PEPCID AC TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

FAMOTIDINE

Pieejams no:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

ATĶ kods:

A02BA03

SNN (starptautisko nepatentēto nosaukumu):

FAMOTIDINE

Deva:

10MG

Zāļu forma:

TABLET

Kompozīcija:

FAMOTIDINE 10MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

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

Receptes veids:

OTC

Ārstniecības joma:

HISTAMINE H2-ANTAGONISTS

Produktu pārskats:

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

Autorizācija statuss:

CANCELLED PRE MARKET

Autorizācija datums:

2016-01-22

Produkta apraksts

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