TEVA-RANITIDINE TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Dostopno od:

TEVA CANADA LIMITED

Koda artikla:

A02BA02

INN (mednarodno ime):

RANITIDINE

Odmerek:

150MG

Farmacevtska oblika:

TABLET

Sestava:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 150MG

Pot uporabe:

ORAL

Enote v paketu:

100/500/30/60 TAB

Tip zastaranja:

Prescription

Terapevtsko območje:

HISTAMINE H2-ANTAGONISTS

Povzetek izdelek:

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

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2018-06-22

Lastnosti izdelka

PRODUCT MONOGRAPH
PR
TEVA-RANITIDINE
(ranitidine tablets, Teva Standard)
150 mg and 300 mg Film Coated Tablets
PR
TEVA-RANITIDINE SOLUTION
(ranitidine oral solution, USP)
15 mg/mL
PR
TEVA-RANITIDINE INJECTION
(ranitidine injection, USP)
25 mg/mL
THERAPEUTIC CLASSIFICATION
HISTAMINE H
2
-RECEPTOR ANTAGONIST
Teva Canada Limited
Date of Revision:
30 Novopharm Court
May 19, 2015
Toronto, Ontario
M1B 2K9
Submission Control No: 179744
_Teva-Ranitidine _
_ _
_ _
_2 _
PRODUCT MONOGRAPH
PR
TEVA-RANITIDINE
(ranitidine tablets, Teva Standard)
150 mg and 300 mg Film Coated Tablets
PR
TEVA-RANITIDINE SOLUTION
(ranitidine oral solution, USP)
15 mg/mL
PR
TEVA-RANITIDINE INJECTION
(ranitidine injection, USP)
25 mg/mL
THERAPEUTIC CLASSIFICATION
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.
Bioavailability of oral ranitidine is approximately 50% to 60%