Product Monograph ZANTAC - GlaxoSmithKline

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HaematologicBlood count changes (leukopenia, thrombocytopenia) have occurred in a few patients.These are usually reversible. Rare cases of agranulocytosis or pancytopenia,sometimes with marrow hypoplasia or aplasia have been reported.EndocrineNo clinically significant interference with endocrine or gonadal function has beenreported. There have been a few reports of breast symptoms and breast conditions(such as gynaecomastia and galactorrhoea).DermatologicRash, including cases suggestive of mild erythema multiforme. Rare cases of vasculitisand alopecia have been reported.OtherRare cases of hypersensitivity reactions (including chest pain, bronchospasm, fever,rash, eosinophilia, anaphylaxis, urticaria, angioneurotic edema, hypotension) and smallincreases in serum creatinine have occasionally occurred after a single dose. Acutepancreatitis and reversible impotence has been reported rarely.SYMPTOMS AND TREATMENT OF OVERDOSAGEThere is no experience to date with deliberate overdosage. The usual measures toremove unabsorbed drug from the gastrointestinal tract (including activated charcoal orsyrup of ipecac), clinical monitoring and supportive therapy should be employed.For management of a suspected drug overdose, contact your regional PoisonControl Centre.February 18, 2014Page 12 of 41
DOSAGE AND ADMINISTRATIONTablet AdministrationDuodenal ulcer or benign gastric ulcer300 mg once daily at bedtime or 150 mg twice daily taken in the morning and beforeretiring. It is not necessary to time the dose in relation to meals. In most cases ofduodenal ulcer and benign gastric ulcer, healing will occur in four weeks. In the smallnumber of patients whose ulcers may not have fully healed, these are likely to respondto a further four week course of therapy. In the treatment of duodenal ulcers, 300 mgtwice daily for 4 weeks may be of benefit when more rapid healing is desired.Maintenance therapyDuodenal ulcers, benign gastric ulcers: Patients who have responded to short-termtherapy, particularly those with a history of recurrent ulcer, may benefit from chronicmaintenance therapy at a reduced oral dosage of 150 mg once daily at bedtime.In the management of duodenal ulcers, smoking is associated with a higher rate of ulcerrelapse (up to 9.2 times higher in one trial), and such patients should be advised to stopsmoking. In those patients who fail to comply with such advice, 300 mg nightly providesadditional therapeutic benefit over the 150 mg once daily dosage regimen.Reflux esophagitisAcute treatment300 mg once daily at bedtime, or alternatively 150 mg twice daily, taken in the morningand before retiring for up to eight weeks. In patients with moderate to severeesophagitis, the dosage of ranitidine may be increased to 150 mg four times daily for upto 12 weeks.February 18, 2014Page 13 of 41
Page 1 and 2: Product MonographPr ZANTAC ®raniti
Page 3 and 4: Bioavailability of oral ranitidine
Page 5 and 6: Ranitidine injection is well tolera
Page 7 and 8: Use in Pregnancy and Nursing Mother
Page 9 and 10: 2) Competition for renal tubular se
Page 11: CardiovascularIsolated reports of t
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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