABS, [P/S] G/12/105.
oed., yell.stain.of soft contact lens., optic neuropathy, trans.myop., tin- infects.in childr. 775614-009: 100 mg, 6, R41,89
nit., pancreatit., pseudom. colit., ulcer.colit.aggravat., hepatit., arthralg., (S4) TABS. 31/12/0472. (S1) SUSP, [P/S] K/12/206. 100 mg/5 ml.
periph.-neuropathy/neurit., asept. meningit., convuls., MS, chorea, de- 840262-019: 400 mg, 1, R21,78 775606-006: 30 ml, R41,44
press., fibros. alveolit., dyspn., cough, photosens., yell.skin discol., alopec., Dosage: Adults & childr.over 2 yrs: 400 mg as sngl.dose. Dosage: Adults & childr: as specif.below for var.worms.
nephrotox.reacts., exfoliat. dermatit., tox.epiderm.necrolys., Stev.-John- Strongyloidiasis/Taeniasis: 400 mg dly.x3 days.rep.aft. 3 wks. All worms except tapeworm, strongyloides: Adults & childr:
son syndr.(due to crystallur.), prot.& haematur., SLE, erythema nodos., if necess. 100 mg 2xdly x3 days.
188 / 2020-04 Anthelmintics / Dermatologicals - 13 / 14 / 14.1
Tapeworm: Adults & childr: 100 mg 2xdly x6 days. BACTIGRAS, Smith & Nephew Pharm [P/S] & Contraindications: Large broken skin areas, pregn., lactat./ allergy.
Strongyloides: Adults: 200 mg 2xdly x3 days. Childr: 100 mg 2xdly Chlorhexidine acetate. Side effects: Hypersens.reacts., loc.irrit., hypothyroid.aft.applic.
x3 days. Rep.aft. 3-4 wks if necess.if helminth is not suscept.treat for Indications: Infect.reduct.in surg.trauma, ulcerat. wounds & other to neonates.
longer than 3 days &/or higher doses. skin condits.
VERMOX 500 mg (S0) TULLE GRAS, J/14.2/31. 0,5%/100 g DERMOBAN OINTMENT, Unicorn [P/S]
Indications: Sngl.& mix.helminth infestat.caus.by nematodes. 836206-002: 10x100x100 mm, R634,30 Mupirocin
(S1) TABS. [P/S] W/12/42. 836214-005: 10x100x400 mm, R1 301,74 Indications: Prim.& second.S.aureus & other suscept.organ.skin
807524-018: 500 mg, 1, R41,22 Dosage: Dress.may be chang.dly, freq.of applicat. will depend on infects., to prev.bact.contam./ infects.of small wounds & abras.
Dosage: Whipworm, Hookworm, Large Roundworm, Pin- clinical circumstance. Principally for use on body wounds cover.up (S2) OINT, 44/20.1.6/0972. 20 mg/g
worm: Adults & childr.old. than 1 yr: 1 tab as sngl.dos. A 2nd to 10% surf.area. May be used in conjunct. with other top./ sys- 721693-001: 15 g, R61,59
course may be given 3-4 wks.aft.1 course in those pts.still infect. tem. antibact. agents. Dosage: Adults & childr.old than 2 mnths: Apply 2-3xdly.for up
st
(S1) SD SUSP. [P/S] 34/12/0058. 500 mg/10 ml See also MDR page 688. to 10 days depend.on respons.
881546-003: 10 ml, R42,25 Apply on clean affect.area & cover with gauze dress. if need.
Dosage: Whipworm, Hookworm, Large Roundworm, Pin- BACTRAZINE, Smith & Nephew Pharma [P/S] Contraindications: Skin lesions infect.with P.aeruginosa.
worm: Adults & childr.over 1yr: 10 ml as sngl.dos. Second course Silver sulphadiazine Side effects: Second.wound infect., dizzin., hypersens. reacts., GI
to be giv.if pts.still infect.3-4 wks.aft.first cours. Indications: Prevent.& treatm.of burn wound infects. caus.by G–ve disturbs. incl.ulcerat. stomatit., skin reacts.incl.dryn./swell., headache.
Contraindications: Childr.und.1 yr., pregn.& lactat., concom. organisms, leg ulc., press. sores. Warnings and special precautions: Not suit. for ophth.& intra-
metronidazole. (S4) CREAM, X/14.2/130. 0,01g/g nasal use, in conjunct.with cannul. /at site of centr.ven.cannulat.,
Side effects: Abdom.pain, diarrh.(heavy infestat.), neutropen., hy- 791725-006: 50 g, R40,33 avoid contact with eyes, ren.impairm., discont.use in sensitisat.
persens.reacts.incl. anaphylax., convuls. in childr., hepatit., abnorm. 791725-014: 250 g, R201,57 reacts./sev.loc.irritat., superinfect.with irreg./ prolong.use, do not
liv.funct.tests, skin. disords.incl.tox.epiderm. necrolys., Stev.-Johns. 791725-022: 500 g, R403,11 mix with other preps., safety in pregn.& lactat.not est., extens.open
syndr., angio-oed., urticar., alopec., glomerulonephrit. (prolong.use at Dosage: Burns: Apply dly in 3-5 mm layer, use sterile gloved wounds/ damag.skin/burns.
dos.substan. above recomm.) hand/spatula.
Special precautions: Teratogen./embryotox. activ. in rats & mice, Leg ulc./press.sores: First cleans.& debrid. Fill ulc.cavity to depth of FUCIDIN, AI Pharm Ltd [P/S] &
revers.liv.funct.disturbs., hepatit.& neutropen.with massive dos.over 3-5 mm avoid.non-ulcerat. areas follow.by absorb.pad/gauze dress.& Na fusidate (oint.), fusidic acid (cream).
prolong. period., give only to very young childr.if nutrit.status & physic. press. bandag. Change dress.dly./less.freq.(48 hrs) for less exudat. Indications: G+ve partic.staph.skin infect.
developm.interfer.with. wounds. Not recomm.in very exudat. cases. (S2) OINT, [P/S] G2410. 20 mg/g.
Drug interactions: Cimetidine may incr.plasma conc.dur.prolong. Contraindications: Sulphon.sens., pregn.at term., prem.infts./dur. 727377-019: 15 g, R99,91
treatm., concom.metronidazole to be avoid. first mnths.of life, porphyr., imp.hepat./ren.funct. (S2) CREAM, [P/S] Q/20.1.6/128. 20 mg/g.
WORMSTOP, (Ranbaxy) Be-Tabs [P/S] Side effects: Loc.skin sensit.esp.if expos.to sunlight, fung.invas. 727431-005: 15 g, R99,43
Dosage: Apply 3-4xdly, less freq.if covered.
Mebendazole. of wound, eschar.separat. delay., leucopen., prurit., applicat.site Contraindications: Non-suscept.organ.infect., esp. Pseudomonas
rash incl. eczema & contact dermatit., argyria, ren.fail., pain, app-
Indications: Sngl.& mix.helminth infestat.caus.by nematodes, ces- aeruginosa.
todes, moniliformis moniliformis. plicat.site burn./irrit. Side effects: Hypersens.
Special precautions: System.absorpt.to produc. therapeut.bld.lev.
(S1) SUSP, [P/S] 31/12/0248. Special precautions: Not to be used near eyes.
845698-001: 100 mg/5 ml, 30 ml, R14,94 poss., adeq.fluid intake, acid base bal., G6PDD, poss.delays sepa- See also MDR page 90.
rat.of burn eschar & alt.burn wounds appear., avoid in breastfeed.
(S1) TABS, [P/S] 31/12/0526.
845671-006: 100 mg, 6, R10,34 Drug interactions: Syst.meds.effs.poss.alt.in large burn areas FUREX, (Aspen Pharmacare: Pharma) Pharmacare [P/S]
Dosage: Dos.same for adults , childr.& infts. where ser.sulphadiazine lev.may approach therapeut.lev.esp.for oral Nitrofurazone.
All worms: 100 mg 2xdly x3 days. hypoglycaem. agents & phenyt.in which case bld.lev.monit. recomm. Indications: Superfic.wounds, burns, ulc.& skin infects.
Threadworm: Adults: 2 tabs/10 ml 2xdlyx3 days. Childr: 1 tab/5 ml as effs.poss.potent. (S1) OINT. 27/14.1/0494. 50 mg/25 g.
2xdlyx3 days. BETADINE, Mundipharma [P/S] & 805416-005: 25 g, R16,32
Tapeworm: Adults,childr.& infts: 1 tab/5 ml 2xdly x6 days. Rep. Povidone-iodine. 805416-013: 500 g, R326,19
aft.3-4wks.if necess. If helminth not suscept., treat for long.than 3 Indications: Gen.antisept.for skin infects., decubit.ulc., wounds, Dosage: Apply to affect.areas 2xdly/ as direct. restrict.to 5-7 days.
days &/admin. high. than recomm.dos. cuts, abras.& burns, post-op wounds. Side-effects: Sensitisat.& gen.allerg.skin reacts., cross-sens.with
WORMSTOP 500 mg. [P/S] (S0) ANTISEPT.OINT. [P/S] G1574. 100 mg/g. other nitrofurans.
Indications: Sngl.& mix.helminth infestat.caus. by nematodes. 707945-013: 20 g. Special precautions: Ren.dysfunct.
(S1) TABS, [P/S] 31/12/0527. 707945-012: 100 g.
845701-002: 500 mg, 1, R13,40 Dosage: Apply as often as reqd.on dry, clean skin. Cover with HIBITANE, Glenmark [P/S]
Dosage: Large roundworm, whipworm, hookworm & pin- dress./bandage. Chlorhexidine glucon.
worm: Adults & childr.over 5 yrs: 1 tab.as sngl.dos. Rep.dos.3-4 (S0) ANTISEPT.SOL. [P/S] G1570. 100 mg/ml. Indications: Gen.antisept.
wks.later in those pts.still infect. Indications: Wounds/lacerat./burns/abras.disinfect., infect.in (S0) ANTISEPT.CREAM, [P/S] G1385.
Contraindications: Pregn. hosp.& surg.proced.prophylax., skin/mucous membr.prep.bef.surg.& 730823-008: 10 mg/g, 50 g, R89,29
Side effects: Abdom.pain & diarrh.in heavy infestat., agranulo- Dosage: As reqd.
cytos., hypersens.reacts., bone marr. suppress., hepatit., glomerul. post-op.against infect., skin infect.condits.treatm. (S2) OBSTET.CREAM, [P/S] G1390. 10 mg/ml
707996-008: 250 ml.
nephrit., fev., headache, trans.neutropen.& alopec.with dos. ex- Indications: Obstet.&gynae pract.antisept.& lubricant.
ceed. recomm.dos. Dosage: Apply full strength as a paint or soak/spray as oft.as 730858-065: 250 ml, R118,13
Special precautions: In accelerat.GI transit.time rep. at more freq. need. Not for douch. Dosage: Undil.as reqd.
interv.dly., childr.und.2 yrs., admin. to very young childr.only if nutrit. (S0) MEDIC.SHAMP. [P/S] G1572. 4,0 g/100 ml Contra-indications: Extern.use only, not for brain, meninges,
status & physic. developm.interfer.with., monit.haematol. paramet. Indications: Seborrh.scalp condits.assoc.with excess.dandruff/ eyes, middle ear.
& liv.funct.with prolong.ther. prurit./scaling/exudat./erythema/pityrias.capit./infect.scalp les. Side-effects: Idiosyncrat.skin reacts., ototox.
Drug interactions: Cimetidine may incr.plasma conc.dur.pro- 835560-008: 125 ml.
long.treatm. Dosage: Wet hair, then apply adeq.amnt.warm water to lather. Rinse. NUBAN, Pharma Dynamics [P/S]
Repeat applic.& massage into scalp.
YOMESAN, Bayer [P/S] Allow to remain on scalp for at least 5 mins. Work up lather & Mupirocin
Indications: Prim.& second.S.aureus bact.skin infects., infects.of
Niclosamide. rinse thorough. Repeat treatm.at least 2x/wk.unt.improvem. Use small clean lesions prophylax.
Indications: Beef/pork/fish/dwarf tapeworm infects. once/wk.afterw. (S2) OINT, 44/20.1.6/0971. 20 mg/g
(S0) TABS. H890. (S0) SURG.SCRUB SOL. [P/S] G1571. 7,5 g/100 ml 721587-001: 15 g, R63,01
778877-019: 500 mg, 4, R56,03 Indications: Hand disinfect.bef.surg.proced./in OR, pt.skin prep. Dosage: Adults & childr.old than 2 mnths: Apply 2-3xdly.for up
778877-027: 500 mg, 100, R1 400,72 bef.surg.proced./operat., skin infect.condits.treatm., germicid.skin to 10 days depend.on respons.
Dosage: Only remove from foil immed.prior to admin. Admin.as cleans.in consult.rooms. Contraindications: Skin lesions infect.with P.aeruginosa, safety in
sngl.dose aft.breakf. Chew thorough. bef. admin.with water. Tabs 708003-002: 250 ml. pregn.& lactat.not est., mix. with other preps.
may be disintegrat. in little water. Advis. to grind tabs & mix with Dosage: Pre-op.hand wash: Spread over hands & rub thorough. Side effects: Second.wound infect., dizzin., hypersens.reacts., GI
water for small childr. for 2 mins./use nail brush if need. Add water for copious lather. Rinse disturbs.incl.ulcerat. stomatit., skin reacts.incl.dryn./swell., headache.
Beef/pork/fish tapeworm: Adults & childr. over 6 yrs: 4 tabs. well und.runn.water. Warnings and special precautions: Not suit. for ophth.& intrana-
Childr. 2-6 yrs: 2 tabs. Und.2 yrs: 1 tab. Pre-op pt.prep: Wet area aft shav. Apply sol., rub in thorough.for
Dwarf tapeworm: 7 day treatm.recomm. First day: Adults & at least 2 mins. Devel.copious lather using ster.gauze soak.in water. sal use, in conjunct.with cannul. /at site of centr.ven.cannulat., avoid
contact with eyes, ren.impairm., discont.use in sensitisat. reacts./sev.
childr.over 6 yrs: 4 tabs. Childr. 2-6 yrs: 2 tabs. Und.2 yrs: 1 tab. Rinse off, dry with sterile gauze.
For follow. 6 days: ½ the origin. dly.dose. Consult.room use: Proceed as above for wash.when germicid. loc.irritat., superinfect.with irreg./prolong.use, extens.open wounds/
Admin. saline purge 2 hrs.aft.dos.to ensure rapid & complete expuls. soap reqd. damage. skin/burns.
Side effects: Naus., retch., abdom.pain., hypersens. reacts. Not for douch. SEPTADINE, (Ranbaxy) Be-Tabs [P/S]
Special precautions: No system.therapeut.effs., use only where Contraindications: Non-tox.nodule colloid goitre, avoid large Povidone-iodine.
strictly indicat.dur.pregn. esp.dur. 1 st trimest., exist.risk of cysticercos. broken skin areas. Indications: Antisept.for skin infects., wounds, cuts, abras., burns
in pork tapeworm avoid.by recomm.drastic.purge. Side effects: Hypersens.reacts., loc.irrit., hypothyroid.aft.applic. & post-op wounds.
to neonates. (S0) OINT. 28/14.1/0651. 2,5 g/25 g.
Warnings and special precautions: Not to be used if allerg. 821713-019: 25 g, R12,97
14 DERMATOLOGICALS to iodine/pregn.& lactat., discont.ther.& consult dr.if irritat./swell./ 821713-027: 500 g, R60,98
Dosage: Apply 2xdly/as direct. An occlus.dress. may be used
redn.occur.
See also MDR page 515. if necess.
14.1 Anti-bacterial antiseptic DERMADINE, ANTISEPTIC OINTMENT Contraindications: Large broken skin areas, pregn., lactat., allergy.
Side effects: Hypersens.reacts., loc.irrit., hypothyroid. aft.applic.
Cipla Medpro [P/S]
to neonates.
agents Povidone-iodine. SILBECOR, Biotech [P/S]
Indications: Gen.antisept.for skin infects., wounds, cuts, abras.&
BACTIGRAS (MDR Listing) burns. Silver sulphadiazine
BETADINE (MDR Listing) (S0) OINT. H1049. 2,5 g/25 g. Indications: Short-term treatm.of min.burns.
FUCIDIN (MDR Listing) 788716-093: 25 g, R35,08 (S2) CREAM, [P/S] 29/14.2/0338. 10 mg/g
IODOSORB (MDR Listing) Dosage: Apply 2xdly/as direct. 836664-019: 50 g tube, R53,21
Dermatologicals - 14.1 / 14.2 / 14.3 2020-04 / 189
(S4) CREAM, [P/S] 29/14.2/0338. 10 mg/g Indications: Dermatomycos.due to dermatophyt., moulds & other CANEX T, (Ascendis Pharma) Akacia [P/S]
836664-027: 250 g jar, R266,06 fungi, skin dis.with second.fung. infect. Clotrimazole.
836664-035: 500 g jar, R532,13 (S1) CREAM. 27/20.2.2/0201. 10 mg/g. Indications: Dermatomycos.due to dermatophytes, moulds & other
Dosage: Apply dly in 3-5 mm layer, use sterile gloved hand/spatula. 793493-005: 20 g, R10,58 fungi, skin dis. with second.fung.infects.
Contraindications: Sulphon.sens., pregn.at term., prem.infts./dur. Dosage: Apply thin.to affect.area 2-3xdly.Contin. for 2wks.aft.sympt. (S1) CREAM. 28/20.2.2/0626. 10 mg/g.
first few mnths.of life, porphyr., lactat., imp.hepat./ren.funct. disappear.to prev.relapse. 824011-007: 20 g tube, R9,99
Side effects: Poss.sulphon.system.effs.if applied to large areas/ Contraindications: Ophthalm.use. Dosage: Apply thin.to affect.areas 2-3xdly. Contin. for 2 wks.aft.
deep les., loc.reacts., poss.fung. infect. of wound. Side effects: Loc.reacts., contact allerg. dermatit. disappear.of sympts.to prev.relapse.
Special precautions: Monit.bld.counts., adeq. fluid intake, elderly, Special precautions: Near eyes. Side effects: Loc.reacts., cont.allerg.dermatit.
HIV pts., acid base bal. ALMATIL 1%, Litha [P/S] Special precautions: Around eyes.
Drug interactions: Effs.of oral anticoags., methotrex. & pheny- Terbinafine HCl. CANSTAT, (Aspen Pharmacare: Consumer) Pharmacare [P/S]
toin poss.potent. Indications: Fung.skin infects.caus.by dermatophyt., yeast infects., Nystatin
SUPIROBAN, Glenmark [P/S] tinea vesicol.in adults & childr.over 12 yrs. Indications: Cutan.monilia infects.
Mupirocin. (S1) CREAM, 42/20.2.2/382. 10 mg/g. (S1) CREAM, F/13.9.2/158. 100 000 u/g
Indications: Prim.& second.S.aureus bact.skin infects., prevent in- 720777-001: 7,5 g, R40,38 784966-001: 15 g, R54,77
fects.of small clean lesions. 720777-002: 15 g, R80,80 Dosage: Apply to affect.area 2xdly.
(S2) OINT, 43/20.1.6/0680. 20 mg/g Dosage: Apply thin layer 1-2 xdly to clean & dry affect. area. In case COVAREX, (Glenmark) MeyerZall [P/S]
715837-003: 14 g, R61,50 of intertriginous infects: Cover applic.with gauze esp.at night. Sympt. Miconazole nitrate
715837-001: 15 g, R65,87 relief usual. with.few days. Verify diagn.aft.2 wks if no improvem. Do Indications: Cutan.candida albicans candidiasis, tinea corporis,
715837-002: 50 g, R219,67 not use long.than 4 wks. tinea cruris, trichophyton rubrum/ T.mentagrophytes & epidermo-
Dosage: Apply 2-3xdly.for up to 10 days depend. on respon. Adults & adolesc: phyton floccosum tinea pedis.
Contraindications: Skin lesions infect.with P.aeruginosa. Tinea corpor./cruris: Apply 1-2 x dly for at least 1 wk unt. signif. (S1) CREAM, 33/13.9.2/0124
Side effects: Loc.burn., sting., erythema, dryn., itch., poss.syst.allerg. improvem. Not to be contin. long.than 4 wks. 877719-007: 2 g/100 g, 25 g, R43,23
reacts., poss.overgrowth of S aureus & other organis. Tinea pedis, interdigit: Apply 2 x dly for at least 1 wk unt.signif. 877719-004: 2 g/100 g, 30 g, R51,86
Special precautions: Not suit.for ophth.& intranasal use, in con- improvem. Not to be contin. beyond 4 wks. 877719-005: 2 g/100 g, 40 g, R69,11
junct. with cannul./at site of centr.ven.cannulat., avoid contact with Tinea pedis, plantar: Apply 2 x dly for 2 wks. Ther.poss.affect,by 877719-006: 2 g/100 g, 50 g, R86,43
eyes, large ulc./burns, ren. impairm., discont.use in sensitisat. re- onychomycos. Dosage: Apply 2xdly.to affect.area x2-4 wks.
acts./sev.loc.irritat. Cutan.candidias: Apply 1-2 x dly for 1 wk. Contraindications: Safety in pregn.& lactat.not est.
Pityrias.versicol: Apply 1-2 x dly for 2 wks.
Contraindications: Onychomycos., safety in childr. bel.12 yrs.not Side effects: Skin irrit., poss.system.effs.
est., no clinic.exper.in pregn., applic.to breasts in lactat. Special precautions: Poss.system.absorpt.with prolong./ extens.
14.2 Anti-parasitics Side effects: Redn., itch./sting./burn./peel./ tingl./dryn., Stev.Johns. ther., avoid occlus.dress.in candidias. treatm., apply for recomm.
syndr., tox.epiderm. necrolys., photosens., angioed. full durat.
SKABI-RID, TomarMed [P/S] Special precautions: Excret.in breast milk, discont. if progress.rash DAKTARIN, Janssen Pharmaceutica [P/S]
appears/allerg.react., psorias., avoid eyes/nose & mouth, recurr.risk
Permethrin Miconazole nitrate.
Indications: Scabies with irreg. use/prem.treatm.discontin. Indications: Dermatomycos., tinea cruris, candid.infect.
(S0) LOTION, A40/13.2/0756. 50 mg/g CANALBA, (Aspen Pharmacare:Pharma) Pharmacare [P/S] (S1) CREAM, G/13.9.2/106. 20 mg/g.
713148-002: 50 ml, R37,04 Clotrimazole. 717274-004: 30 g, R316,96
713148-001: 100 ml, R64,33 Indications: Dermatomycos.due to dermatophytes, moulds & other Dosage: Apply 2xdly. Cont.10-14 days aft.lesions clear.prev.relapse.
Dosage: Do not apply to face. fungi, second. fung. infects. Contraindications: Safety in pregn.& lactat.not demonstrat.
Apply to body from ears to soles of the feet. Leave on overnight (8-12 (S1) CREAM. 29/20.2.2/0129. Side effects: Skin & subcut.skin disords., applicat. site reacts.incl
hrs) then rinse off. Rep. aft.2 wks.if necess. 796336-008: 10 mg/g, 20 g, R18,20 irrit., hypersens., angioneurot. oed., anaphylact. reacts.
Contra-indications: Safety in pregn.& lactat. not est. Dosage: Apply thin. 2-3xdly x3-4 wks. Special Precautions: Concom. warfar./oral hypoglycem.& pheny-
Side-effects: Burn.skin, itch., sting., redn. Side effects: Loc.reacts. toin., discont.if sensitiv./ irrit.occurs., avoid eye contact.
Special precautions: Discont.if hypersens. occurs, avoid eye Drug interactions: Inhibits CYP3A4/2C9.
contact. CANDASPOR, (Be-Tabs) Ranbaxy [P/S] KETAZOL, (Aspen Consum) Pharmacare [P/S]
Clotrimazole.
SPREGAL, Cipla Medpro [P/S] Indications: Dermatomycos.due to dermatophytes, moulds & other Ketoconazole.
Esdepallethrin 6,3 mg, piperonyl butoxide 50,4 mg/g fungi, skin dis. with second. fung.infects. Indications: Skin dermatophyte infects., cutaneous candidias.,
Indications: Scabies in adults,childr.& infts (S1) CREAM. Y/20.2.2/290. tinea versicolor.
(S1) AEROSOL, 31/13.2/0296. 788554-018: 10 mg/g, 20 g tube, R12,11 (S1) CREAM. 33/20.2.2/0503. 20 mg/g.
861065-018: 200 ml, R179,43 Dosage: Apply thin.to affect.areas 2-3xdly. Contin. for 2 wks. aft. 890760-001: 20 g, R42,13
Dosage: All persons liv.in same house must be treat.at same time disappear.of sympts.to prev.relapse. Dosage: Apply 1-2x dly till few days aft. disappear. of sympts. Usual
in well-ventil.area .Hold can at 20-30 cm from skin, spray once over Side effects: Loc.reacts., contact allerg.dermatit. treatm.durat: T versicol. & yeast infects: 2-3 wks. T.cruris: 2-4 wks,
T.corporis: 3-4 wks. T.pedis: 4-6 wks.
entire body incl. und.arms & feet, betw.fingers, toes,spray genitals & Special precautions: Around eyes.
most aff.areas, excl.face & scalp, leave on for at least 12 hrs. where- CANDIZOLE TOPICAL CREAM, (Aspen Pharmacare: Con- Contra-indications: Pregn., safety in lactat.not est.
Side-effects: Irrit., prurit., burn.sensat., contact dermatit.,
aft.wash thoroughly with soap, rinse well. Disinf.clothes, shoes &
bedding. Apply to fac.les.using soak.cotton wool. sum) Pharmacare [P/S] Special precautions: Reconsid.diagn./treatm.if no improvem.aft.
4 wks., apply gen.hygiene meas. to control source and prev.re-infect.,
Clotrimazole.
Contraindications: Pregn.& lact.consider risk: benefit, childr.und.2
yrs without physic.advice Indications: Dermatomycos.due to yeasts, dermatophytes, moulds safety & effic. in childr.not est., if used immed.aft.prolong. corticoster.
& fungi & second.fung. infects.
contin.apply.mild corticoster. in morn.& apply Ketazol in even.then
Side effects: Skin irrit., N&V, restlessn., headaches (S1) CREAM. P/20.2.2/164. 200 mg/20 g grad.withdr. ster.over 2-3 wks.
Special precautions: Do not spray on face or inhale., avoid mu- 797006-001: 20 g, R15,06 Warnings: Not for ophth.use.
cous membr.& open wounds, protect nose & mouth of childr.<5 yrs., Dosage: Apply 2xdly to affect.area contin.for at least 2 wks.aft.
if condit. does not improve notify dr. disappear.of sympts. KEZ, Pharma Dynamics [P/S]
Side effects: Loc.reacts. Ketoconazole.
Special precautions: Around eyes. Indications: Infects.due to yeast Pityrosporum eg pityriasis versi-
14.3 Fungicides CANESPOR, Bayer Consum. [P/S color/capitis, seborrhoeic dermatit., seborrhoeic dermatit.prohylax.
(S1) LIQ, 33/20.2.2/0472.
(See also 18.8) Bifonazole 701565-003:20 mg/g, 80 ml, R61,72
Indications: Skin mycos.& mucocut.part dermatophyt. infects.
Dosage: Apply to affect.wet skin area/wet hair leav.on for 3-5
A-POR, (Aspen Pharmacare: Consum) Pharmacare [P/S] (S1) CREAM, [P/S] R/13.9.2/203 10 mg/g mins.bef.rins.
Clotrimazole. 745251-005: 15 g, R133,04 Pityriasis versicolor: Apply dly x max.5 days.
Indications: Dermatomycos.due to dermatophytes, moulds, & other (S1) SOL, [P/S] R/13.9.2/204 10 mg/ml Seborrhoeic dermatit/pityriasis capitis: Apply 2x/wk x2-4 wks.
fungi, second. fung. infects. 835862-003: 15 ml bot., R120,43 Seborrhoeic dermatit.prohylax: Use once a wk.
(S1) CREAM. Z/20.2.2/375. 10 mg/g. 793957-001: 25 ml bot., R200,74 Side effects: Irritat., dermatit., burn., sting., itch., dry/oily hair, hair
826952-003: 20 g, R11,10 Dosage: Apply thin.1xdly.pref.bef.retir. discol., incr.hair shedd., irrit.when used immed.aft. prolong. top.
Dosage: Apply thin. 2-3xdly x3-4 wks. Side effects: Allerg.reacts., pain, contact dermatit., eczema, prurit., corticoster.treatm.
Side-effects: Loc.reacts. vesiculobull.rash, dry skin, trans.skin red., burn.sensat. Special precautions: Discont.if sev.rash/irrit. appears, if used im-
Warnings and special precautions: Do not stop when ac.inflam. med.aft. prolong. cortico-ster. contin.apply.mild corticoster.in morn.&
ADCO-DERMED, AI Pharm Ltd [P/S] sympts.subside (cont.x2-4 wks.), consult dr bef.using in 1 trimest. apply shampoo in even and grad.withdr.ster.over 2-3 wks., safety in
st
Ketoconazole. of pregn., sol.inflammable, avoid eyes, only use cream for candida pregn.& lactat. not est.
Indications: Infects.involv.yeast Pityrosporum eg pityriasis versi- balanit., safety & effic.not est.in childr.
color/capitis, seborrhoeic. dermatit. LAMISIL, GSK Consum [P/S]
(S1) SHAMPOO. 34/20.2.2/0244. 20 mg/ml. CANESTEN, Bayer Consum., [P/S] & Terbinafine HCl.
899101-007: 80 ml, R63,94 Clotrimazole Indications: Fung.skin infects.caus.by dermatophyt., yeast in-
Dosage: Pityriasis versicolor: Apply 1xdly x max.5 days. Indications: All dermatomycos.(dermatophytes, yeasts, moulds & fects., tinea vesicol.
Seborrhoeic dermatit/pityriasis capitis: Apply 2x/wkx2-4 wks. other fungi) & skin dis.with second. fung.infects. (S1) CREAM, [P/S] Z/20.2.2/186. 10 mg/g.
Side effects: Irritat., dermatit., burn., hair discol., incr.hair shedd., irrit. (S1) TOPIC.CREAM, E/20.2.2/49. 200 mg/20 g 792705-017: 7,5 g, R77,32
when used immed. aft.prolong. top.corticoster.treatm., 712205-004: 20 g, R102,59 792705-009: 15 g, R154,67
Special precautions: Discont.if sev.rash/irrit. appears, if used Dosage: Apply sparingly 2-3xdly.x1-4 wks. depend. on condit. Cont. Dosage: Adults & childr.12 yrs & over: Apply 1-2xdly until in-
immed.aft. prolong. cortico-ster. contin.apply.mild corticoster.in treatm.for 2 wks.aft. sympts. disappear. fect.clear.
morn.& apply shampoo in even and grad.withdr.ster.over 2-3 wks., Contra-indications: Safety in pregn.not est. (S1) SPRAY, [P/S] 31/20.2.2/0613. 10 mg/g.
not recomm since safety in pregn.& lactat. not est. Side-effects: Loc.reacts., contact allerg.dermatit., in system.absorpt. 703033-001: 15 ml, R118,43
low abdom.cramps, incr.urin. freq./skin rash. 836486-005: 30 ml, R236,94
ADCO-NORMOSPOR, AI Pharm Ltd [P/S] Special precautions: Not intend.for ophthalm. use. (S1) DERMGEL, [P/S] 32/20.2.2/0564 10 mg/g
Clotrimazole. See also MDR page 248-250. 880892-005: 15 g, R166,01
190 / 2020-04 Dermatologicals - 14.3 / 14.4
Dosage: Apply to affect.area aft.clean. Dosage: Apply 2xdly.morn & even. of cutan. vessels, rosacea-like dermatit., perioral dermatit., hypopig-
Tinea corporis, cruris: 1xdly.x7 days. Contraindications: Safety in pregn.& lactat. not est. mentat., acne-form erupts., syst.absorpt. (large doses), HPA depress.,
Tinea pedis: 1x/day x7 days. Sideeffects: Prurit., skin.burn.sensat., pain, erythem., discomf., growth retard., benign IC hypertens.
Pityriasis versicolor: 2x/day x7 days. swell., hypersens.., angioed., cont.dermat., rash, urticar., blist., Special precautions: Teratogen.in animals, occlus. dress., review
(S1) FILM FORM.SOL, A39/20.2.2/0439. 10 mg/g skin exfoliat, regul.for contin.treatm., institut. suit.concom.anti microb.therapy
Indications: Mild to mod.sev.tinea pedis. Warnings and special precautions: Monit. oral anticoag.effs., if second. microb.skin infect.pres., near eyes, treatm.of psorias.
709809-001: 4 g, R175,45 keep oozing skin & intertrigenous areas dry with gauze, use occlus. may provoke pustul.form of the dis., long-term treatm.esp.in childr.
Dosage: Adults & adolesc.over 15 yrs: Wash & dry both feet dress.in onychomycos. treatm., treat exzemat.skin changes prior to
and hands and then apply even thin layer as sngl.admin.once only use, not for ophthalm./oral use., discont.if react.sugg.sensitiv./chemic. ADVANTAN, (Adcock Ingram) Bayer [P/S] &
to both feet even if les. only visible on one foot. Apply betw.& around irrit.occurs, powd. contains talc theref.avoid inhalat. of powd.to prev. Methylprednisolone aceponate
toes as well as sole and 1,5 cm up sides of foot. Allow to dry x1-2 irrit.of airways partic.in childr.& infts., powd. supports treatm.with Indications: Ac.& chron.steroid respons.eczema & dermatit.
mins. Do not massage into skin. Do not wash for 24 hrs.aft.applicat. cream & sol./used as follow-up & prophylact.treatm. (S4) CREAM, [P/S] X/13.4.1/384. 1 mg/g
Contraindications: Safety in infts./childr.und. 12 yrs.& 15 yrs for 793108-039: 20 g, R201,97
film form.sol./pregn.& lactat.not est. TERBANE, Sandoz [P/S] 793108-020: 50 g, R504,99
Side effects: Redn., itch./sting., very rarely allerg. reacts. such as Terbinafine HCl. (S4) OINT, [P/S] X/13.4.1/385. 1 mg/g
rash/prurit./dermatit.& urticar. Indications: Fung.skin infects.caus.by dermatophyt., yeast in- 793086-043: 20g, R201,97
Special precautions: Avoid eyes, excret.in breast milk, Spray: fects., tinea versicol. 793086-035: 50 g, R504,99
Where alcoh.may be irritat. Film form.sol.not recomm.for hyperkera- (S1) CREAM, 39/20.2.2/0009. 10 mg/g. (S4) FATTY OINT, [P/S] X/13.4.1/386. 1 mg/g
tot.chron. plant.tinea pedis., remove film with organ.solv.& then wash 711199-001: 7,5 g, R56,23 793116-031: 20 g, R201,97
with soap in the event of allerg.react. 711199-002: 15 g, R112,54 793116-023: 50 g, R504,99
(S4) MILK, [P/S] 32/13.4.1/0362. 1 mg/g
LOCERYL 5 %, Galderma [P/S] Dosage: Adults & childr.12 yrs & over: Apply 1-2xdly until infect. 883180-006: 20 g, R230,39
clear. Max.treatm.durat: 1 mnth.
Amorolfine. Contraindications: Safety in infts./childr.und. 12 yrs./pregn.& Dosage: Apply thin.once dly. For milk durat. should gen.not ex-
Indications: Onychomycos.caus.by dermatophyt., yeasts & moulds. lactat.not est. ceed 2 wks.
(S1) NAIL LACQUER. 27/13.9.2/0163. 50 mg/ml. Sideeffects: Redn., itch./sting., very rarely allerg. reacts. (S4) SCALP SOL, [P/S] 32/13.4.1/0361
703124-001: 2,5 ml & accessor., R464,65 Special precautions: Avoid eyes, excret.in breast milk, irreg. Indications: Inflamm.& prurit.dermatos.of hairy scalp.
Dosage: File affect.nail areas thoroughly & cleanse first with alcoh. use/premat.discontinuat.carries re-infect.risk, verify diagnos.if no 701417-001: 1 mg/ml, 20 ml, R230,39
soaked swab remov. remain.lacquer. Apply nail lacquer.to entire surf., improvem.aft.2 wks. Dosage: Apply dropwise once dly. Durat.not exceed.4 wks. No data
allow to dry for approx.3-5 mins. Apply 1-2x/wk. Contin.treatm.with- avail.for use in childr.
out interrupt. Durat.of treatm. depends on infect.intens.& localisat.& TERBASPOR TOPICAL CREAM, (Unicorn) Sandoz [P/S] Contraindications: TB or syphilitic process.in area, vir.dis., pregn.
growth rate of nails. Gen.fingernails: 6 mnths; toenails: 9-12 mnths. Terbinafine HCl Side effects: Itch., burn., erythema, vesiculat., folliculit., hypertri-
Contra-indications: Pregn. & lactat., young childr.& infts. Indications: Fung.skin infects.caus.by dermatophyt., yeast infects., chos., peri-oral dermatit., allerg. skin reacts., atroph.skin chang.,
Side-effects: Trans.burn.sensat., nail disords., cont.dermatit. tinea vesicol.in adults & childr.over 12 yrs. HPA-axis depress, benign intracran.hypertens., growth retardat.,
Special precautions: Avoid use of cosmetic lacquers/artific.nails. (S1) CREAM, A39/20.2.2/0010. 10 mg/g. Cushingoid state.
MEDASPOR, Cipla Medpro [P/S] 720710-001: 7,5 g, R47,13 Special precautions: Teratogen.in animals, occlus.dress., poss.
syst.absorpt., fac.dermatos., near eyes, inft.nappy area, treat sec-
720710-002: 15 g, R94,34
Clotrimazole. Dosage: Apply thin layer 1-2 xdly to clean & dry affect. area. In- ond.microb./ fung.infect., psorias.treatm.may provoke pustul. form
Indications: Dermatomycos.due to dermatophytes, moulds, & other tertrigin. infects: Cover applic.with gauze esp.at night. Sympt.relief of dis., skin crease areas, outweigh benef.-risk in lactat., eval.reg.
fungi, second. fung. infects. usual.with.few days. Verify diagn.aft.2 wks if no improvem. Do not for contin.ther.
(S1) CREAM. 28/20.2.2/0119. 10 mg/g. use long.than 1 mnth. See also MDR page 246-247.
799696-005: 20 g, R19,98 Duration of ther: Tinea corpor./cruris: Apply 1 x dly for 1 wk.
Dosage: Apply thin. 2-3xdly x3-4 wks. Tinea pedis: Apply 1 x dly for 1 wk. Cutan.candidias: 1 wk. Pit- ASPEN MOMETASONE, (Aspen Pharmacare) Pharmacare [P/S]
Side effects: Loc.reacts., contact allerg.dermatit. Mometasone furoate
yrias.versicol: 2 wks. Indications: Inflam.manifest.of psorias.& corticoster. respons.
MYCOTA, Reckitt Benckiser [P/S] Contraindications: Safety in childr.und.12 yrs./ pregn.& lac- dermatos.
Zn undecenoate 10 g, undecenoic acid 1 g/50 g. tat.not est. (S4) CREAM, A38/13.4.1/0668. 1 mg/g
Indications: Athletes foot, fung.skin infects. Side-effects: Redn., itch./sting. 705444-001: 20 g, R141,16
(S0) POWD, [P/S] G1684. Special precautions: Excret.in breast milk, discont. ther.in case of Dosage: Apply thinly 1xdly. Ther.durat.depends on clin.respons.
833576-003: 50 g, R83,65 allerg.react., avoid eyes. Contraindications: H.simplex, vaccin./ varicella., untreat.fung.
Dosage: Apply morn.& night. inects., pregn.
(S0) CREAM, [P/S] G1685. TERBICIL 1 % , (Aspen Pharmacare: Consum) Pharmacare [P/S] Side effects: Atroph.skin chang.with longterm contin. use, allerg.
Zn undecenoate 5 g, undecenoic acid 1,25 g/25 g. Terbinafine HCl. cont.dermatit., burn., dryn., folliculit., itch., second.infects., acneiform
Indications: Athletes foot, fung.skin infects., auxill. treatm.of prurit. Indications: Fung.skin infect.caus.by Trichophyton, Microsporum erupt., perioral dermatit., hypopigmentat., miliar., skin macerat., striae,
vulv., flexural infect.eczema, psorias.& neurodermatit. canis & Epidermophyton floccosum, skin yeast infects. principally. poss.system.absorpt., benign intracran. hypertens., HPA axis depress.
745340-008: 25 g, R55,76 Candida albicans, pityriasis versicolor. Special precautions: Not for ophthalm.use, safety for more than
Dosage: Apply once dly. (S1) CREAM, 38/20.2.2/0148. 10 mg/g 3 wks.not est., childr.und.2 yrs. not recomm., safety in lactat.not est.,
Side effects: Skin irrit. 706073-001: 7,5 g, R72,40 teratogen. in animals., re-eval. aft.3 wks., occlus. dress., discont.in
706073-002: 15 g, R144,76
NIZCREME, Janssen Pharmaceutica [P/S] Dosage: Durat.varies accord.to indicat.& severity. Irreg.use/premat. case of irritat./sensitisat., short cours. only in fac. dermatos., applic.
Ketoconazole. discont.incr.risk of recurr. Verify diagnos.aft.2 wks.if no improvem. Do to damag. skin, inft.nappy & skin crease areas, near eyes, treatm.
Indications: Skin dermatophyte infects., cutaneous candidias., not use long. than 1 mnth. of psoriasis may provoke pustul.form of dis., suit.anti-microb.ther.
tinea versicolor. Apply as thin layer 1-2xdly to clean & dry affect. area. Treatm. in second.infects.
(S1) CREAM. S/20.2.2/161. 20 mg/g. durat.:Tinea corporis/cruris & pedis x1 wk. Cutan.candidias: x1 wk. BETNOVATE, Sekpharma [P/S]
747327-009: 20 g, R255,16 Pityriasis versicol: x2 wks.
Dosage: Apply once dly till few days aft. disappear. of sympts. Usual Contraindications: Imp.liv.funct., safety in pregn. & lactat.not est., Betamethasone as valerate.
Indications: Non-infect.steroid-respons.dermatos.
durat.of treatm: T versicol. & yeast infects: 2-3 wks. T.cruris: 2-4 wks, limit.data on use in childr.theref. not recomm.
T.corporis: 3-4 wks. T.pedis: 4-6 wks. Side effects: Rash, urticar., Stev.-Johns. syndr.& tox. epiderm.necro- (S4) CREAM [P/S] G/13.4.1/1825.
708313-019: 0,1g/100 g, 15 g, R27,24
Contraindications: Safety in pregn.& lactat.not est. lys., photosens., angioneurot. oed., psorias., allerg.reacts.
Side effects: Erythema, prurit., skin burn., applicat. site bleed./dis- Special precautions: Excret.in breast milk, psorias. poss. exacer- 708313-027: 0,1g/100 g, 30 g, R28,48
(S4) OINT, [P/S] G/13.4.1/1829.
comf./dryn./inflammat./ irrit./ paraesthes./react., hypersens., bullous bat., avoid eye contact
erupt., dermatit.contact, skin rash, skin exfoliat., sticky skin, urticar. 708348-009: 0,1g/100 g, 15 g, R28,17
(S4) ½ STRENGTH CREAM, [P/S] G1826.
Special precautions: Reconsid.diagn./treatm.if no improvem. TRIMAZE, (Unicorn) Pharmacare [P/S]
aft. 4 wks., if used immed.aft. prolong. corticoster.contin.apply. Clotrimazole. 708321-003; 0,05 g/100 g, 15 g, R23,10
708321-011: 0,05 g/100 g, 45 g, R69,31
mild corticoster. in morn.& apply Nizcreme in even., grad.withdr. Indications: Dermatophyt.infect., cutan. candidias., pityrias.versicol.,
ster.over 2-3 wks. paronychia, skin dis. with second.fung.infect. Dosage: Apply 2-3xdly, reduc.on improvem., then discont.
(S4) SCALP APPLIC.SOL, [P/S] G1832.
Warnings: Not for ophth.use. (S1) CREAM. 31/20.2.2/0072. 10 mg/g.
839639-007: 20 g, R16,62 824208-005: 0,1 g/100 g, 30 ml, R78,30
NYSTACID, (Aspen Pharmacare: Consumer) Pharmacare [P/S] Dosage: Apply thin.to affect.area 2-3xdly. Cont.for 2wks.aft. sympt. Dosage: Apply 2xdly, reduc.on improvem.to dly or less often.
Nystatin disapp. to prevent relapse. Contra-indications: Rosacea, acne vulgar., peri-oral dermatit., peri-
Indications: Candida albicans. Side-effects: Loc.reacts., contact dermatit. anal & genit.prurit., skin les. caus.by vir./fung./bact.infect., skin TB,
(S1) OINT. L/20.1.6/394. 100 000 u/g Special precautions: Athlete’s foot: dry feet caref.esp.betw.toes. varicose ulc., childr.und.1 yr.incl.dermatit.& nappy erupts., pregn., skin
797022-007: 15 g, R29,56 crease area applic., Scalp lot: use near naked flame.
Dosage: Apply 2xdly to affect.area. Side-effects: Atroph.skin chang.with prolong./ intens.ther., pig-
mentat.chang., hypertrichos., syst.absorpt. (large doses) & HPA
PEVARYL, Janssen Pharmaceutica [P/S] 14.4 Cortico-steroids axis depress., poss.glauc.if applic.to eyelids, growth retard.& poss.
Econazole base. Cushingoid-state, benign IC hypertens.
Indications: Dermatomycoses caused by dermatophytes, yeasts, ADVANTAN (MDR Listing) Warnings and special precautions: Poss. teratogen.in anim.foll.
g+ve bact., moulds. derm.applic., short cours. only, occlus.dress., infts.& young childr., reg.
(S1) CREAM, [P/S] H/13.9.2/162. 1 g/100 g. ADCO-BETAMETHASONE, AI Pharm Ltd [P/S] re-eval. for cont.ther., discont.applic.in case of hypersens., treatm.of
Econazole nitrate. Betamethasone valerate equiv.to betamethasone. psorias.may provoke pustul. form of the dis., fac.dermatos., near eyes,
754498-018: 15 g, R201,08 Indications: Non-infect.steroid respons. dermatos. concom. eff.chemother. if used in infects., withdr.& admin. syst. anti-
754498-026: 30 g, R402,22 (S4) CREAM. 30/13.4.1/0252. microb. ther.if infect.spreads,stain.
Dosage: Apply 2xdly.morn & even. Reg.use accord.to instruct. 827290-004: 5 mg/5 g, 15 g, R18,94
POWD, [P/S] H/13.9.2/163. 1 g/100 g. Dosage: Apply to affect.area 1-3xdly. BIOCORT, (Ascendis Pharma) Akacia [P/S]
833584-006: 30 g, R320,83 Contraindications: Rosacea, acne, peri-oral dermatit., skin TB, Hydrocortisone acetate
Dosage: Apply 2xdly.morn & even. Support for cream & sol.ther.also varicose ulc., prim.skin.les. caus.by vir., fung.or bact.infects., nappy Indications: Corticoster.respons.dermatos.
F/U & prophylact.treatm. areas of infts.for flex.erupts., ac.infects., pregn., infts.& small childr. (S2) CREAM, G2022. 10 mg/g
SPRAY SOL, [P/S] H/13.9.2/165. 1 g/100 g. Side effects: Atroph.skin changes, skin dry.& thin., loss of elastic., 807834-018: 20 g, R19,38
800678-028: 30 ml, R477,82 dilat.of superfic.bld.vessels, telangiectas., ecchymos., incr.fragility Dosage: Apply thin layer to affect.area.
Dermatologicals - 14.4 2020-04 / 191
Contraindications: H.simplex, vaccinia, varicella, nappy areas in form of psorias., extrem.of pts.with imp. periph.circulat.& diab.mel- Apply thin.2-4xdly or as reqd., use occlus.dress.if necess. Aft.init.
infts., infts., young childr., pregn., leg ulc., rosacea. lit., reg.pt.re-eval.for cont.ther., pref.not for young childr., psorias., therapeut.respons.reduc.applicat. to once dly.or 2-3x/wk.
Side effects: Atroph.skin chang., mild depigmentat., acne spots at not for ophthalm.use. (S4) CRELO TOPIC.EMULS.[P/S] 34/13.4.1/0221. 1mg/g
applicat.site, allerg. contact dermatit., syst.absorpt., HPA-axis de- Indications: Superfic.corticoster.respons. dermatos. not caus.by
press., benign intracran.hypertens. DIPROSONE, MSD [P/S] micro-organisms.
Special precautions: Teratogen.in anim., occlus. dress., broken Betamethasone (as dipropionate) 890396-007: 30 g, R75,59
skin, concom.antimicrob. ther. with infect., childr.absorb.proport.large Indications: Corticoster.respons.skin dis. 890396-015: 100 g, R251,95
amnts., stress, fac.dermatos., near eyes, long term use. (S4) CREAM, [P/S] F/13.4.1/17. 0,5 mg/g Dosage: Apply 1-3 xdly. Aft.improvem apply 1xdly or 2-3 x/ wk.
720399-009: 20 g, R181,09
CORTODERM, (Aspen Pharmacare: Pharma) Pharmacare [P/S] (S4) OINT, [P/S] F/13.4.1/18. 0,5 mg/g Contraindications: Broken skin, bact./vir.or fung. skin infects.,
wound treatm.esp.of ulcer.les., peri-oral dermatit., allerg.hist.
Fluocinolone acetonide. 720410-002: 20 g, R178,71
Indications: Steroid respons.dermatos. Dosage: Apply 2xdly. to ingred.
Side effects: Skin atrophy, telangiectas., skin striae, pustul.acne,
(S4) OINT, [P/S] L/13.4.1/29. 1,25 mg/5 g. Contraindications: H.simplex, vaccin., varicella, pregn., lactat.
716286-009: 15 g, R18,82 Side effects: Loc.reacts., burn., itch., irrit., dryn., atroph.skin chang., peri-oral dermatit., rebound eff., skin depigmentat., dermatit., ec-
zema, rosacea-like skin, infect.mask./spread., steroid acne, adren.
716286-017: 500 g, R627,42 system.absorpt., HPA axis depress.esp.in childr., benign intracran.hy-
(S4) CREAM, [P/S] L/13.4.1/42. 1,25 mg/5 g. pertens., hypertrichos., acneiform erupt., hypopigmentat., perioral/ suppress., hypersens.
Special precautions: Cross.placent.barr., teratogen. in animals,
716278-006: 15 g, R13,14 allerg.cont.dermatit., skin macerat., striae, miliaria, blurr.vis.
716278-014: 500 g, R438,02 Warnings and special precautions: Suit.anti-microb.ther.in sec- large quantit.admin.dur. breast feed., glauc.simplex.if applied near
Dosage: Apply 2-3xdly. ond.infects., facial dermatos., near eyes., occlus.dress., prolong./ eyes., fac. /genit.skin/rect.mucosa & intertrigin.areas extra sens.to
Contraindications: H.simplex, vaccin./varicella, leg ulc., skin crease large quantit. used, inft.nappy & skin crease areas, poss. provokes corticoster., childr., inft.nappy areas, poss. syst.effs.with prolong.&
areas, infts.& young childr., pregn., long term use with diab.mellit/TB pustul.form of psorias., reg.pt.re-eval.for contin.ther., pref. not for occuls.dress.lead.to adren.cortex funct.suppress.& growth horm.
Side effects: Atroph.skin chang., syst.absorpt., HPA-axis depress., young childr., not for ophthalm. use, refer.to opthalmolog.to eval. secret. suppress.
adren.gland suppress., growth retard., benign intracran.hypertens., poss. vis. disturbs.causes, MOMATE, (Activo) Glenmark [P/S]
delay.wound heal., incr.infect.liabil., psorias.(provok.pustul. form). Mometasone furoate
Special precautions: Avoid long term treatm., fac.dermatos., near DOVATE, (Aspen Pharmacare: Pharma) Pharmacare [P/S] Indications: Inflam.manifest.of psorias.& corticoster. respons.
eyes, occlus.dress. Clobetasol propionate. dermatos.
Indications: Short-term treatm.of steroid respons.dermatos.resist.
DERMOVATE, Sekpharma [P/S] to less potent topical corticosteroids. (S4) CREAM, [P/S] 43/13.4.1/0250. 1 mg/g
Clobetasol propionate. (S4) CREAM, [P/S] 27/13.4.1/0316. 718942-001: 20 g, R134,20
Indications: More resist.dermatos.incl.psorias. (excl.widespread 807249-009: 0,0025 g/5 g, 25 g, R57,48 (S4) OINTMENT, [P/S] 44/13.4.1/0095. 1 mg/g
plaque psorias.), intractable eczemas, inflam.dermatos. (S4) OINT. [P/S] 27/13.4.1/0122. 718307-001: 20 g, R141,30
(S4) CREAM, [P/S] F/13.4.1/176 807230-006: 0,0025 g/5 g, 25 g, R57,48 Dosage: Apply thinly 1xdly. Ther.durat.depends on clin.respons.
718718-003: 0,05 g/100 g, 25 g, R49,22 Dosage: Apply sparing.to affect.area 1-2x/day. Contraindications: H.simplex, vaccin./varicella., untreat.fung.in-
(S4) OINT, [P/S] F/13.4.1/175 Contraindications: Bact.(incl.TB), fung./vir.skin infects., ulcerat.skin ects., pregn.& lactat.
718726-006: 0,05 g/100 g, 25 g, R49,22 les., rosacea, leg ulc., long-term use in diab.& TB, pregn. Side effects: Atroph.skin chang.with longt. contin. use, Cushingoid
Dosage: Apply 1-2xdly. Discont.once contr.achiev. Cont.ther.not Side effects: Atroph.skin chang., syst.absorpt. (large dos.) & HPA state, HPA axis depress. with poss.growth retard.esp.sev.in childr.,
long. than 4 wks if need. depress., benign IC-hypertens., growth retardat., provoke pustul.form allerg. cont. dermatit., burn., dryn., folliculit., itch., second. infects./
(S4) SCALP APPLIC.SOL, [P/S] H/13.4.1/268 of psorias., may exacerb.loc.infects. skin atrophy, acneiform erupt., perioral dermatit., hypertrichos., hy-
824216-008: 0,05 g/100 g, 30 ml, R109,36 Special precautions: Short cours.only, facial dermatos., near popigmentat., miliar., skin macerat., striae, poss.steroid rosacea-like
Dosage: Apply 1-2xdly init., discont.once contr. achiev. eyes, occlus.dress., infts.& young childr., inft.nappy areas, porphyr. facies, poss.system.absorpt., benign intracran. hypertens.
