Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
RANITIDINE (RANITIDINE HYDROCHLORIDE)
GLAXOSMITHKLINE INC
A02BA02
RANITIDINE
300MG
TABLET
RANITIDINE (RANITIDINE HYDROCHLORIDE) 300MG
ORAL
30
Prescription
HISTAMINE H2-ANTAGONISTS
Active ingredient group (AIG) number: 0115150001; AHFS:
CANCELLED POST MARKET
2017-09-14
_ _ _January 9, 2015 _ _ _ _ _ _ _ _Page 1 of 41_ PRODUCT MONOGRAPH PR ZANTAC ® ranitidine tablets USP, 150 mg, 300 mg ranitidine injection USP, 25 mg/mL HISTAMINE H 2 -RECEPTOR ANTAGONIST GlaxoSmithKline Inc. DATE OF REVISION: 7333 Mississauga Road January 15, 2015 Mississauga, Ontario L5N 6L4 SUBMISSION CONTROL NO: 179097 © 2015 GlaxoSmithKline, All Rights Reserved ® ZANTAC is a registered trademark of Johnson & Johnson Inc., used under license by GlaxoSmithKline Inc. _ _ _January 9, 2015 _ _ _ _ _ _ _ _Page 2 of 41_ PRODUCT MONOGRAPH PR ZANTAC ® ranitidine tablets USP, 150 mg, 300 mg ranitidine injection USP, 25 mg/mL 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. _ _ _January 9, 2015 _ _ _ _ _ _ _ _Page 3 of 41_ Bioavailability of oral ranitidine is approximately 50% to 60%. Serum protein binding of ranitidine in man is in the Aqra d-dokument sħiħ