SUCRALFATE- sucralfate tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Actavis Pharma, Inc.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Sucralfate tablets, USP 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.

Product samenvatting:

Sucralfate tablets, USP are available as white, capsule-shaped, biconvex, scored tablets, debossed “TEVA” on one side, and “22” and “10” on the scored side, containing 1 gram of sucralfate USP, packaged in bottles of 100 (NDC 0591-3892-01) and 500 (NDC 0591-3892-05) tablets. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Croatia By: Pliva Hrvatska d.o.o. Zagreb, Croatia Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. 08/16

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

SUCRALFATE- SUCRALFATE TABLET
ACTAVIS PHARMA, INC.
----------
SUCRALFATE TABLETS, USP
3892
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. 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
3
2
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