Contra-indications: Rosacea, acne vulgar., peri-oral dermatit., peri- Special precautions: Not for ophthalm.use, safety & effic. in paed.
anal & genit. prurit., skin les. caus.by vir./fung./bact.infect., childr. ELOCON, MSD [P/S] pts.for more than 3 wks. not est., childr.und.2 yrs.not recomm., terato-
und.1 yr.incl. dermatit. & nappy erupts., pregn., skin crease areas Mometasone furoate gen. n animals., childr.2 yrs.& old., re-eval.aft.3 wks., occlus. dress.,
applic., Scalp lot: use near naked flame. Indications: Inflam.manifest.of psorias.& corticoster. respons.der- applicat.to face, short cours. only esp. fac. dermatos., inft.nappy &
Side-effects: Atroph.skin chang.with prolong./ intens.ther., pig- matos.lot. for scalp les. skin crease areas, near eyes, discont.in case of irrit./ sensitisat., ap-
mentat.chang., hypertrichos., syst.absorpt. (large doses) & HPA (S4) CREAM, [P/S] V/13.4.1/272. 1 mg/g plic.to damag.skin, treatm.of psorias. may provoke pustul.form of dis.,
axis depress., poss.glauc.if applic.to eyelids, growth retard.& poss. 782017-002: 20 g, R177,21 suit.anti-microb. ther. in second.infects.
Cushingoid-state, benign IC hypertens. (S4) OINT, [P/S] V/13.4.1/273. 1 mg/g MYLOCORT, (Aspen Pharmacare: Consum) Pharmacare [P/S]
Warnings and special precautions: Poss. teratogen.in anim.foll. 782025-005: 20 g, R188,88 Hydrocort.acetate.
derm.applic., short cours. only, occlus.dress., infts.& young childr., reg. Dosage: Apply thinly 1xdly.
re-eval.for cont.ther., discont.applic.in case of hypersens., treatm.of (S4) LOT. [P/S] X/13.4.1/266. 1 mg/g Indications: Tempor.relief of itch.assoc.with min.skin irritat.& ext.
genit.& anal itch.
psorias.may provoke pustul. form of the dis., fac.dermatos., near eyes, 788791-030: 30 ml, R246,94
concom. eff. chemother.if used in infects., withdr.& admin. syst. anti- Dosage: Apply thinly 1xdly. (S2) CREAM, [P/S] P/13.4.1/93. 1 g/100 g
745472-001: 25 g, R50,13
microb.ther.if infect.spreads, stain. Contraindications: H.simplex, vaccin./ varicella., pregn.& lactat.,
childr.und.2 yrs. (S2) OINT, [P/S] P/13.4.1/112. 1 g/100 g
DILUCORT, (Aspen Pharmacare: Consum) Pharmacare [P/S] Side effects: Burn., itch., irritat., dryn.& other loc.reacts., system. 745448-003: 25 g, R50,13
Hydrocortisone acetate. absorpt., HPA axis depress. more sev.in childr., benign intracran. Dosage: Apply up to 4xdly. Reduc.grad.as improvem. occurs
Indications: Tempor.relief of itch.assoc.with min.skin irritat.& ext. hypertens., blurr.vis. Contraindications: Pres.vagin.disch., cosmet. purp., rect.insert.,
genit.& anal itch Warnings and special precautions: Safety of use for more than nappy rash, bact./fung./viral infects., childr.und.2 yrs.or 12 yrs.for
(S2) CREAM, [P/S] R/13.4.1/21. 0,5 g/100 g 3 wks.not est., discont.in case of irritat./ sensitisat., prolong./large genit./anal use, pregn.
720011-019: 25 g, R38,75 quantit.used, suit. anti-microb.ther.in second.infects., fac. dermatos., Side effects: Atroph.skin chang., syst.absorpt., HPA-axis depress.,
(S2) OINT, [P/S] R/13.4.1/20. 0,5 g/100 g near eyes, short courses only, inft. nappy & skin crease areas, treatm. benign intracran.hypertens.
720038-006: 25 g, R39,52 of psoriasis may provoke pustul.form of dis., not for ophthalm.use, Special precautions: Corticoster.teratogen.in anim., consult
Dosage: Apply up to 4xdly. Reduc.grad.as improvem.occurs. refer.to opthalmolog.to eval.poss.vis.disturbs. causes. Dr.immed.in event of extern.anal itch.accompan.by bleed., do not
Contraindications: Pres.vagin.disch., cosmet .purp., rect.insert., insert into rectum using fingers/any mechanic.device, facial derma-
nappy rash, bact./fung./viral infects., childr.und.2 yrs.or 12 yrs.for LENOVATE, (Aspen Pharmacare: Pharma) Pharmacare [P/S] tos., near eyes, prolong./large quant.used, occlus. dress., broken skin,
genit./anal use, pregn. Betamethasone valerate equiv.to betamethasone. concom.antimicrob. ther. with second.microb.infect.
Side effects: Atroph.skin chang., syst.absorpt., HPA-axis depress., Indications: Non-infect.steroid respons. dermatos.
benign intracran.hypertens. (S4) OINT, [P/S] 27/13.4.1/0308. 5 mg/5 g PERSIVATE, (Aspen Pharmacare: Pharma) Pharmacare [P/S]
Special precautions: Corticoster.teratogen.in anim., consult 800171-004: 15 g, R23,12 Betamethasone valerate equiv.to betamethasone
Dr.immed.in event of extern.anal itch.accompan.by bleed., do not 800171-012: 500 g, R770,96 Indications: Non-infect.steroid respons. dermatos.
insert into rectum using fingers/any mechanic.device, facial derma- (S4) CREAM, [P/S] 27/13.4.1/0493. 5 mg/5 g. (S4) CREAM, [P/S] L/13.4.1/382. 5 mg/5 g.
tos., near eyes, prolong./large quant.used, occlus.dress., broken skin, 800163-028: 15 g, R18,92 754064-018: 15 g, R19,77
concom.antimicrob. ther. with second.microb.infect. 800163-036: 500 g, R630,56 754064-026: 500 g, R659,12
(S4) OINT, [P/S] L/13.4.1/395. 5 mg/5 g.
DIPROSALIC, MSD [P/S] Dosage: Apply 2-3xdly to affect.area. 754072-002: 15 g, R30,20
Contraindications: H.simplex, vaccinia, varicella, long term use in
Betamethasone (as dipropionate) 0,5 mg, salicylic acid 30 mg/g. diab.mellit.& TB, pregn. 754072-010: 500 g, R1 006,88
Indications: Corticoster.respons.subac.& chron. hyperkeratot.& Side effects: Atroph skin chang., rosacea-like dermatit., perioral Dosage: Apply 2-3xdly.
dry dermatos. dermatit., hypopigmentat., acneiform erupt., delay.wound.heal., Contraindications: H.simplex, vaccin./varicella, leg ulc., skin crease
(S4) OINT, [P/S] H/13.4.1/32 incr.liabil.to infects., syst.absorpt.(large dos.) & HPA depress., be- areas, infts.& childr., pregn., long term use in diabet.mellit.& TB.
720380-006: 20 g, R335,48 nign IC-hypertens., growth retardat., provoke pustul.form of psorias. Side effects: Atroph.skin chang., syst.absorpt., depress.of HPA-
Dosage: Apply 2xdly. Special precautions: Short courses only, near eyes, occlus.dress., axis, adren.gland suppress., growth retard., benign intracran.hy-
(S4) LOT, [P/S] L/13.4.1/66. infts.& young childr., use.in infects., avoid skin crease areas. pertens., delay. wound heal., incr.liabil.to infect., psorias. (provokes
Betamethasone (as dipropionate) 0,5 mg, salicylic acid 20 mg/g. pustul.form).
Indications: Corticoster.respons.dermatos.esp. hairy areas, psorias. LOCOID, (Adcock Ingram) Astellas [P/S] Special precautions: Avoid long term treatm., fac.dermatos., near
828726-020: 30 ml, R404,06 Hydrocortisone 17-butyrate. eyes, occlus.dress.
Dosage: Apply 2xdly. Indications: Inflammat.skin condits., psorias., lichen ruber planus,
Contraindications: H.simplex., vaccin., varicella, pregn., lactat. intertrigo caus.by chem. /mechan.irrit. PROCUTAN, (Bayer Consumer) MSD [P/S]
Side effects: Loc.reacts., hypertrichos., acneiform erupt., hypopig- (S4) CREAM, [P/S] H/13.4.1/107. 1 mg/g Hydrocortisone.
ment., perioral/allerg. cont. dermatit., skin macerat., second.microb. 738875-007: 15 g, R115,75 Indications: Corticoster.respons. dermatos.
infect., striae, miliaria, pain, rhagades, atroph.skin chang. with long- (S4) LIPOCREAM, [P/S], W/13.4.1/355. 1 mg/g (S2) CREAM, N/13.4.1/42. 10 mg/g
term use, system.absorpt., HPA axis depress. esp.in childr., retard. 793930-006: 15 g, R115,75 757217-001: 20 g, R227,29
growth, Cushingoid state, benign intracran. hypertens., imp.ren./ (S4) OINT, [P/S] H/13.4.1/109. 1 mg/g Dosage: Apply 2xdly.
hepat. funct.with widespread applic., blurr.vis. 738891-002: 15 g, R109,40 Contraindications: H.simplex, vaccin., varicella, pregn., lactat.,
Warnings and special precautions: Refer.to opthalmolog. to (S4) LOT, [P/S] H/13.4.1/108. 1 mg/ml not for ophthalm.use.
eval.poss.vis.disturbs.causes, suit.anti-microb.ther.in second.infect., 828890-013: 30 ml, R128,61 Side effects: Loc.reacts., hypertrichos., acneiform erupt., hypopig-
facial dermatos., near eyes, occlus. dress., broken skin, prolong./large Dosage: Avoid long-term applic.esp.in childr. Adapt.formulat.accord. ment., perioral/allerg.cont. dermatit., atroph.skin chang., system.
quantit used, inft.nappy & skin crease areas, poss.provokes pustul. to nature of skin disord. absorpt., HPA axis depress.esp.in childr., benign intracran. hypertens.
192 / 2020-04 Dermatolgoicals - 14.4 / 14.4.1
Special precautions: Suit.antimicrob.ther.in second. microb.in- (S4) CREAM, [P/S] F/13.4.1/223 Side effects: Benign intracran.hypertens., system. absorpt., HPA-
fects., facial dermatos., near eyes, occlus.dress., prolong./excess.use. 720356-008: 20 g, R314,58 axis-depress., retard.growth, Cushingoid state, loc.reacts., atroph.
REPIVATE, Cipla Medpro [P/S] (S4) OINT, [P/S] F/13.4.1/224 skin chang., hypersens.reacts.
720364-019: 20 g, R296,56
Special precautions: Teratogen.in anim., occlus. dress., large area/
Betamethasone valerate equiv.to betamethasone. Dosage: Apply 2xdly. damag.skin applic., fac. dermatos., second.bact.infect., near eyes,
Indications: Non-infect.steroid respons. dermatos. Contraindications: H.simplex, vaccin., varicella, skin TB. psorias. treatm. may provoke pustul.form of dis., review treatm. reg.,
(S4) CREAM. 31/13.4.1/0688. 1 mg/g. Side effects: Loc.reacts., burn., itch., irrit., dryn., follliculit., hyper- long term treatm.esp.childr.
882934-003: 15 g, R11,16 trichos., acneiform erupt., hypopigmentat., perioral/allerg.cont.der-
882934-011: 500 g, R186,77 matit., skin macerat., second.infect., skin atrophy, striae, miliaria, PEVISONE, Janssen Pharmaceutica [P/S]
Dosage: Apply to affect.area 2-3xdly. Short courses only. gentamic.syst.absorpt.& poss.assoc. ototox., blurr.vis. Econazole nitr. 150 mg, triamcinolone acetonide 15 mg/15 g.
Contraindications: H.simplex, skin vaccinia/ varicellia & TB, pregn., Warnings and special precautions: Not for ophthalmic use, HPA Indications: Steroid respons.inflamm.dermatos. with econa-
infts., young childr., infects., leg ulc. axis depress.esp.in childr., benign intracran.hypertens., fung.super-in- zole-sensit.
Side effects: Atroph.skin chang., skin dry.& thin., loss of elastic., fect., facial dermatos., near eyes, occlus.dress., prolong. large quantit. (S4) CREAM, Q/13.4.1/220.
dilat.of superfic.bld.vessels, telangiectas., ecchymos., incr.fragility used, applicat.to large areas/damag. skin, inft.nappy & skin crease 754579-018: 15 g, R255,49
of cutan. vessels, syst.absorpt.(large doses) & HPA depress., growth areas, poss. provokes pustul.form of psorias., reg.pt.eval.for cont. Dosage: Appl.spar.to affect.area no more than 2x/day pref.in morn.&
retard., benign IC hypertens. ther., pref.not for young childr., refer.to opthalmolog. to eval.poss.vis. even. Avoid occlus.dress.& applic.to large skin areas. Limit treatm.to
Special precautions: Teratogen.in anim., occlus. dress., institut. disturbs.causes., teratogen. in anim.theref.do not use in pregn., lactat. 2 wks.thereaft.contin.iwth econazole prep.
suit.concom.anti microb. ther.if second. microb.skin infect.pres., fac. Contraindications: Tuberculos.skin les., varicella., H.simplex, viral
dermatos., near eyes, treatm.of psorias.may provoke pustul. form of FUCIBET, Adcock Ingram Ltd [P/S] & infects.of skin, fresh vaccin.sites
the dis., don’t apply to skin crease area Fusidic acid 20 mg, betamethasone val.1 mg/g Side effects: Common: Skin burn.sensat., irrit., erythema. Post
Indications: Short term treatm.of eczematous dermatos.colon.
market: Hypersens., applic.site pain/swell., angioed., cont.dermatit.,
STOPITCH, AI Pharm Ltd [P/S] by sens.bact. skin atrophy, prurit., skin exfoliat., striae, telangiectas.
Hydrocortisone acetate. (S4) CREAM, 45/13.4.1/0678 Warnings and special precautions: Near eyes, avoid prolong
Indications: Corticoster.respons.dermatos. 720972-001: 30 g, R276,11 admin.to thin skin & face, avoid skin crease areas, childr.<3 mnths.,
(S2) CREAM. G2212. 0,1 g/10 g. Dosage: Adults & childr: Apply 2-3xdly to affect.areas. Treatm. discont.if hypersens./ chemic.reacts.occur., syst.absorpt. when ap-
810223-007: 20 g, R29,96 durat: of 2 wks.usually suffic. plied to large areas/damag.skin/occlus. dress. /prolong.ther., cata-
Dosage: Apply thin layer to affect.areas 2xdly. Contraindications: Prim.bact./fung.or vir.skin infects., rosacea, racts induc./ocul. hypertens. /incr.glauc.risk with rep.applic./& pro-
Contraindications: Rosacea, acne, peri-oral dermatit., skin TB, perioral dermatit. vaccinat. reacts., skin manifestat.relat.to TB & long. applic.in peri-orbit.region, skin thinn.& atrophy, striae, rosacea,
varicose ulc., vir., fung./bact. skin infects., pregn. syphil., ulcus cruris, und.occlus., intertrigen.les., pregn., childr. <2 yrs. perior.dermatit., acne telangiectas., hypertrichos., delay.wound heal.,
Side effects: Loc.atroph.skin chang., prolong. use/use of large Side effects: Hypersens.reacts., skin atrophy, striae, thinn.& dilat.of incr. superinfect./opportunist.infect.risk, HPA-axis depress., retard.
amounts/applic.to extens. areas/to damag.skin/or occlus.dress.tech- superfic.bld.vessels esp. with occlus., syst.absorpt.to prod.hypercorti- growth/ Cushingoid state in childr., benign IC hypertens., instit.suit.
niq.can result in syst.absorpt., HPA axis depress., benign IC hypertens. cism esp. in childr./infts.with prolong.use & occlus. dress., telangiec- concomit. anti-microb.ther.if second.microb.skin infect.pres., fac.
Special precautions: Concom.antimicrob.ther.in second. microbial. stas., steroid acne, hypertrichos., follicullit., allerg.contact dermatit., dermatos., short course.only, review treatm. reg., not for use in in-
skin infects., short courses only, fac. dermatos., near eyes. perioral dermatit., otit.externa, UTI, eczema aggrav., skin dryn. /irritat., fts.& young childr., psorias. treatm. may provoke pustul.form of dis.,
SYNALAR, Glenmark [P/S] scalp dermatit., prurit., sore throat, flu-like illn., H simplex infect.activat. monit.INR in pts.tak.warfar., teratogen.in anim.theref.do not use in
pregn./breast feed.
Special precautions: Incr.risk of contact sensitis. & antibiot.resist.
Fluocinolone acetonide with extend./recurr. applic., avoid long term contin.ther as adren. sup- Interactions: Clinic.interacts.report.with oral anticoags.
Indications: Inflam.prurit.& allerg.dermatos. press. poss.even without occlus., large skin areas/ face & intertrigen.
(S4) CREAM, [P/S] G1396. 0,25 mg/g skin areas, near eyes, safety in lactat.not est., use beyond 7 days in QUADRIDERM, MC Pharma [P/S]
768278-007: 15 g, R77,12 absenc. of clinic.improvem., avoid skin atrophy/ cutan. ulc./acne vul- Betamethasone (as 17-valerate) 0,5 mg, gentamicin (as sulph.) 1 mg,
(S4) OINT, [P/S] G1397. 0,25 mg/g gar/fragile skin/perianal & gen. prurit./open wounds & muc.membr. tolnaftate 10 mg, clioquinol 10 mg/g.
768286-018: 15 g, R77,12 See also MDR page 89. Indications: Allerg./inflam.corticoster.resp. dermatos.with bact./
(S4) GEL, [P/S] B/13.4.1/133. 0,25 mg/g fung.infect.
768294-002: 30 g, R178,26 FUCIDIN H, Adcock Ingram Pharm [P/S] & (S4) CREAM. G2331.
Dosage: Apply small quant.to areas 2-3xdly. Fusidic acid 20 mg, hydrocortis.acet.10 mg/g 758760-020: 15 g, R229,40
Contraindications: Bact./fung./vir.prim.skin infects., acne rosacea, Indications: Short term treatm.of mild to mod. eczema & dermatit. Dosage: Apply 2-3xdly. Ther.durat.determin.by pt. respons.
perioral dermatit., napkin rash, anogenit.prurit., pregn. with second.suscept.bact. infect. Contraindications: TB and most vir.skin lesions esp. H.simplex/
Side effects: Atroph.skin chang.with long term use & occlus.dress., (S4) CREAM, 45/13.4.1/0568 vaccin.& varicella, pregn.
syst.absorpt., HPA-axis depress. with adren.gland suppress., growth 720973-001: 30 g, R266,06 Side effects: Atroph.skin chang., HPA-axis depress. with conseq.
retardat., benign IC hypertens. Dosage: Adults & childr: Uncov.les: apply 3xdly to affect.areas. For adren.gland suppress., benign intracran.hypertens., cloth stain.
Special precautions: Instit.suit.anti-microb. therapy in second.mi- cov.les.apply less freq. Treatm.durat: up to 2 wks. Warnings and special precautions: Corticoster. teratogen.in
crob.skin infect., near eyes, fac.dermatos., short cours.only, treatm. Contraindications: Prim.bact./fung.or vir.skin infects.& skin anim.follow.derm. applic., atroph.skin changes with long-term con-
of psorias. provoke pustul.form of dis., relapse & loc./system. toxic., manifest.relat.to non-suscept. organ., childr.<2 yrs., pregn.as tera- tin. use partic.on face and with occlus.dress., poss. system.absorpt.
avoid skin crease areas. togen.in anim., with applic.of large quantit/ to wide areas of body/to damag.skin &
Warnings: No occlus.dress.when treat.childr., max.therapy 5 Side effects: Hypersens.reacts., skin atrophy, telangiecstas., striae, occlus. dress., HPA-axis depress.with conseq. adren. gland suppress.
days, do not use in childr.und.1 yr., use only for short periods if fac. follicullit., hypertrichos., perioral dermatit., allerg.contact dermatit., partic.sev.in childr., suit. antimicrob. ther.in second.microb.infects., fac.
applicat.necess. system. activ., depigmentat., syst.absorpt.to prod. hypercorticism dermatos., near eyes, use only for short courses, inft.nappy areas for
esp.in childr./infts.with prolong.use & occlus.dress., otit.med., URTI, flex.erupt., ideally to not apply to infts./young childr., poss.provokes
diarrh.& vomit., eczema aggrav., prurit., skin irrit., burn./sting.skin pustul. form of psorias.
14.4.1 Cortico-steroids with sensat., rash, low back pain, flu-like illn. SYNALAR-C, Glenmark [P/S]
Special precautions: Incr.risk of contact sensitis. & antibiot.re-
Fluocinolone acetonide 0,25 mg, clioquinol 30 mg/g
anti-infective agents sist.with extend./freq.applic., avoid long term contin.ther as adren. Indications: Inflam.dermatos.where second. bact.and/or fung.
suppress. poss. even without occlus., near eyes, safety in lactat. not
infect.pres./likely
FUCIBET (MDR Listing) est., avoid damaged skin/open wounds & muc.membr., use beyond (S4) CREAM, [P/S] G1398
7 days in absenc.of clinic.improvem.
FUCIDIN-H (MDR Listing) See also MDR page 91. 768316-006: 15 g, R114,44
TRAVOCORT (MDR Listing) (S4) OINT, [P/S] G1399
LOTRIDERM, MSD [P/S] 768324-009: 15 g, R114,44
DAKTACORT, Janssen Pharmaceutica [P/S] Betamethasone (as dipropionate) 0,5 mg, clotrimazole 10 mg/g. SYNALAR-N, [P/S]
Miconazole nitr. 20 mg, hydrocortisone 10 mg/g. Indications: Corticoster.respons.dermatos. accomp.by suscept. Fluocinolone acetonide 0,25 mg, neomycin sulph.3 500 iu/g
Indications: Steroid respons.fung.dermatos. fung.infect. (S4) CREAM, [P/S] G1400
(S4) CREAM. M/13.4.1/173. (S4) CREAM, R/13.4.1/38 768367-018: 15 g, R111,44
717266-001: 20 g, R297,95 739391-003: 20 g, R324,44 (S4) OINT, [P/S] G1401
Dosage: Apply 1-2xdly x14 days aft.les.clear.to prev.relapse. Dosage: Apply regul. 2xdly.morn.& night to cover area completely. 768332-001: 15 g, R112,89
Contraindications: Skin TB, H.simplex., vaccin./ all forms of vari- Contraindications: Imidazole sens., H.simplex, vaccin./varicella., Dosage: Apply small quantit.to affect.areas 2-3xdly.
cella, hypersens.to other imidazole derivat., pregn. pregn., lactat., not for ophthalm. use/occlus.dress. Contraindications: Bact./fung./vir.prim.skin infects., rosacea acne,
Side effects: Skin irrit & burn.sensat., irritabil., anaphylact.react., Side effects: Loc.reacts., erythema, burn., peel., blister., prurit., ur- perioral dermatit., napkin rash & anogenit.prurit., pregn. Synalar N
hypersens., angioed., urticar., rash, contact dermatit., prurit., ery- ticar., gen.skin irrit., hypertrichos., acneiform erupt., hypopigment., also: Applic.to ext.audit.canal in perforat.eardrums.
thema, skin inflammat., skin hypopigment., applic.site react., atroph. perioral/ allerg.cont.dermatit., skin macerat., second. microb.infect., Side effects: Atroph.skin chang.with long term use & occlus.dress.,
skin chang. (prolong.use/occlus.dress.), syst. absorpt., HPA depress., striae, miliaria, atroph.skin chang., syst.absorpt., HPA axis depress. syst.absorpt., HPA-axis depress.with adren.gland suppress., growth
adren.suppress., growth retard., Cushing state, benign IC hypertens., esp.in childr., benign intracran.hypertens., paraesthes., oed., blurr.vis. retardat., benign.IC hypertens.
steroid.rosacea-like facies. Warnings and special precautions: Discont.if irrit./ sensiti- Special precautions: Instit.suit.anti-microb. therapy in second.mi-
Warnings and special precautions: Second. microb. skin infect. sat.develop, facial dermatos., avoid skin crease areas, near eyes, crob.skin infect., fac. dermatos., near eyes, short cours.only, treatm.
(instit.suit.concom.ther.), facial dermatos., near eyes, extens.surf.area treatm.long.than 4 wks.not recomm., inft.nappy areas, pref.not for of psorias.provok.pustul.form of dis., relapse & loc./ syst.toxic., avoid
applic., occlus. dress., discont.ther.if hypersens./allerg. react.occurs, young childr., poss.provokes pustul.form of psorias., repeat appropr. skin crease areas. Synalar-N also: As it’s nephro & ototox.avoid pro-
avoid long term treatm., once inflamm. sympts.disapp.cont.with anti-microb.tests bef.start. new treatm.if respons.inadeq., refer.to long.use & large amounts where neomycin absorpt.poss.
miconazole cream, avoid contact with latex products as damage to opthalmolog. to eval.poss.vis.disturbs.causes, Warning: No occlus.dress.when treat.childr., max.therapy x5 days,
latex poss., lactat., safety in pregn.& lactat. not est., cross.placenta, do not use in childr.und.1 yr., use only for short periods if fac.ap-
teratogen.in anim. follow.derm.applic., in anim.miconaz.embryo toxic MAXADERM, Cipla Medpro [P/S] plicat.necess.
at matern.tox.dos., elderly, monit.oral anticoags. Isoconazole nitrate 10 mg, diflucortolone valerate 1 mg/g.
Drug interactions: CYP3A4/2C9 inhib.by system. miconaz., may Indications: Inflam.fung.skin infect., eczemat.skin condits. TRAVOCORT, (Adcock Ingram) Bayer [P/S] &
potent.act.of oral anticoag./oral hypoglyc.& phenyt., metab.of hy- (S4) CREAM. 33/13.4.1/0303 Isoconazole nitrate 10 mg, diflucortolone valerate 1 mg/g.
drocort.decr. 709808-001: 20 g, R196,87 Indications: Fung.skin infect., inflam./eczemat. fung.skin condits.
(S4) CREAM. N/13.4.1/171.
Dosage: Apply to affect.areas 2xdly. Once inflammat/ eczemat.con-
DIPROGENTA, MSD [P/S] dit.improv.discont.& apply isoconazole prep.only. 771937-016: 20 g, R238,79
Betamethasone (as dipropionate) 0,5 mg, gentamicin (as sul- Contraindications: H simplex, vaccinia/ varicella, skin TB, pregn., Dosage: Apply 2xdly. Apply to gauze for interdigit.applicat. Dis-
phate) 1 mg/g. skin crease areas, occlus. dress.to large skin areas, rosacea, indis- cont.ther.aft. inflamm./ eczemat.condit. regress.& contin.with prep.
Indications: Second.infect.corticoster.respons. dermatos. crim.use for prurit., safety in lactat.not est., leg ulc. not contain.corticoid.
Dermatologicals - 14.4.1 / 14.5 / 14.6 2020-04 / 193
Contraindications: TB or syphilitic process./ rosacea/perioral der- (S5) CAPS, W/13.4.2/73, 74 Dosage: Indiv.depend.on pts.weight & severity. Admin. with meals.
matit./post-vaccinat.skin reacts.in treatm. area, viral dis., skin crease 817732-004, 10 mg, 30, R924,72 Low dos.once dly.& high. dos. as sngl.or div.dos. Init: 0,5 mg/kg dly.
areas, safety in pregn.& lactat.not est. 817740-007, 25 mg, 30, R2 060,20 x2-4 wks until.respons.est. Maint: Contin.at 0,5 mg/kg dly.if respons.
Side effects: Loc.reacts.incl.atroph./acneform skin chang., system. Dosage: Prescribe only for 1 mnth.to ensure reg. monitor. Indiv.ad- good reduc.to 0,1 -0,2 mg/kg with intol. dur. init.ther. Incr.to 1,0 mg/
absorpt., HPA-axis-depress., retard. growth, Cushingoid state, be- min.once dly.with meals/milk. kg/day where init. respons.inadeq.& in partic.sev.cases if well toler.
st
nign intracran. hypertens., folliculit., hypertrichos., perior. dermatit., Init.dly.dos: 25/30 mg x 2-4 wks. Maint: 25-50 mg/day x further Admin. maint.ther. x12 wks.for 1 stage of ther. Observ. 8-20 wk. in-
allerg.skin reacts. 6-8 wks. Max.75 mg dly. terv. bef.admin.2nd.course.if necess.
Special precautions: Suit.anti-microb.ther.in second.infects., tera- Keratiniz.disords: Contin/maint.dos.at low level of 20 mg & up Contraindications: Pregn.& lactat., acitretin/ tretinoin & vit.A de-
togen.in animals, specif.ther. in bact.skin infects., near eyes, incr.S/E/ to 50 mg dly. rivat.hypersens., hepat./ren. impairm., hypervitaminos. A, hyperlipi-
glauc.risk with contin. longt.use/large quantit.used/applic.to large ar- Combinat.treatm: Reduc.dos.depend.on indiv. repons. Std.topic. daem., concom. vit.A/other retinoids & tetracycl., women of childbear.
eas/ occlus.dress.& poss.more sev.in childr., short cours.only, review treatm.except.keratolyt.can gen. be contin. potent.unless uninterrupt. effect. contracept.practis.x1 mnth.prior to
regul.if contin. ther. necess. Contraindications: Pregn.(teratogen.) & lactat., women of childbear. ther./dur.& at least one mnth.aft.discont.
See also MDR page 255. potent.not to rec.bld.from pts. treat.with Neotigason, sev.liv./kidn.im- Side effects: Teratogen., dry skin & mucosa, dry eyes, keratit., con-
pairm., chron. abnorm.bld.lipid values, microdos. progesterone preps. junctivit., revers.corn.opacit., contact lens intol., skin reacts., nail dys-
(minipills), retinoid hypersens., hypervitaminos.A, childr.und.18 yrs.or trophy, incr. granulat.tiss.format., persist.hair thinn., revers. alopec.,
14.5 Psoriasis until bone developm.compl., treatm.long.than 12 mnths., bld. donat. hirsut., acne fulmin., hyperpigmentat., photosens., musc.& joint pain,
CNS effs., depress., psychot. sympts., suicid. behav., benign.IC hyper-
dur.treatm. & 2 yrs.thereaft., alcoh.ingest. dur treatm.& x 2 mnths.
(See also 14.4, 23) aft.ther.discont., women of childbear.potent. tens., night vis.& colour impairm., imp.hear.at cert. freq., GI disturbs.,
inflammat.bowel dis., pancreatit., hepatit., bronchosp.most. with
Side effects: Hypervitaminos.A, ocul.disturbs. incl. decr.night vis.&
DOVOBET (MDR Listing) cont.lens.intol., corn ulcerat., lenticul.cataract., init.worsen.of psorias. asthma hist., bld.dyscras., incr.serum triglycer./ cholester. lev., decr.HDL,
sympts., sev. skin.reacts.incl.exanthema, erythema multiforme & tox. hyperuricaem., skelet.hyperostosis, loc./ system. infects., lymphade-
CLOBEX, Galderma [P/S] epiderm.necrolys., photosens. reacts., dryn.& thinn./scal.skin.esp.on nopathy, haemat./ proteinur.,allerg.vasculit., hypersens.incl. anaphylax.
Clobetasol propionate. face, palms & soles (palmo-plant.exfoliat.), sticky skin, dermatit. facial, Special precautions: Two simultan.reliable methods of contracept.
Indications: Short term topic.treatm.of mod.to sev.scalp psorias. prurit., pyogen.granuloma & incr. granulat. tiss.format., allerg.vascu- recomm., explicit. explanat. of pregn.risk & relev.contracept.meas.
in adults over 18 yrs. lit.incl. Wegener’s granulomatos., acne fulminans., hair loss /thinn., to pt., pregn. test.prior & dur.ther., avoid other keratolyt. / exfoliat.
(S4) SHAMPOO, A40/13.4.1/0035 alopec., nail fragil., paronych., hirsut., hyperpigmentat., lymphade- agents, avoid UV expos., trans. incr.in acne at init.of ther., pancreatit.
710464-001: 0,5 mg/g, 125 ml, R374,77 nopathy, bull.erupt., abnorm.hair text.chang., loc.or syst.infects.with risk with high serum triglycer., est.liv.funct.prior to ther./ aft.1 mnth
Dosage: Init.treatm.course: Limit.to 4 consec. wks.treatm. Max. Staphylococ.A, cheilit./rhagad.of mouth corners, dry mouth & thirst, treatm.& at 3 mnthly interv., observ.for depress. discont.& init.appropr.
dos. 50 ml/wk. Re-assess. diagn. if no improvem.within 4 wks. dry.inflam.react.of mucous membr. lead.to nose bleed.& rhinit., sto- treatm. if occurs, concom.tetracycl.assoc.with benign IC-hypertens.,
Apply on dry scalp once dly.& massag.les. Leave on x15 mins.with- matit., gingivit., taste disturbs., incr.incid.of vulvo-vaginit., musc./joint/ diagnos.of diabetes, discont.in pres.of vis.chang./pres.of uncontrol.
out occlus.bef.lather.& rins. bone pain, other musc.-skelet.chang. incl.hyperostos.exostos./soft hypertriglyceridaem./ pancreatit., sympts.of inflammat.bowel dis/
Maint.treatm: When pt.is clear/has mild plaque psorias.aft.4 wks. tiss. calcificat..oesteoporos./premat.epiphys.clos.& painless icterus, diabet./ fam.hist. thereof., est.lipid profile prior to ther./1 mnth aft.
of once dly treatm.apply 2x/wk. to maint.therapeut.eff.& prev.re- inflamm.bowel dis., CNS effs., hear. defic., behav.disords., headache, init. ther.& at end of treatm.& more freq.in high risk pt.groups, do
curr. Safety & effectiven. of maint treatm.not demonstrat.for more malaise, sweat., benign intracran.hypertens., bld.dyscras., elev. bld. not donate bld.dur.ther.and x1 mnth. aft.cessat., avoid skin resurfac.
than 6 mnth period. lipids in high risk pts.with high dos., trans. revers.elev.transaminas.& proced.dur.& x6 mnths.aft.ther., avoid diet.supplem.contain. Vit.A,
(S4) SPRAY, 46/13.4/0556 alkaline phosphatas., pancreatit., hyperuricaem., hematur./ proteinur. poss.intol.to vigorous exerc.
722469-001: 500 µg/g, 120 ml, R350,12 Special precautions: Do not start treatm.till 2 –3 day of next Drug interactions: Addit.effs.tox.effs.with vit.A incl.diet.supplem.,
nd
rd
Indications: Topic.treatm.of mod.to sev.plaq.-type psorias.in adults. norm.menstr.period, obtain negat. pregn.test result two wks.prior.to concom.tetracycl. assoc.with benign IC-hypertens.
Dosage: Spray directly to affect areas 2xdly.& rub in until absorb. commencem.of treatm., pregn.test every mnth., monit.hepat. funct.,
Max.50 g per wk. Limit. treatm. to 4 wks. If furth.treatm.necess.use bld.donat.prohib.dur.& 2 yrs.aft.compl.of treatm., avoid.alcoh.x2 ACNETRET, Cipla Medpro [P/S]
less potent ster. Discont.when dis.controlachiev. May be rep.for pso- mnths aft.cessat.of treatm., disc.& refer for neurolog.evaluat.if sev. Isotretinoin
rias.exacerbat.aft. an off treatm. period headache/ N&V & vis disturbs.exper., monit.ser.cholester.& triglycer- Indications: Sev. nodul.acne unrespons.to convent. ther.incl.antibiot.
Contraindications: Infect.scalp area, areas other than scalp, ul- ides.esp.in high risk pts., disturb.lipid metabol., diabet.mellit., obesity, (S5) CAPS. 38/13.4.2/0267, 0265
cerat.skin les., childr.und.18 yrs., pregn.& lactat. Spray also: skin alcohol., monit. bld. sug.lev.more freq., investig.atypic. musculoskelet. 711877-001: 10 mg, 60, R232,41
areas affect.by bact./vir/fung.or parasit.infects., skin TB, skin dis. sympts., period.exam.for poss. acitret. induc.bone chang.& extra- 711876-001: 20 mg, 60, R455,40
caus.by syphil., acne vulgar., rosac/ perioral dermat., applic.near skelet. calcificat. abnormalit., eff.of UV light enhanc. Dosage: Admin.dly.dos.with meals/milk. Indiv. depend. on sever.&
eyes, peri-anal & genit.prurit. Interactions: Incr.risk of hepatit.with methotrex., etretinate for- S/E. Init: 0,5 mg/kg dly.x2-4 wks. Until respons.est. Maint: 0,5-
Side effects: Skin atroph.changes, benign intracran. hypertens., mat.enhanc.by alcoh.which has long half life, Vit A & other retin- 1 mg/kg dly. for 12-20 wks. If well-tol.dly.dos.may be incr.to 1 mg/
Cushing.state, HPA-axis depress., dryn., irritat., hypopigmentat., oids incr. hypervitaminosis A risk, reduc.phenytoin protein bind., kg where init.respons.inadeq.or in sev.cas. Max. dos.of 1 mg/kg/day
hypersens., applic.site burn., perioral dermatit./ skin atrophy/wors. dimin.eff.of progest.preps.or “minipills”, avoid tetracyclines which to be giv.for limit.per. only.
rosac./acne & hypertrichos. with spray can cause rais.ICP Low.dos.may be giv.once dly.& high.dos.2xdly.or more. Maint.at
Warnings and special precautions: Poss. treatm.rebound relaps., Warnings: High teratogen.theref.strict. contracept. use 4 wks.bef./ low.dos.in pts.show.sev.intol.to norm. dos. Incr.remiss.rate & re-
tol.developm., loc./ system. toxic., high.risk of system.effs.with con- dur.& for 2 yrs.aft. discont. ther., risk sev.foet.malformat. laps.prevent.with cumulat. dos.of at least 120 mg/kg/treatm. Ther.
tin.long-term use/large quantit.used/appl.to large/damaged areas/ durat. depend.on dly.dos. Compl.& prolong.remiss. poss. in some
occlus.dress.& poss.more sev.in childr., ac.adren.insuffic.with abrupt STELARA, Janssen Pharmaceutica (Pty) Ltd. pts.aft.sngl.course for 16-24 wks. Observ. at least 8 wk.interv.bef.
withdr., near eyes, intertrig.areas, suit.anti-microb. ther.in second. See Section 24.1 admin.2nd course if necess.
bact.infects., poss. provokes pustul.form of dis., sev.liv.dysfunct., XAMIOL, AI Pharm [P/S] Contraindications: Pregn.& lactat., women who may become
sev.diab.mellit., decr.fertility with SC admin.in rats, teratogen.fol- Calcipotriol 50 µg, betamethasone dipropion. 0,5 mg/g pregn.dur.treatm., women of childbear. potent.unless uninterrupt.
effect. contracept. practis.x1 mnth.prior to ther./dur.& at least one
low.derm.applicat.in anim. Indications: Scalp psoriasis. mnth.aft.discont., pre-exist. hypervitaminos. A, hepat./ren.insuff.,
DOVOBET, AI Pharm [P/S] & (S4) GEL, 44/13.9.1/0632 excess.elev. bld. lipids, concom.tetracycl., sorbitol intol.
Calcipotriol 50 µg, betamethasone dipropion. 0,5 mg/g 717191-001: 30 g, R435,22 Side effects: Bld.dyscras., CNS effs., headache, malaise, drowsin.,
Indications: Psoriasis vulgaris Dosage: Do not wash hair prior to applicat.and gel to remain on seiz., behav.disords., incr. ser. triglycer./ cholester.lev., HDL reduct., ac.
(S4) OINT, 37/13.9.1/0241 scalp for full night/day pancreatit., hyperuricaem., GI disturbs., dry mouth/ pharyng. mucosa,
708636-001: 30 g, R435,29 Apply to affect.area once dly upto 8 wks. Applicat. of 1-4 g/day bleed.gums/nose, inflamm. bowel dis., haematur., proteinur., hepatit.,
708636-002: 60 g, R870.57 gen.suffic. Rep.treatm.may be init. und. med.supervis. Max.wkly poss. fatal, musc./joint pain, skelet.hyperostos.& prem. epiphys.clos.,
Dosage: Apply to affect.area once dly upto 4 wks. Max.wkly dos: dos: 100 g. dry eyes, conjunctivit., keratit., cont. lens intol., bronchosp., skin re-
100 g. Max.dly.dos: 15 g Contraindications: Known Ca metabol.disords., vir./fung./bact. acts., lips/nose dryn., photosens., hair thinn., alopec., hirsutism, hyper-
Contraindications: Known Ca metabol.disords., vir./fung./bact. or parasit.skin infects., sev.hepat. disords., sev.ren.insuffic., safety pigmentat., allerg. vasculit., nail dystrophy, sweat., incr.granulat.tiss.
or parasit.skin infects., sev.hepat. disords., sev.ren.insuffic., safety in pregn.& lactat. not est., no exper.in childr.& adolesc.und.18 yrs. format.in acne erupt., acne fulminans, hear.defic., loc./syst.infects.,
in pregn.& lactat. not est., no exper.in childr.& adolesc.und.18 yrs. Side effects: Hypercalcaem.if max.wkly.dos. exceed., prurit., skin depress., psychos., suic.ideat./suic., corn.opacit. esp.with high dos.
Side effects: Hypercalcaem., prurit., rash, skin burn., skin irritat., burn., skin pain/irritat., folliculit., dermatit., erythema, acne, dry Warnings and special precautions: Teratogen., explicit explanat.
dermatit., erythema, psorias. exacerbat., folliculit., pigment.changes, skin, psorias. exacerbat., rash, pustul.psorias./-rash, skin atrophy, of pregn.risk & relev. contracept.meas.to pt., pregn.test.prior & dur.
pustul. psorias., skin atrophy, telangiectas., striae telangiectas., striae, hypertrichos., perioral dermatit., allerg.con- ther., 2 reliab.forms of contracept.recomm.to be used simultan., to
Special precautions: Avoid face/scalp,mouth or eyes, wash hands tact dermatit., depigmentat., syst.effs.of hypercalcaem & adren. be admin.by spec.physic.only, est. liv.funct.prior to ther./aft.1 mnth
aft.apply., system.corticoster. treatm. advers.effs.poss., avoid apply. cortex inhibit. treatm.& as appropr. dur.treatm., discont.ther.if liv.enzym. remain
to large areas damag.skin/und.occlus.dress & in skin folds, discont. Special precautions: Avoid face/mouth or eyes, wash hands aft. elev./hepatit.susp., depress.hist., monit.for depress. signs & init.
if second.infect.develops apply., system.corticoster. advers. effs.poss., avoid apply.to large appropr.treatm.if reqd., hypercholesterolaem., hypertriglyceridaem.
See also MDR page 81. areas damag.skin/ und.occlus.dress & in skin folds, discont.if sec- tend. developm., est.lipid profile prior to ther.& thereaft. mnthly. dur.
ond. infect.develops. treatm., freq.bld.gluc.lev.in diab. mellit., discont.ther.& screen pts.with
LINOTAR GEL 1 (Glenmark) MeyerZall [P/S] sympt.of pseudotum. cerebri for papilloed.& ref.to neurolog. for furth.
Coal Tar diagn.& care, discont.ther./ophthalmolog. exam. if vis.chang., warn
Indications: Psorias.& eczemat.condits.of skin & scalp, cold sores. pt.of potent.decr.night vis., pancreatit.risk with high ser.triglycer.,
(S0) EMULS, A27/13.9.1/0357 14.6 Acne discont. ther. in case inflamm.bowel dis.sympt.exper., do not donate
794422-012: 1 g/100 g, 250 ml, R280,95 bld.dur.ther.and x1 mnth.aft.cessat., avoid diet.supplem.contain.Vit.
Dosage: Extern.use only. Apply thin layer on clean les.2-3x/day. (See also 18.4) A, concom. tetracycl. indicat.as assoc.with benign IC-hypertens.,
Massage gent.& leave to dry. CLINDOXYL (MDR Listing) concom.keratolyt./exfoll.anti-acne agents not indic., radiat./UV ther.
Contraindications: High.inflam./brok.skin, use in/ around rect./ ORATANE (MDR Listing) not to be start. dur. treatm., avoid excess.dermabras./wax epilat.
genit.area/groin. SKINOREN (MDR Listing) dur. & 5-6 mnths.aft.treatm., trans.acne worsen. gen. dur. init.per.
Side effects: Poss.enhanc.skin photosens., skin irrit./acne-like erupt. Drug interactions: Addit.tox.effs.with vit.A incl. diet. supplem.
Warnings and special precautions: Avoid cont. with eyes, dis- ACNETANE, AI Pharm [P/S]
cont.ther.if irrit.occurs, avoid dir. sunl.expos.aft.applic. Isotretinoin ANDROCUR, Bayer [P/S]
Cyproterone acet.
Indications: Sev.recalcitr.nodul.acne & sev. nodul. acne unrespons.
NEOTIGASON, (Cipla) Teva [P/S] to convent.ther.incl.syst. antibiot. Indications: Sev.& mod.sev.forms of acne & seborrh., mod.sev.forms
Acitretin (S5) CAPS. 34/13.4.2/0356, 0357 of hirsut., mod.sev. androgenet.alopec.
Indications: Sev.extens.psorias., loc.or gen. pustular psorias., sev. 701667-001: 10 mg, 60, R296,28 (S4) TABS, R/21.12/159
keratiniz.disords.resist.to other ther. 701656-001: 20 mg, 60, R582,63 791970-019: 10 mg, 15, R400,78
194 / 2020-04 Dermatologicals - 14.6
WITH ALDARA YOUR PATIENTS
HAVE EFFECTIVE SUSTAINED
ACTINIC / SUPERFICIAL EXTERNAL
SOLAR BASAL CELL GENITAL CLEARANCE FOR AK, sBCC
KERATOSIS CARCINOMA WARTS AND EGW 1-4
Dosage: Commenc.on 5th day of menstr.cycle with 1 tab taken Side effects: V.common: Skin irritat., dry skin, urticar., peel. Com- depress., fluid retent., risk of thrombos., oligomenorrh., amenorrh.,
from appropr. marked blister, contin. with 1 tab dly.till tab. mark.with mon: GI disords., seborrh. Post market: Folliculit., eye pain, pseu- hypercholest., famil.hyperlipoprot.
no.15. Foll. above regim.every 28 days. Length of treatm. determ. domembran. colit., abdom.pain, contact dermatit. Interactions: Anti-epilep.agents, antibiot., barbit., rifampicin decr.
by severity & respons. Warnings and special precautions: Investig. prolong./signif. effic.insulin & other hypoglyaem. requirem.may change.
Contraindications: Pregn.& lact., liv.dis., hist. of persist.itch/ jaund./ diarrh.& discont.ther.if necess., topic.absorpt.occurs, avoid mouth
herpes dur.prev.pregn., Dubin Johnson syndr., Rotor syndr., wast.dis., & sensitive surf./ abrad.skin & muc.membr., atopic pts., safety in DIFFERIN, Galderma [P/S]
depress., prev./exist.liv.tumours or thromboembol. process., diab.with pregn.& lactat.not est., report.in breast milk aft. oral & parenter.admin. Adapalene.
vascul. changes, sickle cell anaem., admin.bef.conclus.of puberty. Interactions: Antiperistalt.meds.poss.prolong/ aggrav.colit., system. Indications: Acne vulgaris where comedones, papules & pus-
Side effects: Body weight & libido chang., breast tens., tiredn., rest- admin.enhanc.neuromusc. block act. tules predominate.
lessn., depress.moods, liver funct. disturbs., reduc.adren.cortex funct. (S3) GEL. 29/13.12/0606. 1 mg/g.
with high dos.treatm., imp.concent. DAPTA, Litha [P/S] 827215-002: 30 g, R274,45
Special precautions: Concurr.contracept., reg. check of liv.funct., Adapalene. (S3) CREAM. 32/13.12/0476. 1 mg/g.
monit.carbohydr.metabol.of diab. CV dis., ischaem.heart dis., cer- Indications: Acne vulgaris where comedones, papules & pustules 863939-007: 30 g, R274,45
ebrovasc.dis. & hypertens., consult Dr.if bleed.fails to occur aft. predomin.in pts. 12 yrs.& old. Dosage: Apply once dly.to affect.area bef.retir.& aft.wash.
28 day cycle., bear in mind that sex.steroids can promote growth (S3) GEL. 1 mg/g. 46/13.11/0163 Contra-indications: Childr.und.12 yrs., sev.acne, concom.retinoids/
of cert.horm.depend.tiss.& tumours., consid.different.diagn.of liv. 721708-001: 30 g, R192,63 meds with similar act.
tumour if sev.upper abdom.compl., liv.enlargem./signs of intra-ab- (S3) CREAM. 1 mg/g. 46/13.11/0162 Side-effects: Skin irritat., dry skin, burn.sensat., erythema, contact
domin.haemorrh.occur. 721707-001: 30 g, R192,63 dermatit., skin discomf., sunburn, prurit., skin exfoliat., acne flare, skin
Dosage: Apply once dly.to affect.area bef.retir.& aft.wash. Improvem. pain & swell., eyelid irrit./-erythema/-prurit/-swell.
BENZAC AC 5, Galderma [P/S] expect.aft.4-8 wks ther. & furth.with contin.use. Treatm.to be eval.if Special precautions: Allerg.reacts.may arise aft.treatm.completed,
Benzoyl peroxide. no improvem.aft. 8-12 wks. not to be used in pregn.& lactat., tetratogen.shown in anim.with oral
Indications: Acne vulgaris. Side effects: Freq: Skin burn./sting.sensat., ythema, skin dryn./ ir- admin., discont.in case of sev.irritat., do not apply to broken skin/large
(S0) GEL. [P/S] X/13.12/133. 5 g/100 g. ritat. Less freq: Acne flares, cont. dermatit., skin discomf./-exfoliat., surf.areas esp.in women of childbear.age not on adeq.contracept.,
807842-029: 15 g, R77,05 photosens., prurit. other retinoids/ meds.with simil.mode of act.not to be used concur.,
807842-028: 40 g, R196,29 Warnings and special precautions: Reduc. dos.or discont.in eff.of rep.expos.to sun & UV irradiat. not est.theref.avoid, poss ad-
Dosage: Apply 1-2xdly.to affect.areas aft cleans. case of sev.irrit., avoid contact with mouth/angl.of nose/other mu- dit.irrit.effs.with concom. peel.agents/irrit.prod.& astringents, use
(S0) WASH. [P/S] 30/13.12/0044. 5 g/100 g. cous surf., sev.acne/acne to large body areas, adeq. contracept. in of other cutan.anti-acne treatm. eg erythromycin, benzoyl perox.
856924-008: 100 g, R194,09 women of child bear.potent., applic. to eczemat./sunburnt/abrad.skin, may be used in morn.
Dosage: Apply 1-2xdly.to affect.areas, rub gently & leave on skin avoid excess.UV /sunlight expos., poss.delay.allerg.reacts., safety &
x30secs.bef.rins. effic.in pregn. /childr.und.12 yrs.not est., breast feeding not recomm, DIVA 35, Unicorn [P/S]
Side effects: Allerg.contact dermatit.& dryn. 21 tabs: cyproterone acetate 2 mg, ethinyl-oestradiol 35 µg. 7 pla-
Special precautions: Safety dur.pregn., lactat. & use in childr.not avoid applicat.to breast if breast feed., use only non-comedogen.& cebo tabs.
est., discont.in case of sev.irrit. non-astring.concom.cosmet. Indications: Sev.androgen-depend.acne, androg. alopec.& mild
Warnings: Avoid contact with eyes, eyelids, lips & muc. membr., Interactions: Avoid other concom.retinoids/ agents with simil. hirsutism in women, oral contracept. where anti-androg.ther.reqd.
poss.bleach./skin discolourat.if in cont.with any materials, poss.trans. mode of act./topic.preps.poss. caus.irrit., apply topic.antibact./ben- (S4) TABS, 38/21.8.2/0055
skin discolourat. if used with PABA-contain.sunscreens. zoyl perox.in morn.& Dapta at night, eff.of rep.expos.to sun & UV ir- 707875-001: 28, 1 mnth.cal.pack, R99,08
radiat.not est.theref.avoid, Dosage: 1 tab.at same time dly.from 1st day of menstr. cycle.
CLINDOXYL, GSK [P/S] & Contra-indications: Pregn.& lactat., mod.imp. liv.funct., cholestas.,
Clindamycin 1 g, anhydr.benzoyl peroxide 5 g/100 g DERIVA, Glenmark [P/S]
Indications: Acne vulgaris esp.inflamm.les.in adolesc.& adults. Adapalene. Dubin-Johns.or Rotor syndr., hepat.adenomas, oestrog.depend. neo-
plasms eg breast or endometr.Ca, CV dis. incl.prev./exist.arter./ven.
(S4) GEL, 42/13.11/0441 Indications: Acne vulgaris of face/chest & back where comedones,
719260-001: 25 g, R258,36 papules & pustules predominat. thrombot.or embol. process. or predispos.condits., lipid metabol.
disturbs., undiag.vag.bleed., cholestat.jaund., chorea, herpes, pem-
Dosage: Wash affect.skin area, rinse & pat dry. Apply gel once dly.in (S3) GEL. 44/13.11/0766. 1 mg/g.
even. In some cases 4-6 wks may be requir.bef.full therap.eff. Treatm. 720276-001: 30 g, R215,80 phigoid gestationis/ deteriorat. otoscleros., sev./foc.migraine, cer-
ebrovasc.condit., advanc.diab.mellit.with vasc. changes, sickle-cell
not to exceed more than 12 wks.contin.use. Dosage: Apply once dly.aft.wash to affect.area bef.retir. Treatm.
Contraindications: Safety in pregn.& lactat.not est., lincomycin may be resum.in the event of tempor.discont./reduc.freq. if pt.judg. dis., porphyr., men, childr.
Side-effects: Hepat.Ca, thrombos., weight gain, depress., N&V, alt.
hypersens., safety & effic.in childr. und. 12 yrs.not est. to tol.treatm.
