APO-RANITIDINE 300MG TABLET

Pays: Malaisie

Langue: anglais

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingrédients actifs:

RANITIDINE

Disponible depuis:

PHARMAFORTE (MALAYSIA) SDN. BHD.

DCI (Dénomination commune internationale):

RANITIDINE

Unités en paquet:

30 Tablets; 100 Tablets

Fabriqué par:

APOTEX INC

Résumé des caractéristiques du produit

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