PEPCID I.V. 10MG/ML SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

FAMOTIDINE

Disponibil de la:

MERCK CANADA INC

Codul ATC:

A02BA03

INN (nume internaţional):

FAMOTIDINE

Dozare:

10MG

Forma farmaceutică:

SOLUTION

Compoziție:

FAMOTIDINE 10MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

2ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

HISTAMINE H2-ANTAGONISTS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2006-11-10

Caracteristicilor produsului

PRODUCT MONOGRAPH
PEPCID
®
Tablets
(famotidine tablets, USP)
20, 40 mg
PEPCID
®
for Oral Suspension
(famotidine for oral suspension)
8 mg/mL
PEPCID
®
I.V.
(famotidine injection)
10 mg/mL
Histamine H
2
Receptor Antagonist
Date of Revision:
August 17, 2007
MERCK FROSST CANADA LTD.
16711 Trans Canada Highway
Kirkland QC H9H 3L1
Canada
www.merckfrosst.com
Control No. 114477
PEPCID
®
is a Registered Trademark of Merck & Co., Inc.
Used under license.
1
PRODUCT MONOGRAPH
NAME OF DRUG
PEPCID
®
Tablets
(famotidine tablets, USP)
20, 40 mg
PEPCID
®
for Oral Suspension
(famotidine for oral suspension)
8 mg/mL
PEPCID
®
I.V.
(famotidine injection)
10 mg/mL
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);
2
6.
Maintenance of remission of patients with GERD.
PEPCID
®
I.V.
is
indicated
in
some
hospitalized
patients
with
pathological
hypersecretory conditions or intractable ulcers, or as an alternative
to the oral
dosage
form
for
short-term
use
in
patients
who
are
unable
to
take
oral
medication.
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
H
2