Side effects: Erythema/peel./dryn./prurit.at applic. site, paraesthes., Contraindications: Neonates & childr.und.12 yrs., sev.acne, safety liv.funct., hepatit., jaund., hepatomegaly, hepat.fail., gall bladd.dis., al-
acne worsen., cont. dermatit., burn., diarrh., isolat.pseudomembr.co- in pregn.& lactat.not est., opec., photosens., allerg.rash, breast tendern., vag.candidias., throm-
lit., resist.with longt.use, allerg.reacts. Side effects: Skin irrit., erythema, dryn., scal., prurit., burn., photo- boembol.disords., thrombosis, reduc.gluc.tol., lipid metabol. changes,
Warnings and special precautions: Avoid mouth/ eyes/skin/ sens., contact dermat., sting.& warm feel. appetite changes, mood/ment./libido changes, dizzin., headache,
mucous membr./abrad.or eczemat. skin, minim.sun/sun lamp expos., Special precautions: Discont.in case of sev. irritat/reduc.freq./ migraine, contact lens intol., fluid retent., hypertens., GI disturbs.,
atop. pts., sens.skin, reduc.applic.freq.in case of excess. dryn./irrit., discont.tempor., avoid contact with eyes/muc.membr./broken or chloasma, melisma, haemorrhag.erupt., cervic. secret.changes,
lincomycin/erythromycin cross-resist., avoid other concom.topic.acne eczemat.skin, sev.acne cover.large areas of body, not to be used in incr.cerv.& breast Ca risk, menstr. irregular., post treatm.anovulat.
preps.cont.Vit.A, potent.synerg.betw.clindamycin & gentamycin, con- women of childbear.age unless effect. contracept. pract., other con- Special precautions: Depress.hist., gall bladd. dis., condits.influ-
com.topic.antibiot./abrasiv./alcoh.cont.prod. &/astring. com.retinoids/ meds. with simil.mode of act., safety of rep.expos. enc.by fluid retent., high BP, varicos.veins., phlebit.hist., otoscleros.,
See also MDR page 359. to sun & UV irradiat.not est, poss addit.irrit.effs.with concom. peel. multipl. scleros., epilep., tetanus, chorea min., asthma, discont.4-6
wks. bef.surg.assoc.with incr. thrombo-embol.risk or prolong.immo-
CYCLIMYCIN, (Aspen Pharmacare: Pharma) Pharmacare [P/S] agents/irrit.prod./astringents, use of other cutan.anti-acne treatm. bilisat., discont.immed.in case of first sign of thrombo-embol.dis-
eg erythromycin, benzoyl perox.may be used in morn., birth defects.
Minocycline HCl equiv.to minocycline report.with topic.retinoid expos.dur.pregn. ords./unusual.sev.prolong.headache / sudd.vis./hear./percept.dis-
Indications: Acne-adjunct. turbs./collapse,/S&S of cerebrovasc.dis./hepatit./jaund./gen.itch./
(S4) CAPS. W/20.1.1/0442, 0443 DIANE-35, Bayer [P/S] liv. enlargem./sev.upper abdom. pain/sev.depress./ signific.incr.BP/
788287-001: 50 mg, 60, R229,24 21 beige tabs: Cyproterone acetate 2 mg, ethinylestradiol 0,035 mg. exacerbat.of condits.known to poss.deterior.dur.OC ther./pregn., past
788295-012: 100 mg, 100, R1 118,40 7 placebo tabs. oligomenorrh. & amenorrh., addit.non hormon. contracept.methods
Dosage: Acne: Init. 50-100 mg 2xdly. Maint: 50 mg 2xdly. Indications: Androgen depend.acne, androgen depend.alopec., when effic.at risk, surg., investig.heavy inter menstrual bleed., incr.
Contraindications: Pregn.& lactat., childr.und.12 yrs, potent. hirsut., contracept. incid. circulat.dis., fam.hist of arter.dis., hypercholesterolaem., fa-
hepatotox.medic. (S4) TABS, V/21.8.2/300 milial hyperlipoproteinaem., diab.mellit., obesity, migraine, benign
Side effects: GI disturbs., non-suscept.organ overgrowth, tooth dis- 825859-018: 28, 1 mnth.cal.pack, R191,23 & malign.liv.tumours observ., consid.liv.tumour in different.diagnos.
col., enamel hypoplas.& retard.bone growth in childr.und.12/foetus, Dosage: 1 tab.at same time dly.from 1st day of menstr. cycle. in pres. of sev.upper abdom.complaints/liv.enlargem./signs of intra
incr.IC-press & bulg. fontanelle in infts., bld.dyscras., vit. defic., allerg. Contraindications: Pregn., lactat., disturb.of liv.funct., cholestat. abdom.haemorrh.
reacts., photosens., poss.neg.N2 bal. in elderly. jaund., Dubin-Johnson syndr., Rotor syndr., prev./exist.liv.tumours, Drug interactions: Reduc.plasma lev.with antibiot., enzyme in-
Special precautions: Imp.liv.funct. thrombo-embol. process., sev.migraine, cerebro-vasc. insuff., sickle- duc.eg.anti-epilept.agents/ griseofulvin /barbitur./phenylbutazone
Drug interactions: Poss.reduc.anticoag.dos., Ca, Mg, Al & iron salts cell anaem., breast/endometr.Ca., undiag. vag.bleed., sev.diabet., & rifampic. imp.act., effic.of anticoags./ antidepress./ anti-diabet./
decr.absorpt., poss.antagon.in act. with concom.penicill. lipometabol. disturb., hist.of herpes/itch./jaund.of pregn., otoscleros. anti-hypertens./ß-blocks. & diurets.reduc., theophyll.& cyclospor.
DALACIN T, Pfizer [P/S] with deteriorat.in prev.pregn. plasma conc.incr., large supplem.Vit.C incr. ethinyloestradiol ser.lev.
Clindamycin phosphate equiv.to clindamycin base Side effects: Coron.& ven.thrombos., CVA’s, hypertens., prolong. DOXYCYCLINE BIOTECH 100 MG, Biotech Laboratories (Pty) Ltd
Indications: Acne vulgaris. amenorrh., N&V, headache, mood chang., chang.in libido, weight See Section 18.4
(S4) SOL, [P/S] P/20.1.6/63. 10 mg/ml. gain, skin pigmentat., poor contact lens toler., gall bladd. dis., vag.
835757-005: 30 ml, R143,36 candidias., GI-irrit., fluid retent., breast tightn.& tendern., benign & DOXYCYL, (Aspen Pharmacare: Pharma) Pharmacare [P/S]
(S4) LOT, [P/S] Y/20.1.6/326. 10 mg/ml. malig.liv.tumours. Doxycycline HCl equiv.to doxycycline
828718-008: 30 ml, R168,25 Special precautions: Rule out clott.syst. disturbs., bear in mind Indications: Acne.
Dosage: Apply thin.to affect.area 2xdly. sex.steroids can promote growth of cert.horm.depend.tiss.& tu- (S4) CAPS. 27/20.1.1/0495.
Contraindications: Lincomycin/clindamycin sens., antibiot.assoc. mours, diabet., hypertens., varicose veins, phlebit.hist., otoscleros., 808407-007: 50 mg, 30, R81,64
colit./ulcerat.colit./Crohn’s dis. multiple scleros., epilep., porphyr., tetany, chorea minor, asthma, Dosage: 1 cap 2xdly with adeq.fluid
References: 1. Krawtchenko N, et al. Br J Dermatol 2007; 157(Suppl.2):34-40. 2. Stockfleth E et al. Arch Dermatol/Vol 140, Dec 2004:1542. 3. Gollnick H, et al. Eur J Dermatol 2005; 15(5):374-381. 4. Edwards L, et al. Arch Dermatol 1998; 134:25-30.
Scheduling status: S4 Proprietary name and dosage form: ALDARA Cream. Composition: Each 2,0 g cream pump contains 5 % Imiquimod (100 mg). ALDARA Cream Sachet. Composition: Each 250 mg cream sachet
contains 5 % Imiquimod (12,5 mg). Preservatives: Methyl hydroxybenzoate 0.2 % m/m, Propyl hydroxybenzoate 0.02 % m/m, Benzyl alcohol 2 % m/m. Pharmacological classification: A 34 Other. Indications: ALDARA
Cream is indicated for the topical treatment of superficial basal cell carcinoma (sBCC), and of external genital/perianal warts (condyloma acuminata) and clinically typical, non hyperkeratotic, nonhypertrophic actinic keratosis
(AKs) on the face or scalp in adult patients. Registration number: 32/34/0541. Name and business address of the holder of the certificate of registration: iNova Pharmaceuticals (Pty) Ltd,. Co. Reg. No. 1952/001640/07,
15e Riley Road, Bedfordview. Tel. No. 011 087 0000. www.inovapharma.co.za. For full prescribing information, refer to the package insert as approved by the SAHPRA (South African Health Products Regulatory Authority).
Further information is available on request from iNova Pharmaceuticals. IN3635/20
Dermatologicals - 14.6 2020-04 / 195
WITH ALDARA YOUR PATIENTS
HAVE EFFECTIVE SUSTAINED
ACTINIC / SUPERFICIAL EXTERNAL
SOLAR BASAL CELL GENITAL CLEARANCE FOR AK, sBCC
KERATOSIS CARCINOMA WARTS AND EGW 1-4
Contraindications: Pregn., lactat., young childr., SLE, concom. ILOTYCIN-A, (Aspen Pharmacare: Pharma) Pharmacare [P/S] incr.in acne at init.of ther., decr.contact lens tol., do not donate bld.
hepatotox.medic., porphyr. Tretinoin. dur. ther.and x1 mnth.aft.cessat., avoid diet. supplem. contain.Vit.A,
Side effects: GI disturbs., bact./fung.overgrowth. incl.enterocolit.& Indications: Acne vulgaris. concom.tetracycl.assoc. with benign IC-hypertens., explicit.explanat.
pseudomembr.colit., uraem., hepatotox., tooth discol.& enamel hy- (S3) CREAM, [P/S] H/13.12/171. 0,05%. of pregn. risk & relev.contracept.meas.to pt., pregn. test.prior & dur.
poplas.in childr., bld.dyscras., vit.defic., allerg.reacts., photosens., 842605-002: 20 g, R126,68 ther., avoid other keratolyt./ exfoliat.agents, avoid UV expos., long
onycholys., nail discolour., rais.IC-press. (S3) GEL, [P/S] H/13.12/172. 0,05%. term therapeut. use not intend.
Special precautions: Liv.funct.impairm., childr. und.12 yrs., my- 842591-001: 20 g, R74,26 Drug interactions: Addit.effs.tox.effs.with vit.A incl.diet.supplem.
asth.sympts.poss.aggrav. Dosage: Wash area with non-irritat.soap then apply 2xdly to af- See also MDR page 462.
Drug interactions: Absorpt.reduc.by di-& trivalent cations eg Al/ fect.areas. ROACCUTANE, Roche [P/S]
bismuth/Ca/Fe/Mg & Zn, sod.bircarab.& colestipol reduc.absorpt., Contraindications: Ac.dermatit.partic.ac. eczema & rosacea.
poss.dos. reduct.of anticoags., nephrotox.effs.exacerbat.by diuret., Li Side effects: Trans.skin redden.& feel.of warmth/ slight sting. Isotretinoin.
Indications: Sev.recalcitr.nodul.acne unrespons. to convent.ther.
& digox.conc.poss.incr., tox.effs.of ergot alkaloids & methotrex.incr., on applic.
poss.antagon.in act. with penicill., effic.of OC’s poss.decr. Special precautions: Discont./reduc.freq.if loc. irrit. warrants, incl.system.antibiot.
(S5) CAPS. R/13.4.2/118, 119.
EPIDUO 0,1%/2,5%, Galderma [P/S] avoid eyes/mouth & mucous membr., other top.meds., peel.agents 761125-020: 10 mg, 30, R272,49
& abrasiv., sun expos.
Adapalene 1 mg, benzoyl peroxide 25 mg/g 761133-004: 20 mg, 30, R495,66
nd
rd
Indications: Acne vulgaris where comedones, papules & pus- MINERVA-35, (Aspen Pharmacare: Pharma) Bayer [P/S] Dosage: Indiv. Start on 2 or 3 day of menstruat. Admin.with food
tules are pres. 21 tabs: Cyproterone acetate 2 mg, ethinylestradiol 0,035 mg & 7 once or twice dly. Init: 0,5 mg/kg dly.with dos.rang.to 1,0 mg/kg/day.
(S3) GEL. 44/13.12/0109 non-hormon.tabs. Sev.dis.& trunc.acne: Up to 2,0 mg/kg/day. Incr. remiss.rates &
720002-001: 30 g, R273,11 Indications: Androgen depend.acne, androgen depend.alopec., prevent relapse admin.cumulat. treatm. dos.120-150 mg/kg. Ther.
Dosage: Treatm.durat.determ.by clinic.condit. Clinic.improvem.ap- hirsut., contracept. durat.in indiv. pts. varies as a funct.of dly dos. Compl.remiss. often
pear 1-4 wks.aft.treatm.init. (S4) TABS, 29/21.8.2/0685 achiev.by 16-24 wks. Reduc.dos.in cases of intol.admin.over a long.
Apply once dly.to affect.area bef.retir.& aft.wash. 897311-004: 28, R146,42 durat. Maj.pts.achiev. compl. clear.of acne with sngl.treatm.course.
Side-effects: Skin irrit./erythema/dryn./scal./ burn.& sting.peak. Dosage: 1 tab.at same time dly.from 1st day of menstr. cycle. Observe interv.of 8 wks.bef.admin.2nd.course.
dur.1 wks., prurit., sunburn, allerg. contact dermatit., fac.swell. Contraindications: Pregn., lactat., disturbs.of liv.funct., choles- Contraindications Lactat., pregn./women intend. to become pregn./
st
Warnings and special precautions: In case of sens.apply non- tat.jaund., Dubin-Johns.syndr., Rotor syndr., prev./exist.liv.tumours, women of childbear.age unless effect.contracept.is used uninter-
comedon.moisturis./less freq./ discont.in case of sev.irrit., safety & thrombo-embol. process., sev.migraine, cerebro-vasc. insuffic., rupt.for 1 mnth.prior to ther., dur.& at least 1 mnth.aft. discont. ther.,
effective.not stud.in childr.und.12 yrs., do not apply to broken skin, sickle-cell anaem., breast/endometr.Ca., undiag. vag.bleed., sev.di- pre-exist.hypervitaminos.A, hepat./ ren. insuff., excess.elev.bld.lipid
avoid contact with eyes/mouth/ nostrils & muc.membr., discont. abet., lipometabol. disturbs., hist.of herpes/otoscleros./itch./jaund. values, concom. Vit.A /tetracycl., other keratolyt./exfoliat.agents,
in case of sens., excess. expos. to sun & UV radiat.to be avoid, of pregn., otoscleros.with deterior.in prev.pregn. concurr.radiat.ther.with UV light, fruct.intol.
bleach.& discolourat.poss.if contact made with col.mater. incl.hair, Side effects: Coron.& ven.thrombos., CVA’s, hypertens., prolong. Side effects: Teratogen., hepatotox., hepatit., depress., psychos., suicid.
other retinoids/benzoyl peroxide & meds. with simil.mode of act.not amenorrh., N&V, headache, mood chang., chang.in libido, weight ideat./attempts & suicide, pseudotumor cerebri, incr.ser.triglyceride &
to be used concur., poss addit.irrit.effs.with concom. desquamat./ir- gain, skin pigmentat., poor contact lens tol., gall bladd. dis., vag. cholest.lev., pancreatit., decr.HDL, elev.bld. gluc., gram+ mucocutan.bact.
rit.& dry.agents, not to be used in pregn.& lactat., tetratogen.shown candidias., GI-irrit., fluid retent., breast tightn.& tendern., benign infects., anaem., incr.RBC sedimentat.rate, thrombocytopen., thrombo-
in anim.with oral admin. & malig.liv.tumours. cytos., neutropen., lymphadenopathy, allerg.skin reacts., anaphylact. re-
acts., hypersens., diab.mellit, hyperuricaem., anx., mood alterat., abnorm.
GINETTE, Cipla Medpro [P/S] Special precautions: Diabet., hypertens., varicose veins, phlebit. behav., psychot.disord., headache, benign intracran.hypertens., convuls.,
hist., otoscleros., multiple scleros., epilep., porphyr., tetany, chorea
21 tabs: ethinyl oestradiol 0,035 mg, cyproterone acetate 2 mg/ minor, asthma, depress., fluid retent., risk of thrombos., excl.andro- drowsin., blepharit., conjunctivit., dry eye, eye irrit., blurr.vis., cataract, col.
tablet & 7 placebo tabs. gen-produc.tumour/adren.enzyme defect if hirsutism is recent/in- blindn., contact lens intol., corn.opacity, decr.night vis., keratit., papilloed.,
Indications: Contracept.in anti-androg.ther., as adj.to ethinyl oestra- tensif., bear in mind sex. steroids can promote growth of cert.horm. photophob., imp.hear., vasculit., epitax., nas.dryn., nasopharyngit., bron-
diol in idiopath.hirsutism, sev. acne esp.androgen-depend. depend. tiss. & tumours, hypercholesterolaem., famil. hyperlipoprot., chosp., hoarsen., colit., dry throat, GI haemorrh.& haemorrhag.diarrh.,
(S4) TABS, 33/21.8.2/0185 oligomenorrh., amenorrh., surg./ immobilisat., very rare indiv.me- inflam. bowel dis., naus., chelit., dermatit., dry skin, loc. exfoliat., prurit.,
897214-005: 28, 1 mnth.cal.pack, R135,58 tabol.disturbs.may decr.effic., adeq.alt.contracept.in the event of erythemat., skin fragility, alopec., acne fulminans, acne aggravat., fac.
Dosage: 1 tab.at same time dly.from 1st day of menstr. cycle. miss. tab./vomit./diarrh./concom.antibiot.ther. erythema, exanthema, hair disords., hirsut., nail dystrophy, paronych.,
Contraindications: Pregn., recent evacuat.of hydatidiform mole until Drug interactions: Anti-epilep.agents/antibiot./ barbit./rifam- photosens.reacts., pyogen.granuloma, skin hyperpigmentat., incr.sweat.,
urine & plasma gonadotrop. norm., lactat., known/suspect.breast Ca, picin decr.effic., insulin & other hypoglyaem. requirem.may change. arthralg., myalg., back pain (partic. adolesc.), arthrit., ligament/ tendon
liv.dis., wast./malign.dis., thrombo-embol. disords./ hist., sev. chron. calcificat., epiphys., premat.fus., exostos.(hyperostos.), reduc.bone den-
depress., sickle-cell anaem., oestrog.depend.neoplasma, funct.ovar. ORATANE, Litha [P/S] & sity, tendonit., glomerulonephrit., incr. granulat.tiss. format., erythema
cyst, Dubin-Johnson or Rotor syndr., lipometabol. disords., sev.liv. Isotretinoin. multiforme, Stev.-John.syndr., tox.epiderm.necrolys.
funct.impairm., cerebrovasc. insuff., coron.arter.dis., deteriorat.oto- Indications: Sev.recalcitr.nodul.acne & sev. inflammat. acne and Special precautions: Incr.spontan.abort.risk, no pregn.until 1 mnth.
scleros., prurit. hist.dur.prev.pregn., undiag.vag.bleed., herpes, recurr. acne conglobata resist.to convent. therapy incl.syst.antibiot. discont.of Roaccutane, poss. contracept.fail., consid.indiv.effic.of con-
cholestat.jaund., porphyr., migraine, use in men & childr. (S5) CAPS. 35/13.4.2/0375, 0376, 42/13.4.2/0460 tracept. methods esp.dur.first cycle of horm.contracept., use two reliab.
Side effects: Breast chang., menstr.flow & libido chang., depress. 701469-001: 10 mg, 60, R301,72 forms of contracept.simultan., negat. pregn.test 11 days prior to ther.,
moods, GI disturbs., dizzin., headache, skin reacts., vag.candidi- 701471-001: 20 mg, 60, R609,03 mnthly. pregn.test recomm.dur.ther., pt.to confirm contracept. meas.
as., mass gain, periph. oed., hair pattern alterat., bld.dyscras., gall 722786-001: 40 mg, 30, R609,03 underst./willingn.to comply, only to be used by spec.physic., est.liv.
bladd.obstruct., hepatit., coron.& ven.thrombos., CVA’s, hypertens., Dosage: Indiv.depend.on pts.weight & severity. Admin. with meals. funct.bef.& 1 mnth. aft.start of treatm.subseq.at 3 mnth.interv., dis-
carbohydr.& lipid metabol. chang., benign & malig.liv.tumours, liv. Low dos.once dly.& high. dos. as sngl.or div.dos. Init: 0,5 mg/kg dly. cont.if hepatit.susp., monit.for signs of depress & init.appropr.treatm.
funct. impairm., incr.cerv.Ca risk, poor contact lens tol., vis. dete- x2-4 wks until.respons.est. Maint: Contin.at 0,5 mg/kg dly.if respons. if reqd., discont.ther.& screen pts with sympts.of pseudotum.cerebri
riorat.in myopic pts. good reduc.to 0,1 -0,2 mg/kg with intol. dur.init.ther. Incr.to 1,0 mg/ for papilloed.& ref.to neurolog.for furth.diagn.& care, monit.pts.with
Special precautions: Excl.pregn.bef.init. ther., diab.mellit., tetany, kg/day where init. respons.inadeq.& in partic.sev.cases if well toler. dry eye syndr., refer pts.with vis. diffic.for ophthalm.exam., advise pts.
of poss.decr. night vis., monit.vis.prob.caref., est.lipid profile prior to
Admin.maint.ther. x12 wks.for 1 stage of ther. Observ.8-20 wk. in-
st
hypertens., epilep., chorea, multip.scleros., ren.dysfunct., asthma, terv. bef.admin.2nd.course.if necess.
depress., varicose veins, card.dysfunct., gallbladd.dis., cont. lens., Contraindications: Pregn.& lactat., acitretin/ tretinoin & vit.A de- ther.& mnthly.thereaft.dur.treatm., discont. ther.in case of uncontr.hy-
pertriglyceridaem./ pancreatit. sympt., freq.monit.recomm.in diabet./
obesity, condits.influenc.by fluid retent., consid. benef.-risk in en- rivat.hypersens., hepat./ren. impairm., hypervitaminos. A, hyperlipi- obesity/ alcohol./lipid metabol.disords., skelet. hyperostos.observ.by
dometrios.& uter.fibroids, discont.in case of onset of migraine/sev. daem., concom. vit.A/other retinoids & tetracycl., women of childbear. X-rays, consid.benef.-risk ratio in case of bone chang.incl.report.pre-
headache, sudd./grad.hear.or vis.loss, first sign of thrombo-embol. potent.unless uninterrupt.effect. contracept.practis.x1 mnth.prior to mat. epiphys.clos.when treatm.exceed.3 mnths., discont.in case of
disords., surg./prolong.bedrest, persist.upper abdom.pain/hepatit./ ther./dur.& at least one mnth.aft.discont. GI S&S incl.sev.haemorrh. diarrh., interv.at 8 wks.bef.repeat.treatm.,
jaund., monit. BP, in hirsut.excl.androg.-produc.tumours & adren. Side effects: Teratogen., jaund., hepatit., pancreatit., depress., psy- rep. course only for definite relapse., avoid sun, adjuv. ther.with mild
enzyme eff.1 , oligomenorrh., amenorrh., hypercholesterolaem., chot.sympts., suicid. behav., benign.IC hypertens., corneal cloud.& topic.meds.admin.as reqd., do not share meds. (partic.females), return
st
hyperlipoproteinaem., addit. non-horm.contracept. dur.antibiot.ther. night vis. impairm., skelet.hyperostosis, hypervitaminos. A, skin unused meds. to pharm.at end of treatm., do not donate bld.x1 mnth.
Drug interactions: Griseofulvin/rifampicin/cert. antibiot.& anti-ep- reacts., nail dystrophy, incr.granulat.tiss. format., persist.hair thinn., aft.stopp., poss.trans.incr.in acne at init.of ther., avoid aggress.derma-
ilep.decr OC effectiven., effic.of some anticoags./antidepress./anti- revers.alopec., hirsut., acne fulmin., hyperpigmentat., photosens., bras.& cutan.las. treatm./ wax depilat.x5-6 mnths.aft.treatm., poss.
diab.agents/ anti-hypertens./ß-blocks.& diurets.reduc., theophyll. & sev.skin reacts.incl.erythema multiforme/Stev.-John.syndr. & tox. decr. contact lens tol., reduc.tol.to vigour.phys. activ., contains sorbit.
cyclospor.plasma conc.incr. epiderm.necrolys., dry eyes, keratit., conjunctivit., bld.dyscras., incr. Drug interactions: Vit.A incr.S/E., tetracycl.incr. intracran. hypertens.
ser.triglycer./ cholester. lev., decr.HDL, naus., headache, haemat./
ILOTYCIN TS, (Aspen Pharmacare: Pharma) Pharmacare [P/S] proteinur., imp.hear., loc./system. infects., musc.& joint pain, in- SKINOREN ACNE CREAM, (Adcock Ingram) Bayer [P/S] &
Erythromycin base. flammat.bowel dis., hyperuricaem., lymphadenopathy, bronchosp. Azelaic acid.
Indications: Acne vulgaris gr.II & III. most. with asthma hist. Indications: Mild to mod.acne vulgar.
(S4) SOL. M/20.1.6/80. 20 mg/ml. Warnings and special precautions: Est.liv. funct. prior to ther./ (S1) ACNE CREAM. W/13.12/228. 200 mg/g.
828874-018: 50 ml, R191,59 aft.1 mnth treatm.& as appropr. dur.treatm., est. lipid profile prior to 794171-001: 30 g, R217,46
Dosage: Apply 2xdly.aft.wash. ther. & thereaft.mnthly dur.treatm., incr.risk of lipometabol. disords., Dosage: Apply to cleans.affect.area 2xdly. Contin. applic.over cou-
Side effects: Prim.irrit./allerg.contact dermatit. pancreatit.risk with high serum triglycer., observ. for depress.discont.& ple of mnths for best results with clin.exper.for applicat.of up to 1 yr.
Special precautions: Antibiot.resist.organ. overgrowth, safety init. appropr.treatm.if occurs, discont.in pres.of vis. changes/ sympts. Reduc amnt & freq.if skin irrit occurs.
in pregn.not est. of inflammat.bowel dis/region. ileitis, diabet./fam.hist.thereof., trans. Contraindications: Safety in pregn.& lactat.not est.
References: 1. Krawtchenko N, et al. Br J Dermatol 2007; 157(Suppl.2):34-40. 2. Stockfleth E et al. Arch Dermatol/Vol 140, Dec 2004:1542. 3. Gollnick H, et al. Eur J Dermatol 2005; 15(5):374-381. 4. Edwards L, et al. Arch Dermatol 1998; 134:25-30.
Scheduling status: S4 Proprietary name and dosage form: ALDARA Cream. Composition: Each 2,0 g cream pump contains 5 % Imiquimod (100 mg). ALDARA Cream Sachet. Composition: Each 250 mg cream sachet
contains 5 % Imiquimod (12,5 mg). Preservatives: Methyl hydroxybenzoate 0.2 % m/m, Propyl hydroxybenzoate 0.02 % m/m, Benzyl alcohol 2 % m/m. Pharmacological classification: A 34 Other. Indications: ALDARA
Cream is indicated for the topical treatment of superficial basal cell carcinoma (sBCC), and of external genital/perianal warts (condyloma acuminata) and clinically typical, non hyperkeratotic, nonhypertrophic actinic keratosis
(AKs) on the face or scalp in adult patients. Registration number: 32/34/0541. Name and business address of the holder of the certificate of registration: iNova Pharmaceuticals (Pty) Ltd,. Co. Reg. No. 1952/001640/07,
15e Riley Road, Bedfordview. Tel. No. 011 087 0000. www.inovapharma.co.za. For full prescribing information, refer to the package insert as approved by the SAHPRA (South African Health Products Regulatory Authority).
Further information is available on request from iNova Pharmaceuticals. IN3635/20
196 / 2020-04 Dermatologicals - 14.6 / 14.7 / 14.8 / 14.9
WITH ALDARA YOUR PATIENTS
HAVE EFFECTIVE SUSTAINED
ACTINIC / SUPERFICIAL EXTERNAL
SOLAR BASAL CELL GENITAL CLEARANCE FOR AK, sBCC
KERATOSIS CARCINOMA WARTS AND EGW 1-4
Side effects: Applicat.site burn./-prurit & site erythema, seborrh., ADCO-BIOHIST, AI Pharm Ltd [P/S] EFUDIX, MEDA Pharma [P/S]
acne, depigmentat., cheilit., applicat.site exfoliat./-pain/-dryness/- Diphenhydramine HCl 10 mg, Zn oxide 50 mg, calamine 150 mg, 5-Fluorouracil
discolourat./ -irrit./-paraesthes./-dermatit./-discomf./-oed./-vesicles/- phenol 4 mg/ml. Indications: Solar & senile keratos., Bowen’s dis., singl./multip.
eczema/-warmth/-ulc., hypersens., Indications: Eczema, infect.skin sores, itch., insect bites, sun- superfic.basal cell Ca, pre-malign. condits.
Special precautions: Avoid eyes.& mucous membr., safety & effic. burn, psorias. (S4) OINT. D/13.8/122. 50 mg/g
in childr.below 12 yrs.not est., worsen.of asthma report. (S2) LOT. G2011. 722367-015: 20 g, R854,83
794120-008: 100 ml, R9,74 Dosage: Sen.& solar keratos: Apply to affect. areas 1-2x dly.
SKINOREN GEL, (Adcock Ingram) Bayer [P/S] & Dosage: Apply to affect.areas 3xdly.
Azelaic acid. Contra-indications: Ac.vesicul.& exudat.skin dis. gen.without dress.
Indications: Mild to mod.acne vulgar.& papulopustular rosacea. Side-effects: Allerg.reacts., light sens. Other condits: Apply occlus.dress.dly. Durat. usual. 3-4 wks. May
(S1) GEL, 36/13.12/0028. 150 mg/g be exceed.if necess.
703471-003: 30 g, R217,46 ALDARA, iNova [P/S] & Contraindications: Pregn./susp.pregn.
Dosage: Apply approx. 0,5 g(2,5 cm) 2xdly to affect.area aft. Imiquimod Side effects: Surround.skin redden.
cleans. In case of irrit.reduc.amnt of gel/freq. Improvem.gen.ap- Indications: Topic.treatm.of superfic.basal cell Ca, extern.genit./ Special precautions: Use und.strict med. supervis., max.skin area
2
parent within 4 wks. perianal.warts (Condyloma acuminata), non hyperkeratotic, nonhy- for treatm.not to exceed 500 cm , treat large areas in sect., avoid mu-
Side effects: Contact.dermatit., applic.site prurit./ burn./pain/dryn./ pertrophic actin.keratos.(AKs) of face or scalp in adults. cous membr & eyes, must wash hands aft.use.
rash/paraesthes./erythema./ exfoliat./ warmth/discolourat., photos- (S4) CREAM, 32/34/0541. 12,5 mg/sachet ELIDEL, MEDA Pharma [P/S]
ens.reacts., skin rash, fac.oed. 851884-008: 12 sngl.use sachets, R1 096,35 Pimecrolimus
Special precautions: Safety in pregn.& lactat. not est., avoid eyes 722706-001: 1 pump (4 actuat.=1 sach), R730,91
& muc.membr.., avoid alcohol. cleans./tinct.& astring./abras.& peel. Dosage: Wash & dry area bef.applicat. Apply prior to sleep.& allow Indications: Mild to mod.atopic dematit.in childr. 2-11 yrs/ado-
lesc.12-17 yrs.& adults for short term treatm.of signs and sympts.&
agents.in papulopustul.rosacea, safety & effic.in childr.und. 12 yrs. skin contact x8-(6-10) hrs. Apply thin layer & rub onto affect.area. Oc-
for acne & und.18 yrs.for papulopustul. rosacea not est., worsen.of clus. dressing not recomm. Wash off aft.rest period. intermitt. ther.for prev.of progress of flares where alternat.convent.
asthma report.post. market. Superfic.basal cell Ca: Apply once dlyx5 consecut. days/wk.x6 ther.deem.inadvis./ respons. inadeq./intol.
See also MDR page 254. wks. Clinic.outcome determ. aft.treat.skin regenerates approx.6-12 (S4) CREAM, 36/34/0522. 10 mg/g
wks. aft. treatm.ends. 702081-002: 30 g, R393,96
TETRALYSAL, Galderma Laboratories SA (Pty) Ltd Extern.genit./Perianal warts: Apply once dly 3x/wk.(every oth- 702081-003: 60 g, R787,91
See Section 18.4 er day follow.by a 2 day treatm. free interv) prior to norm.sleep. Dosage: Adults and childr.2 yrs & over: Apply thin layer to affect.
TRIPHASIL, (Aspen Pharmacare: Pharma) Pharmacare [P/S] hrs. Keep on skin for 8-(6-10) hrs. Cont. treatm. till clear of warts area 2xdly. May be applied to all skin areas incl.head,/face,/neck &
or for max.16 wks.
intertriginous areas. Apply on appear.of 1 S&S & resume on 1 recurr.
st
st
6 brown tabs: ethinyl oestradiol 30 µg, levonorgestrel 50 µg. 5 white
tabs: ethinyl oestradiol 40 µg, levonorgestrel 75 µg. 10 yellow tabs: Actinic Keratosis: Apply 3x/wk.prior to normal sleep. hrs.leave of S&S if discont to prev. dis. flares. Due to low system.absorpt.tot.
in position x8 hrs,contin.x4 wks. If any AK’s persist.repeat treatm.
ethinyl oestradiol 30 µg, levonorgestrel 125 µg. 7 red placebo tabs. dly.dos. / surf.area treat/durat.of treatm.is not restrict. Emol.may be
Indications: Fertil.contr.in women, dysfunct. uterine bleed.& prim. for addit.4 wks. Max. total treatm.durat.8 wks. Assess treatm.aft applied immed.aft.use, however aft. bath/show.apply emol.bef.Elidel
4 wk. treatm.free period. Sub-clinic.les.may appear in treatm.area.
dysmenorrh.where contracept. desir., may benefit women on contra- Side effects: V.common: Itch., burn.sensat., pain at wart treatm. Contraindications: Childr.und.2 yrs., safety & effic. in pregn./
cept.with coincident.acne. site, erythema, eros., excoriat./ flak., oed., scabb., crust., myalg., ar- lactat.& elderly not est., potent. malign./ pre-malign.skin les., act.
(S3) TABS. N/18.8/40. thralg., infect., pustules, naus., prurit./pain/burn./irritat./ erythema/ cutan.vir. infects.
825832-004: 28, R68,48 Side effects: Infect.relat.lymphadenopathy, wart developm., skin/
Dosage: 1 tab at same time dly, commenc.1st day menstr.cycle. bleed./& pustules at applic.site. Common: Anorex. Uncommon: subcutan.tiss.reacts., headache, nasopharyngit., influenza, pharyngit.,
Migraine, headache, fatig., influenza-like sympts., dermatit./ scar/
Contraindications, Side effects, Special precautions, Drug ulc./warmth & hyperaesthes.at applic.site, asthen., malaise. V.rare: vir. infect., pyrex., cough, herpeticum eczema, alcoh .intol., allerg.re-
interactions: See sect.head note for oral contraceptives in Pharm. ulcerat., indurat., vesicles, acts.incl.rare anaphylax., resp. tract. infects., skin infects., otit.media,
Class.in 17.1.1. Warnings and special precautions: Safety & effic. in pts.und.18 rhinorrh., rhinit., wheez., GI disturbs., urticar., hypersens., applic.site
ZINERYT, (Adcock Ingram) Astellas [P/S] yrs.of age not est., auto-immune condits.exacerbat., organ transplant reacts.incl.impetigo herpes
Special precautions: Long-term safety not est., rare cases of
Erythromycin 40 mg, zinc acet.12 mg/ml pts., consid. interrupt.dos.if intens.loc.inflamm.reacts. occur, assoc. malign.report., treat.loc.clinic. infects. 1 incr varicella zoster/H
st
Indications: Mod.to sev.acne vulgaris betw.complete clear.rate & loc.skin reacts. intens. which may be relat. simplex vir. infect. risk theref.eval.risk vs.benef.in pres.of such
(S4) TOP.LOT, 34/13.12/0474 to stimulat.of loc. immune respons., effic.decr.if too many dos. miss. infects., investig.aetiology of lymphadenopathy which may have
897783-007: 30 ml, R182,32 in AK treatm., skin noticeably diff.dur.AK ther. & until heal., protect develop.& ensure it resolves, discont.in pres.of ac.infect. mono
st
Dosage: Reconstit.accord.to direct. treat.skin from solar expos., allow time for skin to recov.1 from any nucleos./unclear aetiology of lymphadenopathy, not recomm.in
Apply to skin of entire face 2xdly.x10-12 wks. prev. med./surg.treatm., treat any infect that develops, wash skin immunocompromis. pts., time to skin tumour format. in anim.
Contraindications: Pregn. bef.sex.activ., condoms & vag. diaphragms.poss.weaken., inflam- photo-carcinogenic.study shortened theref.minim.or avoid nat./
Side effects: Erythema, skin.burn.sensat., dry skin, prurit., skin ir- mat.skin condits. poss.exacerbat., treatm.of ureth./intra-vag./ cervic./ artific. sunlight expos., concom.CYP3A inhibit., if S&S persist be-
ritat./exfoliation, antibiot.cross-resist.organ.overgrowth, hypersens rectal or intra-anal warts, not eval. for superfic.basal cell Ca within 1 yond 6 wks.re-exam.pt.to confirm diagnos., applicat.to vaccinat.
Special precautions: In human exper.oral erythromyc.poss.causes cm of eyelids/ nose/ lips, no exper.in immunocomprom.pts., hypo-/
congenit.malformat., avoid eyes, nose & other muc.membr., concom. hyperpigmentat.report., not recomm.in pregn.& lactat., Also pump: sites not recomm., do not mix.with other top.meds., incr.S/E incid.
report. when topic.corticoster.used sequent., Netherton’s syndr.due
top.acne ther., poss.mutual cross allerg.betw.macrolides. Discard pump 4 wks.aft.open.
Interactions: Caut.with concom. immunosuppress. ther. to incr.system.absorpt. potent.
See also MDR page 389. HISTODOR, (Aspen Pharmacare: Pharma) Pharmacare [P/S]
14.7 Melanin inhibitors and ALLERGEX MEPYRAMINE CREAM, AI Pharm [P/S] Mepyram.mal.50 mg, diphenhydram.HCl 50 mg/5 g.
Mepyramine maleate.
Indications: Allerg.& prurit.skin condit., insect bites & stings.
stimulants Indications: Allerg.& prurit.skin condits. (S2) CREAM. G1756.
731269-004: 20 g, R15,08
(S2) CREAM. G1540. 2 g/100 g.
No products listed 800511-018: 25 g, R12,62 Dosage: Apply to affect.area 2-3xdly.
Dosage: Apply to affect. area 3-4xdly. Contra indications: Eczema.
14.8 Emolients and protectives Contraindications: Ac.vesicul.& exudat. dermat. Side effects: Skin sensitisat., dermatit., system.S/E aft.applicat.
Side effects: Skin sensitisat.with eczemat. erupt., poss.system.
to large skin areas.
eff.if large areas treat.
E45 CREAM, Reckitt Benckiser [P/S] CALASTHETIC, AI Pharm Ltd [P/S] INTRASITE APPLIPAK, Smith Nephew Pharm [P/S] &
Na Carboxymethyl cellulose.
White soft paraff. 14,5 g, light liq.paraff. 12,6 g, anhydr.lanolin Calamine 1,22 g, benzocaine 279,4 mg, phenol 25,3 mg, pheniramine
(woolfat) 1 g/100 g. mal. 10,2 mg/10 g. Indications: Dress.for cavity wounds, extravasat. injur., ven.&
Indications: Moisturise & relieves dry skin cond. for 48 hrs. Indications: Sunburn, prurit., itch.skin condits. decubit.ulc.
(S0) CREAM. G1686. (S2) CREAM. G1796. (S0) GEL, 30/14.2/0117.
725412-003: 50 g, R35,85 711624-003: 35 g, R41,18 894664-018: 0,345 g/unit, 10 x 15 g units, R1 041,66
725415-046: 125°g, R61,24 Dosage: Apply 3-4xdly as reqd. 835323-021: 0,575 g/unit, 10 x 25 g units, R1 302,03
725412-038: 500 g, R141,45 Contraindications: Ac.vesicul.& exudat. dermatos., infts. Dosage: Prepare wound & using asept.techniq. introd. gel into
Dosage: Apply as reqd. Side effects: Allerg.reacts./skin sensitisat.with rep. applic., syst.effs. wound, smooth over wound surface to minimum depth of 5 mm.
Also avail in: Lotion Special precautions: Do not appl.near eyes/ large skin areas. Cover with second. dress. Change dress.when necess., gel should
not be left in wound for longer than 3 days.
DUOFILM, GSK [P/S] Contraindications: Extern.use only, expos. musc. tendon/ bone,
14.9 Others Salicylic acid 16,7 g, lactic acid 15,03 g/100 g. deep part.& full thickn.burns.
Indications: Plantar & mosaic warts.
Side effects: Trans.discomf/irrit.
(See also 4.3) LIQ, S/13.8/82. Special precautions: Treat wounds with signs of clinic. in-
828750-009: 15 ml, R64,05.
fect.appropr.bef.use, seek medic.advice bef. using on wound
ALDARA (MDR Listing) Dosage: Apply 1-2 x dly.until cleared. at high risk of infect., ulc. caus. by arter.insuffic.should be in-
INTRASITE (MDR Listing) Contraindications: Applic.to normal skin, face, ano-genit region. spect.reg.by dr.
IRUXOL (MDR Listing) Side effects: Skin irrit., dermatit. See also MDR page 688.
References: 1. Krawtchenko N, et al. Br J Dermatol 2007; 157(Suppl.2):34-40. 2. Stockfleth E et al. Arch Dermatol/Vol 140, Dec 2004:1542. 3. Gollnick H, et al. Eur J Dermatol 2005; 15(5):374-381. 4. Edwards L, et al. Arch Dermatol 1998; 134:25-30.
Scheduling status: S4 Proprietary name and dosage form: ALDARA Cream. Composition: Each 2,0 g cream pump contains 5 % Imiquimod (100 mg). ALDARA Cream Sachet. Composition: Each 250 mg cream sachet
contains 5 % Imiquimod (12,5 mg). Preservatives: Methyl hydroxybenzoate 0.2 % m/m, Propyl hydroxybenzoate 0.02 % m/m, Benzyl alcohol 2 % m/m. Pharmacological classification: A 34 Other. Indications: ALDARA
Cream is indicated for the topical treatment of superficial basal cell carcinoma (sBCC), and of external genital/perianal warts (condyloma acuminata) and clinically typical, non hyperkeratotic, nonhypertrophic actinic keratosis
(AKs) on the face or scalp in adult patients. Registration number: 32/34/0541. Name and business address of the holder of the certificate of registration: iNova Pharmaceuticals (Pty) Ltd,. Co. Reg. No. 1952/001640/07,
15e Riley Road, Bedfordview. Tel. No. 011 087 0000. www.inovapharma.co.za. For full prescribing information, refer to the package insert as approved by the SAHPRA (South African Health Products Regulatory Authority).
Further information is available on request from iNova Pharmaceuticals. IN3635/20
Dermatologicals / Ophthalmics - 14.9 / 15 / 15.1 2020-04 / 197
IRUXOL MONO, Smith & Nephew [P/S] & Childr.>2 yrs.: 0,03 %: 2xdly.for up to 3 wks.then reduc.to 1xdly
Collagenase clostridiopeptidase A 1,20 u, proteases 0,24 u/g. until clear.of les. 15 OPHTHALMICS
Indications: Wound cleans.in various types of ulcerat. incl.decubit. Adults & childr.> 16 yrs.: 0,03 % & 0,1 %: Start with 0,03 % 2xdly.
ulc.& poor.heal.necrot.wounds contin.until clear.of les., if sympts. not resolv.start treatm.with 0,1 %
(S1) OINT. G1633. 2xdly. Attempt to reduc.freq./use of low.strength if poss. 15.1 Anti-infectives
734012-012: 10 g, R122,37 Contraindications: Immunocompromis.adults & childr., mac-
734012-004: 30 g, R367,20 VIGAMOX (MDR Listing)
Dosage: Apply 1xdly. rolide hypersens.
Contraindications: Other topic.preps. Side effects: Skin irrit./-burn./-prurit./-erythema/ -warm.sensat./- BROLENE, (Adcock Ingram) Genop [P/S]
Side effects: Burn.sensat., loc.irrit. pain/-rash & -paraesthes., herpes vir.infects., Kaposi’s variceliform Propamidine isethionate.
See also MDR page 690. erupt., folliculit., acne, paraesthes.& dyaesthes., alcoh.intol. Indications: Eye & eyelid infects., eye infect. prophylax.aft.mi-
nor eye injur.
METVIX, Galderma [P/S] Warning and special precautions: Malign.incl. cutan.& other (S0) EYE DROPS, [P/S] H1212. 1 mg/ml.
types of lymphoma & skin cancers have been report.with the use
Methyl aminolevulinate. 710466-005: 10 ml, R55,86
Indications: Thin or non-hyperkeratotic and non-pigment.ac- of Protopic, minimise sun/UV expos., safety & effic.not demonst. Dosage: 1-2 drps. 4x/day for max.1 wk.
tinic keratos.on face and scalp when other ther.consid.less ap- for >12 mnths., not recomm.in genet. epiderm. barrier defects due Special precautions: Discont.in cases of sensitis., adverse effs.on
propriat., superfic.&/ nodul. basal cell Ca unsuit.for other avail. to incr.syst.absorpt. potent, extens.skin involvem.over extend per.of corn.permeability & disrupt.of corn.epithelium poss.reg.ophthalm. ex-
ther.due to poss.treatm.relat.morbid.& poor cosmet. outcome, time esp.childr., do not apply to potent./pre-malign. areas, investig.& aminat.with prolong.use, extens.ocul.surf.dis.
squamous cell carcinoma in situ (Bowen’s dis.) when surg.excis. observ.any lymphadenopathy prior to init.ther., concom. system. ad-
consid.less appropriate. min.known CYP3A4 inhibit.in widespr. &/erythroderm.dis., admin. CHLORAMEX OPHTHALMIC OINTMENT, (Aspen Pharma-
(S4) CREAM, A38/26/0528. 160 mg/g. vaccinat.prior to commencem./ dur.treatm free interv.with 14 days or care: Pharma) Pharmacare [P/S]
705611-001: 2 g, R3 753,35 28 days for live attentuat.vaccinat.betw.last applic., consid.alternat. Chloramphenicol.
Dosage: Two sess.1 wk.apart. Prepare affect.area to remove scales vaccinat., reproduct.toxicity follow.system.admin., pregn.& lactat., Indications: Superfic.eye & eyelid infects.
and crusts and roughen les.surf. Apply 1 mm thick layer with spatula childr.und.2 yrs., do not apply emollients to same area within 2 hrs., (S4) OINT. H1193. 10 mg/g.
to les.& surround. 5-10 mm norm.skin. Cover with occlus. dress.& other concom.topic.meds/system.ster./ immunosuppress. agents & in 713724-005: 3,5 g, R13,58
leave x3 hrs. Remove dress., clean area with saline & immed.ex- Dosage: Apply small amnt.4xdly.
pos.les.to red light with contin. spect.of 570-670 nm and tot.light clinic.infect.atop. dermatit.not assess., treat clinic.infects.bef. admin., Contraindications: Prev./fam.bld.dyscras.hist. incl. aplast.anaem.
2
dos.of 75 J/cm at les.surf. Red light with narr.spectrum giv.same do not admin.in presc.of herpes & viral infects., loc.immunosuppress. Side effects: Less.freq: Bone marr.depress., aplast. anaem., bld.
activat.of accumulat.porphyr.may be used. Light intens.at les.surf. potent unknown for treatm. beyond 1 yr., hepat.fail. dyscras., anaphylax., angioed., trans.burn.& sting., urticar., vesic.&
should not exceed 200 mW/ cm . Use only CE mark.lamps equipp. maculopap. dermatit., fev.
2
with necess.filters &/reflect.mirrors. Admin.correct light dos. Light RETACNYL, Galderma [P/S] Warnings and special precautions: Ophthal. use only, supplem.topic.
dos.determin.by var.fact.& lamp should be used accord.to manual. Tretinoin. ther.with appropr. syst. treatm. in case of sev.infects., sensitisat.& emerg.
Monit.light dos. deliv.if poss. Multiple les.may be treat.dur.same Indications: As adjunct.treatm.of photodamag. skin due to sun ex- of resist.organ.with prolong.use, medic.advice if no improvem. aft.2 days/
session. Assess respons.aft.3 mnths. Confirm BCC & Bowen’s dis pos.in pts.unrespons.to skin care programs & sun avoid. if sympts.worsen/eye injury/ other concom.eye drops or oint./rec.conjunc-
les.respons.by histologic.biopsy. Les.that show non-complete re- (S3) CREAM, 29/13.5/0353. 0,5 mg/g. tivit./ glauc./ dry eye syndr./eye surg/laser treatm.in last 6 mnths., do not
sponse may be re-treat.if desir. Close clinic.monit.of Bowen’s dis. 874752-019: 30 g, R359,08 wear contact lense dur.ther/24 hrs. thereaft., eval.eff.on ability to drive/
with histology.if necess.recomm. Dosage: Apply once dly.to affect.areas bef.retir. & aft.wash. Allow use mach./ tasks req.conc., safety in pregn.& lactat.not est.
Contra-indications: Morpheaform bas.cell Ca, porphyr., not area to dry for at least 20-30 mins. bef.applic. Maint: Apply 1-3 x Interactions: Concom.meds.liable to depress bone marr.funct., poss.
recomm.dur.pregn., hyperkeratot. actin. keratos., no exper.in wkly.once max. benef.achiev. interfers with meds. metabol. by hepat.microsom.enzymes, effs.of cou-
pts.und.18 yrs., no exper.with pigment./high.infiltrat.les./les Contra-indications: Safety in pregn.& lactat. not est. mar. anticoags./warfar/some hypoglycaem eg chlorpropamide & tolbu-
locat.on genital./Bowen’s les.>40 mm/Bowen’s dis in trans- Side-effects: Loc.reacts.incl.slight erythem., hypo/ hyperpigmentat., tamide.& antiepilept.eg phenytoin enhanc., metabol.incr.by hepat.en-
plant pts.on immunosuppress.ther.& arsenic expos.hist.there- highten.UVB suscept., sev.irrit.of eczemat.skin. zym. induc., poss.decr.effs.of Fe & Vit.B12 in anaem. pts., OC’s act.imp.
fore not recomm., Special precautions: Safety & effic.for use long. than 12 mnths.
Side-effects: Painf.skin sensat., loc.phototox.of erythema & oed., CHLORNICOL EYE OINTMENT, (Ascendis Pharma) Aquila [P/S]
burn/sting./prick.& tingl.skin, itch., crust., ulcerat., blisters, suppurat., not est., effic.in pts.old.than 50 yrs.or on mod.to heavily pigment.skin Chloramphenicol
infect., peel., applicat.site reacts., bleed.skin, hypo-/hyper pigmentat., not est., discont./reduc.freq.if loc.irrit. warrants, eczema, weather Indications: Eye infects.
rash, urticar., eczema, headache, naus., eye pain & irrit., fatig., dizzin., extrem., avoid/minim. sunlight expos., pt.educat.advis., avoid eye (S4) OINT. H1207. 10 mg/g.
scar, skin sensitisat., allerg.reacts.poss.delay. cont., eyelids, nose angles, mouth & mucous membr., teratogen.in 713872-004: 3,5 g, R205,81
Special precautions: Admin.only by photodynam. ther.train.health experim.animals, concom. topic.meds., peel. agents & abrasiv.esp. Dosage: Instill into infect.eye 2 or 3xdly
care prof., exper.of long term effic.limit., in absenc.of clinic.exper. dis- those contain.alcoh. Contraindications: Min.infects./bact.infects. prophylax., dur.act.im-
cont. breast feed.x48 hrs.aft.applicat., pt.& operat.to observ.specif. munisat., concom.other meds. poss.depress.bone marrow., pregn.&
safety precaut., discont.any UV ther.1 , avoid sun expos.for couple ROZEX, Galderma [P/S] lactat., newborns unless life-sav./no alt.treatm.
st
of days, avoid eye contact. Metronidazole. Side effects: Poss.ser.& somet.fatal adverse eff., bld. dyscras., bone
Indications: Inflamm.papules, pustul., & erythema of rosacea. marrow depress., sev.irrevers. aplast.anaem., haemolyt.anaem.poss.
OILATUM PLUS, GSK [P/S] (S3) GEL. 29/13.4.2/0771. 7,5 mg/g. in gluc.-6-phosph. defic.dehydrogen.activ., periph./opt. neurit., opt.at-
Benzalkonium Cl 6 g, triclosan 2 g, light liq.paraffin 52,5 g/100 g. 820210-005: 30 g, R239,69 rophy & blindn., sens./Jarisch-Herxheim.-like reacts.
Indications: Temp.relief of eczam.sympts.& reduc. risk of infect. Dosage: Adults: Apply & rub a thin film 2xdly to affect.area. Special precautions: Grey syndr.risk, avoid repeat. course &
LIQ, 31/13.9/0181. prolong.ther., chloramphen. absorpt., discont.ther.in case of tox.
838675-018: 150 ml, R82,57 Contra-indications: Pregn.& lactat., childr.not recomm. sympt., bone marrow aplas./hypoplas.poss.wks./mnths.aft. ther.,
Dosage: Add 1-2 capf.to bath of 10-20 cm deep and soak for 10- Side-effects: Watery eyes, loc.irrit., trans.redn., mild dryn.&burn. routine bld.exam.advis., ren.fail., imp.liv. funct., neonat.with im-
15 min.once dly. Special precautions: Bld.dyscras./hist.thereof, reduc.freq./discont. mat.metab.process.
Infts: Add 1 ml to baby bath/basin of water. if loc.irrit.occurs, avoid.UV expos., Drug interactions: Poss.interact.with meds. metabol.by hepat.
