Nazione: Canada
Lingua: inglese
Fonte: Health Canada
RANITIDINE (RANITIDINE HYDROCHLORIDE)
RANBAXY PHARMACEUTICALS CANADA INC.
A02BA02
RANITIDINE
150MG
TABLET
RANITIDINE (RANITIDINE HYDROCHLORIDE) 150MG
ORAL
100
Prescription
HISTAMINE H2-ANTAGONISTS
Active ingredient group (AIG) number: 0115150002; AHFS:
APPROVED
2010-04-28
1 PRODUCT MONOGRAPH RANITIDINE TABLETS RANITIDINE TABLETS USP 150 MG AND 300 MG OF RANITIDINE (AS RANITIDINE HYDROCHLORIDE) HISTAMINE H 2 -RECEPTOR ANTAGONIST Ranbaxy Pharmaceuticals Canada Inc. Date of Preparation: 2680 Matheson Blvd East April 27, 2010 Suite 200 Mississauga, Ontario L4W 0A5 Submission Control No: 138017 2 PRODUCT MONOGRAPH RANITIDINE TABLETS ranitidine tablets USP 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 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 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%. Estimates of the IC 50 rang Leggi il documento completo