APO-RANITIDINE TABLET 300MG

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Available from:

APOTEX INC

ATC code:

A02BA02

INN (International Name):

RANITIDINE

Dosage:

300MG

Pharmaceutical form:

TABLET

Composition:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 300MG

Administration route:

ORAL

Units in package:

30/100/500

Prescription type:

Prescription

Therapeutic area:

HISTAMINE H2-ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0115150001; AHFS:

Authorization status:

MARKETED

Authorization date:

1987-12-31

Summary of Product characteristics

Page 3 of 25
PRODUCT MONOGRAPH
PR
APO-RANITIDINE
RANITIDINE TABLETS USP
150 MG AND 300 MG RANITIDINE (AS RANITIDINE HYDROCHLORIDE)
HISTAMINE H
2
- RECEPTOR ANTAGONIST
APOTEX INC.
DATE OF REVISION:
150 Signet Drive
Toronto, Ontario
May 04, 2016
M9L 1T9
CONTROL # 190974
Page 4 of 25
PRODUCT MONOGRAPH PR
APO-RANITIDINE
RANITIDINE TABLETS USP
150 MG AND 300 MG RANITIDINE (AS RANITIDINE HYDROCHLORIDE) HISTAMINE H2 - RECEPTOR ANTAGONIST
ACTIONS AND CLINICAL PHARMACOLOGY
Ranitidine is an antagonist of histamine at gastric H2-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.
Bioavailability of oral ranitidine is approximately 50% to 60%. Serum
protein binding of
ranitidine in man is in the range of 10 to 19%. The elimination
half-life is approximately 2 to 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 ga