PEPCID AC TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

FAMOTIDINE

Disponibbli minn:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

Kodiċi ATC:

A02BA03

INN (Isem Internazzjonali):

FAMOTIDINE

Dożaġġ:

10MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

FAMOTIDINE 10MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

2/6/12/18//30/50/75/100

Tip ta 'preskrizzjoni:

OTC

Żona terapewtika:

HISTAMINE H2-ANTAGONISTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0118722003; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED PRE MARKET

Data ta 'l-awtorizzazzjoni:

2016-01-22

Karatteristiċi tal-prodott

PRODUCT MONOGRAPH
PEPCID AC
®
(famotidine tablets, Frosst Std.)
GELCAPS 10 MG
THERAPEUTIC CLASSIFICATION
HISTAMINE H
2 RECEPTOR ANTAGONIST
McNeil Consumer Healthcare, division of Johnson & Johnson Inc.
88 McNabb Street
Markham, Ontario
L3R 5L2
Date of Preparation: November 16, 2011
Control Number: 150805
2
PRODUCT MONOGRAPH
PEPCID AC
®
(famotidine tablets, Frosst Std.)
GELCAPS 10 MG
THERAPEUTIC CLASSIFICATION
HISTAMINE H
2 RECEPTOR ANTAGONIST
CLINICAL PHARMACOLOGY
PEPCID AC
®
(famotidine) is a competitive inhibitor of histamine H
2
-receptors. The primary
clinically important pharmacologic activity of PEPCID AC
®
is inhibition of gastric juice secretion.
PEPCID AC
®
reduces the acid and pepsin content, as well as the volume, of basal,
nocturnal, and
stimulated gastric secretion.
INDICATIONS AND CLINICAL USE
PEPCID AC
®
(famotidine) is indicated in the treatment of the following conditions
where a
controlled reduction of gastric secretion is required, such as acid
indigestion, heartburn, sour or upset
stomach. PEPCID AC
®
is also indicated for the prevention of these symptoms when associated
with
the consumption of food and/or
beverage including nocturnal symptoms associated with the evening
meal and expected to cause sleep disturbance.
CONTRAINDICATIONS
Hypersensitivity to any component of this medication. Cross
sensitivity in this class of compounds
has been observed. Therefore, PEPCID AC
®
should not be administered to patients with a history of
hypersensitivity to other H
2
-receptor antagonists.
PRECAUTIONS
GENERAL
In clinical trials, patients with other underlying acid
gastrointestinal diseases (e.g. duodenal ulcer,
gastric ulcer) did not experience complications; in general, they did
not exhibit a clinically significant
deterioration in their condition. However, if patients have difficulty
swallowing or if abdominal
discomfort persists, the underlying cause should be determined.
Symptomatic response to therapy
with PEPCID AC
®
(famotidine) does not preclude the presence of gastric malignancy.
Patie