SUCRALFATE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

SUCRALFATE (UNII: XX73205DH5) (SUCRALFATE - UNII:XX73205DH5)

Commercializzato da:

Cardinal Health

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Sucralfate tablets, USP are indicated in: Sucralfate tablets are contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.

Dettagli prodotto:

NDC: 55154-8133-0 Overbagged with 10 tablets per bag Distributed By: Cardinal Health Dublin, OH 43017 L55213640719

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

SUCRALFATE- SUCRALFATE TABLET
CARDINAL HEALTH
----------
SUCRALFATE TABLETS, USP
2210
RX ONLY
DESCRIPTION
Sucralfate, USP is an α-D-glucopyranoside, β-D-fructofuranosyl-,
octakis(hydrogen sulfate), aluminum
complex.
R = SO Al(OH)
Tablets for oral administration contain 1 g of sucralfate, USP and the
following inactive ingredients:
corn starch, magnesium stearate, and microcrystalline cellulose.
THERAPEUTIC CATEGORY
antiulcer
CLINICAL PHARMACOLOGY
Sucralfate is only minimally absorbed from the gastrointestinal tract.
The small amounts of the sulfated
disaccharide that are absorbed are excreted primarily in the urine.
Although the mechanism of sucralfate’s ability to accelerate healing
of duodenal ulcers remains to be
fully defined, it is known that it exerts its effect through a local,
rather than systemic, action. The
following observations also appear pertinent:
1.
2.
3.
4.
These observations suggest that sucralfate’s antiulcer activity is
the result of formation of an ulcer-
3
2
Studies in human subjects and with animal models of ulcer disease have
shown that sucralfate
forms an ulcer-adherent complex with proteinaceous exudate at the
ulcer site.
_In vitro_, a sucralfate-albumin film provides a barrier to diffusion
of hydrogen ions.
In human subjects, sucralfate given in doses recommended for ulcer
therapy inhibits pepsin
activity in gastric juice by 32%.
_In vitro_, sucralfate adsorbs bile salts.
adherent complex that covers the ulcer site and protects it against
further attack by acid, pepsin, and bile
salts. There are approximately 14 to 16 mEq of acid-neutralizing
capacity per 1 g dose of sucralfate.
CLINICAL TRIALS
ACUTE DUODENAL ULCER
Over 600 patients have participated in well-controlled clinical trials
worldwide. Multicenter trials
conducted in the United States, both of them placebo-controlled
studies with endoscopic evaluation at 2
and 4 weeks, showed:
STUDY 1
TREATMENT GROUPS
ULCER HEALING/NO. PATIENTS
2 WK
4 WK (OVERALL)
Sucralfate
37/105 (35.2%)
82/109 (75.2%)
Placebo
26/106 (24.5%)
68/107 (6