Država: Kanada
Jezik: angleščina
Source: Health Canada
RANITIDINE (RANITIDINE HYDROCHLORIDE)
MYLAN PHARMACEUTICALS ULC
A02BA02
RANITIDINE
150MG
TABLET
RANITIDINE (RANITIDINE HYDROCHLORIDE) 150MG
ORAL
3/8/16/24/30/60/100
OTC
HISTAMINE H2-ANTAGONISTS
Active ingredient group (AIG) number: 0115150002; AHFS:
CANCELLED PRE MARKET
2016-11-02
PRODUCT MONOGRAPH ACID REDUCER MAXIMUM STRENGTH NON-PRESCRIPTION Ranitidine Tablets, USP, 150 mg (from Ranitidine Hydrochloride) Histamine H 2 -receptor Antagonist Mylan Pharmaceuticals ULC DATE OF PREPARATION: 85 Advance Road SEPTEMBER 28, 2010 Toronto, Ontario M8Z 2S6 CONTROL NUMBER: 141653 2 PRODUCT MONOGRAPH ACID REDUCER MAXIMUM STRENGTH NON-PRESCRIPTION Ranitidine Tablets, USP, 150 mg (from Ranitidine Hydrochloride) Histamine H 2 -receptor Antagonist 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. 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 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 single oral doses up to 300mg. In healthy subjects a single 75mg dose of ranitidine significantly reduced meal-stimulated intragastric acidity ([H + ] AUC) compared with placebo. The effect of ranitidine on Preberite celoten dokument