RANITIDINE TABLETS

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Available from:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC code:

A02BA02

INN (International Name):

RANITIDINE

Dosage:

150MG

Pharmaceutical form:

TABLET

Composition:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 150MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

HISTAMINE H2-ANTAGONISTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2010-04-28

Summary of Product characteristics

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