Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
SUCRALFATE (UNII: XX73205DH5) (SUCRALFATE - UNII:XX73205DH5)
Amneal Pharmaceuticals NY LLC
ORAL
PRESCRIPTION DRUG
Sucralfate tablets 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 1 g are available as light pink, oblong tablets debossed with “A56” on one side and plain on the other side with a score line. They are supplied as follows: Bottles of 100 with child-resistant closure: NDC 69238-1656-1 Bottles of 500 with child-resistant closure: NDC 69238-1656-5 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Rx Only Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 05-2021-01 www.amneal.com
Abbreviated New Drug Application
SUCRALFATE- SUCRALFATE TABLET AMNEAL PHARMACEUTICALS NY LLC ---------- SUCRALFATE TABLETS, USP DESCRIPTION Sucralfate tablets, USP contain sucralfate, USP and sucralfate, USP is an α-D- glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. Tablets for oral administration contain 1 g of sucralfate, USP. Also contain: D&C Red #30 Lake, 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% Lugege kogu dokumenti