SUCRALFATE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Bryant Ranch Prepack

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Sucralfate tablets are indicated in: - Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination. - Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. Sucralfate tablets are contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.

Descriptif du produit:

Sucralfate 1 g tablets, USP White, oblong, bisected tablets debossed with "N'' and ''S1'' on one side. NDC: 72162-2264-1: 100 TABLETs in a BOTTLE, PLASTIC NDC: 72162-2264-5: 500 TABLETs in a BOTTLE, PLASTIC Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

SUCRALFATE- SUCRALFATE TABLET
BRYANT RANCH PREPACK
----------
SUCRALFATE TABLETS, USP1 GRAM
DESCRIPTION
Sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-,
octakis-(hydrogen sulfate), aluminum complex. It
has the following structural formula:
Tablets for oral administration contain 1 g of sucralfate, USP.
Also contain: povidone, magnesium stearate, and colloidal silicon
dioxide.
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. 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.
2. _ In vitro_, a sucralfate-albumin film provides a barrier to
diffusion of hydrogen ions.
3. In human subjects, sucralfate given in doses recommended for ulcer
therapy inhibits pepsin activity in
gastric juice by 32%.
4. _ In vitro_, sucralfate adsorbs bile salts.
These observations suggest that sucralfate’s antiulcer activity is
the result of formation of an ulceradherent
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 (63.6%)
STU