SUCRALFATE- sucralfate tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

PD-Rx Pharmaceuticals, Inc.

DCI (Dénomination commune internationale):

SUCRALFATE

Composition:

SUCRALFATE 1 g

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Sucralfate is 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 is contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.

Descriptif du produit:

Sucralfate 1-g tablets are supplied in bottles of 40. Light blue, scored, oblong tablets are engraved WATSON 780 on one side and are blank with bisect on the other. Rx Only

Statut de autorisation:

New Drug Application Authorized Generic

Résumé des caractéristiques du produit

SUCRALFATE- SUCRALFATE TABLET
PD-RX PHARMACEUTICALS, INC.
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SUCRALFATE TABLETS
DESCRIPTION
Sucralfate Tablets contain sucralfate and sucralfate is an
α-D-glucopyranoside, β-D-fructofuranosyl-,
octakis-(hydrogen sulfate), aluminum complex.
Tablets for oral administration contain 1 g of sucralfate.
Also contain:
FD&C Blue #1 Lake, magnesium stearate, microcrystalline cellulose, and
starch. 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 ulcer-
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 (63.6