ACID REDUCER MAXIMUM STRENGTH NON-PRESCRIPTION TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Dostępny od:

MYLAN PHARMACEUTICALS ULC

Kod ATC:

A02BA02

INN (International Nazwa):

RANITIDINE

Dawkowanie:

150MG

Forma farmaceutyczna:

TABLET

Skład:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 150MG

Droga podania:

ORAL

Sztuk w opakowaniu:

3/8/16/24/30/60/100

Typ recepty:

OTC

Dziedzina terapeutyczna:

HISTAMINE H2-ANTAGONISTS

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED PRE MARKET

Data autoryzacji:

2016-11-02

Charakterystyka produktu

PRODUCT MONOGRAPH
ACID REDUCER MAXIMUM STRENGTH NON-PRESCRIPTION
Ranitidine Tablets, USP, 150 mg
(from Ranitidine Hydrochloride)
Histamine H
2
-receptor Antagonist
Mylan Pharmaceuticals ULC
DATE OF PREPARATION:
85 Advance Road
SEPTEMBER 28, 2010
Toronto, Ontario M8Z 2S6
CONTROL NUMBER: 141653
2
PRODUCT MONOGRAPH
ACID REDUCER MAXIMUM STRENGTH NON-PRESCRIPTION
Ranitidine Tablets, USP, 150 mg
(from Ranitidine Hydrochloride)
Histamine H
2
-receptor Antagonist
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. 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.
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).
There is a significant linear correlation between the dose
administered and the inhibitory effect
upon gastric acid secretion for single oral doses up to 300mg. In
healthy subjects a single 75mg
dose of ranitidine significantly reduced meal-stimulated intragastric
acidity ([H
+
] AUC)
compared with placebo. The effect of ranitidine on