Country: Canada
Language: English
Source: Health Canada
CIMETIDINE
TEVA CANADA LIMITED
A02BA01
CIMETIDINE
200MG
TABLET
CIMETIDINE 200MG
ORAL
100/500
Prescription
HISTAMINE H2-ANTAGONISTS
Active ingredient group (AIG) number: 0111925005; AHFS:
CANCELLED POST MARKET
2018-06-05
PRODUCT MONOGRAPH PR NOVO-CIMETINE TABLETS Cimetidine 200 mg, 300 mg, 400 mg, 600 mg, and 800 mg PR NOVO-CIMETINE INJECTION Cimetidine Hydrochloride Injection 300 mg/2 mL cimetidine HISTAMINE H2 RECEPTOR ANTAGONIST Teva Canada Limited 30 Novopharm Court Toronto, Ontario DATE OF PREPARATION: M1B 2K9 May 23, 2014 Control # 173478 2 PRODUCT MONOGRAPH Pr NOVO-CIMETINE Tablets Cimetidine 2OO mg, 300 mg, 400 mg, 600 mg, and 800 mg Pr NOVO-CIMETINE Injection Cimetidine Hydrochloride Injection 300 mg/2 mL cimetidine THERAPEUTIC CLASSIFICATION Histamine H 2 Receptor Antagonist ACTION AND CLINICAL PHARMACOLOGY Cimetidine competitively inhibits the action of histamine at the histamine H 2 -receptor and thus represents a new class of pharmacological agents, the histamine H 2 -receptor antagonists. Cimetidine is not an anticholinergic agent. Studies have shown that cimetidine inhibits both daytime and nocturnal basal gastric acid secretion. Cimetidine also inhibits gastric acid secretion stimulated by food, histamine, pentagastrin, caffeine, and insulin. Its ability to inhibit gastric acid secretion via this unique mechanism of action permits a new approach to the treatment of acid- related gastrointestinal disorders. In addition to its antisecretory effects, cimetidine also has cytoprotective properties. In therapeutic studies, patients with NSAID-induced lesions or ulcers had symptomatic relief and healing when cimetidine was co-administered with the existing NSAID therapy. Cimetidine is absorbed rapidly after oral administration. The plasma half-life is approximately 2 hours. The principal route of excretion is the urine. The degree and duration of inhibition of basal and stimulated gastric acid secretion are dose related; the data suggest that 80% or higher inhibition throughout a 24 hour period can be achieved by a dosage regimen of 1.2 g daily given in divided doses. Cimetidine 300 mg reduced total pepsin output as a result of the decrease in volume of gastric juice. The drug had no effect on the rate of gastric emptyin Read the complete document