MYLAN-RANITIDINE TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Disponibbli minn:

MYLAN PHARMACEUTICALS ULC

Kodiċi ATC:

A02BA02

INN (Isem Internazzjonali):

RANITIDINE

Dożaġġ:

300MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 300MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

30/35/60/100/500

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

HISTAMINE H2-ANTAGONISTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0115150001; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2017-05-08

Karatteristiċi tal-prodott

_Page 1 of 35 _
PRODUCT MONOGRAPH
PR
MYLAN-RANITIDINE
Ranitidine Tablets
150 mg and 300 mg Ranitidine (as Ranitidine Hydrochloride)
USP
Histamine H
2
-Receptor Antagonist
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No.: 187977
Date of Revision: October 05, 2015
_Page 2 of 35 _
_ _
PRODUCT MONOGRAPH
PR
MYLAN-RANITIDINE
Ranitidine Tablets
150 mg and 300 mg Ranitidine (as Ranitidine Hydrochloride)
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.
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
_Page 3 of 35 _
_ _
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