SUCRALFATE tablet
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
13-02-2024
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Active ingredient:
SUCRALFATE (UNII: XX73205DH5) (SUCRALFATE - UNII:XX73205DH5)
Available from:
REMEDYREPACK 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 are contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.
Product summary:
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 NDC: 70518-0775-00 NDC: 70518-0775-01 NDC: 70518-0775-02 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 60 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Authorization status:
Abbreviated New Drug Application
Summary of Product characteristics
SUCRALFATE- SUCRALFATE TABLET
REMEDYREPACK INC.
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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. 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.
3
2
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%)
68/10
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