ACID REDUCER TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Dostępny od:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

Kod ATC:

A02BA02

INN (International Nazwa):

RANITIDINE

Dawkowanie:

150MG

Forma farmaceutyczna:

TABLET

Skład:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 150MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

HISTAMINE H2-ANTAGONISTS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2007-01-25

Charakterystyka produktu

PRODUCT MONOGRAPH
PR
ACID REDUCER
(Ranitidine Tablets, USP)
150 mg
Histamine H
2
-Receptor Antagonist
PENDOPHARM,
DIVISION OF/DE PHARMASCIENCE INC.
Date of Preparation:
8580 Esplanade
January 23, 2007
Montréal, Quebec
H2P 2R8
CONTROL NUMBER: 110389
2
PRODUCT MONOGRAPH
PR
ACID REDUCER
(Ranitidine Tablets, USP)
150 mg
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, peak plasma
concentrations being achieved
within 2 to 3 hours. 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.
3
Bioavailability of oral ranitidine is approximately 50%. Serum protein
binding of ranitidine in man
is in the range 10 to 19%. The elimination half-life is approximately
3 hours. The principal route
of excretion is the urine (40% recovery of free and metabolized drug
in 24 hours).
A comparative biostudy was conducted to compare the single - dose
bioavailability of pms-
RANITIDINE (Ranitidine Tablets USP) and ZANTAC® of Glaxo Wellcome
purchased in Canada.
Both products contain ranitidine as the hydrochloride. The study was a
randomized, two-way
crossover design in which a single dose (300 mg tabl