Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
SUCRALFATE (UNII: XX73205DH5) (SUCRALFATE - UNII:XX73205DH5)
Mylan Pharmaceuticals Inc.
ORAL
PRESCRIPTION DRUG
Sucralfate oral suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer. Sucralfate oral suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.
Sucralfate Oral Suspension is a pink oral suspension containing 1 g of sucralfate, USP per 10 mL. It is available as follows: NDC 0378-9205-35 bottle containing 420 mL of liquid suspension SHAKE WELL BEFORE USING. AVOID FREEZING. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Halo Pharmaceutical Canada, Inc. 17 800 Lapointe Mirabel, QC J7J 0W8 Canada C-11240-3 Revised: 1/2020 HLC:SUCROS:R2
Abbreviated New Drug Application
SUCRALFATE- SUCRALFATE SUSPENSION MYLAN PHARMACEUTICALS INC. ---------- SUCRALFATE ORAL SUSPENSION DESCRIPTION Sucralfate oral suspension contains sucralfate and sucralfate is an α-D-Glucopyranoside, ß-D-fructofuranosyl-, octakis(hydrogen sulfate), aluminum complex. x = 8 to 10, and y = 22 to 31 Sucralfate oral suspension for oral administration contains 1 g of sucralfate per 10 mL. Sucralfate oral suspension also contains: artificial cherry flavor, colloidal silicon dioxide, FD&C Red No. 40, glycerin, methylcellulose, methylparaben, microcrystalline cellulose, purified water, simethicone (which contains polydimethylsiloxane and silicon dioxide) and sorbitol solution. 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. 2. 3. _In vitro_, sucralfate adsorbs bile salts. 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. _In vitro_, a sucralfate-albumin film provides a barrier to diffusion of hydrogen ions. In human subjects, sucralfate given in doses recommended for ulcer therapy inhibits pepsin activity in gastric juice by 32%. 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 In a multicenter, double-blind, placebo-controlled study of sucralfate oral suspension, a dosage regimen of 1 gram (10 Lesen Sie das vollständige Dokument