ZANTAC TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Available from:

GLAXOSMITHKLINE INC

ATC code:

A02BA02

INN (International Name):

RANITIDINE

Dosage:

150MG

Pharmaceutical form:

TABLET

Composition:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 150MG

Administration route:

ORAL

Units in package:

60

Prescription type:

Prescription

Therapeutic area:

HISTAMINE H2-ANTAGONISTS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2017-09-14

Summary of Product characteristics

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_January 9, 2015 _
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_Page 1 of 41_
PRODUCT MONOGRAPH
PR
ZANTAC
®
ranitidine tablets USP, 150 mg, 300 mg
ranitidine injection USP, 25 mg/mL
HISTAMINE H
2
-RECEPTOR ANTAGONIST
GlaxoSmithKline Inc.
DATE OF REVISION:
7333 Mississauga Road January 15, 2015
Mississauga, Ontario
L5N 6L4
SUBMISSION CONTROL NO: 179097
©
2015 GlaxoSmithKline, All Rights Reserved
®
ZANTAC is a registered trademark of Johnson & Johnson Inc., used under
license by
GlaxoSmithKline Inc.
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_January 9, 2015 _
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_Page 2 of 41_
PRODUCT MONOGRAPH
PR
ZANTAC
®
ranitidine tablets USP, 150 mg, 300 mg
ranitidine injection USP, 25 mg/mL
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 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.
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_January 9, 2015 _
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_Page 3 of 41_
Bioavailability of oral ranitidine is approximately 50% to 60%. Serum
protein binding of
ranitidine in man is in the