Contraindications: Infts.less than 6 mnths.old, concom.soap use, Drug interactions: Oral metronidazole potent. anticoag.eff of microsom.enzym., effs.of some coumar.anticoags./hypoglycaem.
direct.applic.to skin. coumar.& warfar. agents/anti-epilept. enhanc., half-life/plasma conc.poss.aff.by par-
Side effects: Mild prurit. acetamol/phenobarb./phenytoin/rifampicin.
Special precautions: Avoid eyes, slip.in bath, discont. in case THROMBOPHOB, Winthrop [P/S]
of sev.irritat. Heparin. CILOXAN, Novartis [P/S]
Indications: Circulat.disords., superfic.phlebit.& thrombophlebit.,
PHENERGAN, Zentiva [P/S] varicos.veins., indol.ulc., bed sores, ext.haemorrh., accidents & injur., Ciprofloxacin.
Indications: Corn.ulc.& conjunctiv.caus.by suscept.bact.
Promethazine 2 g, dibromopropamidine isethionate 0,15 g/100 g sprains, strains, contus., haematomas., scar tiss.to prev.keyloid tiss. (S4) SOL. Z/15.1/202. 3 mg/ml.
Indications: 1 & 2 degr.burns, scalds, insect bites and stings. (S1) GEL, [P/S] G1635. 20 000 iu/100 g.
nd
st
(S2) CREAM, G1334 770671-004: 25 g, R75,59 794104-002: 5 ml, R1282,84 st
Dosage: Corneal ulc/abscesses: 1 day 2 drps.in affect. eye
754722-007: 25 G, R54,62
Dosage: Burns & scalds: Apply directly to affect.area. Cover with Dosage: Apply thin.to skin 2-3xdly. every 15 mins. x6 hrs, then 2 drps.every 30 mins.for remain.of day.
2 day: 2 drps.hrly. 3 -14 day: 2 drps 4 hrly. Dos.regim.may be ex-
th
rd
nd
dress.when indicat. Special precautions: Avoid eye contact, apply to open wound
Insect bites: Apply immed.& rep.2-3xdly or more oft.if necess. edges only. tend.at discret.of physic.
Bact.conjunctivit: First 2 days 1-2 drps.in conjunctiv. sac. 2 hrly
Contraindications: Prolong.treatm.of burns & scalds, ac.vesicul.& WART MAGIC LIQUID, (Ascendis Pharma) Beige Pharma [P/S]
exudat.dermatos. Podophyllin 0,75 g, salicylic acid 0,5 g, benzoin tinct.co.to 5 ml/5 ml while awake, then 1-2 drps. 4 hrly while awake until infect.resolv.
Dos.regim. may be extend.at discret.of physic.
Side effects: Photosensitisat., skin sensitisat.
Special precautions: Discont.in case of photosenitisat.or if no Indications: Topic.treatm.of warts/vener.warts, corns & callous. (S4) OINT. 35/15.1/0410. 3 mg/g
improvem.within 3 days, brok./eczema.skin, restrict applicat.if (S2) SOL, G1995 701064-001: 3,5 g, R192,68
large areas affect.to avoid system.absorpt.effs.eg.drowsin., stains 813990-009: 7 ml, R57,36 Dosage: Corneal ulc/abscesses: Apply 1,25 cm into conjunctiv.
cloth./bedlinen. Dosage: Apply to wart/corn at night. Allow to dry. Wash.with soap sac every 1-2 hours around the clock for 2 days then 4 hrly for furth.12
days. Dos.regim.may be extend.at discret.of physic.
PROTOPIC, (Adcock Ingram) Astellas [P/S] & water in the morn. Rep.for 4-5 days & wk.later if reqd. Bact.conjunctivit: Apply 1,25 cm into conjunctiv. sac/lid margin
Special precautions: Apply to affect.area only, discont.applicat.if
Tacrolimus pain/inflamm.exper.dur.treatm., medic.supervis. 3xdly.for 2 days then 2xdly.for furth. 5 days. Dos.regim.may be ex-
Indications: 0,03 % Second line ther.in adults & childr.over 2 yrs.for tend.at discret.of physic.
treatm.mod.to sev.atopic dermatit. WARTEC, GSK [P/S] Contraindications: Hypersens.to other quinolon., safety in pregn.&
0,1 % Mod.to sev.atopic dermatit.in adults not adeq.respons.to Podophyllotoxin lactat.not est.
0,03 % or intol.to convent.ther. Indications: Penile warts in preputial space, ext. genit.warts in Side effects: Eye drops: Itch., foreign body sensat., lid marg.crust.,
(S4) OINT, A40/13.12/0219, A40/13.12/0231 women. crystals/scales, conjunctiv. hyperaem., corn.sting., keratopathy/ker-
712758-001: 0,3 mg/g, 30 g, R337,17 (S2) SOL, 28/13.9/0142. 5 mg/ml atit., allerg.rects., lid oed., tear., photophob., corn.infiltrates, decr.
712758-002: 0,3 mg/g, 60 g, R674,34 vis, poss.hypersens.
712759-001: 1,0 mg/g, 30 g, R373,67 815616-007: 3 ml, R380,78 Eye ointm: Blurr.vis., hyperaem., prurit., decr.vis. acuity, pain, tear.,
712759-002: 1,0 mg/g, 60 g, R747,33 Dosage: Clean & dry affect.area, paint.warts 2xdly. x3days. If residual photophob.
Dosage: Prescr.by medic.profess. Intermitt.not contin.treatm.stop. warts persist treatm.may be rep.aft. 7 days. Apply sol.to wart only. Drops & Ointm: Loc.burn., white precipitat, naus., metal.taste, dermatit.
if no improvem.aft.3 wks. Contraindications: Open wounds, childr., pregn.& lactat. Special precautions: Discont.at first sign of rash/ hypersens.re-
Use on any part of the body, incl.face/neck & flexure areas.except Side effects: Loc.irrit., tendern., smart., erythema, superfic.epithel. acts., overgrowth of non-suscept. organ.incl.fung.with prolong.use,
muc.membr. Do not apply und.occlus. Apply thin layer to affect.areas. ulcerat., balanoposthit. init. appropr.meas.in superinfect.examin.pt.with aid of magnificat
198 / 2020-04 Ophthalmics - 15.1 / 15.1.1 / 15.2
(eg slit-lamp biomicroscopy) & fluoresc. stain.where appropr., poss. Special precautions: Base contin.of ther.on clinic. re-eval.& addit. diplop., eye pain/-swell./-prurit./-irrit./-inflammat./-hypoaesthes.,
adverse eff.on corn. permeabil. & corn.epithel.with prolong.use, reg. lab.stud.if no improvem.of infect.aft.7-10 days.treatm., susp.adheres naus., metall. taste, diarrh., abdom.pain, dermatit.
ophthalmolog. exams.requir., extens.ocul.surf.dis., ser. anaphylact.re- to areas of epithel.ulcerat./retent.in fornices occurs reg., pregn.& lac- Warnings and special precautions: Discont.at first sign of rash/
acts.to system.quinolone admin. tat., safety & effective.in paed.pts.not est., advise pts.not to touch hypersens.reacts./tendon. inflammat, rhinopharyng.passage risk
Drug interactions: With system.admin.theophyll. plasma conc.elev., drop.tip, contact lenses not to be worn if S&S of fung.blepharit./ contribut.to bact. resist.diffus., remove contact lenses bef. instill.,
caffeine metabol.interf.with, eff. of warfarin & its.derivat.enhanc.& conjunctiv.or keratit.pres. ser.anaphylact.reacts.to system.quinolone admin., overgrowth of
trans.incr.in serum creatinine with cyclosporin. non-suscept.organ.incl. fung. with prolong.use, init.appropr.meas.
OCTIN, Cipla Medpro [P/S] in superinfect. examin.pt.with aid of magnificat (eg slit-lamp bi-
EXOCIN, Allergan [P/S] Ofloxacin omicroscopy) & fluoresc. stain.where appropr., poss.adverse eff.on
Ofloxacin. Indications: Suscept.conjunctivit.& corn.ulc. corn.permeabil.& corn. epithel.with prolong.use, reg.ophthalmolog.
Indications: Suscept.extern.ocul.infects., (S4) OPHTHALM.DROPS, 36/15.1/0002 exams.requir., extens.ocul.surf.dis., format.of white precipit.does not
(S4) EYE DROPS. Z/15.1/347. 3 mg/ml. 702935-018: 3 mg/ml, 5 ml, R73,44 preclude contin.use, safety in pregn.& lactat.not est., avoid contami-
839957-009: 5 ml, R94,35 Dosage: Keep eyes clos.for 1-2 min.aft.applic. Compl. treatm.course. nat.of dropp.by avoid.eye/surround.area contact.
Dosage: Bact.conjunctivit: 1 drp. 2-4 hrly. x2 days then 4xdly. Conjunctivit: Days 1&2: 1 drp.2-4 hrly; days 3-5: 1 drp. 6 hrly. Interactions: With system.admin.theophyll. plasma conc.elev., caf-
for max.10 days. Bact.corn.ulc: Days 1&2: 1-2 drps.every 30 mins. while awake & feine metabol.interf.with, eff. of warfarin & its.derivat.enhanc.& trans.
st
Bact.corn.ulc: 1 2 days: 1-2 drps.every 30 mins. while awake . then 4-6 hrly aft.retir; days 3-7: 1-2 drps. hrly.while awake, days 7-9 incr.in serum creatinine with cyclosporin.
Awaken approx.4 & 6 hrs.aft.retir. and instill 1-2 drps. Day 3 through or complet:1-2 drps. 4xdly.
7 to 9: 1-2 drps. hrly.while awake. Day 7-9 through treatm. com- Contraindications: Soft contact lens.use, pregn. & lactat., safety ZYMAR, Allergan [P/S]
plet: 1-2 drps.4xdly. & effic.in infts.und.1 yr.not est. Gatifloxacin
Contraindications: Pregn., lactat., safety & effic. in childr.bel.1 Side effects: Trans.ocul.irritat., haemorrhag. conjunctivit., palpebr. Indications: Conjunctiv.caus.by suscept.bact.
yr not est. oed., poss.effs.as for system. admin.incl.GI disturbs.& hypersens.re- (S4) EYE DROPS, A39/15.1/0367. 3 mg/ml
Side effects: Stev.John.syndr., corn.precipitat.& perforat. with pre- acts.incl. fac. oed./swollen tong/anaphylax., super-infect. 709867-001: 5 ml, R207,13
exist.corn.epithel.defects./corn. ulc., eye irrit./ocul.discomf., poss.re- Special precautions: Prolong.use in extens. surf. ocul.dis., reg. Dosage: Bact.conjunctivit: Day 1& 2: 1 drp. 2 hrly. while awake
port.system. effs., dizzin., keratit., conjunctivit., blurr.vis., photphob., ophthalm.examinat., poss pseudomembr. colit., imp.hepat./ren.funct., up to 8xdly. Day 3-7: 1 drp. 4xdly.while awake
eye-/periorbit.oed., foreign body sensat. in eyes, incr.lacrimat., dry G6PD defic., myasthen.grav., avoid prolong.expos.to sun., sensitiv. to Contraindications: Hypersens.to other quinolon., pregn., nurs.
eye, eye pain/-prurit, eyelid prurit., ocul.hyperaem., naus., hypers- other quinolone antibact.agents. mother., safety & effic.in infts.und.1 yr.not est.
ens. reacts., fac.oed. Drug interactions: NSAID’s & theophyllin.may potent.CNS Side effects: Conjunctivit., punctate keratit., papill. conjunctivit.,
Warnings and special precautions: Not for inj., ser. hypersens./ stimul.eff. incr.lacrimat., conjunctiv. disords., eyelid oed., reduc.vis.acuity, red
anaphylact.reacts.report.with syst. admin., other quinolone hypers- TOBREX, Novartis [P/S] eye, eye irritat./ pain/disch., dry eye, conjunctiv.haemorrh., chemos.,
ens, rhinopharyng. passage poss.contrib.to diffus.bact.resist., poss. Tobramycin. erythema, contact dermatit., taste disturbs., headache, hypersens.
superinfect., extend.use extens.ocul.surf.dis., reg. opthalmol.exam., Indications: Suscept.ext.bact.infects.of eye & adnexa. reacts.incl anaphylact. reacts., overgrowth of non-suscept. organ.
soft contact lens use, excret.in breast milk, (S4) SOL. [P/S] P/15.1/58. 3 mg/ml. incl.fungi with prolong.use, blepharit., conjunctiv./ ocul, hyperaem.,
blurr.vision, eye prurit./ swell., naus., dyspn., skin rash, prurit., urticar.
FUCITHALMIC, Pharmaco [P/S] 771082-002: 5 ml, R122,08 Warnings and special precautions: Advers. effs. on corn.permea-
Fusidic acid hemihydr.equiv.to fusidic acid anhydr. Dosage: 1-2 drps. 4 hrly. Sev.infects: 2 drps.hrly till improvem., bil.& disrupt.of corn.epithel with prolong./rep.use, reg.ophthalmolog.
Indications: Staphylococ.conjunctivit. then reduc.bef.discont. exam., extens. ocul.surf.dis., not to be inj.subconjunctiv./ introd. direct.
(S4) DROPS. W/15.1/196. 10 mg/g. (S4) OINT. [P/S] P/15.1/205. 3 mg/g. in anter.chamb.of eye, superinfect., do not use contact lenses if S&S
783641-001: 5 g, R89,82 771104-006: 3.5 g, R122,55 of bact. conjunctivit. exist., discont.in case of rash/allerg. react., avoid
Dosage: All ages: 1 drp. 2xdly contin. x2days aft.eye returns Dosage: Mild or mod: 1 cm 2-3xdly. Sev. infects: 1 cm 3-4 hrly till touch.dispens.contain.to eye/any oth. surf.
to normal. improvem.then reduc.bef. discont. Drug interactions: With system.quinolone admin. theophyll.plas-
Side effects: Trans.sting., hypersens. Side effects: Loc.ocul.toxic., hypersens. ma conc.elev., caffeine metabol. interfer. with, warfarin & derivat.
Special precautions: Not for use with contact lens, prolong.use of Special precautions: Syst.aminoglycosides, discont.if sensitiv. effs.enhanc., trans. elev.in ser.creatinine with system. cyclosporine.
benzalkon.chlor.preserv. preps.in pts.with extens.ocul.surf.dis., resist. occurs, as no well control.stud.in pregn. admin.only if potent.benef.
outweigh risks, eval.benef.vs.risk in nurs.mothers, skin sensit., su-
LENNON SULPHACETAMIDE, (Aspen perinfect.(prolong.use), oint.may retard corn. heal.
Pharmacare Consum), Pharmacare [P/S] Drug interactions: Ototoxic, neuromusc.block. drugs or carbeni- 15.1.1 Antivirals
Sulphacetamide sodium. cillin (enhanc.eff.).
Indications: Eye & eye socket infects., styes, trachoma. ZOVIRAX OPHTHALMIC OINTMENT, GSK [P/S]
(S2) OINT, H1169. VIGAMOX, Novartis [P/S] & Acyclovir.
767360-001: 350 mg/3,5 g, R29,25 Moxifloxacin HCl equiv.to moxifloxacin Indications: H.simplex keratit.
Dosage: Apply small quantity to inner corner of eye 3x/day. Indications: Topic.treatm.of suscept.bact. conjunctivit. (S4) OINT. P/15.4/238. 30 mg/g.
Contraindications: Corneal penetrat.wounds, concurr.Ag salt preps. (S4) SOL. 40/15.1/0164. 5 mg/ml 779407-008: 4,5 g, R491,05
Side-effects:.Loc.burn.& sting., hypersens.reacts. 707883-001: 5 ml, R219,35 Dosage: 10 mm ribbon into lower conjunct.sac 5xdly.at 4 hrly.interv.
Special precaution: Poss.cross sens.with furosemide/ thiazide Dosage: Adults: 1 drp.in affect.eye(s) 3xdly x4days. Childr: Safety Cont.treatm.for at least 3 days.aft.heal.
diuret./sulphonylureas & carbon anhydrase inhibit. & effic.demonstr.in paed. pts.incl.neonates at same dos.as adults.
Contraindications: Quinolone hypersens., no adeq. stud.in pregn. Side-effects: Mild sting., superfic.punctate keratopathy., blephar-
MINIMS CHLORAMPHENICOL 0,5 %, (Bausch & Lomb) Side effects: Ocul.discomf./-hyperaem./-pain, ocul.prurit., dry eyes, it., conjunctivit.
SofLens [P/S] headache, taste pervers. Special precautions: Safety in pregn.not est., pass.into breast milk.
Chloramphenicol Special precautions: Ser.& occas.fatal hypersens./ anaphylact. Drug interactions: Probenecid incr.mean half-life.
Indications: Ac.eye infect.caus.by suscept. organ. react.(some follow.1 st dos.) report. with system.quinolones, non-
(S4) SOL, E/15.1/223. 2,5 mg/0,5 ml suscept. organ. overgrowth with prolong use, discont.if allerg.
743550-013: 20x0,5 ml, R308,07 react./superinfect.occurs., no contact lenses in pres.of ocul.bact. 15.2 Corticoids
Dosage: Sngl.dos.eye drops. Adults & childr. accord. to ophthalmol. infect., lactat., pregn.
Contraindications: Minor infects./ prophylactic. use, dry eye See also MDR page 138. ALREX (MDR Listing)
syndr.(long term use). SPERSADEX (MDR Listing)
Side effects: Loc.hypersensit. XINOCT, (Gen-Eye) Actor Pharma [P/S]
Special precautions: Newborn infts., anaem. pts., concom.agents Ciprofloxacin ALREX, (Bausch & Lomb) SofLens [P/S] &
which suppress bone marr. funct. Indications: Suscept.bact.conjunctivit.& corn. ulcerat. Loteprednol etabonate
(S4) OPHTH.SOL, 47/15.1/0959
Indications: Short-term(6wks) treatm.of season. allerg. conjunctivit.
NATACYN, Novartis [P/S] 3001392-001: 3 mg/ml, 1x5 ml, R138,25 (S4) OPHTH.SUSP. 38/15.2/0203. 2 mg/ml
Natamycin. Dosage: Adults & childr.over 2 yrs: 722716-001: 5 ml, R148,74
Indications: Fung.blepharit., conjunctiv., keratit. caus.by suscept. Corneal ulc/abscesses: 1 day 2 drps.in affect. eye every 15 mins. Dosage: Admin.concom.ophthal.products at least 10 mins.apart.
st
organ.incl.Fusarium solani keratit. x6 hrs, then 2 drps.every 30 mins. for remain.of day. 2 day: 2 drps. Adults: Instil 1-2 drps.4xdly into affect. eye(s). Dur.1 wk.dos.may
nd
st
th
rd
(S4) SUSP. RX/15.1/240. 50 mg/ml. hrly. 3 -14 day: 2 drps 4 hrly. If treatm.long.than 14 days reqd.dos. be incr.to 1 drp. hrly. if necess.
745987-001: 15 ml, R2 105,35 regim.may be extend.at discret.of physic. Contraindications: Other corticoster. hypersens., vir.dis.of cornea &
Dosage: Fung.keratit: 1 drp. 1-2 hrlyin the conjuctiv.sac. Reduc. Bact.conjunctivit: First 2 days 1-2 drps.in conjunctiv. sac. 2 hrly conjunctiva, untreat. purul.ocul. infect., suspect./confirm.eye infects.,
freq.to 1 drp. 6-8x dly.aft. 3-4 days. Cont. 14-21 days/until resolut. while awake, then 1-2 drps. 4 hrly while awake until infect.resolv. amoeb./ mycobact. infects., fung.dis.of ocul.struct., glauc., childr. und.
of infect. In many cases reduc.dos.grad.at 4-7 day interv.to ensure Contraindications: Hypersens.to other quinolon. 18 yrs., pregn.& lactat.
replicat.organ.elimin. Side effects: Freq: Dysgeus., corn.deposits, ocul. discomf., ocul. Side effects: Incr.IOP, itchy eyes, conjunct. hyperaem., epiphor., burn./
Fung.blepharit.& conjunctivit: Less.freq.init. dos. (4-6 applic) hyperaem. Less freq: Hordeol., rhinit., hypersens., headache, diz- sting., foreign body sensat., abnorm.vis., dry eyes, photophob., eye
may be suffic. zin., itch., for.body sensat., lid marg.crust., cryst./scales, conjunct. discomf./ -discharge/-pain/-irrit./-disord./-infect., chemos., blurr.vis.,
Side effects: Allerg.react., chest pain, dyspn., eye discomfort & tear., hyperaem./-oed./-stain., keratopathy/keratit., allerg.reacts., lid oed., headache, eyelid erythema/-abnormal., ant.chamb.cells/-synech./-
change in vis., corn.opacity, eye oed./-hyperaem./-irrit./-pain, foreign tear., photophob., corn. infiltrat.& decr.vis.acuity, eyelid erythema, flare/-inflammat., irit., uveit., corn.abnormal., ciliary flush, keratit.,
body sensat., paraesthes. blurr. vis., dry eye; incr.eye discharge., eyelid exfoliat., conjunctivit., kerat.precipit., macul.oed., papilla, conjunct.oed., fluorescein stain.,
Strike at the core of ocular allergies,
time and again with 1
0.2%
An advancement in corticosteroid therapy
that treats the full spectrum of inflammatory mediators 1-3
Modulates and inhibits early- and late-phase inflammatory mediators for multi-symptom relief 1,3
No meaningful increases in IOP elevations in short and long-term use 1
References: 1. Ilyas H, et al. Long-term safety of loteprednol etabonate 0.2% in the treatment of seasonal and perennial allergic conjunctivitis. Eye Contact Lens 2004;30(1):10-13. 2. Comstock TL, et al. Advances in corticosteroid therapy for ocular
inflammation: loteprednol etabonate. Int J Inflam 2012;789623:1-11. 3. Pavesio CE, et al. Treatment of ocular inflammatory conditions with loteprednol etabonate. Br J Ophthalmol 2008;92:455–459.
Scheduling status: S4 Proprietary name and dosage form: Alrex Ophthalmic Suspension. Composition: Each 1 ml contains: Loteprednol etabonate 2,00 mg (0,2 % m/v) and Benzalkonium chloride (preservative) 0,01 % m/v.
Pharmacological classification: A 15.2 Ophthalmic preparations with corticosteroids. Registration number: 38/15.2/0203.
For full prescribing information, refer to the professional information as approved by the South African Health Products Regulatory Authority (SAHPRA). ©2003 Bausch
& Lomb Incorporated. ® / TM denote trademarks of Bausch & Lomb Incorporated. Applicant: Soflens (Pty) Ltd. Reg. no.: 1968/011787/07. 254 Hall Street, Centurion,
0157. Tel: +27 10 025 2100. www.bausch.co.za. BL395/19
319754 Alrex Mims Ad FIN3.indd 1 2019/03/19 16:52
200 / 2020-04 Ophthalmics - 15.2
hyphema, ophthalmit., sticky eye, rash, urticar., nervousn., taste disturb., Contraindications: Vir.dis.of cornea & conjunctiva incl.epithel. Drug interactions: Effs.of barbit./sedat.hypnot. & TCA’s poss.incr.,
diarrh., N&V., migraine, rhinit., pharyngit., incr.cough, UTI, asthen., chest H.simplex keratit., vaccinia/ varicella eye infects., TB of the eye, effs.of anticholinester./ antivir. eye preps.& salicylates decr., CYP3A
pain, chills, fac.oed., fev., pain, conjunctivit., glauc., lacrimat. discharge, fung. dis. of ocul.struct., childr.und.2 yrs., safety in pregn. not est, inhibit.incl.cobicistat incr.system.S/E.
mydrias., vitreous disord./-discharge, corn.les./-opacity/-ulc., cataract, not recomm.in lactat.
abnorm. accommodat., vis.field.defect, H.simplex, sweat., prurit., skin Side effects: Glauc.with prolong.use, opt.nerve damage, defects in OZURDEX, Allergan [P/S]
discolourat., spasms, dizzin., paraesthes., trem., anx., insomn., otit.med., vis.acuity & fields of vis., poster. subcapsul.cataract format., delay. Dexamethasone in polymer matrix of 50:50 poly-D,L-lactideco-
parosm., ear discharge/-pain, depress., dyspeps., glycosur., palpitat., wound heal., second.ocul.infects., dis.caus.thin.of corn./ sclera & per- glycolide (PLGA)
vasodilat., hypertens., tachycard., lung disord., voice alterat., laryng- for., eye irrit./-pain/-discharge/-prurit./ -swell., conjunctiv./ocul.hyper- Indications: Adults with vis.impairm.due to diabet. macul.oed.who
ism., asthma, dyspn., laryngit., lung discharge, allerg. react., aggrav. aem., foreign body sensat., eyelid & eye oed., blurr.vis., incr. lacrimi- are pseudophak./insuffic. responsive/unsuit. for non-corticoster.ther.;
react., hair abnormalit., abnorm. feel., anorex., malaise, photosens. nat., mydrias., ulcerat./punct.keratit., hypersens., dysgeus., skin rash. macul.oed.follow.either branch/central retin.vein occlus., poster.eye
Warnings and special precautions: Poss. adverse eff.on corn. Warnings and special precautions: Safety in pregn. not est., not segm.inflammat.present.as non-infect. uveit.
permeabil.& corn.epithel.with prolong.use., prolong.use with extens. recomm.in lactat., poss.adverse effs.on corn.permeabil.& disrupt.of (S4) INTRAVITREAL IMPLANT, 44/15.2/0045. 700 µg/implant
ocul.surf. dis., do not use contact lenses, in dis.caus.thinn.of cornea/ corn.epithel. with prolong/rep.use reg.ophthal.exam.reqd., prolong. 713829-001: 1, R13 692,23
sclear peforat.poss., eye infects.poss. enhanc. / mask., re-eval.condit. use in extens.ocul.surf.dis., intraocul. steroids may prolong & exacerb. Dosage: Effic.& safety not demonstrat.for more than 1 applicat.
if no improv.within 2 days, monit.IOP if used >10 days. vir.eye infects., glauc. with freq.IOP monit., ac.untreat.infect.may be Monit.pt.for IOP elev & endophthalmit. aft.admin. Intravitreal admin.
Drug interactions: Potent.to incr.IOP advers. affect. by system.an- mask. or activ.enhanc., soft contact lense users, suspect fung.invas. only by exper.qualif.ophthalmologist.
ticholinerg., poss.decr.of ocul. hypotens. eff.of ocul.hypotens.ther., in any persist.corn.ulcerat. concom./ prior steroid use, restrict.use to Asept.techniq.with adeq.anaesthes.& broad spectrum topic.antimi-
incr.IOP risk with cyclopleg., CYP3A inhibit.incl.cobicistat incr.syst.S/E 10 days unless und.strict ophthal.supervis., avoid dispen. contain. crob.admin.prior to inj.
See also MDR page 232. Admin.one implant intra-vitreally into affect.eye. Rep.dos.may be
touch.eye/any other surf., in pres.of blurr. vis.& other vis.disturbs. admin.depend.on ophthalmologists assessm.
BETNESOL, (Aspen Pharmacare: Pharma) Pharmacare [P/S] eval.for other poss.caus. eg. cataract/glauc.& centr.serous chori- Insert needle into the vitreous cavity until silicone sleeve against the
Betamethasone sod.phosph. oretinopathy, ocul.admin.teratogen.in rabbits, premat.discont., vis. conjunctiva. Slow.press actuat. button until audible click noted. Ensure
Indications: Non-infect.inflam.condit. to clear bef.driv./operat. Machin. actuat. button is fully pressed and lock.flush with applicat. surf.re-
(S4) EYE DROPS, H1257. 1 mg/ml. Interactions: CYP3A inhibit.poss.incr.risk of system. corticoster. mov.needle in same direct.used to enter the vitreous. Follow.intravitr.
708267-009: 5 ml, R176,10 relat.effs. inj.pts should contin.to be treat. with a broad spectrum antimicrob.
Dosage: 1-2 drps. 1-2 hrly until control.achiev. then reduc. Contraindications: Act./suspect.ocul.or periocul. infect.incl.most
Contraindications: Poss.herpet.keratit., glauc., viral, bact., fung., LOTEMAX (Bausch & Lomb) SofLens [P/S] & cornea & conjunctiva vir.dis./hist. thereof, vaccinia/varicella/my-
TB & purul.infects., ulcerat. condits., rosacea, H.simplex, vaccinia, Loteprednol etabonate cobact.infect.& fung. dis., act.ocul.H.simplex, advanc.glauc.where
varicella, soft contact lens, pregn. Indications: Allerg.conjunctivit.&.ac.anter. chamb. uveitis. not adeq.control., aphak.eyes with rupt.of poster.lens capsule, eyes
Side effects: Reduc.vis.funct, incr.IOP (S4) EYE DROPS, 37/15.2/0588 with anter.chamb.intraocul.lens /iris/transscler.fixat. IOLs & ruptur.
Special precautions: Long term use in childr., infect.sympt.poss. 721666-001, 5 mg/ml, 5ml, R179,01
mask., incr.suscept.to infect., admin.to red eyes until defin.diag.made, Dosage: Allerg. conjunctivit: 1 drp.in conjunctiv. sac of affect. poster.lens capsule., safety in pregn.& lactat.not est., no relev. in-
dicat.for childr.und.18 yrs.
poss. advers. effs.on corn.permeabil.& disrupt.of corn. epithel.with eye(s) 4 x dly. Treatm.not to exceed 6 wks.
prolong./rep.use, reg.ophthalm.exam. reqd., corn.perforat.report.in Ac.anter.chamb.uveitis: 1 drp. in conjunctiv.sac of affect.eye(s) Side effects: Incr.IOPpeak.at day 60 return.to baseline by day 180
dis.caus.thinn.of corn., cataracts with unduly prolong.treatm., fung. 4 x dly. Dur.init.treatm.within the 1st wk dos.may be incr.up to 1 either not req.treatm./tempor. top.IOP low.meds.admin., conjunct.
haemorrh., headache, migraine., vitreous detach., cataract format./
keratopathy, glauc., adren.suppress.esp.in infts., grad, withdr., HF, drop hrly.if necess.
rec.MI, hypertens., diab.mellit., epilep., hypothyroid., hepat.fail., os- Contraindications: Vir.dis.of cornea & conjunctiva incl. progress., ster.induc.glauc., second.infect., subcaps. cataract, vis.dis-
teoporos., pept. ulcerat., psychos., sev.affect.disords., ren. impairm. epithel.H.simplex keratit. (dendrit. keratit.)/vaccinia & varicella, my- turbs., ocul.hypertens., blepharit., necrotis.retinit., eyelid prurit. Side
Drug interactions: Corticoster.eff.reduc.by barbitur./ carbamazepine/phe- cobact.infect.of eye & fung.dis.of ocul.struct., safety & effic.in paeds. effs. consid. relat.to proced.incl.vitreous haemorrh., reduc. vis.acuity,
nytoin/primidone & rifampic., corticoster.plasma conc.incr.by OC’s & ritonavir, not est., safety in pregn.not est., lactat. vitreous opacit./floaters, eye pain, photops., conjunct.oed., ant.cham-
+
corticoster.with K deplet.diuret.poss. caus. excess K loss & incr.hypokalaem. Side effects: Abnorm.vis./blurr., burn.upon instillat., chemos., dis- ber cell, conjunctiv. hyperaem./oed., endolphthalmit., retin. detachm.,
+
with amphotericin B/xanthines & ß2-agon., incr.GI bleed. & ulcerat.with con- charge, dry eyes, epiphora, foreign body sensat., itch., infect., pho- retin.tear, eye hypotony, ant.chamb. flare/ inflammat.., scler.hyper-
com.NSAID’s, alt. respons. to anticoags., poss.incr.antidiab./ antihypertens. tophob., conjuntivit., corn.abnormalit., eyelid eryth., keratoconjunc- aem., abnorm. sensat. in eye, device dislocat.with/-out corn.oed., de-
requirem., salicyl.ser.conc.decr., antimuscar. effs.in myasth.grav.poss.decr., tivit., ocul.irrit./pain/discomf., papill., uveit., elev.IOP, post.subscap. vice insert.complicat.result.in ocul.tiss.damage, implant misplacem.
poss. interacts with antivir./neuromusc.block.& fem. hormones. cataract format., second.ocul.infect., perforat.of globe, headache, Warnings and special precautions: Ocul.H. simplex hist., ad-
vers.event incid.high.in pts.with centr.retin.vein occlus., corticoster.
DEXAGEL, (Bausch & Lomb) SofLens [P/S] rhinit,. pharyngit. may produc. glauc.& enhanc.second.ocul.infect., temp.use of topic.
Dexamethasone sod.phosph. Warnings and special precautions: Embryotox. & teratogen. in IOP low.meds.if necess., monit.for IOP elev/ infect./ endophthalmit.
Indications: Reduc.ocul.inflammat.aft.cataract surg. anim., glauc., fung.infects., may incr. haz.of second.ocul.infects.& may aft.admin., effic.& safety of bilat. treatm.not stud., not stud.in pts
(S4) GEL, 37/15.2/0275, 0.985 mg/g mask infect./ enhanc.exist.infect., may prolong course & exacerb.se- with macul. oed. second.to RVO with signific.retin.ischaem., pts.
708581:001: 5 g, 1, R143,57 verit.of vir.eye infects, hist.of H simplex, may.delay.heal.& incr.incid. tak.anti-coag./anti-platel.meds., no driv.or operat.mach.until poss.
Dosage: Do not to exceed 4 wks. Init.1 drp.4 hrly. Therafter 3 to of bleb format.aft. cataract surg., only prescrib.aft.examinat.involv. temp.vis.blurr.resolv.
4 dly.applic.suffic. magnificat.& fluoresc.stain.if approp., re-eval.aft. 2 days if S&S fail
Contraindications: H.corneae superficial., bact.& vir.infects without to improv., monit.IOP if use ≥ 10 days., poss. adverse effs.on corneal PRED MILD, Allergan [P/S]
concomit.anti-infect. basic. ther., ocul.TB, ophthalm.mycos., ulcer.les permeabil.& danger of disrupt.of corneal epithelum with prolong./ Prednisolone acet.
of cornea, narr./open angle glauc. rep.benzalkonium chloride use, reg. ophthalmolog. exam.reqd., avoid Indications: Mild to mod.allerg., inflamm.disord.
Side effects: Unknown freq: Glauc.& cataract. with prolong.use, cont. lens. dur. treatm. (S4) EYE SUSP, [P/S] J/15.2/73. 1,2 mg/ml.
perforat.of globe assoc.with dis. caus.thin.of corn./sclera & long Interactions: CYP3A inhibit.incl.cobicistat incr. syst. S/E 756466-008: 5 ml, R171,76
term use, elev.bld gluc. lev in diabet., allerg.reacts. Dosage: 1-2 drps. 2-4xdly. Init. 24-48 hrs.safely incr.to 2 drps.hrly.
Warnings and special precautions: As antibact. resist.impair.infect. MAXIDEX, Novartis [P/S] PRED FORTE, [P/S] J/15.2/77.
is poss., discont.if infect. occurs unless inflamm.react.so sev.that corti- Dexamethasone. Indications: Steroid respons.inflamm.of palpebr. & bulb.conjunctiva,
sone treatm.is absolut.necess., persist. corneal. ulcerat.with prolong. Indications: Steroid respons.ocul.inflamm. cornea & anter.segm.of eye globe.
use poss.from fung. infect., do not use for undiagnos.red eye, safety & (S4) SUSP. H1143 (Act 101/1965). 1 mg/ml. (S4) EYE SUSP, [P/S] 10 mg/ml.
effic.in childr.not est., adren.suppress.with long time use in childr., trans. 740446-002: 5 ml, R175,89 756458-005: 5 ml, R211,84
blurr.vis.through streak format., vehicle driv./mach.operat., concom. Dosage: Ophthalm.sev.ac.inflamm: Init.1-2 drps.½-1 hrly. reduc. Dosage: Apply punct.occlus.to reduc.poss. system. absorpt.
contact. lens use should not be used, safety in pregn.& lactat.not est. to 2-4 hrly till fav.respons. obt.then 1 drp.3-4xdly.x3-4 days. Chron. Adults: 1-2 drps 2-4xdly. Dur.init.24-48 hrs.safely incr. dos.to
Interaction: Five min.interv.if admin.with other eye drops/oint.& ad- inflamm: 3-8 hrly. Allerg.or min.inflamm: 3-4 hrly. 2 drps.hrly.
min.last, cotreatm.with CYP3A inhibit.incl.cobicistat.contain.products Contraindications: Epithel.herpes simplex keratit.(dendrit.keratit), Contraindications: Ac.untreat.purul.ocul. infects., superfic.
expect.to incr.syst.ster.effs. vaccinia, varicella, other vir.corn.& conjunctiv.dis., mycobact.eye in- H.simplex, vaccinia, varicella, other vir.dis.of corn.&conjunctiva, my-
fect. fung.dis., aft.uncomplic. remov. of corn.foreign body, mechan.
FLUCON, Novartis [P/S] lacerat.& abras. cobact.eye infect., fung.dis.of the ocul.structs., safety & effic. in paed.
Fluorometholone. Side effects: Delay.wound heal., progress.of H.simplex infect.(irre- not est., safety in pregn.& lactat.not est.
Indications: Ster.resp.non-infect.inflamm.of palpebr.& bulbar con- vers.cornea cloud.), developm. & spread of second.& fung.infects., Side effects: IOP, opt.nerve damage, defects in vis. acuity & fields of
vis., poster.subcapsul. cataract format.aft.prolong.use, hypersens., ur-
junctiv./cornea & globe ant.segm. defects in vis. acuity, post.subcaps.cataract format., prolong.use incr.
(S4) SUSP. N/15.2/16. 1 mg/ml. IOP with poss.glauc.develop.& opt.nerve damage. ticar., headache, eye penetrat., sclear./corn. perforat., fung./vir./bact.
eye infect., ocul.sting., ocul. hyperaem., eye irrit./pain, blurr.vis., my-
726702-005: 5 ml, R191,25 Warnings: Glauc.not always revers.on treatm. cessat., perforat.in
Dosage: 1-2 drps 2-4xdly.may be incr.to 2 drps.hrly.dur. 1st 24-48 dis.caus.corn./sclera thin., corn.ulcerat.aggravat., correct.corn.ulc. drias., foreign body sensat., dysgeus., prurit., skin rash.
hrs. Do not discont.prematur. diagnos. import. bef.init.corticoster.treatm., ac.purul.infects. may be Warnings and special precautions: Restrict. use to 10 days un-
Contraindications: Ac.superfic.H.simplex keratit., fung./vir.& bact. mask./enhanc.until sight is lost, ophthalmolog. ref.if no respons.in less und.strict ophthal.supervis., soft contact lense users, poss.ad-
infect., TB, mech.lacerat./abras., glauc., childr. und. 2 yrs. verse effs.on corn. permeabil.& disrupt.of corn.epithel.with prolong/
Side effects: Delay.wound heal., promotes developm.& spread of in- 48 hrs., freq.slit-lamp microscopy mandat.in H.simplex.treatm., due rep.use reg.ophthal.exam.reqd., prolong.use in extens.ocul.surf.dis.,
to poss.adverse eff.on corn.permeabil.& corn. epithel. with prolong.
fects and masks evid.of progress until sight lost, perforat., exacerbat. poss.allerg.-type reacts.from sulphite sensitiv., perforat.report.in dis.
of herpes infect., glauc., opt.nerve damage, defects in vis.acuity and use reg.ophthalm.exam.reqd. prolong.use with extens.ocul.surf.dis., caus.corn./ sclera thinn., incr.second.ocul.infect.hazard with prolong.
fields of vis., post.subcaps.cataract format.or may aid in est.second. monit.IOP rout. if used for 10 days or long. use, H.simplex hist., ac.purul.eye infect. may be mask.or enhanc., sus-
ocul.infect.from pathog.liberat.by ocul.tiss., fung.infects. MINIMS PREDNISOLONE SODIUM PHOSPHATE 0,5 %, pect fung.invas.in any persist. corn.ulcerat.concom./prior steroid use,
Warnings: Perforat.in dis.caus.corn./sclera thin., great.caut.in (Bausch & Lomb) SofLens [P/S] glauc. with freq.IOP monit., refer.condits.not respond. within 48 hrs.to
strom.H.simplex treatm.with freq.slit lamp microscopy mandat., Prednisolone sod.phosph. ophthalmolog., poss. delay. heal.& incr.bleb.format.with use aft.cata-
corn.ulcerat.aggravat., suspect.fung.invas.in any persist.corn.ulcerat. Indications: Non-infect.inflammat.condits.of out.eye & anter. ract surg., avoid dispen.contain.touch.eye/any other surf., poss.adren.
where ster.admin., infects.may be mask./enhanc., monit.IOP freq., segment. suppress.with prolong./freq.high dos., in pres.of blurr.vis.& other vis.
ophthalmolog.ref.if no respons.in 48 hrs., due to poss.adverse eff. (S4) SOL, P/15.2/212. 2,5 mg/0,5 ml disturbs.eval. for other poss.caus.eg. cataract/glauc.& centr. serous
on corn.permeabil. & corn. epithel.with prolong.use reg.ophthalm. 743607-015: 20x0,5 ml, R421,65 chorioretinopathy, premat.discont.
exam. reqd., use over extend.period in pts.with extens.ocul.surf.dis. Dosage: Sngl.dos.eye drops. Adults: 1-2 drps.as reqd. Childr: At Interactions: CYP3A inhibit.may incr.risk of system. side effs.
FML LIQUIFILM, Allergan [P/S] discret.of ophthalmol. SPERSADEX 0,1%, (Restan) AI Pharm Ltd [P/S] &
Fluorometholone 1 mg, polyvinyl alcoh. 14 mg/ml. Contraindications: Viral, fung., TB & other bact. infects., ulcerat., Dexamethasone disod.phosph.0,1 g, hydroxypropylmethyl-
Indications: Steroid respons.inflamm.of palpebr. & bulb.conjunctiva, glauc., pregn. cell.0,2 g/100 ml
cornea & ant.segm.of the globe. Side effects: Incr.IOP, corneal ulc., reduc.vis. funct., subcapsul. Indications: Allerg./inflamm.eye condits.
(S4) EYE SUSP, J/15.2/327. cataract.with prolong.treatm., poss.adren.suppress.with prolong. (S4) DROPS. H1285.
726958-018; 5 ml, R199,07 use in childr. 765821-001: 5 ml, R160,99
Dosage: 1-2 drps. 2-4 x dly. Init. 24-48 hrs. safely incr.to 2 drps.hrly. Special precautions: Incr.suscept.to infects., prolong.use Dosage: 1 drp 4xdly.
Ophthalmics - 15.2 / 15.3 / 15.4 2020-04 / 201
Contraindications: Bact./vir.corn.injur./ulc., purul., conjunctiv./eyelid Special precautions: Perforat.in dis.caus.thin.of cornea/sclera, Contra-indications: MAOI’s, clos.angle glauc., safety in pregn.&
infect., TB, mycos., glauc. strom.H.simplex, second.& fung. infects., avoid prolong.loc.use as lactat. not est., childr.und. 6 yrs.not recomm.
Side effects: Second.glauc., complic.cataract developm.(pro- sensitisat.poss., delay.hypersens.reacts.poss.mask.by dexamethas. Side-effects: Trans.irrit., syst.reacts., hypersens. reacts., naus.,
long.use). headache, drowsin.
Special precautions: Poss.induc.of corn. abscess, fung.keratopa- SPERSADEX COMP, AI Pharm Ltd [P/S] & Special precautions: Poss.adverse effs.on corn. permeabil.& corn.
thy, glauc., regul. opthalmolog.exam.requir., extens.ocul.surf.dis. Dexamethasone disod.phosph. 1 mg, chloramphen. 5 mg, hydroxy- epithel.with prolong.use, reg. ophthalmolog.exam.requir., extens.
See also MDR page 106. propylmethylcellul. 2 mg/1 ml. ocul.surf.dis., hypertens., card.irreg., hyperglycaem., hyperthyroid.
Indications: Infect.& allerg.condits.
(S4) DROPS. H1278. OCULOSAN, AI Pharm Ltd [P/S]
765813-009: 5 ml, R170,16 Zn-sulph. 0,2 mg, naphazoline nitr.0,05 mg/ml.
15.3 Combinations Dosage: 1 drp 1-4xdly. Indications: Non-infect.conjunctivit., irrit., allergy, aft.bact.& vir.in-
fect.treatm., tear duct irrigat.
Contraindications: H.simpl.cornealis, tubercul. process.involv.con-
(anti infectives with junct., cornea & ant. uvea. (S0) EYE DROPS. H1272.
750271-019: 10 ml, R46,90
Side effects: Second.glauc.& compl.cataract developm.with
corticoids) prolong use. Dosage: 1 drp 4xdly.
Contraindications: Narr.-ang.glauc., dry eyes, keratoconjunctivit.
Special precautions: Poss.induct.of corn. abscess./ fung.kera-
SPERSADEX COMP (MDR Listing) topathy/glauc. sicca, infts., MAOI’s, safety in pregn.& lactat.not est.
BETNESOL-N, (Aspen Pharmacare: Pharma) Pharmacare [P/S] See also MDR page 107. Side effects: Rebound eff.with longt.treatm., burn., mydrias., blurr.
vis., incr.IOP, poss.system. absorpt.
Betamethasone sod.phosph. 0,1 g, neomycin sulph. 0,35 mg/100 ml TOBRADEX, Novartis [P/S] Special precautions: Hyperthyroid., CV dis., hypertens., diab.mel-
Indications: Non-infect.inflam.condits. Dexamethasone 1 mg, tobramycin 3 mg/ml. lit./hyperglycaem., eye dis., infect.or injury, remove cont.lens.bef.
(S4) EYE DROPS, [P/S] H1258. Indications: Ocul.inflammat.reduct.& suscept. organ.infect.prophy- instill.& 15 mins.aft., discont.if eye pain, vis.chang.& loc.eff. cont.
708291-007: 5 ml, R137,03 lax.follow.intraocul.surg. for long.than 72 hrs.
708429-009: 10 ml, R274,06 (S4) SUSP. [P/S] X/15.3/91. Drug interactions: Pressor eff.potent.with TCA’s if system.absorb.
Dosage: 1-2 drps. 1-2 hrly until control achiev. then reduc. 789194-007: 5 ml, R188,60
Contraindications: Viral, fung., TB & purul. infect., poss.herpet.ker- Dosage: Admin.other topic.ophth.meds.at least 5 min.apart with OPTILAST, MEDA Pharma, [P/S]
atit., glauc., soft contact lens., neonates, pregn., lactat. eye ointm.admin.last. Azelastine HCl
Side effects: Incr.IOP., ac.sensitisat. Instil.1 drp.4 hrly while awake x3 days pre-op, then 1 drp.immed.on Indications: Treatm.& sympt.prev.of season. allerg. conjunctivit.in
Special precautions: Do not admin.to red eyes until defin.diagn. conclus.of surg. At 1 dress. change, 1 day follow.surg.instil 2 drps. adults & childr.over 4 yrs. Sympt.treatm.of perenn.allerg.conjunctivit.
st
made, unnecess.use to avoid neomycin resist.organ.occur., poss.in- 2 hrly.while awake x2 days, from post-op.day 3, 1 drp.4x/day x1 wk. in adults & childr.over 12 yrs.
ducem.of corn. abscess & fung.keratopathy, corn.perforat. report.in Maint: 1 drp/day x10 days. Max 20 ml. (S2) EYE DROPS, 36/15.4/0011. 0,5 mg/ml
dis.caus.thinn.of corn., cataracts with unduly prolong.treatm., advers. (S4) OINT. [P/S] X/15.3/92. 706558-001: 10 ml, R51,10
effs.on corn. permeabil.& disrupt.of corn.epithel.with prolong./ rep. Dexamethasone 1 mg, tobramycin 3 mg/g. Dosage: Limit.course durat.to 6 wks.
use, glauc., reg.ophthalm.exam.reqd., prolong. use with extens.ocul. 789186-004: 3,5 g, R188,40 Season.allerg.conjucntivit: Adults & childr. over 4 yrs: 1 drp.
surf.dis., adren.suppress.esp. in infts. Dosage: Admin.other topic.ophth.meds.at least 5 min.apart with in each eye twice dly. Incr.if necess to 4xdly. Admin.prophylact.prior
to allergen expos.
FML-NEO, Allergan [P/S] eye ointm.admin.last. Perenn.allerg.cojunctivit: Adults & childr. over 12 yrs: 1 drp.in
Fluorometholone 1 mg, neomycin sulph. 5 mg/ml. Apply 1.5 cm 3xdly x3 days pre-op, then 1.5 cm immed.upon complet. each eye twice dly. Incr.if necess to 4xdly.
Indications: Infect.conjunctivit.sens.to neomycin, anter. segm.in- surg. At 1st dress. change, 1 day follow.surg.apply 1.5 cm 3xdly for Contraindications: Childr.und.4 yrs., safety in pregn.& lactat.not est.
flamm.disords.complicat.by bact. sens. to neomyc., foll.remov.for- 1st 9 days. Maint: Apply 1.5 cm dly.from day 10 to day 20. Max. 7 g. Side effects: Mild trans.irrit./burn., conjunctivit., eye pain, ab-
eign bodies, pre-/post-op. Contraindications: Epithel.H.simplex keratit., vaccinia, varicella, norm.vis., headache, taste pervers., prurit.,dry mouth, naus., asthen.
(S4) SUSP. J/15.2/335. other corn.& conjunct.vir.dis., ocul. fung.dis., uncomplic.remov.of Special precautions: Avoid with contact lens., not intend.for eye
726966-002: 5 ml, R207,72 corn.foreign body, mechan.lacerat.& eye abras. infects., poss.adverse effs.on corn. permeabil& disrupt.of corn.epithel.
Dosage: 1-2 drps. 2-4xdly. Dur.init. 24-48 hrs. safely incr.to 1 drp.hrly. Side effects: Uncomm: Incr.IOP, eye pain/-prurit./-irrit., ocul.dis- with prolong./ rep.use, reg.ophthalmolog.exam., extens. ocul.surf.dis.,
Do not discont. prematur. comf. Less.freq: Eye infects. (exacerbat./second.) adren.suppress., lacks signific.sedat.effs.but sedat. poss.in some indiv.
Contraindications: Ac.untreat.purul.ocul. infects. not sens.to neo- reduc. vis.acuity, glauc, vis.field defects, subcapsul. cataract., imp.
mycin, ac. superfic.keratit.& conjunctivit. due to superfic.H.simplex., heal.of admin.site, optic nerve injury, corn.perforat., eye irrit., Rare: OXYLIN, Allergan [P/S]
fung.dis., vaccinia/ varicella/most other conjunctiv.& corn. vir. dis., Keratit., eye allergy, blurr.vis., dry eye, ocul.hyperaem., dysgeus., Oxymetazoline HCl 0,25 mg, polyvinyl alcoh. 14 mg/ml.
ocul.TB, mycobact.infects., glauc., pregn. & lactat., safety & effic. periorbit.erythema, Post-market: Hypersens., dizzin., headache, Indications: Conjunctivit., eye irrit.
not est.in childr. <2yrs eye lid oed./-erythema/-prurit., mydrias., incr.lacrimat., naus., abdom. (S2) EYE DROPS. V/15.4/41.
Side effects: Post.subcapsul.lenticul.opacit., system. hypercor- discomf., rash, swell.face, 751952-001: 15 ml, R68,68
ticoid., corneal ulcerat./thinn./ calcificat., keratic perforat., incr. Warnings and special precautions: High.risk of corticoster.in- Dosage: 1-2 drps. 2-4xdly.
IOP, eye irrit./ prurit./ pain/disch./oed/swell, conjunctiv./ocul. hy- duc.glauc.with fam./person.glauc. hist., glauc.not always revers.on Contraindications: Clos.angle glauc.
peraem., vis.disturb., foreign body sensat.in, eyelid oed., blurr.vis., discont., monit. IOP rout.with use x10 days/long & wkly.for glauc. Side effects: Pupill.dilat., rebound congest.& mios., ocul.pain., incr.
incr.lacrimat., mydrias., cataract, ulcerat. kerat., conjunct.ulc., ocul. pts.esp.paeds., may mask progress.of bact./vir & fung.conjunctivit. IOP., sedat.in childr.
infect. incl. bact./fung.& vir.infects., vis.field defects, punctate kera- infects.till sight is lost, poss. perforat. with dis.caus.corn./sclera thin., Special precautions: Uncontr.hypertens., card. irreg., diabet., hy-
tit., skin rash, hypersens. poss. aggravat. of corn.ulcerat. theref.ulc.to be correct. diagnos.bef. perthyroid., other medicat.
Warnings and special precautions: Prolong. use may incr. IOP init.treatm., incr.risk of second.ocul. infects., poss.progress.of dendrit. Drug interactions: MAOI.
with poss.glauc.& damage to opt. nerve/defects in vis.acuit.& field. keratit., poss. cross sensitiv.to other concom.topic./system. amino- Warnings: Ingest.may cause sev.CNS depress.
of vis./delay. wound healing./incr.risk of secondar.ocul.infects, ac. glycos. antibiot., not for inj.into eye, concom. soft contact lens wear PATANOL, Novartis South Africa (Pty) Ltd
untreat./resist.infect.may be mask./activat.or enhanc., H.simplex not recomm.but when still wear.remove lenses bef.insert.& wait at See Section 15.7
hist., suspect fung.invas.in any persist.corn.ulcerat.with concom./ least 15 mins.bef.re-insert., tempor.blurr.vis.may affect ability to drive/
prior steroid use, discont.if sensitiv./other untow.reacts.occ., refer. operate machin., due to poss. adverse eff.on corn.permeabil.& corn. PREFRIN, Allergan [P/S]
condits.not respond.within 48 hrs.to ophthalmolog., poss.adverse epithel.with prolong.use reg.ophthalm.exam.reqd., prolong.use with Phenylephr.HCl 1,2 mg, polyvinyl alcoh. 14 mg/ml.
effs.on corn. permeabil. & disrupt.of corn.epithel.with prolong/ rep. extens.ocul.surf.dis., safety in pregn.& lactat. not est. Indications: Minor eye irrit.
use reg.ophthal.exam.reqd., prolong.use in extens. ocul.surf.dis., re- Interactions: Concom.topic.NSAID’s may delay corn.heal., (S0) EYE DROPS, J/15.4/84.
move soft cont.lens prior to admin. & wait >15 mins.follow.admin. 756555-019: 15 ml, R44,36
bef. reinsert., allow.15 mins.bef.installat.of other eye drops, avoid Dosage: 1-2 drps.3-4 hrly.as reqd.
dispen.contain.touch.eye/any other surf., in pres.of blurr.vis.& other Contraindications: Narr.angle glauc., not for use with soft cont.
vis.disturbs.eval. for other poss.caus.eg. cataract/glauc.& centr. se- 15.4 Decongestants lens., safety & effic.in pregn./ lactat./ paeds.not est.
rous chorioretinopathy, compress.lacrim.sac at medial canthus aft. Side effects: Dry eye, eye disch./irrit./pain/ prurit., incr.lacrimat.,
instill.to reduc.poss.system. absorpt. EMADINE, Novartis South Africa (Pty) Ltd mydrias., ocul.hyperaem., blurr. vis., hypersens.react.incl.sympts./
Interactions: CYP3A inhibit.poss.incr.risk of system. corticoster. See Section 15.7 signs of eye allergy & skin allergy
relat.effs. LIVOSTIN ED, Janssen Pharmaceutica [P/S] Warnings and special precautions: Arterioscleros. / hyper-
MAXITROL, Novartis [P/S] Levocabastine HCl equiv.to levocabastine. tens./hyperthyroid./prostat. enlargem./ diabet., MAOI ther./within
14 days of discont. such treatm., to minim.risk of potent. system.
