RANITIDINE TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Disponibil de la:

MYLAN PHARMACEUTICALS ULC

Codul ATC:

A02BA02

INN (nume internaţional):

RANITIDINE

Dozare:

150MG

Forma farmaceutică:

TABLET

Compoziție:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 150MG

Calea de administrare:

ORAL

Unități în pachet:

60/100/500

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

HISTAMINE H2-ANTAGONISTS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2012-10-19

Caracteristicilor produsului

PRODUCT MONOGRAPH
PR
RANITIDINE
(RANITIDINE TABLETS, USP)
150 MG AND 300 MG RANITIDINE (AS RANITIDINE HYDROCHLORIDE)
HISTAMINE H
2
-RECEPTOR ANTAGONIST
Mylan Pharmaceuticals ULC
Date of Revision:
85 Advance Road
Etobicoke, Ontario
May 10, 2012
M8Z 2S6
Submission Control #: 154794
1
PRODUCT MONOGRAPH
PR
RANITIDINE
(Ranitidine Hydrochloride Tablets, USP)
150 mg and 300 mg
PHARMACOLOGICAL 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.
2
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%. Serum
protein
binding of ranitidine in man is in the range of 10 to 19%. The
elimination half-life is
approximately 2 to 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