PEPCID AC (CHEWABLE TAB) - 10MG TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

FAMOTIDINE

Saatavilla:

MERCK CANADA INC

ATC-koodi:

A02BA03

INN (Kansainvälinen yleisnimi):

FAMOTIDINE

Annos:

10MG

Lääkemuoto:

TABLET

Koostumus:

FAMOTIDINE 10MG

Antoreitti:

ORAL

Kpl paketissa:

30

Prescription tyyppi:

OTC

Terapeuttinen alue:

HISTAMINE H2-ANTAGONISTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2005-07-29

Valmisteyhteenveto

PRODUCT MONOGRAPH
PEPCID AC
®
(famotidine tablets, Frosst Std.)
Film Coated Tablets 10 mg
and
PEPCID AC
®
(famotidine chewable tablets)
Chewable Tablets 10 mg
and
PEPCID AC
®
(famotidine tablets, Frosst Std.)
Gelcaps 10 mg
THERAPEUTIC CLASSIFICATION
Histamine H
2
Receptor Antagonist
Distributed by:
Johnson & Johnson•MERCK
Consumer Pharmaceuticals
Guelph, Canada, N1K 1A5
Manufacturer:
MERCK FROSST CANADA LTD.
KIRKLAND, QUEBEC, CANADA
PEPCID
®
AC
is a Trademark of Merck & Co., Inc.,
Used under license.
Date of Preparation: August 4, 2005
Date of Revision:
Control Number: 100128
2
PRODUCT MONOGRAPH
PEPCID AC
®
(famotidine tablets, Frosst Std.)
Tablets 10 mg
and
PEPCID AC
®
(famotidine chewable tablets)
Chewable Tablets 10 mg
and
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.
PEPCID AC
®
is a Trademark of Merck & Co., Inc.
Used under license.
3
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
H2-receptor antagonists.
PRECAUTIONS
General
In clinical