SULCRATE SUSPENSION PLUS

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

SUCRALFATE

Предлага се от:

APTALIS PHARMA CANADA ULC

АТС код:

A02BX02

INN (Международно Name):

SUCRALFATE

дозиране:

1G

Лекарствена форма:

SUSPENSION

Композиция:

SUCRALFATE 1G

Начин на приложение:

ORAL

Броя в опаковка:

500ML

Вид предписание :

Prescription

Терапевтична област:

PROTECTANTS

Каталог на резюме:

Active ingredient group (AIG) number: 0114237003; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2004-02-02

Данни за продукта

Page 1
PRODUCT MONOGRAPH
PR
SULCRATE
®
(sucralfate)
1 g Tablets
PR
SULCRATE
® SUSPENSION PLUS
(sucralfate)
1 g/5 mL Oral Suspension
Gastro-Duodenal Cytoprotective Agent
APTALIS PHARMA CANADA INC.
Date of Revision:
597 Laurier Blvd.
September 12, 2013
Mont-St-Hilaire, Quebec
Canada J3H 6C4
CONTROL NO. 166321
Page 2
PRODUCT MONOGRAPH
PR
SULCRATE
®
(sucralfate)
1 g Tablets
PR
SULCRATE
® SUSPENSION PLUS
(sucralfate)
1 g/5 mL Oral Suspension
THERAPEUTIC CLASSIFICATION
Gastro-Duodenal Cytoprotective Agent
ACTIONS AND CLINICAL PHARMACOLOGY
SULCRATE
®
(sucralfate) exerts a generalized gastric cytoprotective effect by
enhancing natural
mucosal defence mechanisms. Studies conducted in animals and clinical
trials in humans have
demonstrated that sucralfate can protect the gastric mucosa against
various irritants such as
alcohol, acetylsalicylic acid (ASA), hydrochloric acid, sodium
hydroxide or sodium taurocholate.
In addition, sucralfate has been demonstrated to have a greater
affinity for ulcerated gastric or
duodenal mucosa than for non-ulcerated mucosa.
Sucralfate produces an adherent and cytoprotective barrier at the
ulcer site. This barrier
protects the ulcer site from the potential ulcerogenic properties of
acid, pepsin and bile.
Furthermore, sucralfate blocks acid diffusion across the sucralfate
protein barrier and also
complexes directly with pepsin and bile.
Page 3
The action of sucralfate is non-systemic as the drug is only minimally
absorbed from the
gastrointestinal tract. The minute amounts of the sulfated
disaccharide which are absorbed are
primarily excreted in the urine.
Each gram of sucralfate contains approximately 200 mg of aluminum. The
aluminum moiety
can dissociate at low pH and aluminum release in the stomach can be
expected; however,
aluminum is poorly absorbed from the intact gastrointestinal tract.
Following administration of
1 g of sucralfate (tablets or suspension) four times a day to
individuals with normal renal
function, approximately 0.001% to 0.017% of sucralfate's aluminum
content is