PEPCID TAB 40MG TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FAMOTIDINE

Available from:

MERCK CANADA INC

ATC code:

A02BA03

INN (International Name):

FAMOTIDINE

Dosage:

40MG

Pharmaceutical form:

TABLET

Composition:

FAMOTIDINE 40MG

Administration route:

ORAL

Units in package:

28

Prescription type:

Prescription

Therapeutic area:

HISTAMINE H2-ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0118722002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2013-07-15

Summary of Product characteristics

PRODUCT MONOGRAPH
PEPCID
®
Tablets
(famotidine tablets, USP)
20, 40 mg
Histamine H
2
Receptor Antagonist
MERCK CANADA INC.
16750 route Transcanadienne
Kirkland QC H9H 4M7
Canada
http//www.merck.ca
Date of Revision:
April 27, 2011
SUBMISSION CONTROL NUMBER. 145448
®
Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC. Used under license.
_© 2011, Merck Canada Inc., a subsidiary OF MERCK & CO., INC. All
rights reserved. _
_ _
1
PRODUCT MONOGRAPH
NAME OF DRUG
PEPCID
®
Tablets
(famotidine tablets, USP)
20, 40 mg
THERAPEUTIC CLASSIFICATION
Histamine H
2
Receptor Antagonist
CLINICAL PHARMACOLOGY
PEPCID
®
(famotidine) is a competitive inhibitor of histamine H
2
-receptors. The
primary clinically important pharmacologic activity of PEPCID
®
is inhibition of
gastric juice secretion. PEPCID
®
reduces the acid and pepsin content, as well as
the volume, of basal, nocturnal, and stimulated gastric secretion.
INDICATIONS AND CLINICAL USE
PEPCID
®
(famotidine) is indicated in the treatment of the following conditions
where a controlled reduction of gastric secretion is required:
1.
Treatment of acute duodenal ulcer;
2.
Prophylactic use in duodenal ulcer;
3.
Treatment of acute benign gastric ulcer;
4.
Treatment of pathological hypersecretory conditions (e.g.,
Zollinger-Ellison
Syndrome);
5.
Treatment of gastroesophageal reflux disease (GERD);
6.
Maintenance of remission of patients with GERD.
CONTRAINDICATIONS
Hypersensitivity to any component of this medication. Cross
sensitivity in this
class of compounds has been observed. Therefore, PEPCID
®
(famotidine)
should not be administered to patients with a history of
hypersensitivity to other
2
H
2
-receptor antagonists.
PRECAUTIONS
PATIENTS WITH MODERATE OR SEVERE RENAL INSUFFICIENCY
Since CNS adverse effects have been reported in patients with moderate
and
severe renal insufficiency, longer intervals between doses or lower
doses may
need to be used in patients with moderate (creatinine clearance 30 -
50 mL/min)
or severe (creatinine cleara