Kraj: Kanada
Język: angielski
Źródło: Health Canada
RANITIDINE (RANITIDINE HYDROCHLORIDE)
RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED
A02BA02
RANITIDINE
150MG
TABLET
RANITIDINE (RANITIDINE HYDROCHLORIDE) 150MG
ORAL
60/100/500
Prescription
HISTAMINE H2-ANTAGONISTS
Active ingredient group (AIG) number: 0115150002; AHFS:
CANCELLED POST MARKET
2014-09-19
1 PRODUCT MONOGRAPH RATIO*-RANITIDINE (ranitidine hydrochloride tablets, BP) 150 mg & 300 mg Histamine H 2 receptor antagonist RATIOPHARM INC. DATE OF PREPARATION: CANADA J7J 1P3 OCTOBER 8, 2003 CONTROL# 087630 DATE DE REVISION: FEBRUARY 05, 2004 * TM used under license from ratiopharm GmbH 2 PRODUCT MONOGRAPH RATIO-RANITIDINE (RANITIDINE HYDROCHLORIDE TABLETS, BP) 150 MG & 300 MG HISTAMINE H 2 RECEPTOR ANTAGONIST ACTION 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, peak plasma concentrations being achieved within 2 to 3 hours. 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%. Serum protein binding of ranitidine in man is in the range of 10 to 19%. The elimination half-life is approximately 3 hours. The principal route of excretion is the urine (40% recovery of free and metabolized drug in 24 hours). There is a significant linear correlation between the dose administered and the inhibitory effect upon gastric acid secretion for oral doses up to 300 mg. A plasma ranitidine concentration of 50 ng/mL has an inhibitory effect upon stimulated gastric acid secretion of approximately 50% Przeczytaj cały dokument