Polymyxin B 6 000 iu, dexamethasone 1 mg, neomycin 3 500 iu/ml or g. Indications: Season.allerg.conjunctivit. effs.depress.punctat aft.instill.to reduc. drainage through nasolac-
Indications: Ac./chron.non-purul.conjunctiv./ blepharoconjunctivit (S2) EYE DROPS. X/5.7.1/268. 0,5 mg/ml (ie. 15 µg/drop) rim.duct to oral & nas. mucosa, inflam.eyes, remove soft cont.lens.
& keratoconjuncitivit., non-spec.superfic.keratit., deep keratit., acne 809896-001: 4 ml, R187,94 prior to admin. & wait >15 mins.follow.admin.bef. reinsert., avoid
rosacea keratit., iridocyclit., mild ac.iritis, recurr.margin. ulcerat.& corn. Dosage: Adults & childr.over 5 yrs: 1 drp.2x/ day incr.up to 1 drp.3- touch.dispen.contain.to eye/any other surf., discont.if pt.exper.
ulc.(caut.in dis.caus.corn.thinn. because of perforat.danger) non-purul. 4xdly. Max.treatm.durat: 8 wks. eye pain/vis.chang./ ocul. irrit./eye irrit.& redn.persist.over 72 hrs.,
blepharit., sclerit., episclerit., scleroconjunctiv., H.Zoster ophthalmi- Side effects: Loc.irrit., eye pain, conjuntiv., eyelid oed./swell., reg. ophthal. exam.reqd.with prolong./rep.use, extend. use with
cus (not for use in H simplex), post-op for ophthalm.infect.prophylax. blepharit., ocul.hyperaem., blurr.vis., applicat.site/allerg.reacts., extens. ocul. surf. dis.
(S4) SUSP. [P/S] H1145 (Act 101/1965). anaphylax., angioed., cont. dermatit., urticar., headache, palpitat Interactions: Concom.MAOIs/TCA’s./ guanethid./ system. adren-
740454-005: 5 ml, R169,70 Warnings and special precautions: Do not wear soft con- erg.blocks.may alter effs.
Dosage: 1-2 drps.4-6xdly.reduc.aft. 3-4 days on satisfact.response. tact lens., effs.on corn.permeabil.& disrupt.of corn.epithel.with
(S4) OINT. [P/S] H1158 (Act 101/1965). prolong.use, reg. ophthalmolog.exam.reqd., extens.ocul.surf.dis., SPERSALLERG, AI Pharm Ltd [P/S]
740462-008: 3,5 g, R174,09 teratogen. eff./embryotoxic.in rats at high system. dos., poss.ad- Antazoline HCl 0,5 mg, tetryzoline HCl 0,4 mg /1 ml.
Dosage: Appl.small amount 3-4xdly. Satisfact. respon.reduc.grad. verse sedat.theref.advis.to determin indiv.respons.bef.driv./per- Indications: Conjunctivit.
to once dly.x sev.days. form.complic.tasks. (S2) DROPS. H1283.
Contraindications: Ac,purul.conjunctiv.& blepharit., tubercul., 765856-018: 10 ml, R49,03
fung.& vir.les.(H.simplex-dentric keratit.), vaccinia, varicella, mechan. OCULERGE, (Aspen Pharmacare: Consum) Pharmacare [P/S] Dosage: Adults: 1 drp 3-4xdly. Childr.2-12 yrs: 1 drp.1-2 xdly.
lacerat.& abras. Antazoline HCl 0,5 mg, tetrahydrozoline HCl 0,4 mg /1 ml. Contraindications: Dry eyes esp. keratoconjunctiv. sicca, narr.
Side effects: Delay.wound heal., develop.& spread. of infect. Indications: Hay fev.& allerg.conjunctivit. angle glauc.risk, MAOI’s, childr.und.2 yrs.not recomm., safety in
mask.progress.until sight lost, glauc.in prolong.use theref.freq.IOP (S2) EYE DROPS. 31/15.4/0144 pregn.& lactat. not est.
monit.reqd., optic nerve damage, vis.acuity defects, post.subcap- 827150-008: 15 ml, R32,51 Side effects: Irrit., blurr.vis., headache, drowsin, tachycard., syst.
sul. cataract format. Dosage: 1 drp 3-4xdly.into low.lid reacts.esp.childr./elderly, antimuscarin. effs.
Ophthalmics - 15.6
202 / 2020-04
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Proprietary name: Artelac ® Advanced Lipids Eye Drops. Contains 2 mg carbomer, medium chain triglycerides. Preservative: Cetrimide (10 g multi-dose only). Proprietary
name: Artelac ® Intense Rebalance Eye Drops. Contains 0,15 % hyaluronic acid (as sodium hyaluronate), 0,5 % polyethylene glycol 8000, vitamin B12. Preservative: Oxyd ®
(a gentle preservative that converts to water, oxygen and salt at the surface of the eye in the 10 ml multi-dose unit only). Proprietary name: Artelac ® Splash Eye Drops. Contains
0,24 % hyaluronic acid (as sodium hyaluronate) in the 10 ml multi-dose unit and 0,2 % hyaluronic acid (as sodium hyaluronate) in the single dose units. Both the 10 ml multi-dose
and single dose units are preservative free. Proprietary name: Artelac ® Moisture Eye Drops. Contains 0,32 % hypromellose. Preservative: Cetrimide (10 ml multi-dose only). For
full prescribing information, refer to the instructions for use. Further information is available on request from Bausch + Lomb. © 2017 Bausch & Lomb Incorporated. ®/™ denote
trademarks of Bausch & Lomb Incorporated. Distributed by: Soflens (Pty) Ltd. Reg. No.: 1968/011787/07. 254 Hall Street, Centurion. Tel: +27 10 025 2100. www.bausch.co.za
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Ophthalmics - 15.4 / 15.5 / 15.6 2020-04 / 203
Special precautions: Poss.adverse effs.on corn. permeabil.& corn. Dosage: Refract: 1 drp. 2xdly 1-2 days bef. exam, 1 drp.1 hr.bef.exam.
epithel.with prolong.use, reg. ophthalmolog.exam.requir., extens.ocul. Uveit: 1 drp 3xdly. 15.6 Glaucoma
surf.dis., soft cont.lens., incr.IOP, hypertens., card.irreg., hyperthyroid., Contraindications: Clos.angle glauc., narr.angle betw.iris & corn.,
diab.mellit., poss.rebound congest. belladonna alkal.hypersens. AZARGA (MDR Listing)
Drug interactions: Addit.antimuscarin.eff.with antimuscarin.drugs. Side effects: Hypersens.as conjunctiv., incr.IOP. AZOPTIC (MDR Listing)
ZADITEN, AI Pharm Ltd [P/S] Special precautions: Syst.toxicity esp.in infts, syst.absorpt.poss. COSOPT (MDR Listing)
DUOTRAV (MDR Listing)
minim.by compress.lacrim.sac x1-2 mins.dur.& follow.instillat., my-
Ketotifen driat.& cyclopleg. admin.to elderly & others where an incr. IOP poss., SAFLUTAN (MDR Listing)
Indications: Season.allerg.conjunctivit. tonometr.exam., due to poss.adverse eff.on corn.permeabil.& corn. SPERSATAN (MDR Listing)
(S2) EYE DROPS, 35/15.4/0076 epithel.with prolong. use reg.ophthalm.exam.reqd., prolong.use with TRAVATAN (MDR Listing)
701256-001: 0,25 mg/ml, 5 ml, R166,88 extens.ocul.surf.dis. XALACOM (MDR Listing)
Dosage: Adults & childr.3 yrs.& old: Instil 1 drp.2-3 x dly. XALATAN (MDR Listing)
Contraindications: Safety in pregn.& lactat.not est. MINIMS CYCLOPENTOLATE HYDROCHLORIDE 1%,
Side effects: Blurr.vis., drowsin., conjunctiv.inj., headache, rhinit., (Bausch & Lomb) SofLens [P/S] ALPHAGAN PURITE, Allergan [P/S]
ocul.allerg.reacts., conjunctivit., discharge, dry eyes, eye pain, Cyclopentolate HCI. Brimonidine tartrate
eyelid disord., keratit., lacrimat.disord., mydrias., photophob., flu Indications: Mydrias.& cyclopleg., iridocyclit., applanat.tonometry. Indications: IOP low.in open-angle glauc/ocul. hypertens.
syndr., pharyngit. (S3) SOL, C/15.4/49 (S3) SOL. A39/15.4/0202. 1,5 mg/ml
Special precautions: Allow 15 mins.to elapse bef.re-insert.contact 743402-014: 5 mg/0,5 ml, 20x0,5 ml, R306,31 709410-001: 5 ml, R178,63
lenses, 5 min.interv.betw. applic.of other ophth.meds, poss.adverse Dosage: Sngl.dos.eye drops. Use accord.to ophthalmol. Dosage: 5 min.interv.betw.other topic.ophthal. meds.
eff.on corn. permeabil.& corn.epithel.with prolong.use., prolong.use Adults & childr: Recomm.dos: 1 drp.in affect.eye(s) 2xdly.12 hrly.apart
with extens.ocul.surf.dis. Refraction: 1 drp.of 0,5 % sol.repeat.aft.5 mins. usual.suffic.but Contraindications: MAOI’s, no studies in pregn. & lactat., not
Drug interactions: Effs.of CNS depress.& antihist. potent. deeply pigment.eye may requir. 1 % sol. recomm.in childr.< 2 yrs.
Lenticul.adhes: Instil 1 or 2 drps.of 0,5 % sol. follow aft.6 hrs.by 1 or Side effects: Allerg./follicul.conjuctivit., conjunctivit. hyperem./fol-
2 drps.of a 2 % sol.of pilocarpine nitr. Altern.treatm.to be repeat.dly. liculos./oed./haemorrh., prurit., blepharit., burn.sensat., conjuctivit.
15.5 Mydriatics Iritis or iridocyclit: Instil 1 or 2 drps.of 0,5 % sol. 6-8 hrly. epiphora, eye disch./dryn./irrit./pain, foreign body sensat., photo-
phob., sting., superfic.punctuate keratophy, vis.disturb., vis.field.
Contraindications: Narr.angle glauc., narr.angle betw. iris & cornea,
neonates except on expert evaluat. defects, vitreous floaters, vis.acuity worsen., blepharoconjunctivit.,
ATROPINE EYE DROPS AI Pharm Ltd [P/S] Side effects: Incr IOP, necr.colit.preterm inft., seiz.esp.childr., mouth corn. eros., cataract, keratit., tear., vitreous detachm./ disord, dizzin.,
Atropine sulph. dryn., photophob., rarely syst.effs.from parasympatholyt.act. headache, somnol., taste pervers., hypertens., insomn., cough, dyspn.,
Indications: Cycloplegic/mydriat.for refract., dilat.of iris or uveal nasal dryn., dyspeps., oral dryn., GI disords., eyelid oed./ erythema,
tract dur.ac.inflamm.condits.. MINIMS PHENYLEPHRINE HYDROCHLORIDE 10 %, rash, allerg.react., bronchit., flu syndr., pharyngit., rhinit., sinus in-
(S3) DROPS. J/15.4/312. (Bausch & Lomb) SofLens [P/S] fect., sinusit., asthen., bradycard., hypotens., irit., mios., skin reacts.,
705632-008: 10 mg/ml, 5 ml, R36,75 Phenylephrine HCI. depress., keratoconjunctivit.sicca, tachycard., apnoea/ bradycard./
Dosage: Uveitis: 1 drp. 3xdly. Indications: Mydriat., open angle glauc. hypotherm./hypoton.& somnol. in infts, fatig., drowsin.
Refract: 1 drp. 2xdly 1-2 days bef.exam.& 1 hr. bef.exam. Maint. (S1) SOL, D/15.4/22. 50 mg/0,5 ml Warnings and special precautions: Concom. b-block./ antihy-
press.over lacrim.sac for 1 min.aft.install. 743429-028: 20x0,5 ml, R315,05 pertens.&/card.glycosides, TCA poss. affect.metabol.& uptake of
Contraindications: Glauc., childr.und.6 yrs., belladonna alkal.sensitiv. Dosage: Sngl.dos.eye drops. Adults & childr.as direct.by oph- circul.amines., sev.CV dis., hepat./ren.impairm., depress., cerebr./
Side effects: Flush., dry skin/mouth, blurr.vis., rapid pulse, dizz., thalmol. coron. insuff., Raynaud’s phenom., orthostat. hypotens., throm-
conjunctiv.irrit. Contraindications: Hypertens., hyperthyroid., part. heart block, boangiit.obliterans, monit.IOP routinely in pts.using IOP low.meds.,
Special precautions: Extens.ocul.surf.dis., reg. opthalm.exams., myocardit., bradycard., coron. circulat. impairm., infts., elderly, card. ocul.surg./ intercurr.ocul.condits.
discont.if eye pain occurs. dis., adv.arterioscleros., angle-clos.glauc., MAOI’s, TAD’s, beta- Drug interactions: Poss.addit./potent.effs.with concom.CNS de-
CYCLOGYL, Alcon [P/S] block., RIMA’s press./antihypertens., MAOIs may affect.metabol.& incr.system.
Side effects: Pseudoephedr.cross-sens., liberate pigm.from iris,
Cyclopentolate HCl. corneal cloud., allerg.conjunctiv., irrit. on applicat.to eye, blurr.vis., adverse eff.
Indications: Mydrias.& cyclopleg.in diagn. proced. photophob., conjunct. sensit., allergy, tachycard.reflex bradycard., ATANA, (Gen-Eye) Actor Pharma [P/S]
(S3) SOL. H1147. 10 mg/ml. palpitat., extrasystoles, card. dysrhythm., periph.vasoconstrict., hy- Latanoprost
717029-018: 15 ml, R194,04 pertens., periorbit. pallor preterm pts, paed.pulm.oed. Indications: Elev.IOP reduc.in open angle glauc./chron.clos.angl.
Dosage: Adults: 1 drp.follow.by 2nd drp.in 5 min. Childr: 1 drp. Warnings and special precautions: Sev. ischaem. heart dis., glauc.& ocul.hypertens.
each time at time of refract.follow. 10 min. by 2nd applic.if necess. diab.mellit., prostat.hyperplas., anter.chamb.angle, ocul.hyperaem., (S4) OPHTH.SOL. 47/15.4/0116. 50 µg/ml.
Contraindications: Clos.angle glauc., narr.angle betw. iris and corn. min.system. absorpt. by compress.lacrim.sac. 720971-001: 2,5 ml, R165,17
Side effects: Trans.sting., incr.IOP, syst.reacts., CNS and card. Interactions: Antihypertens.revers.act., MAOI’s incr. advers.reacts., Dosage: If other topical ophthalmolog.meds.are being used admin.
pulm.S/E esp.in prem.& small infts. with syst.absorpt., feed.intol.in TAD’s potentiat.press.respon. & risk card. dysrhythm., halothane incr. at least 5 mins.apart.
neonat.& infts. follow.ophthal.use, atax., behav.disturbs., psychot. re- ventric. fibrillat., digox,/quinidine incr.dysrhythm. Adults: 1 drp in affect.eye(s) once dly.pref.in even. Do not exceed
acts., confus., fast/irreg.heartbeat, fev., halluc., skin rash, slurr.speech, once dly dos. Cont.with next dos.as plann.if 1 dos.miss. IOP reduct.
swollen stomach in infts., thirst, dry mouth, unusual drowsin., tiredn., MINIMS TROPICAMIDE 1 %, (Bausch&Lomb) SofLens [P/S] init.3-4 hrs aft. admin. with max.effect. obt.8-12 hrs.later.& maint.
weakn., vasodilat., blepharoconjunctivit., hyperaem., punctat.keratit., Tropicamide. for at least 24 hrs.
synech., blurr.vis., eye burn., hypersens.eg. conjunctivit. Indications: Mydriat.& cyclopeg.of rapid onset.& brief durat. Contraindications: Safety in pregn & lactat.not est., safety & ef-
Special precautions: Elderly/where IOP risk incr., with hold inft.feed. (S3) SOL, N/15.4/123. 5 mg/0,5 ml fic.in childr.not est.
x4 hrs.aft.examinat., tonometr. exam.prior to instillat.advis., when pro- 743437-012: 20x0,5 ml, R339,13 Side effects: Incr.iris pigmentat., eye col.& eyelash chang., mild
longat.of cyclopleg.desir only 1 addit.drop recomm., do not drive/operat. Dosage: Sngl.dos.eye drops. Adults: 2 drps.at 5 min.interv.furth.1-2 foreign body sens., punctate epithel. keratopathy, conjunctiv.hyper-
machin.in event of blurr.vis., psychot.react.& behav.disturb.esp.in childr., drps.aft.30 mins.if reqd. Childr: At discret.of ophthalmolog. aem, periorbit. oed., uveit./irit., corn.oed./eros., palpebr. skin darken.,
photophob., safety in pregn.& lactat.not est., observ.infts.x30 mins.follow. Contraindications: Narr.angle betw.iris & cornea. macul.oed., ang.pect., dyspn., cough., ac.asthma attack, asthma ag-
instillat.as system. toxic.report., incr.susceptibil.in infts.& young childr./ Side effects: Photophob., conjunctiv.irrit., poss. syst. toxic.particul. gravat., URTI, colds & flu, musc./joint/back/chest pain, bact.keratit.
childr.with blue eyes& blond hair/ Down’s syndr./spast.paralys.or brain in.small childr.(dry mouth, bradycard. follow.by tachycard.) Warnings and Special precautions: Cont. high benzalkon.chlor.
damage, due to poss.adverse eff.on corn.permeabil.& corn. epithel. Special precautions: Inadeq.for cyclopleg.in childr. conc.poss.absorb by cont. lens., cyst.aphak./pseudophak.pts.with
with prolong.use reg.ophthalm.exam.reqd., prolong.use with extens. torn post. lens capsul./pts.with risk fact.for macul.oed., pts. to be
ocul.surf.dis., poss. undiagn. predisposit.to angle clos.glauc.in elderly. MYDRIACYL, Alcon [P/S] inform.of potent.grad.incr.brown iris pigmentat. & poss. disparity
Tropicamide.
CYCLOMYDRIL, Alcon [P/S] Indications: Mydrias.& cyclopleg.for fundus exam.& refract., pre-& betw.treat.& untreat. eye, eye colour chang.mainly in mix. colour
Cyclopentolate HCl 2 mg, phenylephr.HCl 10 mg/ml. post op.states where short- act.mydriat.reqd. irides with onset within first 8 mnths.of ther., ren./hepat.impairm.,
Indications: Mydrias.of irises for funduscop. exam. (S3) SOL. H1154. 10 mg/ml. URTI, colds, flu, skin reacts., reg.ophthalmolog.exam.reqd., extend.
(S3) SOL. H1149. 745383-009: 15 ml, R187,32 use in pts.with extens.ocul.surf.dis., no exper.in ac. clos. angl.glauc.
717037-002: 5 ml, R177,87 Dosage: Refract: 1-2 drps.rep.in 5 mins. 1 addit. drp.to prolong. attacks, ocul.reacts.esp. conjunctiv. /lid reacts., remove contact lens.
Dosage: Fundoscopy: 1 drp.in each eye every 5-10 min.max.3x. mydriat.eff.if not examin.within 20-30 min. bef. admin.& wait at least 15 min.to reinsert., limit. exper. in inflamm.
Heavily pigment.iris.may req.larg. dos. Apply press.over the nasol- Fundus exam: 1 drp. 15-20 min.bef.exam. ocul.condits./inflamm. neovasc. angl.clos./congenit.or pigment.glauc.
acrim.sac.in premat. & small infts.x2-3 mins.follow.instillat. observ. Compress.lacrim.sac at medial canthus by digit. press for at least /pseudophak. pts.with open angl.glauc., med. advice in case of inter-
closely for at least 30 mins. 1 min aft.instal.to reduc.system. absorpt. curr.ocul.condit., ocul. infects.
Contraindications: Clos./narr.angle glauc., anatom.narr.angle, Contraindications: Narr./clos.angle glauc., safety dur.pregn.& in Drug interactions: IOP reduc.eff.is addit.to that of beta-adrenerg.
MAOI’s/within 10 days of stop.such treatm. breastfeed.women not est., hypersens.to anticholinerg. antagon., eff. was addit.in combin. with adrenerg.agonists (dipiv-
Side effects: Incr.IOP, syst.reacts.partic.in childr., trans.sting., hy- Side effects: Loc.incr.IOP, trans.sting., blurr.vis. & light sens.second.to efrin)/oral carbonic. anhydr.inhibit.(acetazolamide) & partly with
persens.eg. conjunctivit. pupillary dilat., photophob., with/without corneal stain., loc.irrit.with cholinerg.agonist (pilocarpine), precipitat. occurs with eye drops
Special precautions: Psychot.react./behav. disturb. & prolong. admin., hyperaem., oed., conjunctiv., dry mouth/ skin, flush., cont.thiomersal.
cardiopulm.S/E partic.in childr., advis. parents not to get into child’s bradycard.foll.by tachycard.with palpit. & arrythm., urin.urgency/dif-
mouth and to wash hands aft.admin., elderly & other with incr. IOP, fic.& retent., reduc. tone & motility of GI tract lead.to constip., vomit., AZARGA, Novartis [PWR] &
Brinzolamide 10 mg, timolol 5 mg/ml
estim. depth of angle of ant.chamber to avoid induc. angle clos.glauc., giddin., stagger., rash in childr., abdom.distent.in infts.
photophob., driv.& hazard. activ., CV dis., hypertens., hyperthyroid., Special precautions: Elderly, incr.IOP, shallow ant.chamber, estim. Indications: Decr.of IOP in adults with open-angle glauc. or ocular
hypertens.where monother. prov.insuffic.IOP reduct.
reacts. simil. to other anticholinerg.produc., restrict to short term use depth of angle of ant.chamber to avoid induc.angle clos.glauc., poss.
as eff.of long-term admin.not est., due to poss.adverse eff.on corn. CNS. disturbs./ psychot.reacts./behav.disturbs.& CV collaps. from (S4) SUSP. 44/15.4/0046
717260-001: 5 ml, R212,57
permeabil.& corn. epithel. with prolong.use reg.ophthalm.exam.reqd., anticholin.hypersens., infts.& childr., childr. & indiv.suscept.to bel-
prolong.use with extens.ocul.surf.dis. ladonna alkaloids, oral tox., inflam.eye, adverse effs.on corneal per- Dosage: Adults incl.elderly: 1 drp.in conjunctiv. sac of affect.eye(s)
Drug interactions: Phenylephr.effects enhanc.by guanethidine, re- meabil. & danger of disrupt.of corneal epithelum with prolong./ rep. 2xdly. Nasolacrim.occlus. aft.instillat. poss.reduc.system.S/E. Admin.
serpine, methyldopa, TCA’s. benzalkonium chloride use, reg. ophthalmolog. exam.reqd., prolong. other topic. meds.at least 5 mins.apart. Treatm.to start follow.day
when substit.anoth.anti-glauc.agent with Azarga.
ISOPTO-ATROPINE 1%, Alcon [P/S] use with extens. ocul.surf.dis., do not drive/engage in other hazard. Contraindications: Bronch.asthma/hist.therof, sev.chron.obstruct.
nd
Atrop.sulph. activ.unless vis.clear as complet recov. from eff. poss. takes upto 6 hrs. pulm.dis., sinus bradycard.,sick sinus syndr., sino-atr.block, 2 / 3 rd
Indications: Long act.mydriat., cyclopleg. Drug interactions: Concom.admin.of other meds. with anti-mus- degr. AV block, overt CF, cardiogen.shock, sev. allerg.rhinit.& bronch.
(S3) SOL. H1135. 10 mg/ml. carin.propert.eg.amantadine/some anti-histamines/butyrophenones/ hyperactiv., other B-blocks./ sulphonam. hypersens., hyperchloraem.
734276-001: 5 ml, R154,18 phenothiaz.& TCA poss.enhanc.anti-muscarin.agents effs. acidos., sev.ren. impairm., safety & effic.in pregn.& lactat./childr. bel.
204 / 2020-04 Ophthalmics - 15.6
18 yrs.not est., not stud.in narr.-angle glauc., concom.oral carbon.an- agents, diabet., thyrotoxicos., bronch.asthma, chron.bronchit., use Side effects: Conjuctivit. hyperaem./folliculos./ oed./, burn.sensat.,
hydrase inhibit.not recomm. with miot.in angle clos.glauc., maj.surg., concom. adrenerg.psycho- eye prurit., allerg./follicul. conjuctivit., vis.disturbs., eyelid pain/prurit.,
Side effects: Insomn., dysgeus., mydrias., blurr. vis., eye irrit./pain/ trop.drugs, diminish.respons.with prolong.use., poss.adverse eff.on blepharit., epiphora, corn.eros., superfic. punctuate keratit., eye disch./
discharge/prurit., foreign body sensat., punct. keratit., dry eye, ocul./ corn.permeabil.& corn.epithel.with prolong.use, prolong.use in ex- dryn./irritat./pain, foreign body sensat., vis.acuity worsen., vitreous
conjunctiv. hyperaem., allerg.conjunctivit./blepharit., ant. chamber tens. ocul.surf.dis., lactat. floaters, asthenopia, photophob., papillary hypertrophy, conjunctiv.
flare, eyelid marg.crust./erythem., astenop., abnorm.eye sensat., Drug interactions: Mydrias.with concom.ophth. epinephr., poss. blanch., corn.infiltrates, vitreous detachm., depress., somnol., head-
decr.BP, COPD, pharyngolaryng./back/extremit./ren.pain, cough, addit.eff.with catecholamine-deplet. drugs, potent.addit.eff.with ache, dizzin., syncope, CHF, palpitat., hypertens., rhinit., nasal/oral
rhinorrh., hair disord., lichen planus, GI disturbs., nasopharyngit., si- oral ß-adrenerg. block.agents. dryn., taste pervers., eyelid oed./ erythema, allerg.contact dermatit.,
nusit., pharyngit., rhinit., decr. red bld.cells, incr.bld.chlor., hypersens., asthen. Potent.advers.effs: Irit., miosis, insomn., arrhythm., hypo-
hypoglycaem., psych.disords., decr.libido, CNS effs., cerebr.ischaem., BRIMOCT, (Gen-Eye) Actor Pharma [P/S] tens., URT sympts., dyspn., GI disturbs., system.allerg.reacts., decr.
dizzin., paraesthes., trem., headache, hypoaesthes., ageus., CVA, my- Brimonidine tartrate corn. sensitiv., diplop., ptos., choroid.detachm., refract. changes, py-
asth. grav., keratit., keratopathy, incr.opt.nerve cup/disc ratio, corn. Indications: IOP low.in open-angle glauc./ocul. hypertens. sch.disords., memory loss, myasth. grav.S&S incr., paraesthes., cerebr.
disord./epithel.defect/stain/oed./eros., incr.IOP, eye depos./swell./ (S3) OPHTH.SOL. 45/15.4/0688. 2 mg/ml ischaem., tinnit., heart block, card.arrest, bradycard., hypotens., CVA,
allergy, meibomianit., diplop., glare, photophob., photops., vis.acuity 721293-001: 5 ml, R156,95 claudicat., Raynauds, cold hands & feet, bronchosp., resp. fail., cough,
reduc., pterygium, ocul.discomf., keratoconjunctiv. sicca, eye hypo- Dosage: Recomm.dos: 1 drp.in affect.eye(s) 2xdly.12 hrly. 5 min. alopec., psoriasiform rash/psorias.exacerbat., SLE, Peyronie’s dis.,
aesthes., sclera.pigment., subconjunctiv. cyst, incr.lacrimat., eyelid interv.betw.other topic.ophth. meds. oed., chest pain. Aphak.cystoid macul.oed./nas.congest./anorex./
ptos./ disord./ oed., madaros., abnorm.vis., tinnit., vertigo, cardioresp. Contraindications: MAOI’s, safety & effic.in pregn./ childr. behav. changes/hypertens./retroperiton.fibros.& pseudopemphig.
distress, ang., bradycard., dysrhythm., palpitat., tachycard., card.fail./ und.2 yrs.not est. report.but causal relationsh.not est.
arrest, AV block, hypertens., hypotension, dyspn., asthma, bronch. Side effects: Conjunctivit. hyperaem./oed./ haemorrh. /folliculos., Special precautions: Advers.reacts.found with system.admin.
hyperactiv., epistax., URT congest., throat irrit., postnas.drip, sneez., allerg./follicul.conjuntivit., eye prurit./pain/dryn./irrit./disch., burn./ poss., CF to be adeq.control., CV dis., spontan.hypoglycaem/diab.as
nas.dryn., resp.fail., bronchosp., skin reacts., musc.spasm, myalg., ar- foreign body sens., sting., blepharit., epiphora, vis. disturbs. /field ac. hypoglycaem. sympts.poss.mask., not for use in ac. angle-clos.
thralg., pollakiur., erect.dysfunct., asthen., chest discomf./ pain, fatig., defects, worsen.vis.acuity, superfic. punct.keratopathy, vitreous glauc., contact lens., poss.advers. eff. on corn.permeabil.& corn.epi-
periph.oed., feel.abnorm./ jittery, irritability, meds.residue, malaise, float., corn.eros., irit., mios., CNS effs., headache, dizzin., psych.dis- thel.with prolong. use, extens.ocul.surf.dis., concom.b-block. / antihy-
syst. effs., sulphonam.adverse reacts. ords., hypertens., hypotens., palpitat., bradycard., tachycard., allerg. pertens.&/card.glycos., TCA poss. affect. metabol.& uptake of circul.
Warnings and special precautions: Reproduct. toxic.in animals, reacts., eyelid erythem., vasodilat., dyspn., cough, nas./oral dryn., dys- amines., ser. effs. report.in infts.28 days-3 mnths., depress., cerebr./
timolol excret.in breast milk, elderly, asthma, unstab.diab., hypogly- peps., sinusit., sin.infect., flu syndr., broncit., rhinit., pharyngit., asthen. coron.insuffic., Raynaud’s, orthostat. hypotens., thromboanglit.oblit-
caem., hyperthyroid., Prinzmetal ang., sev.periph.& circulat. disord., Warnings and special precautions: Ser.CNS effs.report.in in- erans, other alpha-adrenocept.agon.hypersens., pts.with hist.of sev.
contr.CF bef.init.ther., absorb. system., hypotens., discont.if S&S of fts.with topic.use theref.not recomm. in paed.pts.und.2 yrs., lactat., anaphylact.react.to variety of allerg.poss.more react.to rep.challenge
hypersens./ ser.reacts.occ., pt.hist.of sev.anaphylact.reacts.to a va- soft cont. lens., reg.ophthalmolog.exam., extens. ocul.surf. dis., dry & poss.unrespons.to usual epinephr.dos., maj.surg., thyroidtoxicos.,
riety of allergens poss. unrespons.to usual adrenaline dos., limit.ex- eye syndr., monit.IOP with other concom. IOP low.meds., sev.CV dis., hepat./ ren.impairm., gen.avoid in COPD & bronchospast. dis.or hist.
per.in pseudoexfoliat. /pigment. glauc.& IOP monit.recomm., cont. elderly, Raynaud’s phenom., cerebr./coron.insuff., depress., orthos- thereof, potent.decr. ment.alertn., ocul. surg./intercurr.ocul.condit.
lenses, monit. other condit.with comprom.corneas eg. diab., 15 min. tat. hypotens., thromboangiit.obliterans., no studies in ren./hepat. Drug interactions: Poss.addit.effs.with oral Ca antagon./catecho-
interv.aft.instillat.bef.insert.contact lens., avoid soft cont. lens., con- impairm., concom. b-block./ antihypertens. &/ card.glycosid., TCA lamine deplet.meds./ß-adrenerg. block.agents, poss.addit./poten-
com.CYP3A4 inhibit., poss.mask hypoglycaem./hypothyroid. sympt., poss.affect. metabol.& uptake of circul.amines., syst.clonidine hy- tiat. effs. with concom.CNS depress., mydrias.report. with concom.
monit.with freq./prolong use, CF adeq. contr. bef.init.ther., sev.card. potens.eff.poss.blunt.by TCA’s. epinephr., system.beta-block. potent. with quinidine.
dis.hist., poss.fatal reacts. with bronchosp.in asthma pts., concom. Drug interactions: Poss.addit./potentiat.effs. with concom.CNS
oral ß-adrenerg.blocks., poss. risk of metabol.acidos.in pts. with ren. depress., alpha-agonists may reduc. pulse & BP. COSOPT, Mundipharma [PWR] &
Dorzolamide 20 mg, timolol 5 mg/ml.
impairm.risk., musc.weakn. consist. with cert.myasthen.sympts., CO-ATANA, (Gen-Eye) Actor Pharma [PWR]
choroid.detachm., may block system. ß-agonist effs.of adrenaline Latanoprost 50 µg, timolol 5 mg/ml Indications: Elev.IOP in ocul.hypertens., open angle/pseudoexfoliat.
in surgic.anaesthes. Indications: IOP reduct.in open angle glauc.& ocul.hypertens. when glauc./other second.open-angle glauc.when concom.ther.is appropr.
Interactions: Metabol.poss.inhibit.by CYP3A4 inhibit., poss.hypo- intol.or uncontrol.on monother. other.than latanoprost & timolol. (S3) OPHTH.SOL. 32/15.4/0525
tens.&/mark.bradycard.with Ca chann. blocks./guanethidine/ß-adren- (S4) OPHTH.SOL. 47/15.4/0528. 860379-019: 5 ml, R223,95
erg. blocks./ antidysrhythm./digital.glycosid./ parasympathomimets., 722712-001: 2,5 ml, R172,65 Dosage: 1 drp.2xdly.in affect.eyes. Admin.other topic.meds.10 mins.apart
hypertens.react.potent.to sudd. clonidine withdr., potent.syst.ß-block- Dosage: 1 drp in affect.eye(s) once dly. If other topic.ophth.meds. Contraindications: Bronch.asthma/hist. thereof, sev.chron.obstruct.
ade with CYP2D6 inhibits., poss.incr.eff.of anti-diab. agents. are being used admin.at least 5 mins.apart. pulm.dis., sinus bradycard., 2nd/ 3rd degr.AV block, overt CF, cardio-
See also MDR page 121. Contraindications: Re-act.airway dis.incl.chron. obstruct.pulm. gen.shock., safety & effic.in pregn.not est.
Side effects: SLE, headache, dizzin., paraesthes., depress., incr.S&S
rd
nd
AZOPTIC, Novartis [P/S] & dis/bronch.asthma or hist.thereof, sinus bradycard., 2 /3 de- of myasthen.grav., decr.libido, CVA, loc.ocul.reacts., conjunctiv.inj.,
Brinzolamide gree AV block, cardiogen. shock, card.fail., safety in pregn.not est., blurr.vis., corneal eros., eyelid inflamm.& irrit., superfic. punct. keratit.,
Indications: Monother./adjunct.ther.to ß-block.for elev. IOP in ocular breast feed., childr. iridocyclit., trans.myop., choroid. detachm.aft.filtrat.proced., blephar.,
hypertens./open-angle glauc. Side effects: Incr.iris pigmentat., dark./thicken.& lengthen.of eye decr.corn. sensitiv., dry eyes, conjunctivit., vis.disturbs.incl. refract.
(S3) SUSP. 34/15.4/0382. 10 mg/ml lashes, eye irrit./hyperemia, corn. disords., conjunctivit., blepharit., chngs., ptos., diplop., tinnit., bradycard., syncope, hypotens., chest
701523-001: 5 ml, R202,85 eye pain, headache, skin rash, foreign body sensat., punctate epi- pain, palpitat., oed., arrythm., CHF, heart block, card.arrest, cerebr.
Dosage: Allow 10 mins.betw.admin.of other top. ophthalm.drugs. thelial eros., macul.& cystoid macul. oed., irrit./uveit., corn.oed.& ischaem., claudicat., Raynauds, resp.fail., epitax., dyspn., bronchosp.
Nasolacrim.occlus.aft.instillat. poss. reduc.system.S/E eros.,dyspn., asthma/ exacerbat., darken.of eyelid skin, ocul.irrit., dry in pre-exist.bronchospast.dis., cough, taste pervers., naus., dry mouth,
Monother./adjunct.ther: 1 drp.in conjunctiv.sac of affect.eye(s) eyes, keratit., decr.corn.sensitiv., vis.disturbs. incl.refract.changes, di- dyspeps., diarrh., contact dermatit., rash, alopec., psoriasiform rash
2xdly or 1 drp.3xdly. plop., ptos., choroid. detachm. aft.filtrat.proced., dizzin., insomn., incr. or exacerbat.of psoriasis, urolithias., Peyronie’s dis., asthen/fatig.,
Contraindications: Hypersens.to any compon.& sulphonam., sev. myasth.grav.S&S, paraesthes., nightmares, depress., memory loss., system. allerg.reacts.incl.anaphylax.
ren. impairm., hyperchloraem. acidos., concom.oral carbon.anhydrase tinnit., dysrhythm., heart block, CHF, palpitat., card.arrest, brady- Special precautions: Soft contact lense use, poss. adverse eff.on
inhibit., safety in pregn.,lactat.& paed.not est., hepat. impairm., not card., hypotens., cold hands & feet, claudicat., oed., cerebr.ischaem., corn.permeabil.& corn.epithel. with prolong.use, extend.use in ex-
stud.in narr.-angle glauc. Raynaud’s phenom., CVA, syncope, resp.fail., bronchosp.predom.in tens.ocul.surf. dis., contr.CF adeq.bef.init.ther., monit.sev.card. dis.
Side effects: Sulphonam.adverse reacts., Ocul. effs: Tempor.blurr. pre-exist. bronchosp.dis.,cough, psoriasiform rash, psorias. exacer- pts.,asthma, S/E report.with syst.admin.may occur, poss.addit.effs.
vis., ocul.discomf., foreign body sensat., ocul.hyperaem., dry eye, ocul. bat., alopec., allerg.react.incl.angioed., loc. & gen.rash, urticar., SLE, with syst.ß-adrenerg.block. agents., pts.with hist.of sev.anaphylact.
pain/ discharge /prurit., keratit., blepharit., conjunctivit., lid margin Peyronie’s dis., decr. libido, fatig., chest pain, asthen. react.to a variety of allergens may be more react.to rep. challenge
crust., sticky sensat., tear., eye fatig., keratopathy, abnorm.vis., kera- Warnings and special precautions: System. absorpt.theref. car- while tak.ß-block.& may be unrespons.to usual adrenaline dos., lac-
toconjunctivit., corn. stain., eye disord., photophob., meibomit., vis. diovasc.& resp.reacts.of ß-adrenerg.poss., control card.fail.adeq.bef. tat., elderly, poss.acid-base disturbs., potent.for corn.oed.in pts.with
changes, irritat., glare, lid disord., decr.vis., corn. eros. System.effs: init. treatm., in hist.of anaphylact.reacts.pts.more respons. to rep. low endothelial cell counts incr., safety in hepat. impairm./ childr.und.2
Taste pervers., chest pain, alopec., pain, GI disturbs., hypersens.re- challenge & poss.unrespons.to usual adrenal.dos., with concom.oral yrs.& ac.angl.clos.glauc.not est., concom.oral carbon.anhydr.inhibit.,
acts., CNS effs., rhinit., dyspn., pharyngit., bronchit., dry nose, epistax., beta-block. eff. on IOP & known beta-block.syst.effs.poss. exaggerat., use of 2 topic. ß-adrenerg.block.agents not recomm., not recomm.in
incr.cough, kidney pain, impot., incr.urin. freq. use of two loc.prostagland./two beta-block.not recomm., spontan. sev.ren.impairm.(creatine clear.<30 ml/ min.).
Special precautions: Limit.exper.in pseudoexfoliat. /pigment. hypoglycaem., diab., poss. masks sympts.of ac.hypoglycaem.& cert. Drug interactions: Poss.addit.effs.with concom. oral Ca chann.
glauc./concom. antiglaucoma agents other than timolol, contact. hyperthyroid. sympts., myasth.grav.sympts.aggrav., grad. incr.in brown block./catecholamine deplet.meds. & ß-adrenerg.block.agents,
lenses as corn.hydrat.poss.affect.poss.incr. risk to corn., other condit. pigment of iris.which may be perman., perman.heterochrom.poss. system.ß-block.potent. with CYP2D6 inhibit., acid base disturbs.
with comprom.corneas eg.diab., 15 min.interv.aft.instillat.bef.insert. in unilater. treatm., no/limit.exper.in treatm.of neovasc./ inflamm./ report. with oral carbon.anhydr.inhibit.poss., oral ß-adrenerg. block.
contact lenses, absorb.system., concom.CYP3A4 inhibit. chron.angle clos./congenit.glauc./open angle of pseudophakic agents may exacerb.rebound hypertens.follow.clonid.withdr.
Drug interactions: Metabol.poss.inhibit.by CYP3A4 inhibit. pts./& pigment.glauc., no exper. in ac.clos.angle glauc.attacks, risk See also MDR page 516.
See also MDR page 123. fact.for mac. oed./aphak.pts or in pseudophak.pts.with torn post. DUOTRAV, Novartis &
BETOPTIC, Novartis [PWR] lens capsule, poss.adverse eff.on corn. permeabil. & corn.epithel. Travopost 40 µg, timolol 5 mg/ml
with prolong.use, extend. use in extens.ocul.surf.dis., contact.lens
Betaxolol. use, excret.in breast milk. Indications: Decr.of elev.IOP in pts.with ocul. hypertens./open-
Indications: Low.IOP in chron.open angle glauc., elev.IOP. Drug interactions: Poss.addit.effs.with Ca chan. block./catecho- angle glauc.where treatm. with eith.indiv.ingred.alone prov.insuf-
(S3) SOL. S/15.4/371. 5 mg/ml. lamine-deplet. drugs/ß-block agents / antidysrhythm./parasympa- fic IOP reduct.
708445-004: 5 ml, R230,25 thomimet./digox./ MAOI & narcot., mydrias.with adrenaline, beta- (S4) SOL. A40/15.4/0511
Dosage: 1 drp. 2xdly. blocks.incr.hypoglycaem.eff.of anti-diabet. 708877-001: 2,5 ml, R258,69
(S3) S 0,25% SUSP. Z/15.4/150. 2,5 mg/ml Dosage: Admin.at least 5 mins.apart.from other top. ophthalm.
836052-005: 5 ml, R238,26 COMBIGAN, Allergan [PWR] meds. When substit.for another agent discont.it & then commenc.
Dosage: 1 drp. 2xdly. Brimonidine tartrate 2 mg, timolol 5 mg/ml DuoTrav.ther. follow.day.
(S3)S SNGL.DOS.SUSP. 28/15.4/0716. 2,5 mg/ml Indications: IOP.control in chron.open-angle glauc/ ocul. hypertens. Nasolacrim.occlus./gently clos.eyelid aft.admin.is recom.& may re-
822868-008: 50x0,25 ml units, R879,92 where pts.stabilis.on same dos.of indiv.compon. duc.system.absorpt.
Dosage: 1 drp.2xdly. (S3) EYE DROPS, A39/15.4/0464 Adults incl.elderly: 1 drp.in conjunctiv.sac of affect.eye(s) once dly.
Contraindications: Sinus bradycard.uncorrect. >1st degree AV 709863-001: 5 ml, R227,72 at the same time each day.
block, cardiogen.shock, CF unless /unt.control., safety in pregn.& Dosage: Observe 10 min.interv.if other topic. ophthal. meds.used. 1 If dos.miss.treatm.should contin.with next dos.as plan.ie.dos.should
long term use not est., safety & effic.in childr.not est. drp.in affect.eye(s) 2xdly. 12 hrs.apart. not exceed.1 drp.in affect.eye(s) dly.
Side effects: Discomf.& tear., blurr.vis., decr. corn.sensitiv., erythema, Contraindications: Safety & effic.in pts.less than 18 yrs.not est., Contraindications: Bronch.asthma/hist.thereof, sev.chron.COPD,
itch.sensat., corn. punctate stain., keratit., photophob., syst.reacts. bronch. asthma/hist.therof, sev. chron.obstruct.pulm.dis., sinus brady- sinus bradycard., 2nd/ 3rd degr. AV block, overt CF, cardiogen.
Special precautions: Hist.of CF /heart block, discont.at 1 sign card., 2 /3 degr.AV block, overt CF, cardiogen.shock, MAOI’s, safety shock, pregn., women attempt.to fall pregn., lactat., not recomm.
st
nd
rd
of CF, monit.IOP reg.dur.treatm., tfd.from other sngl./sev.concom. in pregn. & lactat.not est. in pts.bel.18 yrs.
Ophthalmics - 15.6 2020-04 / 205
Side effects: Hyperaem.of eye incl.ocul./ conjunctiv.hyperaem., tens.ocul.surf. dis., concom.oral carbon.anhydr.inhibits.not recomm., Contraindications: Bronch.asthma/hist.thereof, sev.chron.ob-
hypersens., headache, eye pain/irrit./prurit., foreign body sensat. discont.& eval.pt if allerg.-type react. occur, ac.angl.-clos.glauc., poss. struct.pulm.dis., sinus bradycard., 2nd/ 3rd degr.AV block, overt CF,
in eye, dry eye, punct.keratit., photophob., ocul.discomf., abnorm. ocul.infects., cont. mannitol.with poss.mild laxat.eff. cardiogen.shock., sev. ren.impairm., metabol.acidos., sev.periph.
sensat., blurr.vis., keratoconjunctivit.sicca, conjunctivit., allerg.con- Drug interactions: IOP lower.eff.poss.addit.with β-adrenerg. arter. dis., hypotens.
junctivit., meibomianit., eyelid marg.crust./pruritus, asthenop., incr. blocks., potent.addit.eff.on known carbon. anhydr.syst.effs.with oral Side effects: Headache, dizzin., paraesthes., eyelid inflamm.& irrit.,
lacrimat., iris hyperpigmentat., growth of eye lashes, dark circl.under carbon.anhydr. inhibits. superfic.punct.keratit., iridocyclit., trans.myop., corn.oed., ocul.hypoto-
eyes, bradycard., hypotens., skin discolourat., abnorm.hair growth., ny, choroid.detachm.& blurr.vis.aft.filtrat.proced., loc.ocul.reacts.incl.
fatig., decr.heart rate. GLAUCOSAN, Sandoz [PWR] palpebral react., epistax., naus., throat irrit., dry mouth, rash, fatig.,
Warnings and special precautions: Same CV & pulm.advers. effs. Timolol mal. system. allerg.reacts.incl.anaphylax., SLE, hypoglycaem., depress.,
exper.with system.beta adrenerg. block.poss., contr.CF prior to init. Indications: Reduct.of elevat.IOP, ocul. hypertens., glauc., adjunct. insomn., nightmares, memory loss, syncope, CVA, cerebr.ischaem.,
ther., spontan.hypoglycaem., diab.mellit.as sympts.of hypoglycaem. treatm.in paed.glauc. decr.libido, corn. eros., blephar., decr.corn.sensitiv., dry eyes, conjunc-
poss.mask., hyperthyroid.sympts. poss. mask., Prinzmet.ang./periph.& (S3) EYE DROPS 27/15.4/0313 tivit., vis.disturbs.incl.refract.chngs., ptos., diplop., tinnit., bradycard.,
centr.circulat. disords & hypotens.worsen., pts.with hist.of atopy/ sev. 821624-008: 5 mg/ml, 5 ml, R82,13 chest pain, palpitat., oed., dysrythm., CHF, heart block, Raynauds, cold
anaphylact.react.to a variety of allergens may be unrespons.to usual Dosage: Instill 1 drp 2xdly.in affect. eyes. If IOP satisfact. maint. hands & feet, claudicat., card.arrest, hypotens., dyspn., bronchosp.
adrenal.dos., advis.pts.of iris pigmentat.& eyelash changes esp.if consid.once dly. dos.ther.If necess. instit.concom.ther.with miotics, in pre-exist.bronchospast.dis., cough, GI disturbs., dyspeps., alopec.,
only one eye is treat., no exper.in ocul.inflammat./neovasc./ angle epinephr. & system. carbon. anhydrase inhibits. psoriasiform rash or exacerbat.of psoriasis, myalg., Peyronie’s dis.,
clos./narr.angle or congenit.glauc., limit. exper.in thyroid eye dis./ Childr: Instill 1 drp once dly in affect.eyes. Dos.may be incr. to one decr.libido, sex.dysfunct., asthen., sinusit., breathlessn., resp.fail.,
open angle glauc of pseudophak.& pigment/pseudoexfoliat.glauc., drp.12 hrly in each affect.eye if necess. rhinit., bronchosp., urolithhias.
aphak., pseudophak.pts.with torn poster.lens caps./ ant.chamb.lens, Contraindications: Safety in pregn.& longt. admin. not est., not Warnings and special precautions: Soft contact lense use, sys-
cystoid macul.oed.risk fact., irit./uveit.predispos.risk fact., prolong.use recomm.in prems.& neonates., asthma, bronchit., chron. resp.dis., tem.absorpt.poss., sev. periph. circulat.disturbs./disords., contr.CF
rd
nd
in dry eye pts./comprom.corn.condits., soft contact lens use, adeq. 2 /3 degr. heart block, sinus bradycard. adeq. bef. init.ther., monit.sev.card.dis.pts., death assoc. with bron-
contracept., no stud.in pts.with hepat./ ren.impairm. Side effects: Hypoton./collap.& hypoglycaem. new born infts.if giv. chosp/card.fail.report., spontan. hypoglycaem/ labile diabet., signs of
Drug interactions: Poss.addit.effs.with oral Ca chann.block./ to mothers dur.labour/bef. birth, aphakic cystoid macul.oed., ocul.ir- hyperthyroid. poss. mask., corn.dis./defects/intraocul.surg.hist., pts.
beta-block./antidysrhythm./digox.& parasympathomimet., potent. rit., vis. disturbs., CV effs.incl.CCF & card.arrest, resp. disords. incl. with hist.of sev. anaphylact.react.to a variety of allergens may be
hypertens.react.to sudd. clonidine withdr., hypoglycaem.effs.of an- bronchosp., hypersens.reacts., CNS effs. incl.incr.S&S myasth.grav., more react.to rep.challenge while tak.ß-block.& may be unrespons.
tidiabet. agents poss.incr. GI disturbs., poss. syst. absorpt., neuropsychiatr.disords., periph.vasc. to usual adrenaline dos., choroid.detachm.report., surg. anaesthes.,
See also MDR page 126. dis. exacerbat., impot., hypoglycaem., skelet.musc. weakn., periph.
gangr.precipit., pass.into breast milk. concom.oral carbon.anhydr.inhibit.,& topic. ß-adrenerg. block.agents
GANFORT, Allergan Special precautions: Tfd.from other sngl./sever. concom. agents, not recomm., poss. addit. effs.with syst.ß-adrenerg.block.agents.,
Bimatoprost 0,3 mg, timolol 5 mg/ml IOP eval.aft.approx.4 wks., asthma, bronchit., chron. resp.dis., 2 /3 rd withdr. grad.with coron.heart dis., not stud.in ac. angl. clos.glauc.,
nd
Indications: IOP.reduct. in open-angle glauc/ ocul.hypertens. degr. heart block, bradycard.(less than 50 beats/min.), periph. vasc. diminish.responsiven.to ophthal. timolol. with prolong.ther., myas-
where pts.respons.to topic.beta-block/prostagland.analag.given dis., Raynaud’s phenom., obscur.norm. tachycard. respons.to hy- then.grav.sympts. poss. aggrav., poss.adverse eff.on corn.permea-
alone insuffic. povolaem.in peri-op period, extens.ocul.surf.dis., poss.adverse eff. bil. & corn. epithel. with prolong.use, extend.use in extens. ocul.surf.
(S4) EYE DROPS, 42/15.4/0127 on corn. permeabil.& corn.epithel.with prolong.use, reg. opthalm. dis., adverse.reacts.exper.with system. sulfonamides poss., elderly,
714110-001: 3 ml, R245,05 exam.advis., poss.syst.absorpt.in pts. receiv. syst.ß-adrenerg.block. safety in hepat. impairm./childr.und.2 yrs.not est.,esp.avoid concom.
Dosage: Observe 5 min.interv.if other topic. ophthal. meds.used. ther., known ß-blocks. C/I incl. cardiogen.shock & diab., concom. oral IV verapamil, safety & effic.in pregn.not est., excret.in breast milk.
Adults incl.elderly: 1 drp.in affect.eye(s) once dly.in the morn. adeq.contr.of CF bef.init., sev.card.dis.hist., concom. miot.with angle- Drug interactions: Poss.addit.effs.with concom. oral Ca chann.
Contraindications: React.airway dis.incl. bronch. asthma/hist. clos.glauc., soft cont. lens., pts.with hist.of sev.anaphylact.react.to a block./antidysrhythmics/digital. glycos./ parasympathomimet./
rd
nd
therof, sev.chron.obstruct. pulm.dis., sinus bradycard., 2 /3 degr. variety of allergens may be more react.to rep. challenge while taking guanethidine/ narcot./ MAOI’s/catecholamine deplet.meds.& ß-
AV block, overt CF, cardiogen.shock, inadeq.data in pregn., breast ß-blocks., ren. decompensat., myasth.grav., indiv.respons.essent. if adrenerg. block.agents, oral ß-adrenerg.block. agents may exacerb.
feed., childr.or adolesc. CCF develop.& digitalisat.necess., discont.grad., phys.activ.limit.dur. rebound hypertens.follow. clonid. withdr., system.ß-block.potent.
