Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
RANITIDINE
PHARMAFORTE (MALAYSIA) SDN. BHD.
RANITIDINE
30 Tablets; 100 Tablets
APOTEX INC
APO-RANITIDINE TABLETS RANITIDINE HYDROCHLORIDE 150MG AND 300MG HISTAMINE H 2 -RECEPTOR ANTAGONIST PHARMACOLOGY: Ranitidine is a highly selective histamine H 2 -receptor antagonist, and a potent inhibitor of gastric acid secretion. Thus, ranitidine inhibits both basal gastric secretions 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 and it is dose related, a maximum response being achieved at an oral dose of 150mg. PHARMACOKINETICS: Ranitidine is rapidly absorbed after oral administration, peak plasma concentration being achieved within 2 to 3 hours. Plasma concentrations are not significantly influenced by the presence of food in the stomach at the time of oral administration, nor by the presence 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 (cumulative urinary excretion of free and metabolized ranitidine during 24 hours after an oral dose of 100mg was approximately 33%). There is a significant linear correlation between the dose administered and the inhibitory effect upon gastric acid secretion for doses up to 150mg. A plasma ranitidine concentration of 93.6ng/mL (range 48 - 125) has an inhibitory effect upon stimulated gastric acid secretion of approximately 50%. The IC50 of ranitidine is likely to be in the region of 100ng/mL. Following the administration of 150mg ranitidine orally, plasma concentrations in excess of the IC50 (100ng/mL) lasted for more than 8 hours, and after 12 hours the plasma concentrations were sufficiently high as to have a significant inhibitor effect upon gastric acid secretion. In patients with duodenal ulcer, 150mg ranitidine given by mouth ev Baca dokumen lengkap