RATIO-RANITIDINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Available from:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

ATC code:

A02BA02

INN (International Name):

RANITIDINE

Dosage:

150MG

Pharmaceutical form:

TABLET

Composition:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 150MG

Administration route:

ORAL

Units in package:

60/100/500

Prescription type:

Prescription

Therapeutic area:

HISTAMINE H2-ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0115150002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2014-09-19

Summary of Product characteristics

1
PRODUCT MONOGRAPH
RATIO*-RANITIDINE
(ranitidine hydrochloride tablets, BP)
150 mg & 300 mg
Histamine H
2
receptor antagonist
RATIOPHARM INC.
DATE OF PREPARATION:
CANADA J7J 1P3
OCTOBER 8, 2003
CONTROL# 087630
DATE DE REVISION:
FEBRUARY 05, 2004
* TM used under license from ratiopharm GmbH
2
PRODUCT MONOGRAPH
RATIO-RANITIDINE
(RANITIDINE HYDROCHLORIDE TABLETS, BP)
150 MG & 300 MG
HISTAMINE H
2 RECEPTOR ANTAGONIST
ACTION 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 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 of 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%