Side effects: Conjuctivit.hyperaem./oed., headache, eyelash withdr.period, phaeochromocyt. with CYP2D6 inhibit., mydrias.with ophthalm. ß-block.& adrenal.
growth, superfic. punctuate keratit., corn.eros., burn./sting.sensat., Drug interactions: Poss.addit.effs.with oral Ca channel-block./
eyelid prurit./pain & retract., foreign body sensat., eye dryn./pain/ catecholamine deplet.drugs & ß-adrenerg. block.agents, life-threat. IOPIDINE, Novartis [P/S]
disch./prurit./irrit., eyelid oed./ erythema, photophob., vis.disturbs., interacts.with hypoglycaem., anti-arrythm.& phenothiazines., my- Apraclonidine HCl equiv.to apraclonidine.
iritis, blepharit., epiphora, vis.acuity worsen., asthenopia, trichias., drias. with concom.adrenal. Indications: Control./prevent.of postsurgic.incr. IOP follow.ant.
rhinit., blephar.pigmentat., hirsut., infect., dizzin., allerg.conjuctivit., segm.laser surg.
cataract., eyelash darken., incr.iris pigmentat., blepharosp., cystoid GLAUMIDE-CO, (Gen-Eye) Actor Pharma [PWR] (S4) SOL. [P/S] X/15.4/178. 10 mg/ml.
macul.oed., retin.haemorrh., uveit., hypertens., asthen., periph.oed., Dorzolamide 20 mg, timolol 5 mg/ml. 833789-007: 24x0,25 ml units, R3 572,75
abnorm. LFT, pysch.disords., memory loss, myasthen.grav. S&S incr., Indications: Elev.IOP in ocul.hypertens., open angle/pseudoexfoliat. Dosage: 1 drp.in the eye sched.for op 1 hr.pre-op.& 2nd drp.in the
paraesthes., cerebr.ischaem., decr. corn. sensitiv., diplop., ptos., cho- glauc./other second.open-angle glauc.when concom.ther.is appropr. same eye immed.on complet.of proced.
roid.detachm., refract. changes, keratit., tinnit., heart block, card. ar- (S3) OPHTH.SOL. 46/15.4/0684 Contraindications: MAOI., clonidine hypersens.
rest, arrhythm., syncope, bradycard., card. fail., CHF, hypotens., CVA, 721902-001: 5 ml, R194,02 Side effects: Lid retract., conjunctiv.blanch., mydrias.
claudicat., Raynauds, cold hands & feet, palpitat., bronchosp., dyspn., Dosage: 1 drp.2xdly.in affect.eyes. Admin.other topic.meds. at Warnings and special precautions: Transf. from Iopidine, poss.
cough, GI disturbs., alopec., psoriasiform rash/ psorias. exacerbat., least 10 mins.apart. hypertens.crisis on withdr., ß-block.treatm.withheld 24 hrs. pre-op.&
SLE, Peyronie’s dis., oed., chest pain, fatig. Contraindications: Bronch.asthma/hist.thereof, sev.chron.obstruct. 24 hrs.post-op., cerebr./coron.insuffic., Raynaud’s, thromboangiit.
Special precautions: Soft contact lens., poss. advers. eff. on corn. pulm.dis., sinus bradycard., 2nd/3rd degr.AV block, overt CF, cardiogen. obliter., depress.hist., CV dis.incl. hypertens., poss.vasovag.attack
permeabil.& corn.epithel. with prolong.use, extens.ocul.surf.dis., ß- shock, safety in pregn. & lactat.not est., safety & effic.in childr.not est. dur.laser surg., safety in pregn.& lactat.not est.
block. mask hypoglycaem.S&S, hepat./ren.impairm., advers. reacts. Side effects: Sulphonam.-relat.effs.incl.hepat. necros./bld.dyscras., Drug interactions: Alcoh.& other CNS depress. potent.drowsin.&
found with system.admin.poss., CF to be adeq.control., monit.sev.CV conjunctivit., resp./card. effs.incl.death, poss.syst.absorpt., loc.ocul. imp.conc., hypotens.eff.antagon. by TCA’s & enhanc.by thiazide diu-
dis., hyperthyroid. signs poss.mask., worsen.of Prinzmetal ang./sev. reacts., choroid.detachm.aft.filtrat.proced., conjunct. inj., blurr.vis., ret., concurr.ß-block., TCA’s or sudd.withdr.of syst.-alpha-agonist. may
periph.& centr.circulat. disords. & hypotens., spontan.hypoglycaem. tear., corn.eros., eyelid irrit./ inflamm., superfic.punct.keratit., irido- precipit.sev.rebound hypertens.
/diab. as ac.hypoglycaem.sympts.poss.mask., pts. with hist.of sev. cyclit., trans. myop., eyelid crust., SLE, tinnit., headache, dizzin., par-
anaphylact.react.to variety of allerg. poss.unrespons.to usual adren. aesthes., depress., syncope, incr. myasth.grav. S&S, decr.libido, CVA, IOPIDINE 0,5%, Novartis [P/S]
Apraclonidine HCl equiv.to apraclonidine.
dos., pigmentat. changes report.poss.perman., macul. oed. risk fac- CNS effs., bradycard., palpitat., chest pain, CHF, dysrhythm., heart
tors, use not stud.in inflamm.ocul. condits./ neovasc.inflamm.angle block, cerebr.ischaem., Raynaud’s phenom., claudicat., hypotens., Indications: Adjunct.to low.IOP.
(S4) SOL. 30/15.4/0125. 5 mg/ml.
clos.glauc., congenit. glauc., narr.-angle glauc. oed., resp.fail., epistax., dyspn., cough, bronchosp., GI disturbs., skin
Drug interactions: Poss.addit.effs.with oral Ca antagon./ß-block. reacts.incl.psorias. exacerbat./ Stev.Johns.syndr./tox.epiderm. necro- 825484-006: 10 ml, R353,53
agents/anti-arrythm./digital. glycosid.or parasympathomimet., ß- lys., alopec., urolithias., Peyronie’s dis., fatig., asthen., system.allerg. Dosage: 1 drp.in the affect.eye(s) 3xdly. If used in conjunct.with other
block.incr. antidiabet.agents hypoglycaem.eff., ß-block. potent.clo- reacts. incl. anaphylax., blepharit., keratit., decr.corn.sens., dry eyes, meds.wait 5 mins.betw.admin.
nidine sudden withdr.hypertens.react., vis.disturbs.incl.refract.chang., ptos. Contraindications: MAOI., clonidine hypersens.
Warnings and special precautions: Excret.in human milk, poss. Side effects: Lid retract., conjunctiv.blanch., mydrias., poss.hyper-
GLAUCOPRESS, (Gen-Eye) Actor Pharma [P/S] adverse eff.on corn.permeabil.& corn.epithel.with prolong.use, reg. tens.crisis on withdr., allerg. reacts., vis.disturbs.due to large reduct.
Dorzolamide HCl equiv.to base ophthalmolog. exam. reqd., extend.use in extens.ocul.surf.dis., soft of IOP, dry mouth, constipat.
Indications: Elev.IOP in ocul.hypertens./open angl.glauc./pseudo- cont. lense use, poss.syst.sulphonam. absorpt., discont.in allerg./ser. Warnings and special precautions: Transf. from Iopidine, poss.
exfoliative.glauc./other second. open-angl.glauc. hypersens.reacts., concom.oral carbon.anhydr.inhibits./use of 2 topic. hypertens.crisis on withdr., ß-block.treatm.withheld 24 hrs.pre-op.&
(S3) OPHTH.SOL. 45/15.4/1035. 20 mg/ml. ß-adrenerg.blocks.not recomm., poss.addit.effs. with syst.ß-adrenerg. 24 hrs.post-op., cerebr./coron.insuffic., Raynaud’s, thromboangiit.
720983-001: 5 ml, R143,42 block.agents., not recomm.in sev. ren.impairm.(creatine clear.<30 ml/ obliter., depress.hist., CV dis.incl. hypertens., chron.ren.fail., pro-
Dosage: Monotherapy: 1 drp.3xdly. Adjunct.with β-block: 1 drop 2x min.), no studies in hepat.impairm./ac.angl.clos.glauc., elderly, contr. long.use in extens. ocul. surf.dis., vis.disturbs., safety in pregn.&
dly. Admin at least 10 mins apart if used in combinat. CF adeq.bef.init.ther., monit.sev.card. dis.pts., pts.with hist.of sev. lactat. not est.
Substit.for anoth.ophth.antiglauc.agent: Discont. agent aft.com- anaphylact.react.to a variety of allerg.poss.more react.to rep.chal- Drug interactions: Alcoh.& other CNS depress. potent.drowsin.&
plet.dly.dos.& start Glaucopress next day. lenge while tak.ß-block.& may be unrespons.to usual adrenal. dos. imp.conc., hypotens.eff.antagon. by TCA’s & enhanc.by thiazide diu-
Contraindications: No adeq.studies in pregn., not eval.in mod.to Drug interactions: Poss.addit.effs./hypotens.&/ mark.bradycard. ret., concurr.ß-block., TCA’s or sudd.withdr.of syst.-alpha-agonist. may
sev.ren.impairm.but due to ren. excret.not recom.in sev.ren.impairm., with concom. oral Ca chann. block./catecholamine deplet.meds. & precipit.sev.rebound hypertens.
safety & effic. in childr.und.16 yrs.not est. ß-adrenerg. block.agents, poss.acid base disturbs.with oral carbon.an-
Side effects: Burn./sting./itch/tear., blurr.vis., conjunctivit., eyelid hydr.inhibit., oral ß-adrenerg.block. agents may exacerb.rebound hyper- ISOPTO-CARPINE 1 & 2%, Novartis [P/S]
inflamm./irrit., iridocyclit., photophob., myop., superfic.punct.ker- tens. follow.clonid.withdr., system.ß-block.potent.with CYP2D6 inhibit. Pilocarpine HCl.
atit., eye pain, redn., asthen., fatig., headache, dizzin., paraesthes., Indications: Open angle glauc., antagon.effs short-act.mydriat.
epistax., bronchosp., bitter taste, naus., hepat.necros., bld.dyscras. GLAUOPT CO, (Aspen Pharmacare) (S3) SOL. H1129, H1161.
incl. agranulocytos. /aplast.anaem., skin reacts.incl. Stev. Johns.syn- Pharmacare [N/P/S in C] 734284-004: 10 mg/ml, 15 ml, R132,21
dr./tox.epiderm.necrolys., angioed., urolithias., hypersens., loc.reacts. Dorzolamide 20 mg, timolol 5 mg/ml. 734179-006: 20 mg/ml, 15 ml, R127,59
Warnings and special precautions: Malformat. of verebr.bodies Indications: Elev.IOP in ocul.hypertens., open angle/pseudoexfoliat. Dosage: 2 drps. 3-4xdly.
observ.in rabbits., consid. benef.vs.risk in lactat., not recomm.in sev. glauc./other second.open-angle glauc.when concom.ther.is appropr. Contraindications: Ac.irit.
ren. funct.impairm., not eval.in hepat.imairm., soft cont. lens., poss. (S3) OPHTH.SOL. 44/15.4/1052 Side effects: Init.slight incr.IOP, sensitiv.& contact allerg., cil.spasm,
syst.absopt., poss.recurr. sensitisat. if sulphonam.re-admin.irrespect. 721977-001: 5 ml, R199,43 brow ache with tempor. reduct.in vis.acuity.
of route of admin., elderly, poss.adverse effs.on corn.permeabilit. & Dosage: 1 drp.2xdly.in affect.eyes. Admin.other topic.meds.10 Warnings and special precautions: Use over extend. period in
corn.epithel.with prolong.use, reg.ophthalmolog.exams.requir., ex- mins.apart pts.with extens.ocul.surf.dis.
206 / 2020-04 Ophthalmics - 15.6
LOXOPTIC, (Gen-Eye) Actor Pharma [PWR] keratit., tear., ocul.irrit .incl.blepharit., decr.corn.sens., dry eyes, con- blepharit., eye pain, eyelidoed., blurr.vis., uveit./irit., macul. oed.,
Betaxolol junctivit., sinusit., dysgeus., taste pervers., naus., asthen., fatig. Less corn.oed./eros., palpebr. skin darken., bact. keratit., chest pain, ang.
Indications: Low.IOP in chron.open angle glauc., elev.IOP. freq: Bld.dyscras., SLE, S&S syst. allerg.reacts.incl.angioed./skin re- pect., asthma aggravat./-attacks/cough & dyspn., URTI, colds & flu,
(S3) OPHTH.SOL. 47/15.4/0526. 5 mg/ml. acts./ shortn. of breath/anaphylax., hypersens., loc. reacts., psych./ skin rash, musc.-/joint-/back pain
722010-001: 5 ml, R174,21 GI disords., dizzin., paraesthes., CNS effs., CVA, decr.libido, myasth. Warnings and special precautions: Cont. high benzalkon.chlor.
Dosage: Indiv. Usual dos: 1 drp. 2xdly. Syst. absorpt. reduc.when grav.S&S incr., choroid. detachm.foll.filtrat.surg., corn.oed., iridocy- conc.poss.absorb by cont.lens., potent. grad.incr.brown iris pigmen-
using nasolacrim.occlus./ clos.eyelids x2 mins. clit., ocul.hypotony, trans.myop., ptos. diplop., vis.disturbs.incl.refract. tat. & poss. disparity betw.treat.& untreat. eye, eye colour chang.
Contraindications: Card.shock/overt card.fail., sinus bradycard., chang., tinnit., card. disords.incl.card.arrest, CHF, dysrhythm., heart mainly in mix.colour irides with onset within first 8 mnths.of ther.,
rd
nd
sick sinus syndr., sino-atrial block, 2 /3 degr.AV block not contr. block, vasc.disords.incl.cerebr.ischaem., claudicat., oed., Raynaud’s eye lash /-lid changes, cyst.aphak./pseudophak.pts.with torn post.
with pacemak., react.airway dis.incl.bronch.asthma /sev.bronch. phenom., resp.fail., rhinit., epistax., bronchosp.esp.in bronchosp.dis., lens capsul./pts.with risk fact.for macul.oed., extend. use in pts.
asthma hist./sev.COPD, damag. cornea, safety in pregn.not est., cough, dyspn., dry mouth, throat irrit., diarrh., dyspeps., naus., fulmin. with extens.ocul.surf.dis., reg. ophthalmolog.exam.reqd., asthma
safety & effic.in childr.not est. hepat.necros., cont. dematit., Stev.Johns.syndr., tox. epiderm.necro- aggravat./-attacks/ cough & dyspn.poss., ac.clos.angl.glauc. at-
Side effects: Syst./skin reacts., allerg.reacts. incl. angioed., dis- lys., alopec., psorias.exacerbat., SLE, urolithias., peyronie’s dis., sex. tacks, limit.exper. in inflamm.ocul.condits./ inflamm. neovasc.angl.
comf.& tear., decr.corn.sensitiv./ tear prod., corn. punct.stain./eros., dysfunct. Freq.unknown: Incr. in antinucl.antibod., non thrombocy- clos./congenit.or pigment. glauc. /pseudophak.pts.with open angl.
keratit., photophob., anisocor., ptos., diplop., blepharit., psych.disords., topen. purpura, thrombocytopen., trans.eosinophil., hypo-/hypergly- glauc., ren./ hepat.impairm.
CNS effs., headache, memory loss, syncope, CVA, cerebr. ischaem., caem., hallucinat., confus., itch./tear./ sore/red eye, blurr.vis., corn. Drug interactions: IOP reduc.eff.is addit.to that of beta-adrenerg.
incr.myasth.grav. S&S, dizzin., paraesthes., hypoglycaem., card.disor- eros., pneumonit., pulm.-/ retroperiton.fibros., pleurisy, scleros. peri- antagon./adrenerg.agonists (dipivefrin)/oral carbonic. anhydr.inhibit.
ds.incl. mark.bradycard., CCF, chest pain, sev.periph.vasc. dis. & exac- tonit., excess.sweat., prurit., arthralg., myopathy, musc,cramps, male (acetazolamide) & partly with cholinerg.agonist (pilocarpine), precipi-
erbat.thereof, Raynaud’s phenom., periph.gangrene, hypotens., cold/ impot., myalg., triglycerid.& cholester.conc.chang., rais.liv.enzym. tat.occurs with eye drops cont. thiomersal, paradox.IOP elev.follow.
cyanot.hands & feet, intermitt.claudicat. exacerbat., dyspn., asthma, Warnings and special precautions: Resp./ card.reacts.incl.death concom. admin. of two prostagland.analog.
bronchosp.(death report), cough, GI disturbs., alopec., skelet.musc. due to bronchosp./CF, not for use in mild to mod.COPD, sev.card.dis. See also MDR page 107.
weakn., myalg., sex.dysfunct., impot., decr.libido, poss.mask hyper- hist./β-block. ther.adeq.contr.bef.init.ther., monit.CV dis. pts.for de-
thyroid./ac. hypoglycaem.S&S. terior.signs/adverse reacts., 1 degr. heart block, sev.periph.circulat. TIMOPTOL, Mundipharma [PWR]
st
Warnings and special precautions: Secret.in human milk, lac- disturbs./disords., poss. sev.adverse reacts./fatalit.due to sulphonam. Timolol mal.
tat., ren.decomposit., CF hist., 1 degr. heart block, discont.ther.when react.incl.Stev. Johns.syndr./tox.epiderm. necrolys./ fulmin.hepat.ne- Indications: Reduct.of elevat.IOP. Sol.also: concom.ther. in paed.
st
CF signs, CV dis., Prinzmetal’s ang., hypotens., bronchosp./ bronch. cros./bld.dyscras., discont. if ser.reacts./hypersens./loc.adverse eff. glauc.when inadeq.contr.
asthma/ COPD or asthma hist., concom. adrenerg. psychotrop.meds./ esp. conjunctivit. & lid reacts.occur, pts.with hist. of sev.anaphylact. (S3) SOL. K/15.4/339, 340.
hypoglycaem.agents/ phenothiazin., soft cont.lens., dimin.respons. reacts.to variety of allergens poss. more react.to repeat.challeng.& 770833-004: 2,5 mg/ml, 5 ml, R120,01
with prolong. use., monit.for potent.addit.eff.with concom. oral ß- poss. unrespons.to usual epinephrine dos., not recomm. in sev.ren. 770841-007: 5 mg/ml, 5 ml, R147,41
blocks., diabet., thyrotoxicos., pts. subj. to spontan.hypoglycaem., impairm., no studies with hepat. impairm., concom.oral carbon.anhydr. Dosage: Init: 1 drp. 0,25% sol.2xdly.in affect. eye(s). If respons.in-
corn.dis./sicca syndr./ simil.tear film abnorm., pts.with hist.of atopy/ inhib.not recomm., concom.alpha-adrenocept.block.ther.to be giv. in adeq.change dos.to 1 drp. 0,5% sol.2xdly.Other concom.IOP-reduc.
sev.anaphylact.react.to a variety of allerg. poss. more react.to rep. phaeochromocyt., withdr.grad.in coron. heart dis., corn.dis., may mask ther.may be giv. Press. lower.respon.may req.sev.wks.to stabil. &
challenge & may be unrespons. to usual adrenal.dos., syst.absorpt., hyperthyroid.signs, spontan. hypoglycaem./labile diab.as may mask evaluat.should incl.IOP determinat.aft.approx.4 wks. If IOP satisfact.
reg. ophthalmolog.exam.requir., monit.IOP reg.dur. treatm., tfd.from ac.hypoglycaem.signs, surg./anaesthes., incr. urolithias.risk in pts.with maint.consid.once dly.dos. ther.
other sngl./sev.concom.agents, use with miot.in angle clos.glauc., ren.calculi hist., myasth. grav.poss.aggrav., not for use in ac.angl-clos. Childr: Admin.concom.with other anti-glauc.meds. Init: 1 drp.
poss. adverse eff. on corn.permeabil.& corn.epithel.with prolong. use. glauc., soft cont.lens., poss.adverse eff.on corn. permeabil.& corn. 0,25% sol. 12 hrly. in affect.eye(s). May be incr.to 1 drp. 0,50%
Drug interactions: Mydrias.with concom.ophth. epinephr., potent. epithel.with prolong.use, reg. ophthalmolog.exam.reqd., extend.per. sol.12 hrly.if necess.
addit.eff.with oral Ca chann. blocks./ß-adrenerg.block.agents/anti- use in extens. ocul.surf.dis., potent.incr.for corn.oed./ irrevers. corn. Ref.to prod.lit.for instr.on transf.pts.from other ther.
dysrhythm./ parasympathomimets/catecholamine.-deplet. agents. decompensat.developm.in pts.with low endothel.cell counts &/intra- (S3) XE GELLAN SOL. 29/15.4/0230, 0231.
819816-019: 2,5 mg/ml, 2,5 ml, R119,64
LUMIGAN, Allergan [P/S] ocul.surg.hist., choroid. detachm.poss. with Ocudor Co aft.filtrat. pro- 819824-003: 5 mg/ml, 2,5 ml, R147,21
ced., potent.addit.eff.on IOP/known ß-block. syst. effs.in pts.who are
Bimatoprost receiv.ß-block.ther. system., use of 2 ß-adrenerg.blocks.not recomm. Dosage: Init: 1 drp. 0,25% sol.1xdly. If respons. inadeq.admin.1
Indications: Elev.IOP reduct.in chron.open-angle glauc./ ocul.hyper- Interactions: Poss.mydrias.with concom. epinephrine, potent.syst.ß- drp.0,50% sol.1xdly. Admin.other top. meds.no less than 10 mins.prior.
tens.as monother.or as adjunct. ther. to ß-block. blockade with concom. CYP2D6 inhib., poss.incr.hypoglycaem.eff.of Ref.to prod.lit.for instr.on transf.pts.from other ther.
(S4) EYE DROP SOL., 42/15.4/0835, 36/15.4/0157 antidiab. meds., excerbat.rebound hypertens.aft. clonidine withdr., Contraindications: Bronchosp.incl.bronch. asthma, COPD, un-
716754-001: 0,1 mg/ml, 2,5 ml, R217,20 poss.addit.effs./hypotens.&/ mark. bradycard.with concom.oral Ca controll.CF, sinus bradycard., 2nd/3rd degr. AV block, overt CF, car-
703666-003: 0,3 mg/ml, 3 ml, R265,06 chann. block./ catecholamine deplet.meds.& ß-adrenerg. block. diogen.shock
Dosage: Admin.1 drp.in affect.eye(s) once dly in even. Max: once agents/dysrhythm./digox./ parasympathomimets., guanethidine/ Side effects: Common: Headache, ocul. irritat.,conjunctivit.,
dly.as more often may lessen eff. Admin.at least 5 mins.apart from narcot./ MAOI’s. blepharit., keratit., decr.corn.sensitiv., dry eyes. Uncommon: Diz-
other top. ophthalm. meds. zin., depress., vis.disturbs.incl.refract.changes, bradycard., syncope,
Contraindications: Childr./adolesc., safety in pregn.& lactat. not est. SAFLUTAN, Mundipharma & dyspn., naus., dyspeps., asthen., fatig. Rare: Syst.lupus erythematos.,
Side effects: Conjunctiv./ocul.hyperaem., eye. irrit. /prurit., punct.ker- Tafluprost insomn., nightmares, memory loss, paraesthes., incr.S&S of myasth.
atit., asthenop., conjunct. disord./-oed., eyelid erythem.& prurit., eyelid Indications: Elev.IOP reduct.in open-angle glauc./ ocul.hypertens. grav., decr.libido, CVA, ptosis, diplop., choroid.detachm.follow.filtrat.
marg. crust., eyelid oed., incr.eyelash growth, madaros., vis.disturbs., (S4) OPHTH.SOL, A45/15.4/0710. 15 µg/ml (4,5 µg/0,3 ml sngl. surg., tinnit., hypotens., chest pain, palpitat., oed., arrhythm., CHF,
hypertrichos./skin hyperpigmentat., hypersens., instill.site irrit., naus., dos.contain.) heart block, card.arrest, cerebr.ischaem., claudicat., Raynaud’s, cold
prurit., headache, allerg.conjunctivit., blepharit., blepharosp., cataract, 720401-001: 30 sngl.dos., R233,00 hand & feet, bronchosp., resp.fail., cough, diarrh., dry mouth, alopec.,
corn.eros., cystoid macul.oed., eye discharge, eyelash darken., eyelid Dosage: Admin.any other top.ophthal.product at least 5mins apart. psoriasiform rash/psorias.exacerbat., Peyronie’s dis., hypersens. re-
retract., eye pain, foreign body sensat., incr.iris/periocul.skin/blephar. Wipe off any excess from eyelid skin ro reduc.risk of eyelid darken. acts. Unest.causal relationship: Aphakic cystoid macul.oed., nas.
pigmentat., iritis., ocul.burn./-dryn./-irrit./-discomf., photophob., retin. Nasolacrim. occlus. aft.admin.recomm.to reduc.syst.absorpt. congest., anorex., CNS effs.incl.psychic disturbs., hypertens., retro-
haemorrh., tear., uveit., vis.acuity worsen., periorbit.erythem., dizzin., Recomm: 1 drp.in affect.eye once dly in the even. periton.fibros., pseudo pemphigoid
infects.esp. URTI, hypertens., asthen., periph.oed., hirsut., abnorm. hair Side effects: Most comm: Ocul.hyperaem. Freq: Headache, eye Warnings and special precautions: Reg. opthalm. exam.with pro-
growth where sol.comes into rep.contact, bact.keratit., abnorm.LFT, peri- prurit./-irrit./-pain, conjunctiv. hyperaem., eyelash changes, dry eye, long.use, extens.surf.ocul. dis., asthma, bronchit., chron. resp.dis., 2 nd
orbit./ lid chang. incl.deepen.of eyelid sulcus, asthma/-exacerbat., dyspn. foreign body sensat. in eye, eyelash discolour., eyelid erythema, su- & 3 degr.heart block, sinus bradycard. less than 50 bpm., periph.vasc.
rd
Warnings and special precautions: Pts.with act. intraocul.inflam- pefic. punct.keratit., photophob., incr.lacrimat., blurr. vis., reduc.vis. dis., Raynauds, peri-op period, poss.choroid.detach.if admin.aft.filtrat.
mat.as it may be exacerbat., avoid sol. runn.onto cheek/other skin acuity, incr.iris pigmentat. Less freq: Blephar.-/conjunctiv.pigmentat., proc., known C/I’s to syst.beta-adrenerg.recept.block. agents, contr.CF
areas, remove soft cont.lens.prior to admin.& wait >15 mins. follow. eyelid oed., asthenop., conjunctiv.oed, eye discharge, blepharit., anter. prior to init.ther.& monit.sev.card. dis.hist.pts., poss.addit.effs.if oral
admin.bef.reinsert, reg. ophthalmolog. exam., prolong.use in extens. chamb.cells./-flare, conjunctiv. follicles., allerg.conjunctivit.& abnorm. ß-adrenerg. recept. block.ther.admin., use in conjunct.with a miot.in
ocul. surf. dis., concom.anti-glauc.agents other than topic. ß-block. eye sensat., irit./ uveit., lid sulcus deepen., macul.-/cystoid macul. oed, angle-clos.glauc., soft contact lense use, pts.with hist.of atopy/sev.
not eval., ren./mod.to sev.hepat. impairm., advis.pts.of iris& eyelid asthma exacerbat., dyspn., eyelid hypertrichos. Very rarely: Corn. anaphylact.react.to a variety of allergens may be more react.to rep.
pigmentat.& eyelash chang.esp.if only one eye is treat., compromis. calcificat.in pts.with signif.damag.corneas. challenge & poss.be unrespons.to usual adrenal. dos., poss.S/E of
resp.funct., not stud.in heart block more sev.than 1 degr./uncon- Warnings and special precautions: No exper. in neovasc./an- oculo-cutan.syndr.type cannot be excl., myasth.grav., oral beta-adr-
st
trol.CHF/inflamm. ocul. condits./neovasc.-/inflamm.-/angle-clos.-& gle-clos./narr.-angle or congenit. glauc, aphak.pts, pseudophak.pts. energ.block.poss exacerb.rebound hypertens.follow.clonidine withdr.,
congenit.-or narr.angle glauc., aphakic pts./ pseudophakic pts.with wih torn post. lens. caps, anter.chamber lenses, irit/uveit.known risk digital.poss.necess.in pts.rec.long-term ther.if CCF likely., grad.withdr.
torn poster.lens caps./mac. oed.risk fact., avoid touch.dispen.con- fact., inform pt.of poss.eyelash growth/dark. eyelid skin & incr.iris pig- & limit.phys. activ.dur. withdr.per., alpha-adrenerg.block.ther.in phaeo-
tain.to eye/ any other surf., monit.pts.tak.concom. prostanglandin mentat., hair growth where sol.comes in contact, sev.asthma, allow chromocyt., outweigh benef.-risk in pregn.& lactat., pass.into breast
analogs.for IOP chang. poss. blurr.vis.to clear.bef.driv./operat.mach., ren. & hepat.insuffic., milk, use of 2 diff.topic. topic. ß-adrenerg.recept.block.not recomm.,
Interactions: IOP-lower.eff.poss. reduc.in pts. with glauc./ocul.hy- safety & effectiven.in childr. <18 yrs./ pregn.& lactat.not est., effect. transf. from other ther., sol.not recomm.for prems.& neonates, XE
pertens.when used with other prostagland.analogs. contracept. in women of child bear.age, embryotoxic./ teratogen. & Sol: safety & effic.in childr.not est.
OCUDOR CO, (Unicorn) Pharma Dynamics [Not permit. in excret.in milk in anim.stud. Interactions: Mydrias.with concom.adrenal., system. ß-block.po-
tent.with concom.CYP2D6 inhibits., poss.addit.effs.with oral Ca entry
See also MDR page 521.
competit.in certain sports] block./ catecholamine deplet.meds./ß-adrenerg. block. agents, addit.
Dorzolamide 20 mg, timolol 5 mg/ml. SPERSATAN, Adcock Ingram [P/S] & eff.in prolong.AV conduct.time with Ca antagon.& digital., rebound
Indications: Elev.IOP in ocul.hypertens., open- angle/pseudoexfoliat. Latanoprost hypertens.follow. clonidine withraw.may be exacerbat.
glauc./other second.open-angle glauc.when concom.ther.is appropr. Indications: Elev.IOP reduc.in open angle glauc./ chron.clos.angl.
(S3) EYE DROP SOL. 51/15.4/0162 glauc.& ocul.hypertens. TRAVATAN, Novartis [P/S] &
3000372-001: 5 ml, R178,85 (S4) OPHTH.SOL. 46/15.4/0918. 50 µg/ml. Travoprost
Dosage: 1 drp.2xdly.in affect.eye(s). When substit. for anoth.an- 723018-001: 2,5 ml, R166,48 Indications: Reduct.elev.IOP.in pts.with open-angle glauc./other
tiglauc.agent discont.med.aft. complet. dly.dos.& start Ocudor Co Dosage: If other topical ophthalmolog.meds.are being used admin. ocul.hypertens.as monother./as adjunct.ther.
the next day. Admin.at least 10 mins. apart if more than one oph- at least 5 mins.apart. Remove contact lens.bef. admin.& wait at (S4) SOL. 36/15.4/0333. 40 µg/ml
thalm. med.used. Safety & effic.in paed.pts .bel. 2 yrs not est. Data least 15 min.to reinsert. 702534-003: 2,5 ml, R209,69
on safety & effic.insuff.in childr. 2-6 yrs. Adults: 1 drp in affect.eye(s) once dly.pref.in even. Do not exceed Dosage: Admin.at least 5 mins.apart from other top.ophthalm.meds.
Contraindications: Bronch.asthma/hist.thereof, sev. chron.ob- once dly dos. Cont.with next dos.as plann.if 1 dos.miss. IOP reduct. 1 drp.in conjunctiv.sac of affect.eye(s) once dly in even.
struct.pulm.dis., sinus bradycard., 2nd/ 3rd degr.AV block, overt CF, init.3-4 hrs aft. admin. with max.effect. obt.8-12 hrs.later.& maint. Contraindications: Pregn., women attempt.to fall pregn., lactat.,
cardiogen.shock, safety in pregn.& lactat.not est., not for admin. for at least 24 hrs. childr.und.18 yrs.
while using soft cont.lens. Contraindications: Pregn & lactat., childr., contact lens use Side effects: Incr.pigmentat.of iris/periorbit.& periocul. tiss., incr.
Side effects: Freq: Headache, blurr.vis., burn.& sting., corn.eros., Side effects: Incr.iris pigmentat., eye irrit., eye col.& eyelash chang., eyelash growth & discolourat., grad. change in eye col., skin irrit.,
conjunctiv.inj., eyelid inflamm./-irrit., eye itch., superfic.punctuate mild to mod.conjuctiv. hyperaem., trans.punctate epithel.eros., ocul./ conjunctiv. hyperaem., H.simplex, keratit.herpet., hypersens.,
Ophthalmics - 15.6 / 15.7 2020-04 / 207
season.allergy, dysgeusia., dizzin., vis. field defects, headache, punc- consid.anaesthes.risk, spontan. hypoglycaem., unstab.insul.-depend. Interactions: Incr.post.-op bleed.risk poss.with anticoags./coumarin/
tate keratit., bact. keratit., ant.chamb.flare, eye pain, photophob., eye diab., poss. masks sympts. of ac. hypoglycaem.& cert. hyperthyroid. indandione deriv./hepar.& platelet aggregat.inhibit., concom.steroids
discharge, ocul.discomf., eye irrit./-abnorm. sensat., foreign body sympts., in hist.of anaphylact. reacts. pts.more respons.to rep.chal- incr. heal. probl.potent.
sensat., blurr.vis., dry eye, eye prurit., eyelid erythema/-oed., reduc. lenge & poss. unrespons. to usual adrenal.dos., incr.musc.weakn. in ALLERGEX EYE DROPS, AI Pharm Ltd [P/S]
vis.acuity, macul. degenerat., corn.eros., iridocyclit., iritis. uveit., ker- myasth.grav./myasthen.sympt., contact.lens use,
atit., ant.chamb.inflamat./-pigmentat., eye inflamm./-swell., corn. monit.with freq./prolong.use in dry eyes/condits. where cornea com- Oxymetazoline HCl
Indications: Allerg.eye inflamm.
stain., photopsia., blepharit., conjunctiv.oed., corn.epithel.defect, promis., poss.adverse eff.on corn. permeabil.& corn.epithel.with pro-
halo vis., corn.pigmentat., allerg.conjunctivit., conjunctiv. disord., long.use, reg. ophthalmolog.exam.requir., extend.use in extens. ocul. (S2) DROPS. H1274
874922-003: 0,25 mg/ml, 15 ml, R27,68
conjunctivit., conjunctiv. follicles, hypoasthes.eye, meibominit., incr. surf.dis., use of 2 or more topic.ß-adrenerg. blocks./prostagland.not
lacrimat., ectropion, keraconjunctivit.sicca, sicca syndr., pigment recomm., excret. in breast milk, reg.exam.with incr.iris pigmentat.& Dosage: Admin.1-2 drps.in eyes, morn.& even.or when requir.
Contraindications: Childr.und.6 yrs.
dispers.syndr., mydrias., cataract, eye allergy, dark circles und.eyes, poss. discont.ther if necess.
eyelid pain/-disord./- marg.crust./-prurit., scler.hyperaem., asthenop., Drug interactions: Poss.life-threat.interacts.with concom. hypogly- Side effects: Loc.reacts., poss.rebound congest. with prolong use.
Special precautions: Regul.opthalm.exam. requir., extens.ocul.
irreg.-/decr.heart rate, palpitat., hypotens., hypertens., dyspn., asthma, caem.agents/ phenothiazin./ var. anti-dysrhythm., hypoglycaem.eff.
resp.disord., oropharyng. pain, cough, dysphon., nas.congest., throat of anti-diabet. agents incr., IOP eff./known syst. ß- block.effs. poss. surf.dis.
irrit., react.pept.ulc., GI disords., dry mouth, allerg. & contact dermatit., potent.with oral ß-block., poss.addit.effs. with Ca chann.block./ ALOMIDE, Novartis [P/S]
periorbit.oed., erythema, rash, hair colour & texture changes, hypertri- catecholamine-deplet.drugs/ ß-block agents/antiarrhythm./digital. Lodoxamide
chos., madaros., musculoskelet.pain, asthen., malaise. glycos./ parasympathomimet./narcot./MAOI, mydrias.with adrenal. Indications: Non-infect.allerg.conjunctivit.in which type 1 hyper-
Warnings and special precautions: Safety & effic. beyond 3 See also MDR page 663. sens.is maj.fact.
mnths.not est., pigmentat.tiss.& eyelash changes esp.if only one (S2) SOL. X/15.4/26. 1 mg/ml
eye is treat., avoid direct expos.to bot.contents if pregn/attempt. XALATAN, Pfizer [P/S] & 806412-003: 10 ml, R194,52
pregn., teratogenic.demonstr.in experiment. animals, adeq.contra- Latanoprost. Dosage: Adults & childr: 1-2 drps in each eye 4x/day at reg.interv.
cept.in women of child bear. potent., passes into breast milk, iritis/ Indications: Elev.IOP reduc.in pts.with open angle glauc., chron. Improvem.in signs & sympts.in respon.to ther. poss. evid.within 3
uveitis pre-dispos. risk fact., act.intra ocul.inflammat., macul. oed. angle clos.glauc.& ocul. hypertens. days but long.treatm.for up to 4 wks.is somet.reqd.
main.in aphak./pseudophak.pts.with torn poster. lens caps./known (S4) EYE DROPS. 31/15.4/0614. 50 µg/ml. Contraindications: Safety in pregn., lactat.& childr.bel.4 yrs.not est.
risk fact., not eval.for angle clos./inflammat/neovasc.glauc.treatm, 833223-003: 2,5 ml/bot., 1, R192,82 Side effects: V.common: Eye irrit./-pain,ocul. discomf.eg.burn./
asthma poss.exacerbat., do not admin.while wear. contact lens., re- Dosage: Adults: 1 drp in affect.eye(s) once dly. pref.in even. not sting./itch.or tear. Common: Dry eye, eyelikd marg.crust., ocul.hyper-
insert contact lens.15 min.aft. admin., admin.other opthalm.meds. exceed dos. Cont.with next dos.as plann.if 1 dos.miss. If other topic. aem., blurr.vis. Uncommon: Dizzin., flush., headache, somnol., ocul.
at least 5 mins apart, nasolacrim.occlus./gent.clos.of eyelid aft. ad- ophthalm.meds. are being used admin.at least 5 mins.apart. warm.sensat., sticky sensat.in ant.chamb.cell, ocul.fatig., blepharit.,
min.recomm.to reduc.system.absorpt., when substitut. anoth. oph- Contra-indications: Safety in pregn & lactat.not est., childr.not conjunctiv.oed., corn.abras./-eros., eye allergy/-discharge/-disord./-
thalm. antiglauc.agent with TRAVATAN discont. other agent & start recomm., use of 2 ≥ prostagland./ prostagland.analogs/prostagland. oed., eyelid oed., foreign body sensat.in eyes, keratit., keratopathy, vis.
TRAVATAN follow.day. derivat.not recomm. disturb., resp./thorac.& mediastin.disords., sneez., nas.dryn., naus.,
Drug interactions: Addit.eff.with timolol & brimonidine eye drops. Side-effects: Incr.iris pigmentat., eye irrit., blepharit., eye pain, stomach discomf., rash, feel.hot.
See also MDR page 136. eyelid oed., eye col.& eyelash/ vellus hair chang., conjunctiv.hyper- Special precautions: Safety & effic.of prolong. use not est., poss.
aem, trans. punctate epithel.eros.., skin rash, dizzin.,headache, irit./ advers.eff.on corn.permeabil.& corn.epithel.with prolong.use requir.
TRUSOPT, Mundipharma [P/S] uveit., keratit., macul.oed.main.in pts.with aphakia & pseudophakia reg. ophthalmologic. examinat., prolong.use with extens. ocul.surf.dis.
Dorzolamide HCl equiv.to base. with torn post.lens caps./ ant. chamber lens., sympt.corn.oed.& Warnings: Do not wear soft contact lens.while und.treatm.
Indications: Reduc.elev.IOP. eros., periorbit. oed., darken.of the palpebral skin, asthma, dyspn.,
(S3) SOL. 29/15.4/0766. 20 mg/ml. URTI, colds & flu, musc./joint/ back/chest pain, ang. pect., poss.bact. BIOLON PRIME, Litha [P/S]
819832-006: 5 ml, R165,32 keratit., cont. lens absorpt., blurr.vis. Na hyaluronate.
Dosage: Monotherapy: 1 drp.3xdly. Warnings and special precautions: Pts.to be inform.of potent. Indications: Aid in anterior & posterior ophthalm. surg.proced.
Adjunct.with ß-block: 1 drp. 2xdly. Admin at least 10 mins apart grad.incr.brown iris pigmentat. which is irrevers.esp.in case of mix. includ.glauc.filtrat., intraocul.lens implantat., cataract extract., cor-
if used in combinat. colour.irid., aphak./ pseudophak.pts.with torn post.lens capsules/pts. neal transplantat. surg.
Contraindications: Mod.to sev.ren.impairm., hepat.impairm., safety with risk fact.for macul.oed., reg. opthalmolog.exam.reqd., extend. (S4) INTRAOCUL.INJ. 34/15.4/0302. 12 mg/ml.
& effic.in childr.& pts.with ac.angle-clos. glauc.not est., concom.oral use in pts.with extens.ocul.surf.dis., eff.of contin.admin.not est., 701464-001: 1x0,8 ml pre-fill.syringe, R584,61
carbonic anhydr. inhibit. limit. exper.in inflamm.ocul.condits./inflamm./ neovasc./angl.clos./ Dosage: Indiv.accord.to type of surg. Usual dos.of 0,2-0,7 ml inj.into
Side effects: Headache, dizzin, paraesthes., burn., sting., superfic. congenit. or pigment.glauc./ pseudophak.pts.with open angl.glauc., ant.segm. Great.amounts used in the post.segm.
punctuat.keratit., tear., conjunctivit., eyelid inflammat./-irrit./-crust., no exper.in ac.clos.angl.glauc.attacks, ren./hepat.impairm., ocul. Side effects: Trans.incr.IOP, post-op.inflamm. reacts., hypersens
eye itch., blurr.vis., iridocyclit., irrit.incl.redness, pain, trans.myopia, reacts.esp.conjunctiv./lid reacts., limit.exper. in asthma but asthma Special precautions: Do not overfill eye, avoid use of large amounts
corn.oed., ocul.hypotony, choroid. detachm.follow.filtrat.surg., epix- aggravat./ ac.asthma./ cough/ dyspn.poss., avoid cont.betw.dispens. for post.segm.proced.in aphak. diabet., remove all remain.sol by ir-
tax., naus., bitter taste, dry mouth, urolithias., loc.& system. hypers- cont.& eye/surround.struct., heterochrom.poss.in unilater.treatm., rigat./ aspirat. at end of surg., careful.monit.of IOP esp. dur.immed.
ens. reacts., asthen., fatig., Stev.John. syndr., tox.epiderm.necrolys. exceed.1x dly. dos.decr.IOP low. eff,, rem.contact lenses bef.instill.& postop per., institute correct.act.if IOP incr.signific., avoid trapp.of
Warnings and special precautions: Soft cont. lens., outweigh re-insert aft.15 min. air bubbles behind Biolon Prime, be aware of poss.immunologic.&
benef.-risk dur.pregn.& lactat, elderly, since it is a sulphonam.& ab- Drug interactions: IOP reduc.eff.is addit.to that of beta-adrenerg. allerg. risks assoc.with inj.biologic.subst., avoid re-use of cannula
sorb.system. the adverse reacts.attribut.are applic., when subsitit. antagon., eff.was addit.in combin. with dipivefrin, acetazolamide however if necess.rinse thoroughly to remove all traces of resid.
Trusopt for anoth. ophthalm.antiglauc. agent discont.agent aft.prop- & partly with pilocarpine, precipitat.occurs with eye drops con- mat., do not admin. through cannula prev.used.with sols.contain.
er dos.in one day and start Trusopt on next day, reg. ophthalmolog. tain.thiomersal. benzalkonium Cl, precipitate format.poss.which if observ.should be
exams.recomm., extend.use in extens.ocul.surf. dis., discont.& eval. See also MDR page 665. remov.by irrigat.and/aspirat.
pt if allerg.-type react.occur., incr.potent.for corn.oed.in pts.with low
endothel. cell counts. BIOLONE, Litha [P/S]
Na hyaluronate.
XALACOM, Pfizer [PWR] & 15.7 Others Indications: Aid in surgic.proced. includ.glauc. surg., intraocul.lens
Latanoprost 50 µg, timolol 5 mg/ml implantat., cataract extract., corneal transplantat. surg., retin. de-
Indications: IOP reduct.in open angle glauc.& ocul.hypertens. when LUCENTIS (MDR Listing) tachm., vitreal replacem.proced.
intol.or uncontrol. on monother. other than latanoprost & timolol. NEVANAC (MDR Listing) (S4) INJ. 30/3/0194. 10 mg/ml.
(S4) EYE DROPS. 36/15.4/0043. PATANOL (MDR Listing) 836109-007: 1x1 ml pre-fill.syringe, R344,39
702983-003: 2,5 ml/bot., R249,57 Dosage: Slow.& caref.inj.suffic.amount (usually 0,2-0,6 ml) into ant.
Dosage: Adults incl.elderly: 1 drp in affect.eye(s) once dly. Dos.not ACULAR, Allergan [P/S] chamber. Remove all remain.liq.at close of surg.
to be exceed. If other topic. ophthalm.meds.are being used admin. Ketorolac tromethamine. Side effects: Trans.incr.IOP, post-op.inflamm. reacts., corneal
at least 5 mins.apart. Cont.with next dos.as plann.if one dos.miss. Indications: Ocul.pain/burn.& sting.reduct. follow. corn.refract.surg. oed.& decompensat.
Contraindications: React.airway dis.incl.bronch. asthma or hist. (S4) 0,4% EYE DROPS., A40/15.4/0282. 4 mg/ml. Special precautions: Do not use an excess quantity, institute cor-
thereof/COPD, sinus bradycard., 2 /3 degree AV block, card.fail., 713372-001: 5 ml, R247,49 rect.act.if IOP incr.above expect.values, avoid trapp.of air bubbles
nd
rd
cardiogen. shock, safety & effic.in childr.not est., safety in pregn. Dosage: 1 drp. 4xdly.for up to 4 days post-op. behind Biolone, be aware of poss.immunologic.& allerg. risks assoc.
not est., lactat. (S3) 0,5% EYE DROPS, 29/15.4/0265. 5 mg/ml. with inj. biologic.subst., avoid re-use of cannula, do not admin.through
Side effects: Incr.iris pigmentat., darken.of palpebr.eyelid skin, dark./ Indications: Inflammat.follow.ocul.surg. cannula prev. used.with sols.contain.benzalkonium Cl.
thicken./misdirect. growth & lengthen.of eye lashes, macul.oed.incl. 820032-018: 1x5 ml, R230,26 BSS ALCON, Alcon [P/S]
cystoid macul.oed., Prinzmetal’s ang./periph. & circulat.disords.aggra- Dosage: 1 drp.3xdly. start.24 hrs.bef.surg & contin. post-op. Na-Cl 6,4 mg, Na-acet.trihydr.3,9 mg, Na-citr. dihydr.1,7 mg, KCl
vat., hypotens., sev.resp. reacts. incl.fatal bronchosp.in asthma pts., Contraindications: Contact lens, safety & effic. in childr./pregn.& 0,75 mg, CaCl dihydr.0,48 mg, MgCl 0,3 mg/ml.
bradycard., eye irrit./hyperemia, corn.disords., conjunctivit., punctate lactat.not est. Indications: Irrigat.dur.eyes/ENT surg.
epithel. eros., blepharit., headache, skin reacts.,psorias.exacerbat., Side effects: Common: Iritis, keratic precipitat., hem retinal, cys- (S1) SOL. H1353, NX/15.4/151.
infect., sinusit., URTI, diab.mellit., depress., hypercholesterolaem., ab- toid macul.oed., eye burn./prurit./ trauma, incr. intraocul.press., hy- 711020-019: 15 ml, R64,38.
norm.vis., cataract, refract.error., keratit., photophob., vis.field defect., persens., headache. Post market: Eye irrit./oed./swell./ pain, eye- 711039-003: 250 ml, R114,25.
hypertens., hypertrichos., arthrit., foreign body sensat., dizzin., irit./ lid oed., ocular hyperaem., conjunctiv. hyperaem., ulcerative keratit., 711012-008: 500 ml, R224,24.
uveit., asthma/aggravat., ac. asthma attacks, dyspn., cough, localis. bronchosp./ exacerbat. of asthma. Dosage: Follow directions.
skin reacts. on eyelids., muscle/joint/eye pain, non-specif. chest pain, Warnings and special precautions: Allow 15 mins. to elapse Side effects: Keratopathy when corn.endothel.is abnorm., post-op
allerg.reacts.incl.anaphylax./angioed., anorex., psych.disords., decr.li- bef.re-insert.contact lenses, poss. adverse eff.on corn. permeabil.& inflamm.reacts, corn.oed., corn.decompensat.
bido, CNS effs., cerebr. ischaem., cerebrovasc.accid., vis.disturbs. incl. corn.epithel.with prolong.use., reg.ophthal.exam.requir., prolong.use Warning: Medicat.added may result in intraocul. tiss.damage.,
diplop., tinnit., card.disords.incl.CF/arrest, worsen. ang.pect., claudi- with extens.ocul.surf.dis., cross-sens.potent.to acetylsalicyl. acid/ not for inj.or IV use.
cat., Raynauds, cold hands & feet, nas. congest., pulm.oed., resp.fail, phenyl acet.derivat.& NSAID’s, bronchosp./ exacerbat.of asthma in
GI disturbs.incl. retroperiton. fibros., alopec., SLE., impot., Peyronie’s pts.with known hypersens.to aspirin/NSAIDS or past med. hist. of BSS PLUS, Alcon [P/S]
dis., asthen., fatig., oed., ocul. effs. incl. perman.eye colour chang. asthma assoc. with ACULAR, bleed. tendenc., concom.medicat.that Glutathione disulf.0,184 mg, dextrose anhyd. 0,92 mg, CaCl dihy-
Warnings and special precautions: Heterochrom. potent.in uni- prolongs bleed. time, slow/delay.heal.poss.with topic.NSAID’s, may dr.0,154 mg, MgCl hexahydr. 0,2 mg, NaCl 7,14 mg, KCl 0,38 mg,
lat.treatm. of which pt.to be inform.bef.init.ther., aphak./pseudoaphak. mask usual signs of infect., discont.in pts. with evid.of corn.epithel. dibas. Na phos.anhydr.0,42 mg, sod.hydrog.carbon. 2,1 mg/ml.
pts.with torn post.lens.caps./pts.with macul.oed. risk fact., choroid. breakdown & monit.corn. health closely, incr.sight threat.corn.advers. Indications: Irrigat./phacoemulsificat.fluid.dur. intraocul.surg., globe
detachm.aft.filtrat.proced., no exper.in treatm.of inflamm./neovasc./ events in complic. ocul.surg./corn.denervat./corn.epithel. defects / format.& deepen.of anter. chamb.
chron.angle clos./ congenit.glauc./open angle of pseudophak. pts. /& diab.mellit./ocul.surf.dis./rheumat. arthrit. & rep.ocul.surg.within (S1) SOL. 34/34/0447
pigment.glauc., system.absorpt.theref. cardiovasc.& resp. reacts.of ß- short period of time, use more than 24 hrs.prior to surg/beyond 14 700417-006: 500 ml, R280,17
adrenerg.poss., monit.CV dis./hist.therof, withdr.grad.bef.maj. surg., days post surg. may incr.pt. risk for occurr.& sever.of corn. adv. events. Dosage: Follow directions.
208 / 2020-04 Ophthalmics - 15.7
Side effects: Post-op inflamm.reacts., corn.oed., corn.decomposit. warn pt.to report sympts.suggest.endophthalmit.& mang. appropr. incl. clinic. exam./optic.tomography or fluoresc.angiography. Monit.
Special precautions: Do not use other addit., do not use until re- pot.risk of arter.thromboembol.events, pot.for immunogenocit., ensure freq.determ. by treat.med.practit.
constit., diab.pts.& undergo. vitrect. contracept.in wom. of childbear.pot. & contin.for 3 mnths aft.treatm. Admin.und.asept.techniq.as per manufact.instruct. Admin.adeq.an-
CELLUFRESH, Allergan, [P/S] FLUORESCITE 10%, Alcon [P/S] aesthes.& broad spec.topic. microbicide prior to inj. Pt to self-admin.
antimicrob. drps 4xdly x3 days bef.& aft.inj.
Carboxymethylcellulose sod. Fluorescein. Contraindications: Safety & effic.beyond 24 mnths. not est.,
Indications: Lubric.to relieve irrit.& discomf.from dry eyes/wind/sun Indications: Diagnost.angiography/angioscopy of retina & iris act./suspect.ocul./periocul. infects., act.sev.intraocul.inflammat.,
(S0) EYE DROPS. 32/15.4/0477. 5 mg/ml. vasculature. pregn.& lactat., safety & effic.admin.to both eyes concurr. not stud-
861510-003: 30 x 0,4 ml sngl.dos.vials, R105,32 (S3) IV INJ. A40/28/0679. 100 mg/ml. ied, adjunct.with verteporfin photodynam. ther. in wet AMD/PM,
Dosage: 1-2 drps.in affect.eye(s) 4xdly as need. 709634-001: 12 x 5 ml, R4 018,28 mix.with other prod., no studies with concurr.eye condits.e.g. retin.
