Product Monograph ZANTAC - GlaxoSmithKline

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TabletsIn respect of both 24-hour acidity and nocturnal acid output, an oral dose of ranitidine150 mg twice daily was superior to cimetidine 200 mg three times daily and 400 mg atnight (p
Ranitidine injection is well tolerated following intravenous administration at dose levels ofup to 100 mg 4 times daily. It is evident that these levels are in excess of thoserecommended for normal clinical use.At 50 mg intravenously, ranitidine injection had no effect on prolactin levels. Only at the300 mg IV dose level was there an increase in prolactin secretion, which was equivalentto that produced by 200 mg of cimetidine administered intravenously.Patients over 50 years of ageIn patients over 50 years of age, half-life is prolonged (3 to 4 hours) and clearance isreduced, consistent with the age-related decline of renal function. However, systemicexposure and accumulation are 50% higher. This difference exceeds the effect ofdeclining renal function, and indicates increased bioavailability in older patients.INDICATIONS AND CLINICAL USE<strong>ZANTAC</strong> ® (ranitidine hydrochloride) Tablets and Injection are indicated for the treatmentof duodenal ulcer, benign gastric ulcer, reflux esophagitis, post-operative peptic ulcer,Zollinger-Ellison Syndrome, and other conditions where reduction of gastric secretionand acid output is desirable. These include the following:the treatment of nonsteroidal anti-inflammatory drug (NSAID)- induced lesions,both ulcers and erosions, and their gastrointestinal (GI) symptoms and theprevention of their recurrence;the prophylaxis of GI hemorrhage from stress ulceration in seriously ill patients;the prophylaxis of recurrent hemorrhage from bleeding ulcers;the prevention of Acid Aspiration Syndrome from general anaesthesia in patientsconsidered to be at risk for this, including obstetrical patients in labour, and obesepatients.February 18, 2014Page 5 of 41
Page 1 and 2: Product MonographPr ZANTAC ®raniti
Page 3: Bioavailability of oral ranitidine
Page 7 and 8: Use in Pregnancy and Nursing Mother
Page 9 and 10: 2) Competition for renal tubular se
Page 11 and 12: CardiovascularIsolated reports of t
Page 13 and 14: DOSAGE AND ADMINISTRATIONTablet Adm
Page 15 and 16: Prophylaxis of hemorrhage from stre
Page 17 and 18: PHARMACEUTICAL INFORMATIONDrug Subs
Page 19 and 20: Dilution of Parenteral ProductsIntr
Page 21 and 22: AVAILABILITY OF DOSAGE FORMSZANTAC
Page 24 and 25: In the dog up to 70% of the adminis
Page 26 and 27: TOXICOLOGYToxicology, Impairment of
Page 28: Changes in the colour or granularit
Page 31 and 32: sensitive Oral Solution microtitre
Page 33 and 34: 12. Ehsanullah RSB, Page MC, Tildes
Page 35 and 36: 33. Scarpignato C, Bertaccini G, Zi
Page 37 and 38: IMPORTANT: PLEASE READPROPER USE OF
Page 39 and 40: IMPORTANT: PLEASE READPART III: CON
Page 41: IMPORTANT: PLEASE READSERIOUS SIDE

Product Monograph ZANTAC - GlaxoSmithKline

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