ZANTAC SOLUTION

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Fáanlegur frá:

GLAXOSMITHKLINE INC

ATC númer:

A02BA02

INN (Alþjóðlegt nafn):

RANITIDINE

Skammtar:

15MG

Lyfjaform:

SOLUTION

Samsetning:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 15MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

300ML

Gerð lyfseðils:

Prescription

Lækningarsvæði:

HISTAMINE H2-ANTAGONISTS

Vörulýsing:

Active ingredient group (AIG) number: 0115150005; AHFS:

Leyfisstaða:

CANCELLED POST MARKET

Leyfisdagur:

2012-02-29

Vara einkenni

2010-08-12/131-pristine-english-zantac.doc
1
PRODUCT MONOGRAPH
PR
ZANTAC
®
ranitidine tablets USP
ranitidine injection USP
ranitidine oral solution USP
HISTAMINE H
2
-RECEPTOR ANTAGONIST
GlaxoSmithKline Inc.
DATE OF REVISION:
7333 Mississauga Road
Mississauga, Ontario
August 12, 2010
L5N 6L4
SUBMISSION CONTROL NO: 139175
©
2010 GlaxoSmithKline, All Rights Reserved
®
ZANTAC is a registered trademark of Johnson & Johnson used under
license by GlaxoSmithKline Inc.
2010-08-12/131-pristine-english-zantac.doc
2
PRODUCT MONOGRAPH
PR
ZANTAC
®
ranitidine tablets USP
ranitidine injection USP
ranitidine oral solution 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
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.
2010-08-12/131-pristine-english-zantac.doc
3
Bioavailability of oral ranitidine is approximately 50% to 60%. Serum
protein
binding of ranitidine in man is in the range of 10 to