Side effects: Irrit., trans.blurr., eye pain/-prurit.-discharge, vis. Dosage: Inject contents into antecubital vein rapid (1 ml/sec. detachm. /macul.hole.
disturbs. hypersens., incr.lacriminat., ocul.hyperaem., superfic.eye recomm). Adults: Norm.dos.500 mg. Childr.: Recomm.dos.7,7 mg/ Side effects: Endophthalmit., intraocul. inflammat., rhegmatogen.
injur., eye abras. kg body weight. retin.detachm., iatrogen. traumat. cataract, nasopharyngit., influenza,
Warnings and special precautions: Re-assess. condit.in event See manufact.prod.literat.for admin.instruct. UTI, anaem., anx., headache, stroke, vitrit., vitreous float./ detachm.,
of irrit./pain/redn./vis.changes or worsen., avoid.contaminat.& direct Contraindications: Hypersens.to fluorescein sodium or any other retin./conjunctiv. haemorrh., vis. disturbs., eye pain/irrit./prurit./disch.,
eye cont., safety in pregn.&lactat.not est., observ.15 min. interv.betw. ingred., safety & effic.in pregn. & lactat.not est. foreign body sens. in eyes, incr.lacrimat., dry eye, blepharit., ocul. hyper-
other concom.eye med Side effects: Hypersens.reacts, anaphylact reacts./ shock, uriticar., aem., retin.degenerat./disord./ detachm./ tear, retin.pigment epitheli-
CELLUVISC, Allergan [P/S] anaphylactoid reacts./ shock, dysgeus., headache, syncope, convuls., um detachm./tear, vis.acuity reduc., vitreous haemorrh./ disord., uveit.,
Carboxymethylcellulose sod. card.arrest, bradycard., tachycard., thrombophlebit., hypotens., shock, iritis, iridocyclit., cataract, cataract subcapsul., poster.caps. opacificat.,
Indications: Irrit.& discomf.relief of dry eyes/ wind or sun expos. hot flush, hypertens., pallor, bronchosp., asthma, cough, dyspn., la- punct.keratit., corn.abras., ant. chamber flare, blurr.vis., inj.site/eye
(S0) DROPS, 30/15.4/0144. 10 mg/ml. ryngeal/nasal/pulm.oed, resp.arrest, sneez., abdom.discomf., N&V, haemorrh., conjunctivit., allerg.conjunctivit., photops., photophob.,
825085-004: 30x0,4 ml sngl.use contain., R127,67 prurit., extravasat., death ocul.discomf., eyelid irrit./oed./pain, conjunctiv.hyperaem., blindn.,
Dosage: Apply 1-2 drps.in each eye as reqd. Special precaution: Avoid extravasat dur.inj., poss.death due loc.reacts., endophthalmit., hypopyon., hyphaema, keratopathy, iris
Side effects: Eye irrit./-pain, blurr.vis., incr. lacrimat., ocul.hyperaem. to anaphylax.report., allerg./ bronch. asthma hist., yellow skin & adhes., corn.depos./oed./striae, abnorm. sensat.in eyes, cough, naus.,
Warnings and special precautions: Discont.if irrit./pain/redn.or urine discol. skin/allerg. reacts., arthralg., incr.IOP, arter.thromboembol. events.
vis.changes occur/worsen, remove contact lenses & insert.15 mins Warning: Not for intrathecal or intra-arterial use. Warnings and special precautions: Adeq. contracept. in women
aft.admin., concom.ophthalmic meds.to be admin.15 mins prior to I-GLO, (Aspen Pharmacare: Consumer) Pharmacare [P/S] of childbear.potent., potent. teratogen., not recomm.in childr.& ado-
instillat., safety & effic.dur.pregn.& lactat.not est., discard aft.use, Phenylephr.HCl 2,5 mg, boric acid 92 mg, borax 27,5 mg NaCl lesc.due to lack of safety & effic. data, monit.for early detect. & treatm.
do not store open contain. 34 mg/5 ml. of poss. infect., endophthalmit., poss. immunogenicity, arter.thrombot.
DUOVISC, Alcon [P/S] Indications: Inflam.sore irrit./red & tired eyes. event risk., known stroke risk fact.& stroke/TIA hist., limit.exper.with
prior RVO episod./ischaem.branch RVO (BRVO)& centr. RVO (CRVO),
Sngl.blist.packs contain.dispos.glass syringes deliver.0,35 ml or 0,5 ml (S0) DROPS. H1319. ther.not recomm.in RVO pts. present. with signs of irrevers.ischaem.
Viscoat and either 0,4 ml or 0,55 ml Provisc. 783625-006: 15 ml, R14,97 vis. funct. loss, omonit.& manage IOP & perfus.of optic nerve head,
Indications: Prov.of two viscoelastic mat.with diff.physicochemic. Dosage: 1-2 drps.morn.& even. vis.disturbs.may affect driv./mach.operat. abil.
propert.used to perform spec. tasks dur.cataract proced. Contraindications: Narr.angle glauc. See also MDR page 128.
(S4) VISCOELAST.SYST, 33/3/0182 Side effects: Allerg.reacts.
882911-004: 1x0,35 ml Viscoat & 1x 0,4 ml Provisc, R1 261,72 Special precautions: Infts., concom guanethidine & other syst. MINIMS FLUORESCEIN SODIUM 2 %, (Bausch & Lomb)
882903-001: 1x0,5 ml Viscoat & 1x 0,55 ml Provisc, R1 766,39 adrenerg.block.agents. SofLens [P/S]
Special precautions: Allow to attain room temp.prior to use. Fluorescein sod.
See respect.manufact.product lit.for further details. KELOPT, Actor [P/S] Indications: Detect.corneal abras.& foreign bodies, applanation
Ketorolac tromethamine.
DURATEARS PRESERVATIVE FREE, Alcon [P/S] Indications: Inflam.relief follow.ocul.surg. tonometry, assess.patency of nasolacrimal duct,contact lens fitt.
(S1) SOL, T/15.4/86. 10 mg/0,5 ml
Anhydr.liq.lanolin. (S3) OPHTH.SOL., 45/15.4/1033. 5 mg/ml. 743534-026: 20x0,5 ml, R434,85
Indications: Eye lubric. 723869-001: 5 ml, R160,47 Dosage:. Sngl.dos.eye drops. Apply suffic.sol.to stain damage.area,
(S0) OINT. J/15.4/290. 30 mg/g. Dosage: 1 drp.4xdly.commenc.24 hrs.bef.surg.& contin. post-op. wash away excess with sterile saline sol.
721719-007: 3,5 g, R84,90 Use beyond 14 days post surg. incr.risk & sev.of corn.advers.events. Contraindications: Soft contact lenses
Dosage: Small ribbon in conjunct.sac./into affect area Contraindications: Aspir./NSAID’s hypersens., safety & effic. in Side effects: Allerg., anaphylax., allerg. conjunctivit., periorbit.oed.,
Special precautions: Discont.if persist.ocul.irrit. childr.not est., pregn.& lactat., soft contact lens in situ. urticar., rash, angioed.
Side effects: Sting., burn., ocul.oed./-inflammat./-irrit./-pain, su-
EMADINE, Novartis [P/S] perfic.keratit.& ocul. infects., corn.infiltrat., conjunctiv.hyperaem., Special precautions: Avoid microb.contamin.
Emedastine base iritis, dry eyes, corn.oed./-ulcerat./-eros./-perforat./-thinn., epithel. MINIMS LIDOCAINE & FLUORESCEIN, (Bausch & Lomb)
Indications: Season.allerg.conjunctivit. breakdown, allerg./loc.reacts., headache. SofLens [P/S]
(S2) SOL. 34/15.4/0037. 0,5 mg/ml Warnings and special precautions: Due to poss. aspir./NSAID’s Lidocaine HCl 20 mg, fluorescein sod. 1,25 mg /0,5 ml.
891449-007: 5 ml, R156,09 cross-sensitiv.asthma pts./ precipitat.rhinit/urticar., signs of infect. Indications:. Diagnost.loc.anaesth.& stain combin.
Dosage: Adults & childr.over 3 yrs: Instil 1 drp.2xdly into affect. poss. mask., poss.incr.ocul.tiss.bleed.with ocul.surg., pept.ulcerat. (S4) SOL, L/15.4/369
eye(s). Observ.interv.of 10 mins.betw applic.of other ophthal.meds. hist., bleed.tendenc., meds.prolong. bleed.time, discont.& monit.in 743488-016: 20x0,5 ml, R379,39
with oints.applied last. Do not allow dropp.tip to touch eyelids/sur- pres.of corn.epithel. breakd., incr.sight threat.corn.advers.events in Dosage: Sngl.dos.eye drops. Adults: 1 or more drps.as direct.by
round.areas to prev.contamin. Remove snap collar to prev.it acci- complic. ocul.surg./corn.denervat./corn.epithel. defects /diab.mel- ophthalmol. Childr: At discret.of ophthalmol.
dent.fall.into the eye. lit./ocul.surf.dis./rheumat.arthrit. & rep. ocul.surg.within short pe- Contraindications: Hypersens.to anaesth.of same group
Contraindications: Safety in pregn.& lactat.not est., not recom.in riod of time & if used more than 24 hrs.prior to surg/beyond 14 days Special precautions: Protect anaesth.eye from contamin.(esp.el-
pts.>65 yrs.& hepat.& ren. impairm. post surg., slow/delay.heal.poss., HF poss. precipitat. in comprom. derly in whom anaesth.durat. exceed 30 mins.).
Side effects: Dry eye, ocul. hyperaem.& prurit., blurr.vis., corn.stain., pts., poss.adverse eff.on corn. permeabil.& corn.epithel.with prolong.
foreign body sensat., sinus headache, dysgeus., eye pain, conjunc- MINIMS OXYBUPROCAINE HYDROCHLORIDE 0,4 %,
tiv. hyperaem., corn.infiltrates, lacrimat., asthenop., rash, abnorm. use., reg. ophthal.exam.requir., prolong.use with extens. ocul. surf. (Bausch & Lomb) SofLens [P/S]
dreams, tachycard., ocul.irrit., headache. dis., determine S/E bef.driv./operat. machin. Oxybuprocaine HCl.
Special precautions: Discont.ther.& implem. appropr.managem. Drug interactions: Incr.post.-op bleed.risk poss. with anticoags./ Indications: Applanation tonometry, contact lens fitt.
in event of corn.infiltrates, poss.adverse eff.on corn.permeabil.& coumarin/indandione deriv./ hepar. & platelet aggregat.inhibit., con- (S4) SOL. C/15.4/44. 2 mg/0,5 ml
corn. epithel.with prolong.use.req.reg.opthalm. examinat., prolong. com. steroids incr.heal.probl.potent. 743526-015: 20x0,5 ml, R329,59
use with extens.ocul.surf.dis., allow 10 min.interv.bef.insert.contact LUCENTIS, Novartis [P/S] & Dosage: Sngl.dos.eye drops. Adults & childr: 1-3 drps.as direct.
lenses, do not drive/operat.machin.unless vis.clear. Ranibizumab by ophthalmol.depend.on degree of anaesth.reqd. Onset: 6-20
EYLEA, Bayer [P/S] Indications: Neovasc. (wet)age-relat.macul. degenerat.(AMD), vis. secs. Durat: 15 mins.
Aflibercept impairm.due to diabet.macul. oed.(DME) & retin.vein occlus.(branch Contraindications: Allergies, card.dis., hyperthyroid, open lesions.
Indications: Neovascul. (wet) age-relat. macul. degenerat. (AMD), RVO/centr. RVO), vis.impairm. due to choroid. neovascularisat. (CNV) Side effects: Eye allergy, allerg.blepharit., hypersensitiv., anaphylax.,
macul.oed. follow. centr.retin. vein occlus. (CRVO) second.to patholog.myop.(PM) Syst.toxic.( CV-collapse, convuls., hyperexcitab.)
(S4) SOL.FOR INJ., A46/15.4/0841. 40 mg/ml. (S4) SOL.FOR INJ, 41/15.4/0860. 10 mg/ml MINIMS PROXYMETACAINE HYDROCHLORIDE 0,5 %,
722548-001: 1 vial (100 microlitres equiv to 4 mg), R7 773,54 711524-001: 1 vial with filter needles, 2,3 mg in 0,23 ml of which (Bausch & Lomb) SofLens [P/S]
Dosage: Only to be admin.by dr.experienc.in admin. of intravitr.inj., 0,05 ml (equals 0,5 mg) is inject., R7 773,54 Proxymetacaine HCI
monit.pt immed.follow. admin. for elev.IOP. Dosage: Intravitreal inj.only by exper. ophthalmologist. Recomm. Indications: Topic.ocul.anaesth.
Neovascul. age-relat.macul.degenerat: 2 mg by intravitr. inj eve- dos: 0,5 mg (0,05 ml) as sngl.intravitr.inj. (S4) SOL, 35/15.4/0088. 0,0025 g/0,5 ml
ry mnth for 3 mnths then every 2 mnths., treatm.interv.may be extend. Wet age-relat.macul.degenerat./vis.impairm. due to DME: 704504-002: 20x0,5 ml, R321,79
to every 2-3 mnths. aft.12 mnths based on vis.& anatom. outcom. Treatm.giv. once mnthly & contin. until vis.acuit. stable for 3 consec. Dosage: Sngl.dos.eye drops. Adults & childr:
Macul.oed.follow.centr.retin.vein occlus.: 2 mg by intravitr. mnthly. assessm. Monit.vis.acuity mnthly.theraft. Resum. mnthly. inj. Deep anaesth: 1 drp every 5-10 mins.x5-7 applic.
inj every mnth until vis & anatom. outcom. stable (3 or more con- when monitor.indicat.loss of vis.acuit & contin.until.vis.acuit.stable Remov.of sutures: 1-2 drps.2-3 mins.bef.remov. of stitch.
sec.mnthly. injects. may be req.), treatm.should be contin.& interv. for 3 consec. mnthly. assessm. Remov.foreign bodies: 1-2 drps.prior operat.
may be extend.based on vis.& anatom.outcom. Interv. betw.dos. Laser photocoagulat.in DME: Admin.concomit. with laser pho- Tonometry: 1-2 drps.immed bef.measurem.
should not be < 1 mnth. tocoagulat./in pts.with prev.laser photocoagulat. When giv.on same Contraindications: Premat.babies, ocul. inflammat. /infect.
Contraindications: Ocul./periocul.infect., act. sev. intraocul. in- day, admin.at least 30 min.aft. photocoagulat. Side effects: Pupill.dilat./cyclopleg.effs., conjunct. irrit., hyperal-
flammat., pregn.& lactat. Vis.impairm.due to macul.oed.second.to RVO: Treatm.giv.mnthly lerg.corn.react.incl.ac. intense. & diffuse epithel.keratit., allerg.
Side effects: Conjuntiv. haemorrh., eye pain, retin.pigm.epithel.tear, & contin.unt. max.vis.acuity achiev .& confirm.by stable vis.acuit.for contact dermatit.
detachm.of retin.pigm. epithel., cortic/nucl./subcapsul./traumat.cata- 3 consec. mnthly. assessm. Monit.visual acuity mnthly. theraft. Re- Special precautions: Known allerg., card.dis., hyperthyroid., do
ract, corn.eros./abras./oed., IOP, blurr.vis., vitr.floaters/ detachm., inj. sum.mnthly.inj.when monitor.indicat. loss of vis.acuit & contin.unt. not rub./touch eye while anaesth. persist, protect eye from dust
site pain/haemorrh., foreign body sensat.in eye, incr.lacrimat., eyelid vis.acuity stable for 3 consec. mnthly.assessm. & bact.contamin.
oed., punct. keratit., conjuntiv./ocul.hyperaem., endophthalmit., retin. Laser photocoagulat.in branch RVO: Admin. concomit.with la-
detachm./tear, uveit, irit., iridocyclit., lenticul. opacit., corn.epithel. ser photocoagulat./in pts.with prev.laser photocoagulat. When giv. MINIMS TETRACAINE HCL 1 %, (Bausch & Lomb) SofLens [P/S]
defect,anter.chamb.flare, vitrit., hypopyon. on same day, admin.at least 30 min.aft photocoagulat. Tetracaine HCl
Warnings and special precautions: Pts.with poorly contr.glauc., Vis.impairm.due to CNV second.to PM: Init. ther.with sngl.inj. Indications: Loc.anaesth.for ophthalm.proced.& min.surg., goni-
elev.in IOP may occur; monit. perfus. of the optic nerve head & IOP., Furth.treatm.recomm. if monit. indic. signs of dis.activ. Monit. may oscopy in suspect.glauc.
Ophthalmics - 15.7 2020-04 / 209
(S4) SOL, C/15.4/47. 5 mg/0,5 ml Warnings and special precautions: Corn.toxic. report., risk fact. to avoid eye/med.contamin.dropp.tip not to come into contact with
743518-012: 20x0.5 ml, R305,63 for corn.ulcerat.& thinn., poss.incr. ocul.tiss.bleed.in conjuct.with any surf., not stud.in elderly or hepat./ren.impairm., safety & effic.
Dosage: Sngl.dos.eye drops. Use accord.to ophthalmol. Onset: 9-26 ocul.surg., known bleed. tendenc./meds.known to prolong bleed. not est.in childr.und.12 yrs.,
secs. Durat: 10-20 mins. time, poss.masks onset/progress.of ocul.infects., appropr. ther.to be
Contraindications: Concom.sulphonamid. giv.concom.in presenc.of infect./risk. SPERSATEAR, AI Pharm Ltd [P/S]
Side effects: Conjunct.irrit., punctate corneal damage (due to lact. Drug interactions: In pre-exist.signific.corn. inflammat incr.risk. Hydroxypropylmethylcellulose.
acid accumulat.), dermatit., CV-collapse, occas.convuls.& hyperexcitab. of corn.complicat.developm. with topic.steroids, incr.potent.for Indications: Mucin.& aq.defic.dry eye condits.
Drug interactions: Inhib.act.of sulphonamides. heal.probl.with topic.steroids, ophthalm.acetylcholine & carbachol (S0) DROPS. N/15.4/22. 3mg/ml.
preps poss.ineffect. 765740-001: 20 ml, R41,36.
MIOCHOL-E, (Bausch & Lomb) SofLens [P/S] Dosage: 2 drps 3xdly/as reqd.
Acetylcholine Cl. PATANOL, Novartis [P/S] & Special precautions: Reg.opthalm.exam.requir. with prolong.use,
Indications: Mios.of iris in seconds aft.deliv.of lens in cataract Olopatadine extens.ocul.surf.dis.
surg., penetrat.keratoplasty., iridectomy.& other anter.segm.surg. Indications: Tempor.prev.of itch.due to allerg. conjunctivit.
(S3) INJ. 28/15.4/0506. (S2) SOL. 33/15.4/0189 STOP-ALLERG, (Adcock Ingram) Genop [P/S]
825476-003: 20 mg/2 ml, 12x2 ml, R4 569,89 701415-001: 1 mg/ml, 5 ml, R166,57 Na cromoglycate.
Dosage: 0,5-2 ml bef.or aft.secur.one or more sutures. Dosage: Adults & childr.over 3 yrs: 1 drp.in conjunctiv.sac.of Indications: Allerg.conjunctivit.
Contraindications: Safety & effic. in childr.not est., safety dur. affect.eyes 2xdly. (S2) EYE DROPS. W/15.4/430
pregn.& lactat.not est. Side effects: Ocul.discomf., ocul.prurit., ocul. hyperaem., ocul.dis- 894605-003: 20 mg/ml, 13,5 ml, R41,80
Side effects: Corneal oed., cloud.& decompensat., persist.bull.ker- charge, keratit., lid oed., dry eye, foreign body sensat., photophob., Dosage: Adults & childr.incl.elderly: 1-2 drps. in each eye 4xdly
atopathy, retin. detachm., postop irit., bradycard., hypotens., flush., blurr.vis., dry mouth, rhinit., erythema, headache, asthen., dizzin., dur.expos.to allergen.
diffic. breath., sweat., N&V, abdom.pain, salivat., lacrym., rhinorrh., dry nose, taste pervers. Contraindications: Safety in pregn.not est., soft contact lens.
eructat., diarrh., urin.freq., headache Special precautions: Not recomm.in pregn.& lactat., 5 min.interv. Side effects: Loc.reacts.
Special precautions: Use aft.deliv.of lens, remove obstructs.to betw.instill.other concom. ophthalm. preps., preservat.benzalkon. Special precautions: Extens.ocul.surf.dis., reg. opthalm.exam.
mios.bef.use., prep.sol.immed. bef.use., open und. asept. cond.only, chlor. report. to cause punctate keratopathy &/tox. ulcerat. keratopa- with prolong.use.
do not gas sterilise. thy theref.monit.caref.with freq./prolong.use in dry eye pts./condits.
Drug interactions: Poss.ineffect.with topical nonsteroid.anti-in- where corn.comprom., do not drive/operate machin. unless vis.clear., TEARS NATURALE PRESERVATIVE FREE, Alcon [P/S]
flamm.agents, effs.signific. prolong. & enhanc.aft.anticholinesteras., interv.of 10 mins.bef.insert. contact lens. Dextran-70 1 mg, hydroxypropyl methylcellulose 3 mg/ml.
beta block.sev.bronchosp.subs.pulm.oed. See also MDR page 134. Indications: Artific.tear treatm.in mucin.& aq.defic.dry eye condit.
(S0) SOL. 29/15.4/0216.
NEVANAC, Novartis [P/S] & PROVISC, Alcon [P/S] 817511-008: Sngl.dos. 0,4 ml x 30 units, R136,90
Nepafenac Na hyaluronate. Dosage: 1-2 drps.as reqd.
Indications: Prev.& treatm.of pain & inflamm. assoc.with cata- Indications: Aid in surgic.ant.segment proced. includ.cataract ex- Warning: Do not re-use, discard once opened.
ract surg.& reduct.in risk of macul. oed. assoc.with cataract surg. tract.with intraocul.lens implantat.
(S3) EYE DROPS, 42/15.4/1006. 1 mg/ml (S4) VISCOELASTIC DEV. X/3/408. 10 mg/ml. TEARS NATURALE II, Alcon [P/S]
716222-001: 8 ml, R217,33 808296-019: 1x0,4 ml syringe, R277,19 Dextran-70 1 mg, hydroxypropyl methylcellulose 3 mg/ml.
Dosage: 1 drp.in conjunctiv. sac of affect.eye(s) 3xdly. Begin.1 day 814377-009: 1x0,55 ml syringe, R381,14 Indications: Artific.tear treatm.in mucin.& aq. defic.dry eye condit.
prior to surg.,on day of surg.& 2-3 wks post-op. Admin.addit.drop 878081-003: 1x0,85 ml syringe, R589,03 (S0) SOL. J/15.4/315.
30-120 mins. prior to surg. Treatm.can be extend.up to 60 days to Dosage: Slow.& caref.inj.suffic.amount into ant. chamber. Remove 817562-001: 15 ml, R83,90
reduce risk of macul.oed.assoc.with cataract surg. Use low.effect. by irrigat.&/aspirat.at close of surg. Dosage: 1-2 drps.as reqd.
dos.for shortest poss.durat.of treatm. Admin.other topic.ophthalm. Contraindications: Hypersens. UNIVERSAL EYE DROPS, Litha
meds.at least 5 mins.apart. Side effects: Trans.incr.IOP, post-op.inflamm. reacts., corneal Phenylephrine HCl 1,25 mg, boric acid 20 mg/ml.
Contraindications: Other NSAID drug hypersens., HF, GI bleed./ oed.& decompensat.
perforat.hist.relat.to prev. NSAID’s, act./hist.of recurr.GI ulc./haem- Special precautions: Potent.allerg.risks., intra-ocul. use only, ob- Indications: Eye strain, mild inflammat., allerg.conjunctivit.
(S0) DROPS, H1348
orrh. /perforat., where asthma/urticar./ac.rhinit. precipit. by acetyl- serv.rout.precaut.assoc.with surg. proced., monit.post-op IOP & in-
salicyl.acid or other NSAID’s, pregn., breast feed., safety & effic.in stit.ther.if signif. incr. occur, allow to attain room temp.prior to use. 773883-002: 15 ml, R24,05
Dosage: 1-2 drps.in each eye 3-4xdly.
childr.<18 yrs. not est
Side effects: Keratit., hypersens., headache, dizzin., eye pain/pru- REFRESH, Allergan [P/S] Special precautions: Poss.adverse eff.on corn. permeabil.& corn.
rit., blurr.vis., dry eye, foreign body sensat., eyelid marg.crust., eye Polyvinyl alcoh. 14 mg, povidone 6 mg/ml. epithel.with prolong./rep.use, prolong use with extens.ocul.surf.dis.
discharge/-irrit./ swell., photophob., allerg.conjunctivit., punct. ker- Indications: Symptomat.relief of irrit.dry eyes., comfort drop while VISCOAT, Alcon [P/S]
atit., incr.lacrimat., blepharit., conjunctiv. hyperaem., skin reacts.& wear.hard/soft cont.lens. Na chondroitin sulph. 40 mg, Na hyaluronate 30 mg/ml in physi-
allerg. dermatit., GI disturbs., incr.BP, dry mouth, dermatochalasis., (S0) OPHTH.SOL, Z/15.4/348. olog.buffer.
corn.abras./-scar./-opacity/-perforat./-thinn., ulcerat.keratit., ant. 796956-006: 30 x 0,4 ml,sngl.dos.units, R104,51 Indications: Aid in surgic.ant.segment.proced. includ.cataract.ex-
chamb.inflammat., imp.corn. heal., reduc.vis.acuity. Consid.CV/GI & Dosage: 1-2 drps.as reqd. tract.& intraocul.implantat.
skin reacts. relat.to NSAID class., oed./hypertens./CF. Side effects: Post market: Irrit., corneal/eye trauma, eye pain/ (S4) VISCOELASTIC DEV. Y/3/319.
Warnings and special precautions: Discont.& monit. if corn. disch./prurit., ocul.hyperaem., conjunctiv. hyperaem., foreign body 789437-007: 1x0,5 ml/syringe, R1 162,59
epithel.breakd.evid., combin.with topic. ster.poss.heal.probl., in pts. sensat., incr. lacrimat. & blurr.vis, allerg.react. 878103-007: 1x0,75 ml/syringe, R1 743,87
with complicat. ocul. surg./corn.denervat./corn.epithel.defects/ diab. Warnings and special precautions: Discont.if eye irrit./pain/ Dosage: Inj.carefully into ant.chamber prior/ follow. intra-occular lens
mellit./ocul.surf.dis./rheumat.arthrit./rep. ocul. surg.within short per. contin.redn & change in vis.occur/ worsen/incr./persist>24 hrs., avoid deliver. At end of proced. remove by irrigat./aspirat.
at incr.risk of sight threat. advers.corneal.reacts., freq./prolong.use, touch.tip of vial to any surf. & avoid contact with eye., pts.wear. soft Side effects: Trans.incr.IOP.
known bleed.tendenc., concom.meds.that prolong bleed. time, avoid cont.lenses to wait at least 15 mins.aft.instill. bef. re-insert., safety Special precautions: Potent.allerg.risks., fail.to foll. assembly in-
contact lens wear, ocul.infects. poss. mask., hypertens./HF hist., GI dis. & effic.not est.in paeds./ geriatr. pts./pregn. & lactat. struct./use of alt.cannula may result in cannula detachm.& ser.injur.,
hist., elderly, discont.if GI bleed./-ulcerat./skin rash/ mucos. les.or oth- REFRESH TEARS, Allergan [P/S] intra-ocul. use only, observ.rout.precaut.assoc.with surg. proced.,
er hypersens.signs report., poss. cross. sens.with acetylsalicyl.acid/ Carboxymethylcellulose sod. monit.post-op IOP & instit.ther.if signif. incr.occur.
phenylacet. acid derivat./other NSAID’s., reproduct.toxic.in animals Indications: Irrit.& discomf.due to dry eyes, expos.to wind/sun.
Interactions: Incr.S/E with concom.NSAID’s, anticoags. eff.poss.en- (S0) EYE DROPS, 37/32.5/0092. 5 mg/ml. VIVIDRIN, (Unicorn) iNova [P/S]
hanc., incr.intest.bleed.risk with anti-platelet agents & SSRI’s., incr. Na cromoglycate.
risk of GI perforat./ ulcerat./bleed.with concom.corticoster. 704150-001: 15 ml, R104,87 Indications: Allerg.conjuncitiv.
Dosage: Apply 1 drop.in affect.eye(s) 4 x dly.or as reqd.
See also MDR page 131. (S2) EYE DROPS. W/15.4/0086
(S0) LIQUIGEL EYE DROPS, A38/15.4/0592.
NOVESIN WANDER, AI Pharm Ltd [P/S] Indications: Lubric.to relieve irrit./burn.& discomf.due to dry eyes, 804630-003: 20 mg/ml, 10 ml, R51,44
Dosage: Adults & childr: 1 -2 drps in each eye 4xdly.on reg.basis
Benoxinate (Oxybuprocaine HCl) lubricat.of & relieve discomf.assoc.with contact lens.wear
Indications: Loc.eye anaesth. 706240-002: 10 mg/ml, 15 ml, R114,61 due to prophylact.nat.of ther.
(S4) DROPS. H1270. 4 mg/ml Dosage: Instil 1-2 drps.in affect.eye(s) as reqd. Side effects: Headache, skin rash, bronchosp., breathlessn.,
748188-002: 3 ml, R125,68 Contraindications: Infts & childr.und.3 yrs., safety in pregn.& anaphylax.
Dosage: For cornea prep: Instil.may be repeat.2-5 times for adeq. lactat.not est. Warnings and special precautions: Safety in pregn. not est.,
anaesthes.as reqd. Side effects: Burn., dry eye, irrit./-prurit., eyelid oed./erythema, withdr.of Na cromoglycate if concom. steroid dos.has been reduc.,
Side effects: Hyperaem., epithel.les., hypersens. reacts., mild burn. epiphora, conjuctiv.hyperaem., eye pain/-discharge, vis. disturbs. poss. adverse effs.on corn.permeabil.& corn.epithel. with prolong.
Special precautions: Sev.corn.damage with indiscrimin.use. Warnings and special precautions: Discont if pain/vis. chang- use, reg.ophthalmolog.exam.reqd., extens.ocul.surf. dis., do not
wear soft contact lens.
PANAMOR EYE DROPS, (Aspen Pharmacare) Pharmacare [P/S] es/ cont.redness/irritat. & seek medic.advis. if cond.worsen/persist
longer 72 hrs., admin. concom ocul.meds 5 min.apart
Na diclofenac. VOLTAREN OPHTHA, AI Pharm Ltd [P/S]
Indications: Ant.eye segment inflam. assoc.with cataract surg., RELESTAT, Allergan [P/S] Na diclofenac.
short term use for ocul.surf.pain of corn.origin, short term use for Epinastine HCl Indications: Ant.eye segment inflam. assoc.with cataract surg.,
inflammat.follow. argon laser trabeculoplasty. Indications: Short term treatm.of seas.allerg. conjunctivit. short term use for ocul.surf.pain of corn.origin, short term use for
(S3) EYE DROPS. 45/15.4/0686. 1 mg/ml. (S2) EYE DROPS, 37/15.4/0691. 0,5 mg/ml inflammat.follow. argon laser trabeculoplasty.
722050-001: 5 ml, R190,81 707876-001: 5 ml, R152,31 (S3) EYE DROPS. W/15.4/204. 1 mg/ml.
Dosage: 1 drp.4-5xdly.determ.by severity of condit. Dosage: Admin.at least 10 mins.apart.in case of other concom. 886963-006: 5 ml, R234,77
Pre-op: 1 drp.up to 5 times dur.3 hrs.bef.surg. ophthalm.meds. No exper.of use in clinic.stud.for more than 8 wks. (S3) SNGL.DOS.UNITS, 33/15.4/0396. 0,3 mg/0,3 ml
Post-op: 1 drp.up to 3 times aft.surg.on day of surg., thereaft. 1 drp. Adults & childr.12 yrs.& old: 1 drp.2xdly.in each affect.eye. 886971-002: 20x0,4 ml units, R263,28
4-5xdly. Side effects: Comm: Eye burn./-irrit. Uncomm: Conjunctiv. oed./ Dosage: 1 drp.4-5xdly.determ.by severity of condit.
Contraindications: Soft contact lens use, aspir/ NSAID’s/other hyperaem., eye discharge/-dryn./-prurit./-pain, incr. lacrimat., vis. Pre-op: up to 5 drps.dur. 3 hrs.bef.surg.
prostagland.synthetase inhibit. sens., pts.in whom asthma/rhinit.& disturbs., headache, asthma, nas. irrit., rhinit., sinusit., dysgeus. Post-op: 3 drps.aft.surg., thereaft. 1 drp. 4-5xdly.
urticar. precipit. by aspir./other prostagland.synthetase inhibit., pregn., Post market: Eye swell., eyelid oed., skin & eye hypersens. reacts. Contraindications: Pregn., lactat.& young childr., soft contact lens
lactat.& young childr., intraocul. use dur.surg.proced. Warnings and special precautions: Top. ophthalm. use only, soft use, aspir/other prostagland. synthetase inhibit.sens., pts.in whom
Side effects: Trans.burn./sting.& blurr.vis., itch., photosens., con- contact lens users to wait 15 mns.aft.instillat., poss.adverse eff.on asthma, rhinit.& urticar.are precipit.by acetylsalicylic acid.
junct./corn.ulcerat., corn./sclera melts & perforat., allerg.condits.for corn. permeabil. & corn.epithel.with prolong.use., prolong. use with Side effects: Trans.burn.&/blurr.vis., hypersens. reacts.incl.photosens.
ocul.reacts.eg. conjuctiv.hyperaem/allerg.conjunctivit./eyelid erythe- extens.ocul.surf.dis., reg. opthalm. examin.with prolong.use, no Special precautions: Appropr.ther.to be giv. concom.in presenc.of
ma/oed./prurit.& syst.hypersens.reacts., dyspn., asthma exacerbat. driv./operat. mach. until. vis.clear, safety in pregn.& lactat.not est., infect./risk, reg. ophthalmolog. exam, extens.ocul.surf.dis.
210 / 2020-04 Urinary System - 16 / 16.1
(S3) TABS, H1941, H/18.1/2 Special precautions: Admin.in pregn.only for short periods if strict.
16 URINARY SYSTEM 701793-007: 25 mg, 60, R91,12 indicat., monit.electrol.reg. esp.in elderly/diabet& card./hepat.or ren.
+
701807-016: 100 mg, 30, R288,70 impairm., myocard.sensitiv.to digital.incr.with K defic., perm.deafn.
Dosage: Adults: Essent.hypertens: Usual.50-100 mg/day. May with ototox.meds., prostat. hyperplas., imp.micturit., K contain./
+
16.1 Diuretics be grad.incr. at 2 wkly. interv.up to 200 mg/day. Contin.for at least 2 K spar.preps. poss.indicat.
+
wks.ensur. adeq. respons. Adjust dos.as necess. Drug interactions: K -deplet.eff.enhanc.by glucocortoid/laxat.
+
ADCO-DAPAMAX, AI Pharm Ltd. CHF: Init.dly.dos. of 100 mg as sngl./div.dos. Rang.from 25-200 mg abuse, nephrotox.& ototox. eff.of cert.antibiot.(aminoglycos) potent.,
dly. Maint: Indiv.
anti-diabet./pres.amines potency diminish., salicylates/ theophylline/
Indapamide. Sev.heart fail.in conjunct. with stand.ther. (NYHA Class III-IV): Li & curaremimet.musc.relax.eff. potent., enhanc.eff.of antihyper-
Indications: Mild to mod.hypertens., oed.assoc. with CHF. Init. 25 mg once dly.in pts. with ser.K ≤ 5,0 mmol/L & ser.creatin. ≤ tens., NSAID’s antag.act., absorpt.reduc.by sucralfate.
+
(S3) TABS. 30/7.1/0092. 220 µmol/L. May be incr.to 50 mg once dly.as clinic. indic.or reduc.to
819417-009: 2,5 mg, 30, R18,84 25 mg every other day if not toler. BURINEX, AI Pharm Ltd
819417-017: 2,5 mg, 600, R376,72 Cirrhos: Usual.100 mg/day if urin.Na /K ratio > 1,0. 200-400 mg/ Bumetanide
+
+
Dosage: Hypertens: 1 tab.dly.pref.in the morn., may be incr.to day if ratio < 1,0. Maint: Indiv. Indications: Oed.assoc.with CHF/ren.dis./ac. pulm.oed./hepat.ascit.
2 tabs aft. 4 wks. In more sev.cases may be combin. with other cat- Nephrot.syndr: Usual dos: 100-200 mg/day. Use only if other (S3) TABS. G/18.1/94
egor.of antihypertens. ther.ineffect. 711152-005: 1 mg, 30, R181,21
Oed: 1 tab.dly, may be incr.to 2 tabs.aft.1 wk. Childr: Init.dos.3 mg/kg bm dly.in div.dos. Adjust accord.to re- 711152-004: 1 mg, 100, R604,15
Contraindications: Sulphonam.-type meds. hypersens., sev.ren./ spons.& toler. Dosage: Most.dly.dos.of 1 mg requir.giv.as sngl. morn.dos. 2 dos.
nd
hepat.dysfunct., Addison’s dis., pre-exist.hypercalcaem., safety in Diuret.-induc.hypokalaem. &/ hypomagnesaem: 25-100 mg/ may be giv.6-8 hrs.later depend. on respons. May be incr.until sat-
pregn.& lactat.not est., concom.thiazide diuret.not recomm. day when oral K &/ Mg supplem.consid.inappropr. isfact.respons. obtain.in refract. cases. Dos.to be titrat.indiv. accord.
+
Side effects: Metab.disords., electrol.imbal., GI disturbs., headache, Diagn. & treatm. of prim.hyperaldosteronism: Init.diagnost. to respons.& reqd.therap.activ. When control on low.dos.inadeq.init.
dizzin., impot., photosens./ hypersens.reacts., postur.hypotens., par- meas.while pts.are on norm.diets. Adults: Long test: 400 mg dly.for 5 mg dly.then incr. by 5 mg increm.12-24 hrly.until reqd.respons.or S/E
aesthes., yell.vis., cholest.jaund., pancreatit., bld.dyscras. 3-4 wks. Short test: 400 mg dly.for 4 days. appear. Consid.2xdly dos.
Special precautions: Imp.ren./hepat.funct., discont.if azotaem.& Short-term pre-op. prim.hyperaldosteronism treatm: Dly. Contraindications: Anur., hepat.coma, mod.to sev.liv.fail., elec-
oligur.occur, elderly pts. partic. suscept.to electrol.imbal., SLE may be dos.100-400 mg bef.surg. May be giv. as longt.maint.ther.indiv.at trol.deplet., childr.
exacerb./activ.in suscept.pts., no exper.of use in childr. low.effect.dos.if pts. unsuit.for surg. Side effects: Skin rash, musc.leg cramps, abdom. discomf., throm-
Drug interactions: Thiazide diuret.may enhance toxic.of digital. Contraindications: Ac.ren.insuffic., rapid progress. ren.funct.im- bocytopaen., gynaecomast., pancreatit./ sev.gener. musculoskelet.
glycosid., enhanc.neuromusc. block. act.of competit.musc.relax., the pairm., anur., hyperkalaem., concom. eplerenone, Addison’s dis., pain somet. assoc.with musc.spasm in high dos., inj.poss. aggrav.
K deplet. eff. enhanc.by corticoster., corticotroph./ carbenoxolone & safety in pregn.& lactat.not est. pre-exist.electrol.imbal., uric acid incr., hear. disturbs.esp.in ren.in-
dimin.respons.to press.amines, eff. of antihypertens.agents poss. Side effects: Benign.breast neoplasm, leucopen., thrombocytopen., suff., incr.K excret.
+
enhanc., postur. hypotens.poss.enhanc.by concom.alcoh., barbitur./ electrol. disturbs., hyperkalaem., confus., libido chang., dizzin., somnol., Special precautions: Sudd.chang.in CV press./ poss.circulat.col-
opoids, Li may lead to toxic bld.conc., NSAID’s may interfer.with ef- GI disturbs., abnorm. hepat.funct., skin reacts., alopec., hypertrichos., leg lapse with excess. rapid.oed. mobilisat., pre-exist.electrol.imbal.,
fic.& enhanc risk of ren. insuff. cramps, ac.ren.fail., gynaecomast., menstr.disords., breast pain, malaise. high dos./ prolong.per., low salt diet, monit.bld.gluc.period.in diab./
st
ADCO FUROSEMIDE, AI Crit.Care Warnings and special precautions: Anaesthes., liv.dis., hepat. susp.latent diab., avoid in 1 trimest.of pregn., concom.antihypertens.
+
Furosemide. coma poss.precipit.in suscept. pts., per.ser.electrol.monit., crit.K + meds., period.ser. electrol.advis.in deplet.risk pts., high K diet in longt.
+
+
+
+
Indications: Oed.of card., hepat./ren.origin, cardiogen.pulm.oed., monit. in pts.with sev.HF, avoid other K -spar.diurets/oral K supplem. ther., KCl supplem.indic.in pts.where diet. K poss.inadeq., low K lev.,
+
+
mild to mod.hypertens., forced diures.in barbit.poison., prevent.ol- if ser.K > 3,5 mmol/L, discont./interr. treatm.for ser.K >5 mmol/L or K spar.diurets.poss. benef., discont.ther.in oligur.developm., hepat.
+
+
+
igur. progress.to anur. ser.creatin.> 350 µmol/L cirrhos., condits.assoc.with K deplet., low K lev.incr.myocard.sen-
(S3) INJ. X/18.1/58. 20 mg/2 ml. Drug interactions: Digox.half-life incr., reduc. vasc. responsiven.to sitiv.to digital.tox.effs.
801623-006: 10x2 ml amps, R31,00 noradrenal., reduc. diuret. eff.with aspir./other NSAIDs, antipyrine Drug interactions: Eff.of antihypertens.meds. poss.potent.
Dosage: IV or IM. metabol. enhanc., hyperkalaem.metabol.acidos.with concom. am- CATEXAN, (Unicorn) Biogaran
Adults: 20-40 mg slow IVI, (1-2 mins) rep.if necess. aft.2 hrs. mon.Cl & cholestyramine, decr.effic.of Indapamide
Pulm.oed: 40 mg slow IVI (1-2 mins.) follow.by 2nd dose 1-1½ hrs. either agent with carbenoxolone, poss.sev. hyperkalaem.with other Indications: Mild to mod.hypertens.
+
later depend.on respon. Childr: 1 mg/kg. K -spar.diuret./ ACE inhibit./ angiotens.II antagon./aldosterone (S3)TABS, 32/7.1/0406
Contraindications: Incr.azotaem.& oligur.dur. treatm. of sev.pro- block./ heparin, low molecul.weight hepar./ K -supplem./ K -rich 700820-005: 2,5 mg, 30, R18,30
+
+
+
gress.ren.dis., treatm.of hypovolaem. & hypotens.in hepat.coma & diet/ K -cont.salt substit., addit.eff.with other diuret.& antihyper- Dosage: Adult: Max.(2,5 mg)1 tab.dly.pref.in morn. May be used
electrol. deplet. states unless basic condit. correct./ improv., lactat., tens.agents., poss. interfer. with digox.plasma conc.assays. in conjunct.with other antihypertens. No exper.in use for in childr.
safety in pregn.not est., sulphonam. hypersens. AMILORETIC, (Aspen Pharmacare: Pharma) Pharmacare Contraindications: Sulphonamid.derivat. hypersens., hepat.en-
Side effects: Dehydrat.& reduc.bld.vol., electrol. disturb., revers. cephalopathy, sev.hepat. funct. impairm./ren.fail., hypokalaem.
deafn.& tinnit.(high dos.), skin reacts., paraesthes., blurr.vis., postur. Amiloride HCl 5 mg, hydrochlorothiazide 50 mg. Side effects: Common: Hypersens. reacts.esp. skin where predis-
Indications: Oed.of card.decompensat./assoc. with hepat.cirrhos.&
hypotens., N&V, diarrh., dizz., headache, pancreatit., musc. spasm & pos.to allerg/asthmat.reacts. Uncommon: Vomit., purpura. Rare:
cramps, allerg.reacts., bld.dyscras., hyperuricaem., incr.Ca urin.excret. corticoster.ther., essent. hypertens. Vertigo, fatig., headache, paraesthes., naus., constip., dry mouth.
(S3) TABS. L/18.1/396.
Special precautions: K-deplet.steroid ther., prostat. hypertro- Very rare: Bld.disords., dysrhythm., hypotens., pancreatit., abnorm.
phy/imp.micturit., imp.hepat./ ren. funct., diabet.mellit., adren.dis. 702803-014: 100, R39,49 liv.funct., angioneurot. oed.&/urticar., tox.epiderm.necrolys., Stev.
702803-022: 1 000, R394,89
Interactions: Potent.cephalosporin assoc. nephrotoxic., neuromusc. Johns.syndr., ren.fail., hypercalcaem. Not known: Syncope, myop.,
block.act.of non-depolaris. musc.relax.enhanc., eff.of guanethidine, Dosage: 1 tab.dly vis.impairm., Torsade de point., hepat.encephalopathy onset in case
(S3) HS TABS. U/18.1/40.
methyldopa & rauwolfia alkaloids enhanc., alcoh./barbit./narcot.may of hepat. insuff., hepatit., ac.disseminat.LE worsen., photosens.re-
enhanc. postur. hypotens., poss.toxic Li bld.conc. Amiloride HCl 2,5 mg, hydrochlorothiazide 25 mg. acts., K deplet.with hypokalaem.esp. ser. in cert.high risk pts., hy-
702811-009: 30, R46,27
+
ADCO-RETIC, AI Pharm Ltd Dosage: 1-2 tabs.dly ponatraem.with hypovolaem., ECG QT prolong., incr.BGC, incr.uric
Amiloride HCl 5 mg, hydrochlorothiaz. 50 mg. Contraindications: Pregn., sev.ren./hepat. insuff., Li-ther., hyper- acid, elev.liv.enzym.
Indications: Oed.of card.decompensat., hepat. cirrhos., corticoster. kalaem., lactat., childr., porphyr. Warnings and special precautions: Ren.funct. monit., monit.plas-
+
ther., essent.hypertens. Side effects: Hypo/hyperkalaem., skin rash, photosens., dizz., ma K /ECG with digital., avoid in pregn., excret.in breast milk, discont.
(S3) TABS. V/18.1/260. headache, weakn., paraesth., GI upset., bld.disords., hypochloraem., ther.in case of hepat. encephalopathy/photosens.reacts., protect ex-
+
780618-009: 100, R35,62 cholestat. jaund., ac.pancreatit., orthostat.hypotens., low salt syndr., pos.areas from sun/artific.UVA if ther. re-admin. necess., K supplem.
780618-017: 1 000, R356,19 glycosur., hyperglycaem., gout. poss.reqd.if act.of other concom.diurets.potent., plasma sod.meas.
Dosage: Oed: 1-2 tabs/day, once diures.achiev. attempt.reduct.for maint. Special precautions: Ren./hepat.impairm., diabet.mellit., lact.intol. bef. init.ther.& reg.aft., more freq.monit.in at risk pts. eg. elderly/cir-
Hypertens: ½-1 tab dly. May be used as adjunct.to other anti- Drug interactions: Potent.other antihypertens. drugs, incr.respons. rhot.pts., poss.dehydrat./ orthostat. hypotens.with hyponatraem.as-
hypertens.meds. to tubocurarine. soc.with hypovolaem., second.compensat.metabol.alkalos., sudd.
Contraindications: Hyperkalaem., concom. antikaliurets.& K-sup- hypotens.&/ac.ren.fail.risk with ACE-inhib. when ther.init.in pres.
+
plem., imp.ren.funct., childr., pregn.& lactat. AUSTELL-FUROSEMIDE, Austell of sod.deplet., K deplet.with hypokalaem. risk to be prevent.in cert.
Furosemide
Side effects: Orthostat.hypotens., abn.liv.funct., pept. ulc.activat., high risk pts., hypokalaem.incr.card.toxic.of digital./ dysrhythm. risk,
GI disturbs.incl.bleed., dry mouth, skin reacts., bld.disords., CV effs., Indications: Adjunct in ac.pulm.oed., card. oed.with other card. poss.decr.urin.Ca excret., hypercalcaem. poss.due to prev.unrecog-
musc. cramps, CNS eff., elev.ser.K, weakn., vertigo, paraesthes., ther., mild to mod.hypertens., ren.oed.in nephrot.syndr., cerebr.oed., nis. hyperparathyroid. in which case ther.to be withdr. bef. parathyroid
min.psych.chang., vis.disturbs., anaphylact.-type react., fev., ne- ascit.due to liv.cirrhos./mech.obstruct./CF, forced diures.in hypercal- funct.investig., diabet., gout hist, lact. intol., concom.Li not recomm.,
+
crotiz.angiit., Stev. Johns.syndr., digitalis toxic., jaund., pancreatit., caem.& cert.poison.treatm., in burns to reduc.loc.oed & prev.oligur. K lev.monit. bef. init.ther.with Torsades de pointes-induc. meds./ ap-
hyperglycaem., hyperuricaem., gout, photosens., sialadenit., resp. progress.to anur. propr. ther.correct.hypokalaem.if need./ ECG/ electrol. monit.dur.ther.,
dist., malaise, chest pain, flush., nas. congest., impot., urin.disturbs., (S3) TABS, 37/18.1/0433 rehydrat.bef.init. ionat. contrast media.
electrolyte imbal., poss.decr.urin.Ca, hyperkalaem., hyperparathyroid., 707423-001: 40 mg, 30, R28,81 Interactions: Poss.reduc.eff./ac.ren.fail.risk in dehydrat. pts.with
hypercalcaem.& hypophosphataem. with prolong.use. Dosage: Adults: concom.NSAIDs/COX- 2 select. inhib./ salicyl.acid.dos.≥3 g/day, incr.
Special precautions: Part.heart block., imp.ren. /hepat.funct., Usual dos: 20-80 mg as sngl.dos.pef.in morn. hypokalaem. risk with Amphotericin-B IV/gluco-& miner.syst. corticos-
liv.dis.incl.cirrhos., diabet., poss. develop. of acidos., digital.pts., Oed: Init.40 mg once dly adjust.accord.to response. Mild cases: 20 mg ter./ tetracosactide/stimul.laxat., incr. antihypertens. eff.with baclofen,
adren.dis., discont. in case of incr.azotaem./oligur., ren.funct.test dly.or 40 mg on alt. days. Some req.80 mg or more dly.as 1-2 dos.dly./ hypokalaem. predispos. to digital.tox.eff., incr.allopurinol hypersens.
advis. bef.init.ther.in diabet./susp.diabet., pass. through breast milk intermitt. Dos.up to 600 mg dly.by grad.titrat.poss. reqd.in sev.cases. reacts., poss.hypokalaem.esp.in pts. with ren. fail./diabet.or hyper-
+
& cross.placenta. Hypertens: 40-80 mg dly. kalaem.with concom. K -spar. diurets., incr.metform.-induc.lact. acidos.
Drug interactions: K-deplet.eff.enhanc.by corticoster., cortico- Forced diuresis: 20-40 mg in addit.to infus.of electrol.sol. risk, incr.ac.ren.fail.risk with large dos.of ionat. contrast med., incr.eff./
trophin, carbenoxalone, act.of other hypertens.potent.esp.gang. Childr: Usual dos: 1-3 mg/kg bm dly.up to max. 40 mg dly. orthostat.hypotens.risk with TCA’s, hypercalcaem.risk with Ca salts,
block., avoid Li (incr.toxicity risk), orthostat.hypotens.potent.by al- Contra-indications: Sulphonam.hypersens., azotem.& oligur.dur. incr. plasma creatin.risk with ciclosporin/tacrolimus, decr. antihyper-
coh., barbit.& narcots., incr.respons.to tubocurarine, poss.decr.arter. sev.progress.ren.dis.treatm., hepat.coma or electrol.deplet.states tens.eff.with corticoster./ tetracosact., incr.plasma Li with poss.Li toxic.
respons.to norepinephr. until condit. correct./improv., lactat.
Side-effects: Bld.dyscras.incl.aplast.anaem.& agranulocytos., fluid CIPLA INDAPAMIDE, Cipla Medpro
ALDACTONE, Pfizer & electrol.disturbs.e.g. hypokalaem./hyponatraem., bld.coag.disords. Indapamide
Spironolactone partic.in elderly, ac. pancreatit., precip.diab.mellit., tetany, blurr.vis., Indications: Mild to mod.hypertens.
Indications: Essent.hypertens., short-term pre-op prim. hyperal- tinnit., deafn., post.hypotens., circulat.disturbs.with poss.vasc.effs.& (S3)TABS, 31/7.1/0097
dosteron.treatm., est. prim. hyperaldosteron. diagn.., CHF alone/ circulat. collapse, GI disturbs., skin reacts.incl.exfol. dermatit. / pho- 710313-001: 2,5 mg, 30, R19,69
combin.with stand. ther., condits.where second. hyperaldosteron. tosens./paraesthes.& vasculit., gout as a result of hyperuricaem., Dosage: Adult: 1 tab.dly.pref.in morn.aft breakf. May be used in
pres., diuret.-induc.hypokalaem./ hypomagnesaem.as adjunct.ther. manifestat./aggravat. of obstruct.micturit.sympts., conjunct.with other antihypertens. agents.
Urinary System - 16.1 2020-04 / 211
Contraindications: Sev.hepat.insuffic., safety in pregn.& lac- HEXAZIDE 25, (Sandoz) Hexal Contraindications: Hypersens.to sulphonamid., incr. azotaem.&
tat.not est. Hydrochlorothiazide oligur., anur./hypokalaem. /hyponatraem./ hypovolaem.with/without
Side effects: Allerg.reacts., electrol.imbal., GI disturbs., headache, Indications: Oed.assoc.with CCF/hepat.cirrhos.& nephrot.syndr., hypotens., hepat.coma, electrol.deplet., lactat., Tabs 500: Ren.fail.due
orthostat.hypotens. hypertens.as sngl./combinat.ther. to Hg-sublimate caus. nephrotox.& in assoc.with hepat.coma, carbon
Special precautions: Elderly, imp.ren./hepat. funct., diabet., gout (S3) TABS, 32/18.1/0419 tetrachlor. poison. caus.hepatotox., Retard 60 & 500 mg tabs: childr.
hist, hyperuricaem., sympathectomy, sulphonamide type med cross 890470-007: 25 mg, 100, R53,76 Side effects: Dermatit., prurit., paraesthes., blurr. vis., postur.hypo-
sens., concom.Li not recomm., pts.at high risk of develop.hypoka- Dosage: Indiv.dos. Init.& maint.at low.effect.dos. tens., N&V, diarrh., allerg. reacts., bld. dyscras., hyperuricaem., liv.
