Friday, September 13, 2013


For the medical profession only EPIRANT® Tablets-Ampoules 
Imd1tiw ha syd:rckioridrl Than0 2mg/mi 
Properties: EPIRANT® (ranitidine) is a histamine H2-antagonist which inhibits actinns nf histamine mediated by H2-receptam sach as gastric add secretion and pepsin antpat, reducing volume of seccetion, acid and pepsin customs, tt is awd where Inhibition of gastric acid secretion is benehciat. Pharmacokinetics: EFIRANT®, tu readily absorbed fcon the gastrn-intesl:nal tract after oral administratIon and rapidly following tM. Injection; absorption may be enhanced by food or decreased by antacid; peak plasma cuncentranons are reached withIn 2 hours after oral administrason and within 15 mInutes after intramuscular tnjectios. tt is weakly bounded to plasma proteIns. It has an elimination halt-life of about 2 — 3 bourn and is incmased in renal impairmnt. tt crosses the placental barrier and Is excreted into breast milk where concentrations are reported to be kjyher than those in plasma. tt dues nut readily cross the blued brain barrier EPIRANT® is wetabolized in the liner; the N-en:de is the malor metahobte. About 301k of an oral dose and 701k of an intravenous dose is eucreted unchanged in the urine within 24 hours; there is some eucrelien is the faeces. Indications: -Ouodenat ulcer. 
-Gastric ulcer. 
-Gasrrn-eesophayeai rekuv disease. 
-Post-operative ulcer. 
-Prophylaxis against daudenal ulceration during therapy with nonsteroidat 
anti-inflammatory drags. 
-Management of patients at risk from stress ulceration of the upper gastrointestinal 
-Pathologic hypersecretnry conditions (such as Zuilinger-Ellisen syndrome). 
-Prophytauts of recurrent haemorrhage in patients with bleeding peptic ulcers. 
-Prophylwris In pakents at rtsk of deneluping actd aspiration syndrome during general 
Dosage and Administration: Adultsr 
Oral Administration: 
-Benign Duedenal and Gastric ulcers (shun-term treatment): One 
EPIRANT® 150 mg tablet 2 times daily C in the muming and at bedtime I for at least 4 weeks, and maintenance dose is One EPIRANT® 150mg tablet daily at bedtime. 
-Gastre-eesephageal Reftux Disease: One EPIRANT® 150 mg fabler 2 times daily for up lee weeks 
or, if required, 12 weeks. This may be increased to One EPIRANT® 150 mg tablet 4 simm daily fur up to 12 weeks In severe rams. In the ma’mrenance ef heatIng eresine nesephagitis: One EPIHANT® 150mg tablet twice daily may be used. 
-Chrenic Episedic Dyspepsia: One EPIRANT® 150 my tablet 2 times daily far up ta £ weeks. 
-Patheteylc Hppersecretery Cendttlens (such as Zeltingec-Elttsen syndremel: An Initial dose of One EPtRANT® 150 my tablet 2-3 times daily and may be increased if necessary; doses uf up toky daily kane keen used. 
-Prephylanis against duedenal utcerarlee during therapy wilh nenstereidat anti-tntlammatery dregs: One EPIRANT® 150 my tablcf 2 Smes daily. 
-Patients at risk of denetepine Acid aspiration syndreme during anaesthesia: One EPIRANT® 050 my tablet may be glenn 2 hears before Ike induction of anaesthesia and preferably also One EPIRANT® 150 my tablet the precious eveniny. 
Parenterat Adarstnistcatiun: 
-The usual dow of EPIRANT® tM. or IV. is 50 my wktch may he repealed enery £ —8 beam. 
-When adminisleriny by the IV. ejection, EPI5tANT® ampoule shuuld be dueled,
with 0.51k sodium chloride or uthnr compa4thle IV. solutions, fn contain Sf1 my In 20 ml and should be glees slowly over not Ie4s than 2 mInutes. 
-Par an inrerminent t.V. infusion, the dose my he 25 my per hour given fm 2 hours and may be repeated every £ —8 hears. 
A rate of 6.25 my per huar has keen suyye®ed for continuous LV infusion althuuyh higher rates may be used fur conditions stick as Zollinyer-Elliuon syndmme or :n pakesta at risk of sImm ulceration. 
-The tM. iniection shuuld be administered undiluted. 
Oesaye tn Renal Impairment: 
Por patients with creatinine clearance 50 mt/minute, an urui dose uf 150 my daily is recommended or 50 my every 18-24 hours 14/. 
-Treatment ef Actise Duedenat and GastrtcUIcecs: The recommended oral dme Is: 
2-4 my/ky twice daily to a maoimum of 300 ny/day. 
-Maintenance ef Healing ef Duedenal and )lantrtc Ulcers: The recommended oral dow is: 2-4 my/ky once daily lea mav:mum]of 150 my/day. 
-Treatment ef Gantru-nesephageal Retlus Disease and Eresive Oesephagitls: 5-10 my/ky per day, usually green as 2 dldded ddses. 
Drug Interactions: EPIR.ANT® dues not seem to affect cytntkromn P450 to any yreat eutent, and therefore iu considered to kane little effect no the metabolism of other drays. However as with other l-12-antayunists, 1st effect on yaêtrlc pH may utter the ahsorpOun of some other druys. Precautions: -Before lherupy with EPIRANT® or other h lamine H2-astayosists for patients with yastric ulcers, the possibility of mallysancy should be considered since these drugs may mash symptoms and delay diaynnstn. 
flPIRAMT® should be used with caution in:1 
-Patients with renal impairment; the dosayn should be reduced. 
-Elderly patients. 
Pregnancy and Lactation: EPIRANT® should be used in pmynancy and lactation only if clearly needed. Children: The solely and etfecl:veness of ranitidine hate keen established in children from 
I munth to 16 years of aye. 
Contraindications: Hyyemensikdly to the drug or to other histamine H2-antayunisls. Side Effects: Side effecta are yeneralty infrequent and are usually reversible following a reduction of dosaye or wIthdrawal of therapy. The tide effects may include dlurrhea and other yastroinlestinal dlsmrkuoces, dizziness, drowsiness, tiredness, headache, and rashes. Altered liner function tests have uccurre and there have been rare repacto of kepatotonicity. Other dde effects that have keen reported rarely are kypersensilivily reactions and fever arlkralgia and mkylyia, blend disorders. As with other H2-aerayonisls, arrkythmiau such as lahycardia, bradycardia, AV block, and premuluce venlricalar beats hone keen repotled rarely. Bradycurdia in association with rapid administrolien of ranitidine lnjectin has been reporfed rarely, usually in parients wllh factors prcdispatiny to cardiac rhythm disturbances. Storage: Store at temperature nut euceediny 30’C. How supplied: EPIRANT® 150 my Tukiels: talntem of 10 tablets each. 
EPIRANT® Ampoules: Ampoales of 2 ml each. 
Date of revision: May2008

cart, dosage ate curtains: Tablet aatpnule
12 nil