PEPCID I.V. 10MG/ML SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

FAMOTIDINE

Доступна з:

MERCK CANADA INC

Код атс:

A02BA03

ІПН (Міжнародна Ім'я):

FAMOTIDINE

Дозування:

10MG

Фармацевтична форма:

SOLUTION

Склад:

FAMOTIDINE 10MG

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

2ML

Тип рецепту:

Prescription

Терапевтична области:

HISTAMINE H2-ANTAGONISTS

Огляд продуктів:

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

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2006-11-10

Характеристики продукта

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