+
laem.may req.K supplem., poss hyperkalaem.with supplementat. Oed: 25-50 mg/day. Max.recomm.dly.dos.100 mg. damage, lower. ser.Ca-lev., tetany, Ca deposits in ren. tiss. in prems.,
Drug interactions: Poss.interacts.with amiodarone, coumarin or Hypertens: Init.dos: 12,5 mg.12,5-25 mg dly.as sngl.dos. Max. excess.diures., GI disturbs., anaphylact. shock, gout precipitat.in pre-
indanlone-deriv. anticoags., digit.glycosides, other antihypertens., recomm.dly.dos.100 mg. disp.pts. due to incr.uric acid conc., pancreatit., rehydr.& reduct. of
non-depolaris.neuromusc.block.agents, & sympathomimet. Contraindications: Sev.ren.& hepat.dysfunct., sulphon. deriv.meds. bld.vol.(circulat. collapse, embol., vasc. thrombos.), excess. K-loss in
DYNA INDAPAMIDE SR, Pharma Dynamics hypersens., Addison’s dis., safety in pregn.& lactat.not est. pts.receiv.card. glycosid., precipit.digital.toxic., electrol. disturbs., re-
vers.deafn.& tinnit.with parent.use, incr. risk of persistence of patent
Side effects: GI disturbs., CNS effs., parasthes., bld. dyscras., orthos-
Indapamide. ductus arterios. in prems., aggrav.of pre-exist.metabol.alkalos., CNS
Indications: Mild to mod.hypertens. tat.hypotens., hypersens. reacts. incl.anaphylact.reacts., metabol.& effs., obstruct.micturit.sympts.manifest./ aggrav.
electrol. disturbs., ren.dysfunct./fail., interstit.nephrit., musc. spasm,
(S3) SR TABS, 42/7.1/0790. weakn., restlessn., trans.blurr.vis., impot., yellow vis., cholestat.jaund., Special precautions: Elderly, pregn.& then only for short periods,
716962-001: 1,5 mg, 30, R44,34 pancreatit., precipitat. of gout, exacerbat./activat.of SLE imp.hepat./ren.funct., diab. mellit./ adren.dis., K-rich diet advisab.,
Dosage: One SR tab.dly.pref.in the morn. May be combin.with Special precautions: Monit.electrol.bal., imp. ren. & hepat. K-deplet. steroid ther., correct shock bef.commenc. high dos.ther., in-
other antihypertens. funct., elderly, poss.diabet.agents dos. adjustm., diabet.poss.un- fus.250 mg strength only using vol./rate controll.infus.pumps, concom.
Contraindications: Hypersens.to other sulphonamide type meds., mask./aggrav. cisplat. due to hear.damage risk, concom.chlor.hydr.not recomm., do
sev.hepat.impairm., sev.ren.fail., safety in pregn.& lactat.not est., not infus./combine in same syr.with other meds., monit.for excess.
safety & effic.in childr.not est., other concom. diuret.caus.hypoka- Drug interactions: Toxic.of digital.glycos.poss enhanc., alcohol/ BP decr., poss.incr. K loss with laxat.abuse., monit.ser.creatin., urea
+
barbit.& narcot.may potent. orthostat.hypotens., effs.of other anti-
laem.not recomm. & electrol. reg.dur.long-term treatm.
Side effects: Thrombocytopen., granulocytopen., leucopaen., hypertens. agents potent., sev.electrol.deplet.esp. hypokalaem. with Drug interactions: K defic.incr.myocard.sens.to digital., cephalo-
+
corticoster.& ACTH, respons.to press. amines decr., incr.respons.to
aplast.anaem., hypochloraem. alkalos., hyponatraem., hypokalaem., sporin & aminoglycosid.assoc. nephrotoxic. potent., ototox.of amino-
hyperuricaem., skin rash, itch., pulm.oed., pneumonit., cholestat. non-depolaris. skelet. musc.relax., poss.Li toxic., diuret./natriuret. & glycosid.& other ototox.drugs incr., may dimin./potent other meds.
jaund., pancreatit., headache, postur.hypotens., dizzin., anorex., antihypetens.eff.reduc.by NSAID’s. effs., act.of other hypotens.meds.poss. potent., NSAID’s may antagon.
N&V, constip., diarrh. electrol./ hypotens.effs., hypersens./allerg. INSPRA, Pfizer act., sucralfate decr. intestin.absorpt.
reacts., alt.lab. test values. Eplerenone
Special precautions: Elderly, consid.benef.vs. risk in sev.ren.im- Indications:.Reduc.CV death risk in stable pts. with L.ventric.dys- LITHA FUROSEMIDE, Litha
pairm./anur./gout hist./diab. mellit./ hyperuricaem./hepat.impairm./ funct.& clinic.evid.HF aft.ac.MI Furosemide.
sympathect., monit.uric acid lev.esp.with gout hist., monit.ser.K in pts. (S4) TABS, A39/6.4/0106, 0107. Indications: Oed.of card., hepat./ren.origin, ac.pulm.oed., cerebr.
+
prone to hypokalaem., K supplem./K spar.diurets.may be reqd., dis- 706121-002: 25 mg, 28, R679,62 oed., forced diures.
+
+
cont.if azotaem./oligur.occurs. 706121-001: 25 mg, 30, R728,16 (S3) INJ. 29/18.1/0663. 20 mg/2 ml.
Drug interactions: Incr.hypokalaem.assoc. arrhythm. risk with ami- 706135-001: 50 mg, 30, R728,16 825298-008: 10x2 ml amps, R24,81
odarone, coumarin/ indandione-deriv.anticoag.eff.decr., enhanc. digi- Dosage: Usual.admin.with std.ther. Dosage: IV or IM. IV rate not to exceed 4 mg/min.
talis toxic.with digital.glycosid., poss. interacts. with other antihyper- Recomm.dos: 50 mg once dly. Init.25 mg once dly. titrat.to targ.dos. Adults: 20-50 mg slow IVI or IM, rep.if necess.aft. 2 hrs.
tens., enhanc.Li-toxic.risk, enhanc.blockade with neuromusc. block. of 50 mg once dly.pref.within 4 wks.as tol. Pulm.oed: 40 mg slow IVI follow.by 2nd dose 1 hr. later depend.on
non-depolaris.agents, reduc.effs.with sympathomimets. Contraindications: Hyperkalaem./condits.assoc. with hyper- respon. May be incr.to 80 mg.
Childr: 0,5-1,5 mg/kg bm.
+
FUROSEMIDE FRESENIUS AMP, Fresenius Kabi kalaem., concom.K -spar.diuret., strong CYP3A4 inhibit., not recomm. Contraindications: Sulphonam.hypersens., anur./ ren. fail.due to
Furosemide. in paed.as data insuffic., pregn., lactat. nephrotox./hepatotox.drugs, ren. fail. assoc.with hepat.coma, pre-
Indications: 20 mg/2 ml: Card.oed.in conjunct. with adeq.gly- Side effects: Hyperkalaem., hypotens., dizzin., GI disturbs., abnorm. comatose states assoc. with hepat.cirrhos.,
cos.ther., ascites due to liv.cirrh./ mech. obstruct.or card.fail., ren./ ren.funct., postur.hypotens., asthen., back pain, malaise, L card.fail., Side effects: Fluid & electrol.imbal., allergy, naus., diarrh., vis.dis-
pulm./cerebr.oed., forc.diures., burns to reduc.loc.oed & prev.oligur. leg cramps, headache, atrial fibrillat., dehydrat., hypercholesterol- turbs., dizzin., headache, pancreatit., photosens., skin rash., hypo-
progress.to compl.anur. 250 mg/25 ml: Oliguria in ac.& chron.ren. aem., hypertriglyceridaem., hyponatraem., MI, insomn., pharyngit., tens., interstit. nephrit., bone marrow depress., bld. dyscras., hepat.
fail., chron.ren.insuffic. prurit., incr.sweat., eosinophil. dysfunct., cholestat.jaund., paraesthes., deafn.& tinnit.(high dos.),
+
(S3) INJ. K/18.1/207, Z/18.1/139. Special precautions: Monit.K when init.ther./ chang.dos.& pe- glycosur., hyperglycaem., hyperuricaem., incr.Ca urin.excret, pancre-
727687-018: 20 mg/2 ml, 10x2 ml, R46,09 riod.dur.ther.where hyperkalaem. risk poss., dos.reduct.shown to atit., ren.stone format.
799955-019: 250 mg/25 ml, 10x25 ml, R580,87 decr.ser.K+lev., imp.ren.funct., diabet.microalbuminur., monit. elec- Warnings and special precautions: Monit. fluid & electrol.imbal.
Dosage: Admin.IVI slow.over 1-2 min. trol.in mild to mod.hepat.impairm., not eval.in sev.hepat.impairm., esp.in pres.of vomit./ dur. parenter.fluid ther., prostat. hypertrophy/
Adults: Recomm.dos: 20-40 mg IV rep.if necess. aft.not less then 2 monit.ser.lev.of concom.Li imp. micturit., imp.hepat./ren.funct., jaund.infts., pregn., lactat., cross.
hrs. Paed.dos: Usuall.1 mg/kg bm. Drug interactions: Signific.interacts.report.with CYP3A4 inhibit. placent.barrier, excret. in breast milk.
Pulm.oed: Init.40 mg IV rep.if necess.aft.approx. 60-90 mins. eg.ketoconazole/erythromycin/ saquinavir/verapamil & fluconazole, Interactions: Potent.cephalospor.& aminoglycoside assoc.nephro-
Oliguria in ac.& chron.ren.fail: 250 mg dil to 250 ml in suit.dil. other K+-spar. agents with NSAIDS have shown sev.hyperkalaem. in toxic., phenytoin & indomethacin may reduc.clinic.eff.
infus.over 1 hr. Max.dly dos: 1 g. imp.ren.funct., Li tox.report.with diuret.& ACE inhibit. MYLAN INDAPAMIDE, Mylan
Contraindications: Sulphon.hypersens., incr. azotaem. & oligur.dur. LASIX, Sanofi-Aventis Indapamide.
treatm.of sev.progress.ren. dis., hepat.coma, electrol.deplet., hypovol- Furosemide. Indications: Mild to mod.hypertens.indiv./in combinat.
aem., hypotens., anur./ren.fail.due to nephrotox.or hepatotox.drugs, Indications: Oed., ascites & ac.pulmon.oed., mild to mod.hypertens., (S3) TABS. 29/7.1/0590
precomat.states assoc.with hepat.cirrhos., lactat., Addison’s dis., barbit.poison.(forced diuresis), burns. 703329-001: 2,5 mg, 30, R18,63
pre-exist. hypercalcaem., safety in pregn.not est. (S3) TABS. E/18.1/201, 202, V/18.1/9. Dosage: 1 tab.dly.in the morn. Further reduct.may be combin.with
Side effects: Fluid & electrol.imbal., revers. deafn. & tinnit.with 735930-007: 20 mg, 30, R146,11 other antihypertens.
rapid IV infus., perman.deafn. with imp.ren.funct., skin reacts.incl. 735949-018: 40 mg, 30, R174,88 Contra-indications: Sev.hepat./ren.insuffic., hypokalaem., safety
photosens.& erythema multiforme, N&V, diarrh., blurr./yell.vis., diz- 735949-026: 40 mg, 250, R1 457,46 in pregn.& childr.not est., Addison’s, exist.hypercalcaem., concom.Li.
zin., headache, pancreatit., musc.spasm, cramps, hypotens., allerg. 780839-005: 80 mg, 30, R563,81 Side-effects: Hyperglycaem.& glycosur.in diab. & other suscept.
reacts., cholestat.jaund., bone marr.depress., bld.dyscras., hyperuri- (S3) INJ. H1777. 10 mg/ml. pts., hyperuricaem., may precipit. gout, electrol.imbal., hypercal-
caem. with gout precipitat., low.ser.Ca lev., dehydrat.& reduc. bld. 735981-019: 5x2 ml, R83,10 caem., hypomagnesaem., seiz., GI disturbs., headache, dizzin.,
vol.with circulat.collaps.& poss.vasc. thrombos. partic.in elderly, (S3) SOL. N/18.1/6. 10 mg/ml. photosens.reacts., postur.hypotens., paraesthes., impot., yell.vis.,
nephrocalcinos.in preterm.infts. 839515-006: 100 ml, R349,75 hypersens.reacts., cholest.jaund., pancreatit., bld.dyscras., poss.
Special precautions: Monit.fluid & electrol.bal., prostat.hypertrohy, Dosage: IV/IM admin.is indicat.in all cases where intest. absorpt. unmask diab.mellit.
imp.micturit., may precipit. diab. mellit.,digital.tox.poss.precipitat.with imp./if prompt diures.reqd. Admin. IV inj.slow.not exceed.rate of 4 Special precautions: Concom.diurets. poss. caus.hypokalaem.not
excess. K loss & concom.card.glycos., K deplet.steroids, concom.ceph- mg/min. Durat.of treatm. at physic.descret. recomm., elderly pts. partic. suscept. to electrol.imbal., imp.ren./hepat.
-
-
alospor.& ototox.meds., imp.ren./ hepat.funct., diab.mellit., adren.dis. Adults: 20-80 mg as sngl.dose in morn, if necess. 6 hrs. aft.40 mg funct., cirrhos. pts., poss.diab.agents dos.adjustm., poss. hyponatraem.
Drug interactions: Neuromusc.block.act.of non-depolar.musc.relax. dose admin.80 mg & if necess. admin. 120 mg aft.another 6 hrs. in sev.CHF where pts.are very oedemat. with high dos.in conjunct. with
enhanc., alcoh./barbit.& narcot.enhanc.post.hypotens., tox.Li bld.conc. Maint: 20-40 mg dly. Admin.dly.dos.exceed.120 mg in 2-3 div.dos. restrict. diet.salt, SLE may be exacerb/activ.in suscept.pts.
FUROBE, (Ranbaxy) Be-Tabs Hypertens: 40-80 mg dly. Drug interactions: May enhanc.toxic.of digital. glycosides, enhanc.
Furosemide. Pulm.oed: Init.40 mg IV, rep.aft.20 mins.if necess. neuromusc.block.act.of competit.musc.relax., eff.of antihypertens.
Indications: Oed.of card./hepat./ren.origin, refract.oed., symptomat. Forced diures: 20-40 mg in addit.to infus.of electrol.sol. agents poss.enhanc., postur.hypotens.poss.enhanc.by comcom.al-
coh., barbitur./opoids, the K deplet.eff. enhanc.by corticoster., corti-
+
hypercalcaem., mild to mod.hypertens. Infts.& childr.und.15 yrs: Oral dos: 2 mg/kg bm/ day in div. doses.
(S3) TABS. S/18.1/31 Titr.to max.of 6 mg/kg. Parenter dos: 1 mg/kg/bm/day given only cotrophin/ carbenoxolone, tox.Li bld.conc.
821845-012: 40 mg, 250, R52,77 in life-threaten. condits. Max.20 mg/day. NATRILIX SR, Servier
Dosage: Adults: 40 mg dly.,may be incr.to 200 mg dly.if necess. (S3) RETARD CAPS. J/18.1/5. Indapamide.
Admin.dly.doses exceed.120 mg in 2-3 div.doses. Maint.therapy Indications: Prolong.diures., oed.due to venous insuffic.& aft.thrombos. Indications: Mild to mod.hypertens.
20-40 mg dly. 735973-008: 60 mg 30, R325,64 (S3) SR TABS, 31/7.1/0166.
Childr: 1 mg/kg bm/day, may be incr.to 3 mg/kg bm/ day if necess. Dosage: Adults: Oed: 60 mg dly./on altern.days in mild cases. 830836-004: 1,5 mg, 30, R129,28
not exceed.120 mg/dly Hypertens: 60 mg dly. May be incr.to 120 mg dly or more in sev. Dosage: One SR tab.in the morn. In more sev. cases may be combin.
Contraindications: Azotaem.& oligur., hepat. coma, electrol. cases. Maint.dos.depend.indiv. response. with other antihypertens.
deplet., lactat. (S3) TABS, D/18.1/266 Contraindications: Sev.hepat.insuff., hypersens. to other sul-
Side effects: Hyperuricaem., metab.alkalos., K deplet., dermatit., 735957-010: 500 mg, 100, R5 553,23 phonamide type meds., sev.ren.fail. (creatinine clear.<36 ml/min),
postur.hypotens., N&V, blurr. vis., bld.dyscras., imp.gluc.tol., dehydr.& Indications: Ac./chron.ren.fail.with filtrat.below 20 ml/min., chron. safety in pregn.not est.
reduct.of bld. vol.with poss.circulat.collapse, electrol. disturbs., vasc. ren.insuffic.in predialyt.stage, ac. ren.fail.in post-op phase & in assoc. Side effects: Giddin., headache, GI disturbs., postur. hypotens.,
thrombos.& embol.esp.in elderly, excess. K-loss in pts.receiv.card.gly- with septic process., nephrot.syndr. electrol.imbal., hypersens. reacts.
cosid.precipit. digital. toxic. Dosage: Gen. 1-4 tabs aft.breakf., if adeq. diures. not achiev.within Special precautions: Ren.insuff., K supplem. may be reqd., monit.
+
Special precautions: K-deplet.steroid therapy. 4-6 hrs incr.init.dose by ½-1 tab. uric acid lev., monit.ser.K in pts.prone/sens.to hypokalaem.as no sig-
+
Drug interactions: Poss.nephrotoxic.with concom. cephalospor. Chron.ren.insuff: Init. 250 mg, if no adeq. respons. in 4-6 hrs.incr.by nif.diures. is usual.produc.
aminoglycosid.poss.enhanc. ototoxic. ½ tab 4-6 hrly.until effect.dose achiev.(gen.betw. ½-4 tabs.). Drug interactions: Could potent.other diuret
212 / 2020-04 Urinary System - 16.1 / 16.2
PHARMA-Q FUROSEMIDE INJECTION, Pharma-Q (S3) TABS. 43/18.1/1042, 1043 (S3) TABS. 28/18.1/0292, 0293, 0294
Furosemide. 3000185-001: 5 mg, 30, R140,70 820369-004: 2,5 mg, 30, R194,42
Indications: Oed.of card./hepat./ren.origin, ac. pulm. oed., cerebr. 3000186-001: 10 mg, 30, R152,65 820377-007: 5 mg, 30, R215,00
oed., forc.diures. Dosage: Essent.hypertens: Init: 2,5 mg/day. Usual maint: 2,5 mg/ 820385-018: 10 mg, 30, R233,10
(S3) INJ. 32/18.1/0194, 29/18.1/0664. 10 mg/ml day. May be incr.to 5 mg/day if eff.insuff. Dosage: Essent.hypertens: Init: 2,5 mg/day. Usual maint: 2,5 mg/
899127-002: 20 mg/2 ml, 10x2 ml, R24,57 Oed.of card.& ren.origin: Init: 5 mg/day. Usual maint: 5 mg/day. day. May be incr.to 5 mg/day if eff.insuff.
703589-001: 50 mg/5 ml, 10x5 ml, R109,43 May be incr.up to 20 mg/day depend. on sev.if eff.insuff. Up to 40 mg Oed.of card.& ren.origin: Init: 5 mg/day. Usual maint: 5 mg/day.
Dosage: IM/IV. IV rate not to exceed 4 mg/min. Adults: has been admin.in indiv.cases. May be incr.up to 20 mg/day depend.on sev.if eff.insuff. Up to 40 mg
Recomm.20-50 mg slow IV repeat.aft.not less than 2 hrs.if need. Contraindications: Ren.fail.with anur., hepat. fail., pregn.& lactat., has been admin.in indiv.cases.
Childr: Usual.0,5-1,5 mg/kg bm. sulfonylurea hypersens., hypovolaem./-natraem./-kalaem., sev.mic- Contraindications: Ren.fail.with anur., hepat. precoma & coma,
nd
Pulm.oed: 40 mg slow IV follow.by 2 dos.1 hr later if need. May turit. disords., childr.12 yrs.or young. pregn.& lactat., sulfonylurea hypersens., hypovolaem./-natraem./-
be incr.to 80 mg. Side effects: Freq: Constip., N&V, headache, dizzin. Less freq: kalaem., sev. micturit.disords., childr.12 yrs.or young.
Contraindications: Sulphonam.hypersens., anur./ ren. fail.due to Water & electrol.disturbs. depend. on dos.& durat.esp.with limit. Side effects: Water & electrol.disturbs.depend. on dos.& durat.
nephrotoxic./hepatox.drugs, ren. fail.assoc.with hepat.coma, pre- salt intake, hypokalaem., hyponatraem., hypochloraem. alkalos., decr. esp.with limit.salt intake, electrol.& vol. defic.incl.headache/dizzin./
comatose states assoc.with hepat.cirrhos., safety in lactat.not est. erythrocyte/leucocyte/platelet counts, hypotens., GI haemorrh., dry weakn./loss of appet. /cramps esp.init.& in elderly pts., hypotens.,
Side effects: Fluid & electrol.imbal.incl. hyponatraem. /hypokalaem./ mouth., allerg. skin reacts., photosens., limb paraesthes., vis. disturbs, confus.states, cerebr.ischaem., GI disturbs., poss. rise in bld.gluc.,
hypochloraem. alkalos., allergy, nausea, diarrh., vis.disturbs., dizzin., ototox. Freq.unknown: Thromboembol. complicats., card./cerebr.is- incr.urine prod.in pts.with urin. obstruct. may lead to urin.retent./
headache, pancreatit., photosens., skin rash., hypersens.reacts., hy- chaem, diarrh., incr.bld. urea & creatin., confus.states, poss.rise in bld. bladd.distent., decr.bld.corpusc.constit., low.K -lev.esp.in low K -di-
+
+
potens., bld.dyscras., hepat. dysfunct., cholestat.jaund., paraesthes., gluc, incr. in Gamma-GT, alter.bld.gluc./lipid metabol. et/chron.liv.disords., allerg.skin reacts., photosens., dry mouth, limb
tinnit. & deafn.esp.high dos., glucosur., hyperglycaem., hyperuricaem., Warnings and special precautions: Monit. electrol.bal./vol.de- paraesthes., vis. disturbs.
incr.Ca ren.excret., ren. stone format.in preterm infts. plet., monit.pts.with hyperuricaem. & gout tend., incr.urine prod.in pts. Special precautions: Monit.electrol.bal./gluc /uric acid/creatin.&
Special precautions: Pregn., cross.placent. barrier, excret.in breast with urin.obstruct.may lead to urin.retent./bladd. distent., lact.intol., lipid lev.reg.dur.longt.ther., monit.pts.with hyperuricaem.& gout tend.,
milk, jaund.infts., monit. fluid & electrol.imbal.esp.in pres.of vomit./ monit.gluc./uric acid/creatin.& lipid lev.reg.dur.longt.ther., carbo- carbohydr. metab.monit.recomm.in latent/ manifest. diab.mellit.
dur. parent. fluid ther., may precipit.gout attacks, prostat. hypertrophy, hydr.metabol. monit. recomm.in latent/manifest. diab.mellit., elderly Drug interactions: With concom.card.glycosid., K &/Mg defic.poss.
+
micturit.impairm., concom. ototox. meds. Interactions: With concom.card.glycosid., K &/ Mg defic.poss.incr. incr.sens.of card.musc.to digit., kalidiuret. eff.of mineralo-& glucoster./
+
Drug interactions: Poss.enhanc.cephalospor./ aminoglycoside sens.of card.musc.to digit., kalidiuret. eff.of mineralo-& glucoster./ laxat. poss.incr., NSAID’s may reduc.eff., eff.of antihypertens. poss.
nephrotoxic., poss.reduc.clinic.eff. with phenytoin & indomethacin. laxat. poss. incr., NSAID’s may reduc.eff., eff.of antihypertens. poss. potent., concom.ACE-inhibit. may result in excess.BP reduct., antidia-
PURESIS, (Aspen Pharmacare: Pharma) Pharmacare potent., concom.ACE-inhibit.may result in excess. BP reduct., antidia- bet.meds. act. reduc., potent.damag.eff.of aminoglycoside/ cisplat.&
Furosemide. bet.meds.act.reduc., potent. damag.eff.of aminoglycoside/cisplat.& cephalospor., act.of curare musc.relax. & theophyll.potent., decr.arter.
Indications: Ascites due to liv.cirrhos./ mechan. obstruct.or CF, prev. cephalospor., act.of curare musc.relax.& theophyll. potent., decr.arter. respons.to press. agents, incr.salicylate toxic.with high dos. salicylat.,
oligur.progress.to complete anuria, card.oed., mild.to mod.hyper- respons.to press.agents, incr. salicylate toxic.with high dos.salicylat., poss.reduc.eff.with cholestyramine.
tens., oed.dur. last 3 mnths pregn.(pre-eclampt.toxaem.& eclamps.) poss. reduc. eff.with cholestyramine., incr.risk of dysrhythm. assoc.
(S3) TABS. H/18.1/185. with hypokalaem.with concom. antidysrhythm.meds., eff.of concom.
758272-006: 40 mg, 30, R26,24 anticoags. decr., incr.Li toxic., probenecid decr.act. 16.2 Anti-diuretics
758272-014: 40 mg, 250, R218,73 SANDOZ INDAPAMIDE 2,5, Sandoz
Dosage: Init. 1-3 tabs. Maint. ½-1 tab.dly. DDAVP (MDR Listing)
Contraindications: Hepat.coma, electrol. deplet., incr.azotaem.& Indapamide. MINIRIN MELT (MDR Listing)
Indications: Mild to mod.hypertens.
oligur.dur.treatm., lactat. women
Side effects: Dermatit., paraesth., blurr.vis., dizzin., pancreatit., (S3) TABS. Z/7.1/203. DDAVP, Ferring [P/S] &
photosens., postur.hypotens., headache, N&V, diarrh., bld.dyscras., 831026-006: 2,5 mg, 30, R26,04 Desmopressin.
asymptomat. hyperuricaem., gout & diabet.precipitat., decr.ser. Ca Dosage: 1 tab.dly.pref.in the morn. Further reduct.in BP in combin. Indications: Symptomat.short-term treatm.of prim.noct. enures.
with result.tetany, dehydrat.& reduc.bld.vol., electrol. disturbs., hepat. with other antihypertens. in young & adult pts. (childr. old.than 5 yrs) who have norm.abil.to
dysfunct., cholestat. jaund., tinnit., deafn. Contraindications: Sev.hepat.insuffic., safety in pregn.& childr. conc.urin. Diagn.centr.diabet.insipid., treatm.vasopressin sensit.centr.
Special precautions: Only for select.pregn.cases & for short per., not est. diabet.insipid., posthypophysect. polyur.& polydips., ren.funct.test.
nephrotox.with concom. cephaloridine, perman.deafn.with con- Side effects: Hyperglycaem.& glycosur.in diab. & other suscept. (S4) NAS.SPRAY, [P/S] U/18.2/99. 0,1 mg/ml.
com.ototox. meds., prostat.hypertrophy, imp.micturit., imp. hepat. pts., hyperuricaem., may precipit. gout, electrol.imbal., GI disturbs., 837555-019: 10 µg/spray, 5 ml, R1 017,98
/ren.funct., porphyr. headache, dizzin., photosens.reacts., postur.hypotens., paraes- Dosage: Noct.enures: Indiv. Dos.varies betw. 10-20 µg given at hr.of
Drug interactions: Enhanc.cephalospor.& aminoglycos. antibiot. thes., impot., yell.vis., hypersens.reacts., cholest. jaund., pancre- sleep. Restrict.water intake 1 hr bef.& 8 hrs.aft.admin. Short-
nephrotoxic., phenytoin & indomethac. poss.reduc.clinic.effs., digit. atit., bld.dyscras. term treatm. period is 4-8 wks. Admin.recomm.dos.only once in 24 hrs.
glycos. toxic. poss.enhnc., neuromusc.block.act.of competit. musc.re- Special precautions: Imp.ren./hepat.funct., diabet., poss.hy- CDI: Withdr.all prev.meds.& est.a baseline polyruria & polydipsia as
lax.enhanc., antihypertens. agents effs.enhanc., K+-delet.eff.enhanc. ponatraem.in sev.CHF where pts. are very oedemat.with high dos. describ.in lit. Dose indiv. aft.test. Suggest.aveg.dos.obt.from prev.
by corticoser./ corticotroph/carbenoxolone, tox.Li bld. lev., chang.in in conjunct.with restrict. diet.salt, elderly pts.partic.suscept.to elec- therapeut. results: Admin. 1-2x dly.intranasal. Childr: 0,05-0,1 ml
antidiabet.agents.dos.poss. trol. imbal., SLE may be exacerb/activ.in suscept. pts., Addisons dis. (5-10 µg). Adults: 0,1-0,2 ml (10-20 µg).
Drug interactions: May enhanc.toxic.of digital. glycosides, enhanc. Ren.conc.capacity test: Admin.as sngl.dos. Adults: 40 µg. Childr:
RIDAQ, (Aspen Pharmacare: Pharma) neuromusc.block.act.of competit. musc.relax., eff.of antihypertens. >1 yr: 20 µg. <1 yr: 10 µg. Aft.admin.of DDAVP any urine collect.with
Pharmacare agents poss. enhanc., postur.hypotens.poss.enhanc.by comcom. al- 1 hr.is discard. Dur.next 8 hrs.2 portions of urine are collected for os-
Hydrochlorothiazide. coh., barbitur./opoids,the K deplet.eff. enhanc. by corticoster., corti- molat.test. Restrict water intake.
+
Indications: Oed., essent.hypertens.in combinat. with other antihy- cotrophin/ carbenoxolone, tox.Li bld.conc. (S4) INTRANAS.SOL, [P/S] M/18.2/117. 0,1 mg/ml (1 dos =
pertens., antidiuret.eff.in diab. insipid. 0,1 ml(10 µg)
(S3) TABS. M/18.1/35 SANDOZ SPIRONOLACTONE 25, Sandoz 717746-003: Multidose: 1x2,5 ml vial, R598,19
880949-007: 25 mg, 500, R523,52 Spironolactone. Dosage: Only.use where oral formulat.not feasible. Start at low.
Dosage: Oed: Adults: Init.25-100 mg later reduc. to small.maint.dos. Indications: Oed., ascites assoc.with hepat. cirrh., nephrot. dos.& incr.progress.with caut. Admin.to childr.only und.adult su-
oft.given on alt.days. An init. dos.of up to 200 mg may be necess.but syndr., CCF. pervis. Ren. conc.capac.test.in childr.und.1 yr.only to be perform.
larg.dos. have no addit.eff. (S3) TABS. Q/18.1/70. in hosp.und.caref.supervis. Grad.plastic catheter (rhinyle) incl. See
Hypertens: Adults: 25-100 mg/day with reduc. dos. of hypo- 769665-004: 25 mg, 30, R46,30 product lit for directs. for use.
tens.agent. 769665-012: 25 mg, 200, R312,20 CDI: Withdr.all prev.meds.& est.a baseline polyruria & polydipsia as
Childr: 2,5 mg/kg bm dly.in 2 div.dos. Dosage: Adults: 100 mg dly in 4 div.dose. Childr: 1,5-3 mg/kg bm dly. describ.in lit. Dose indiv. aft.test. Childr: 0,05-0,1 ml (5-10 µg) 1-2xdly.
(S3) TABS. A39/18.1/0399 Contraindications: Ac.ren.insuff., rapid.progr. ren.funct.impairm., Adults: 0,1-0,2 ml (10-20 µg) 1-2xdly.
Indications: Mild to mod.hypertens.alone or in combinat.with anur., hyperkalaem. Ren.conc.capacity test: Recomm.sngl.dos: Adults: 40 µg. Childr.
other antihypertens. Side effects: Hyperkalaem., hyponatraem., drowsin., headache, over 1 yr: 20 µg. Childr.und.1 yr: 10 µg. Discard.any urine collect.within
710437-001: 12,5 mg, 30, R15,08 atax., maculopap/erythemat. cutan.erupts., impot., gynaecomast., 1 hr.aft. admin. Dur.next 8 hrs.collect.2 urine portions for osmolality
st
Dosage: If sngl.dos.indicat.pref.tak.in morn.to minim.freq.of urinat. coma, mild androgen.eff. test. Observ.water.intake restricts.
dur.sleep. With /aft.meal. Special precautions: Imp.ren.funct., hepat.dis., other K -spar.drugs/ Noct.enures: Clinic.eff.dos.range of 10-20 µg at hr.of sleep. Dos-
+
Hypertens: Adults: 12,5 mg dly. K -supplem., grad.withdr. age should be est.progressiv. begin. with 10 µg dos. Max.dos.not
+
Adjunct in hypertens.: Adults: 12,5-25 mg dly.in conjunct.with anti- Drug interactions: Eff.of antihypertens.agents enhanc. to exceed 20 µg. Recomm.treatm.period 4-8 wks. Admin.only once
hypertens.med. Dos. should not high.than necess.to achieve desir.eff. in every 24 hrs. Restrict water intake 1 hr.bef. & 8 hrs. aft.admin.
Contraindications: Ren./hepat.fail., Addisons’s dis., hypercal- SPIRACTIN, (Aspen Pharmacare: Pharma) Pharmacare (S4) TABS, [P/S] 29/18.2/0429, 34/18.2/0402
caem., lactat., pregn. Spironolactone. Indications: Centr.diab.insipid., short-treatm.of prim. noct.enuresis
Side effects: Metabol.disturbs., hyperglycaem., hyperuricaem., elec- Indications: Oed., hypertens. in childr.over 5 yrs. who have norm. ability to conc.urine.
trol.imbal., hypochloraem. alkalos., hyponatraem., hypokalaem., re- (S3) TABS. L/18.1/186, U/18.1/52 837563-003: 0,1 mg, 30, R540,64
duc.urin. Ca excret., hypomagnesaem., GI disturbs., CNS effs., photos- 765910-004: 25 mg, 30, R45,30 703639-003: 0,2 mg, 30, R716,97
ens.reacts., postur.hypotens., paraesthes., impot., yellow vis., hypers- 765910-012: 25 mg, 200, R302,00 Dosage: Indiv. Centr.diab.insipid: Adults & childr: 0,1 mg 3xdly.
ens.reacts. incl skin reacts., cholestat.jaund., pancreatit., bld. dyscras. 898937-019: 100 mg, 60, R531,60 adjust.accord.to respons. Tot. dly.dos.varies betw. 0,2-1,2 mg. Optim.
Special precautions: HF, restrict.diet.salt, imp. ren./hepat.funct., Dosage: Init.100 mg dly in 4 div.dos. Incr./decr. dos. accord.aft. 5 dos.regim: 0,1-0,2 mg 3xdly.
diabet., monit.fluids/ electrol. bal., elderly, poss.exacerbat./activat. days. Max. 400 mg dly. Concom. convent.diuret.if respon.unsatisf.
of SLE, cross. placenta, distrib.into breastmilk, poss.K ion loss with Contraindications: Ac.ren.insuffic., anur., hyperkalaem., safety in Noct.enures: Init. 0,2 mg at bedt.incr.up to 0,4 mg if low.dos.not
+
suffic.effect. Short-term treatm. period of 4-8 wks recomm. Admin.
-
prolong.use requir.supplementat. pregn.not est., other K spar. diuret./K supplem.,
Drug interactions: Toxic.of digital.glycosides enhanc., enhanc. Side effects: Hyperkalaem., hyponatraem., CNS eff., skin reacts., recomm.dos. only once in 24 hrs. Do not use 0,1 & 0,2 mg tab in-
neuromusc.block.act.of competit. musc.relax., potent.act.of other impot., gynaecomast., androgen. eff. terchangeably.
antihypertens., alcoh., barbit., narcot.aggrav.postur.hypotens., K + Special precautions: Imp.ren.funct., sev.hepat. dis., monit.elec- Contraindications: Nephrogen.diabet.insipid., safety in pregn.&
deplet.eff.enhanc.by corticoster., corticotroph & beta 2-agonists, di- trol.regul., withdr.grad., diab. mellit., pts.likely to develop acidos. lactat.not est., periph.vasc.dis., CF/decomp.card.insuff., cirrhos., ne-
minish.respons.to pressor amines, incr.Li tox. Drug interactions: Enhanc.eff.of other antihypertens. phrot.syndr./ chron.ren.dis., oed., hypertens., cerebr.vasc.dis., habit.&
psychogen. polydipsia, concom.diurets., hyponatraem., do not admin.
RISAT, Aurobindo UNAT, MEDA Pharma to pts.with abnorm. ren.funct.for enures. Intranas.sol.& nas.spray
Torasemide. Torasemide. also: SIADH, mod.to sev.ren.insuffic.
Indications: Essent.hypertens., oed.of card.& hepat.origin, pulm. Indications: Essent.hypertens., oed.of card.& hepat.origin, pulm. Side effects: Sev.allerg.reacts., headache, emot. disturbs.in childr.,
oed.due to ac.card.insuffic. oed.due to ac.card.insuffic. skin reacts., hypertens., trans. hypotens., tachycard., GI disturbs.,
Urinary System - 16.2 / 16.3 / 16.4 2020-04 / 213
flush., vulva pain, water retent./hyponatraem., water intoxicat., Indications: Gastr.antacid., urin.alkalinis., crystallur.prevent.dur. URALYT-U, (Mylan) Takeda [P/S]
large dos. produc.press.eff.in anaesth./ pts.tak. ganglion or adrenerg. sulphonamide treatm. Potassium sod.hydrog.citrate 2,43 g/5 g
neuron.block./sympathet outflow defects. Nas.admin: nas.congest./ (S0) EFFERV.GRANS. 29/18.3/0379. Indications: Urine alkalin., dissolut.& prevent.of uric acid stones,
rhinit./ epistax.& change in nas.mucosa 820059-005: 60 g, R19,77 sympt.treatm.of porphyr.cutanea tarda.
Special precautions: Observe childr.for fluid overingest./ poss.water 820059-013: 120 g, R33,92 (S0) GRAN. H/18.4/1773. 1 meas.=2,5 g.
intoxic., when used for diagnost.purpos. limit fluid.intake to < 0,5 L from Dosage: Take on empty stom.in ½ glass of H2O follow.by addit. H2O. 773948-007: 280 g, R665,45
1 hr.bef.unt.8 hrs.aft.admin., concom.pressor agents, B/P monit.in heart Adults: 1-2 medic.meas. (4-8 g) 2-3xdly. Childr: 6-12 yrs: 1 medic. Dosage: 4 meas./day in div.doses aft.meals. Adjust accord.to urine
dis./hypertens.pts., limit dos.to prod. desir.physiolog.response, do not ad- meas. (4 g) 2-3xdly. pH determ.by indic.paper.
min.to dehydrat. pts.unt.water balance restor., elderly, condit. charact.by Contraindications: Sev.ren.dis., metabol.disturb. with alkalos., Contraindications: CF, imp.liv./ren.funct., hypernatraem., hyper-
fluid/elect.imbal., interrupt treatm. at signs of fluid retent./hyponatraem., hypocalcaem., hypochlorhydr., concom. urin.tract antisept.requir. kalaem., alkalos., K-spar. diuret.
condit. req.concom.diuret.agents, coron.art.insuff. &/ hypertens.CV dis., acid urine. Special precautions: 2-2½ L fluid intake dly., CF, low Na diet.
cyst.fibros., absorpt.with colds not est., pts.at risk of incr.IC-press., consid. Side effects: GI disturbs., metabol.alkalos.with excess.admin.in imp.
sev.bladd.dysfunct.& outlet obstruct.bef. treat. prim.noct.enures., empty ren.funct., musc. hypertonicity, twitch.& tetany in hypocalcaem. pts., URI-ALK, Medchem [P/S]
bladd.at time of admin., precaut. to avoid hyponatraem., do not use in- Na overload.& hyperosmolality with excess. dos. Na-citr. 615 mg, Na-bicarb. 1 362 mg, tartaric acid 860 mg, citr.
tranas. applicat.when absorpt.may be unreliab./ erratic. Special precautions: Ren.insuffic., CHF, hypertens., bacteriu- acid anhydr. 700 mg.
Drug interactions: TCA’s, SSRI’s, chlorpromazine & carbamazepine ria not eradicat. Indications: Gastr.antacid., urin.alkalinis.
may cause addit.antidiuret.eff., chlorpropamide/ clofibrate/carbamaz- Drug interactions: Antacids with comprom.ren. funct.may absorb EFFERV.TABS. 31/18.3/0414.
epine may prolong the act., poss.water retent./hyponatraem. induct. dangerous.high amounts of Al. 841986-002: 12, R51,75
with NSAID’s, glibenclamide may reduc. antidiuret. respons., incr. Dosage: Admin.2-3xdly.on empty stom.in H2O.
plasma conc.with loperamide, indomethacin incr.magnit.of respons. ALKAFIZZ, Cipla Medpro [P/S] Adults: 1-2 tabs. Childr.6-12 yrs: 1 tab.
Warnings: Overhydrat.incl.card.fail., avoid over-ingest. fluid in childr., Na-citr. 0,613 g, Na-bicarb. 1,716 g, citr.acid anhydr.0,702 g, tartaric Contraindications: Sev.ren.dis., metabol./ resp. alkalos., hypocal-
in enures.treatm.limit.fluid intake 1 hr.bef.& 8 hrs.aft.admin., treatm. acid 0,858 g, liq.gluc.0,34 ml/4 g caem., hypochlorhydr., concom. urin.tract antisept.requir.acid urine,
without concom.fluid reduc.poss lead to water retent./ hyponatraem. Indications: Urin.alkalinis., gastr.antacid. pts.on Na restrict.diet.
with/without assoc.effs.incl. convuls. EFFERV.GRANS, 29/18.3/0378 Side effects: GI disturbs.
DDAVP, Ferring [P/S] 816256-012: 60 g, R50,86 Special precautions: Ren.insuffic./abnormalit, CHF, hypertens.,
Desmopressin. 816256-004: 120 g, R76,41 aldosteron., oed., bact.not eradicat., pept.ulc., monit.ser.electrol.
Indications: Diagn.of centr.diab.insipid., urin. conc. capac.test. Dosage: Take on empty stom.in H2O in ren.dis.
(S4) INJ. S/8.1/360. 4 µg/ml. Adults: 1-2 medic.meas. (4-8 g) 2-3xdly.. Drug interactions: Dangerous.high amnts of Al poss.absorb.with
717754-006: 10x1 ml, R1 115,04 Childr: 6-12 yrs: 1 medic.meas. (4 g) 2-3xdly. antacids in comprom.ren.funct.
Dosage: Centr.diab.insipid.diagn: Indiv.dos. Use when intranas. Contraindications: Sev.ren.dis., metabol. disturb.alkalos., hy-
admin.unsuit. Norm.dos, IVI. Adults: 1-4 µg 1-2xdly. Childr.over 1
yr: 0,4-1 µg 1-2xdly. Childr.bel.1 yr: 0,2-0,4 µg 1-2xdly. pocalcaem., hypochlorhydr., concom.urin.tract antisept.requir.
acid urine.
Urin.conc.capac.test: Norm.adult dos: IM/SC admin. 4 µg. Childr. Side effects: GI disturbs., metabol.alkalos.in imp.ren.funct.with ex- 16.4 Urinary antiseptics
over 12 mnths: 1-2 µg. Und. 12 mnths: 0,4 µg. Use intranas.pre-
sentat.primarily for childr. cess.admin., musc. hypertonicity, twitch.& tetany esp.in hypocalcaem. MACRODANTIN (MDR Listing)
Side effects: Tachycard., headaches, mild abdom. cramps, N&V, fac. pts., Na overload. & hyperosmolality & result. oed.with excess.dos.
flush., vulv.pain, water intoxicat. from overhydrat. Special precautions: Ren.insuffic., bacteriur. not eradicat., CHF, DEBLASTON, Takeda [P/S]
Special precautions: Fluid overload., heart dis., hypertens., cyst. hypertens. Pipemidic acid trihydrate (equiv.to pipemidic acid). Sugar-free.
fibros., sensitiv.test in pts. hypersens. to ADH, large dos.pressor eff.in Drug interactions: Poss.danger.high amnts of Al absorb.with ant- Indications: Cystit., urethrit., pyelonephr., ac. prostatit.
anaesth., pts.tak.ganglion/adrenerg.neur.block.or sympathet.outflow acids.in imp.ren.funct. (S4) CAPS. S/18.5/42.
defects, myocard.ischaem. induc./ exacerb., pregn. CITRO-SODA, AI Pharm Ltd [P/S] 717770-001: 200 mg, 20, R178,72
Drug interactions: Indomethac.incr.magnit.of respons., glibencla- Na-citr. 613 mg, Na-bicarb. 1716 mg, tartaric acid 858 mg, citr. 717770-028: 200 mg, 40, R357,52
mide may reduc.antidiuret. respons., carbamazepine may prolong act. acid 702 mg/4 g. Dosage: 2 caps 2xdly with food for at least 5 days not ex-
Warnings: Overhydrat., not suit.for infts.und.3 mnths. Indications: Urin.alkalinis., gastr.antacid., prev.crystallur.dur.sul- ceed.10 days.
See also MDR page 315-320. Contraindications: Grow.childr./adolesc., imp. ren.funct., hepat.
phonamide treatm. dis., pregn.& lactat.
MINIRIN MELT, Ferring, [P/S] & (S0) GRANS, [P/S] E1031. Side effects: GI sympt., headache, dizz., fatig., stomatit., thirst,
Desmopressin acet. 821837-001: 60 g bottles, R37,54 skin reacts., anaphylax.
Indications: Centr.diab.insipid., short-treatm.of prim. noct.enuresis 821837-028: 120 g bottles, R55,21 Special precautions: Avoid excess.sunlight expos./UV radiat., con-
in childr.over 5 yrs. who have norm. ability to conc.urine. 832588-024: 8x4 g sachets, R25,43 sid.benef.-risk ratio in epilep., nalidixic acid cross-resist.
(S4) SUBLING.TABS, 42/18.2/0346, 0347 832588-008: 30x4 g sachets, R67,90 Drug interactions: Caffeine elimin.half-life may be incr.& clear.decr.,
722060-001: 120 µg, 30, R696,65 (S0) CRANBERRY GRANS. [P/S] 28/18.3/0372 poss.reduc.theophyll.clear.
722061-001: 240 µg, 30, R1 394,66 715589-001: 60 g, R37,54
Dosage: Place und.tong. Discont.if adeq.clinic. eff.not achiev. 715589-002: 120 g, R55,21 MACRODANTIN, Aspen Pharmacare [P/S] &
wihthin.4 wks.follow.dos titrat, 715590-001:30x4 g sachets, R67,90 Nitrofurantoin
Centr.diab.insipid: Indiv. Tot.dly.dos.betw.120-720 µg. Adults & Dosage: Take on empty stom.in ½ glass of water follow.by ad- Indications: Treatm.& prev.of recur.uncomplicat. low.UTI’s
childr: Suit.start.dos: 60 µg 3xdly.adjust.accord.to respons. Maint: dit.water. (S4) CAPS, G/18.5/160, 161
Gen.60-120 µg 3xdly. Adults: 1-2 med.meas. (4-8 g) 3-4xdly. 739839-004: 50 mg, 50, R326,48
Prim.noct.enures: Init.120 µg at bedt.incr.up to 240 µg if low.dos.not suf- Long-term ther: 1 med.meas.dly. 739847-004: 100 mg, 50, R627,53
fic.effect. Treatm.period of up to 4-8 wks. Admin.recomm.dos.only once Childr: 6-12 yrs: 1 med.meas.(4 g) 2-3xdly. Dosage: Adults: Ac.UTI: 50-100 mg 4xdly.with meals & at bedt.
every 24 hrs. Assess need for contin.treatm.by withdr.for at least 1 wk. Contraindications: Sev.ren.dis., metabol.disturb. alkalos., hypoc- Prev.recurr: 50-100 mg/day.
Contraindications: Nephrogen.diabet.insipid., known/suspect.card. alcaem., hypochlorhydr., Na-restrict. diet, antisept.requir.acid urine., Ac.UTI: Childr: 5-7 mg/kg bm/day in 4 div.dos.
insuffic.& other condits.req. diuret.treatm., mod.to sev.ren.insuffic., eff.in pregn.not est. Prev.recurr: 1 mg/kg/day
habit.& psychogen. polydipsia, hyponatraem., SIADH, oedemat. states Side effects: GI disturbs., metabol.alkalos.esp.in pts.with imp.ren. Contraindications: Anur., oligur., pregn.at term., infts.und.1 mnth
not assoc.with endogen. vasopress. defic., safety in pregn.not est., dysfunct., hypernatraem.& laxat. eff., Na overload & hyperosmolal. of age, safety in early pregn.not est., G6PD defic., concom.quino-
Side effects: Hyponatraem., anaphylact.reacts., headache, dizzin, in-
somn., somnol., asthen., hypertens., N&V, abdom.pain, diarrh., constipat., with excess.dos. incr.thirst, hypernatraem., musc.hypertonic., twitch. lones, ren.impairm.
& tetany in hypocalcaem.
psych.disords.in childr., bladd.& urethr.sympts., oed., fatig., hypokalaem., Side effects: Haemolyt.anaem., GI disturbs., hypersens. reacts., ana-
paraesthes., vis. impairm., vertigo, palpitat., orthostat.hypotens., dyspn., Special precautions: Pept ulcerat., ren.abnorm., liv.cirrh., CHF, hy- phylax., lupus-like syndr., myalg., arthralg., ac./subac.& chron.pulm.
dyspeps., flatul., bloat.& distens., sweat., prurit., rash, urticar., musc. pertens., periph./pulm.oed., pre-eclamps., bact.not eradicat., lactat., sensitiv. react., interstit. pulm.fibros.in chron.medicat., hepatotox.,
spasm, myalg., malaise, chest pain, flu-like illn., weight incr., incr.hepat. allow 1-2 hrs. aft.tetracycl.admin.& at least aft.ketoconaz. admin., bld.dyscras., periph.neuropathy, headache, dizzin., nystagm., drow-
enzyme, confus.state, allerg.dermat., coma, epistax.in childr. concur.methenamine not recomm. sin., sev. polyneuropath.with demyelinat.& degenerat.of sensory &
Warnings and special precautions: Poss. hyponatraem.with Drug interactions: Concurr.antacid poss.result in system.alkalos., motor nerves, trans.alopec., superinfect. of GUT only.
assoc.effs.incl.convuls.with excess.water intake, when used for poss promote developm.of Ca stones & hypernatrem., Al.contain. Special precautions: Course not to exceed 14 days, separate rep.
prim.noct. enures.minim.fluid.intake from 1 hr.bef.until 8 hrs. aft. antacids poss. incr.Al.absorpt., solubil.of ciprofloxacin/ norfloxacin/ courses., asthma, monit.pulm. funct.in elderly & prolong.ther., dis-
admin., concom.pressor agents, at low dos. food intake may reduc. oflxacin in urine poss.reduc., salicylat. poss.incr.urin.excret.& decr. cont.if haemolys. pres., pseudomon.implicat.in superinfects., urine
intens.& durat.of the antiduret. eff., unknown if enters mothers milk salicylat.therapeut. eff., tetracycl.absorpt.poss.decr., reduc. ketocona- col.brown, early report.of periph. neuropathy/condits.predispos.to
but GI absorpt.unlikely, interrupt treatm.at signs of fluid retent./ hy- zole absorpt., effectiv.of methenamine poss.reduc. periph. neuropathy, predisposit.to pulm./hepat./ neurologic. & al-
ponatraem., treatm.not recomm.in pts. >65 yrs., no stud.perform.in PROPAN MIST.POT.CIT.SIMPLEX, lerg.disord., elderly.
hepat.impairm., hyponatraem. is revers.& in childr.often.occurs in Drug interactions: Probenec/sulphinpyrazone reduc.excret., Mg
relat. to changes in dly routines affect.fluid intake &/ perspirat., incr. AI Pharm Ltd [P/S] trisilicate reduc.absorpt., antagon. with nalidix.& oxolinic acid, do
Potassium citr.(monohydrate).
hyponatraem.risk with ser.Na lev. in low.range of norm., sev.bladd. not admin. with concom.quinolones.
dysfunct.& outlet obstruct., interrupt.treatm.in illn.charact.by fluid. Indications: Urin.alkalinizer in inflamm.bladder condits., to prev. See also MDR page 183.
&/electrol.imbal., incr.IC press.risk, fluid/ electrol. imbal., concom. crystallur.dur.sulphonamide treatm.
meds.known to induc. SIADH, concom. NSAID’s. (S0) LIQ, H/18.3/1859. 1,25 g/15 ml. PUROMYLON, (Aspen Pharmacare: Pharma) Pharmacare [P/S]
Drug interactions: TCA’s/SSRI’s/chlorpromazine/ carbamazepine 805130-004: 100 ml, R3,38 Nalidixic acid.
& antidiab.of sulfonylurea group may cause addit.antidiuret.eff., car- 805130-012: 200 ml, R6,71 Indications: Suscept.gram neg.organ.UTI.
bamazepine may prolong the act., NSAID’s poss induc.water retent./ Dosage: Admin in water 3xdly with/immed.aft. meals. (S4) TABS. K/18.5/247.
hyponatraem., incr.plasma conc.with loperamide. Adults: 10ml. Childr. 6-12 yrs: 5 ml. 745685-005: 500 mg, 100,
See also MDR page 332. Contraindications: Urin.antisept.which req.acid urine, ren.fail./ Dosage: 4 g dly in 4 div.dos.for at least 7 days. R375,46
hyperkalaem., safety in pregn. & lactat.not est. Prolong.treatm: 2 g dly. Childr: 55-60 mg/kg bm dly in 2-4 div.doses.
Side effects: Metabol.alkalos.with excess. admin. esp.in pts.with Contraindications: CNS damage, convuls., imp.ren./hepat funct.,
16.3 Urinary alkalinizers imp.ren.funct., GI disturbs, poss. musc.hypertonic., twitch & tetany infts.und.1 mnth., 1st trimest.pregn.
esp.in hypocalcaem., hyperkalaem with excess.dos.
Side effects: GI disturb.& bleed., CNS eff., bld. dyscras., allerg.re-
Special precautions: Ren.insuffic., bact.not eradicat., pts.on K + spar. acts., musc.weakn., myalg., arthralg.
ADCO-SODASOL, AI Pharm Ltd [P/S] diur., adren.cortic.insuff. acidos., aft.tiss.trauma. Special precautions: Resp.depress., avoid sunlight expos.,
Na-citr. 0,613 g, Na-bicarb. 1,716 g, citr.acid anhydr. 0,702 g, tar- Drug interactions: Dangerous.high amounts of Al poss. absorb. lact.intol.,
taric acid 0,858 g/4 g. with.concom.antacids in comprom. ren. funct. Drug interactions: Nitrofurantoin interfer.with therap.act.
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MIMS April 2020 E4
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