Land: Canada
Taal: Engels
Bron: Health Canada
RANITIDINE (RANITIDINE HYDROCHLORIDE)
TEVA CANADA LIMITED
A02BA02
RANITIDINE
75MG
SOLUTION
RANITIDINE (RANITIDINE HYDROCHLORIDE) 75MG
ORAL
300ML
Prescription
HISTAMINE H2-ANTAGONISTS
Active ingredient group (AIG) number: 0115150005; AHFS:
CANCELLED POST MARKET
2020-06-10
PRODUCT MONOGRAPH PR TEVA-RANITIDINE (ranitidine tablets, Teva Standard) 150 mg and 300 mg Film Coated Tablets PR TEVA-RANITIDINE SOLUTION (ranitidine oral solution, USP) 15 mg/mL PR TEVA-RANITIDINE INJECTION (ranitidine injection, USP) 25 mg/mL THERAPEUTIC CLASSIFICATION HISTAMINE H 2 -RECEPTOR ANTAGONIST Teva Canada Limited Date of Revision: 30 Novopharm Court May 19, 2015 Toronto, Ontario M1B 2K9 Submission Control No: 179744 _Teva-Ranitidine _ _ _ _ _ _2 _ PRODUCT MONOGRAPH PR TEVA-RANITIDINE (ranitidine tablets, Teva Standard) 150 mg and 300 mg Film Coated Tablets PR TEVA-RANITIDINE SOLUTION (ranitidine oral solution, USP) 15 mg/mL PR TEVA-RANITIDINE INJECTION (ranitidine injection, USP) 25 mg/mL THERAPEUTIC CLASSIFICATION HISTAMINE H 2 -RECEPTOR ANTAGONIST ACTIONS AND CLINICAL PHARMACOLOGY Ranitidine is an antagonist of histamine at gastric H 2 -receptor sites. Thus, ranitidine inhibits both basal gastric secretion and gastric acid secretion induced by histamine, pentagastrin and other secretagogues. On a weight basis ranitidine is between 4 and 9 times more potent than cimetidine. Inhibition of gastric acid secretion has been observed following intravenous, intraduodenal and oral administration of ranitidine. This response is dose-related, a maximum response being achieved at an oral dose of 300 mg/day. Pepsin secretion is also inhibited but secretion of gastric mucus is not affected. Ranitidine does not alter the secretion of bicarbonate or enzymes from the pancreas in response to secretin and pancreozymin. Ranitidine is rapidly absorbed after oral administration of 150 mg ranitidine, peak plasma concentrations (300 to 550 ng/mL) occurred after 1 to 3 hours. Two distinct peaks or a plateau in the absorption phase result from reabsorption of drug excreted into the intestine. These plasma concentrations are not significantly influenced by the presence of food in the stomach at the time of the oral administration nor by regular doses of antacids. Bioavailability of oral ranitidine is approximately 50% to 60% Lees het volledige document