SUCRALFATE- sucralfate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Golden State Medical Supply, Inc.

INN (International Name):

Sucralfate

Composition:

Sucralfate 1 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Sucralfate 1-g tablets, USP are supplied in bottles of 100 and 500. White, oblong, bisected tablets debossed with "N" and "S1" on one side. Bottles of 90 ....... NDC 60429-297-90 Bottles of 100 ..... NDC 60429-297-01 Bottles of 360 ..... NDC 60429-297-36 Bottles of 500 ..... NDC 60429-297-05 Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature). Rx Only Manufactured and Distributed by: Nostrum Laboratories, Inc. Kansas City, MO 64120 Marketed/Packaged by: GSMS, Incorporated Camarillo, CA 93012 May 2013

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SUCRALFATE- SUCRALFATE TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
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SUCRALFATE
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 of 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 absorbs 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)
1. Sucralfate
1. 37/105 (35.2%)
1. 82/109 (75.2%)
1. Placebo
1. 26/106 (24.5%)
1. 68/10