TEVA-SUCRALFATE TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

SUCRALFATE

Disponível em:

TEVA CANADA LIMITED

Código ATC:

A02BX02

DCI (Denominação Comum Internacional):

SUCRALFATE

Dosagem:

1G

Forma farmacêutica:

TABLET

Composição:

SUCRALFATE 1G

Via de administração:

ORAL

Unidades em pacote:

100/500

Tipo de prescrição:

Prescription

Área terapêutica:

PROTECTANTS

Resumo do produto:

Active ingredient group (AIG) number: 0114237002; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2011-06-06

Características técnicas

PRODUCT MONOGRAPH
PR
TEVA-SUCRALFATE
(Sucralfate Tablets, USP)
1g
GASTRO-DUODENAL CYTOPROTECTIVE AGENT
Teva Canada Limited
DATE OF PREPARATION:
30 Novopharm Court
June 9, 2011
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Submission Control #: 147748
2
PRODUCT MONOGRAPH
PR
TEVA-SUCRALFATE
(Sucralfate Tablets, USP)
1g
THERAPEUTIC CLASSIFICATION
Gastro-Duodenal Cytoprotective Agent
ACTIONS AND CLINICAL PHARMACOLOGY
TEVA-SUCRALFATE (sucralfate) enhances the natural mucosal defense
mechanisms,
thereby producing a generalized gastric cytoprotective effect. The
ability of sucralfate to
protect the gastric mucosa against various irritants, such as alcohol,
ASA, hydrochloric
acid, sodium hydroxide or sodium taurocholate, has been demonstrated
in animal studies
and in clinical trials in humans. It has also been shown that
sucralfate has a greater
affinity for ulcerated gastric or duodenal mucosa than for
non-ulcerated mucosa.
An adherent cytoprotective barrier is produced by sucralfate at the
site of the ulcer,
thereby protecting it from the potential ulcerogenic properties of
acid, pepsin and bile.
Acid diffusion across the sucralfate-protein barrier is blocked by
sucralfate. Evidence
suggests that sucralfate also complexes directly with pepsin and bile.
The mode of action of sucralfate is non-systemic; only minimal amounts
of the drug are
absorbed from the gastrointestinal tract following oral
administration. The minute
amounts of sucralfate which are absorbed are eliminated primarily in
the urine.
Each gram of sucralfate contains approximately 200 mg of aluminum. At
low pH the
aluminum moiety can dissociate and aluminum release can be expected;
however,
aluminum is poorly absorbed from the intact gastrointestinal tract. In
patients with
normal renal function, administration of 1g of sucralfate four times a
day resulted in
approximately 0.001% to 0.017% of the aluminum content of sucralfate
to be absorbed
and excreted in the urine. This is equivalent to an aluminum load of
between 0.008 mg
and 0.136 mg following a