Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
SUCRALFATE (UNII: XX73205DH5) (SUCRALFATE - UNII:XX73205DH5)
Mylan Institutional Inc.
SUCRALFATE
SUCRALFATE 1 g
ORAL
PRESCRIPTION DRUG
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.
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. They are available as follows: NDC 51079-753-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured in Croatia by: PLIVA HRVATSKA d.o.o. Zagreb, Croatia Manufactured for: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-11970 R2 5/20
Abbreviated New Drug Application
SUCRALFATE- SUCRALFATE TABLET MYLAN INSTITUTIONAL INC. ---------- SUCRALFATE TABLETS, USP 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/ Læs hele dokumentet