Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
SUCRALFATE (UNII: XX73205DH5) (SUCRALFATE - UNII:XX73205DH5)
Physicians Total Care, Inc.
SUCRALFATE
SUCRALFATE 1 g in 10 mL
ORAL
PRESCRIPTION DRUG
Sucralfate Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer. There are no known contraindications to the use of sucralfate.
Sucralfate Suspension 1 g/10 mL is a pink suspension. NDC 54868-5299-1 Ten (10) 10 mL oral liquid unit dose cups per tray. Ten (10) trays per shipper. NDC 54868-5299-0 Ten (10) 10 mL oral liquid unit dose cups per tray. Three (3) trays per shipper. SHAKE WELL BEFORE USING Store at controlled room temperature 20-25°C (68-77°F) [see USP]). Avoid freezing.
New Drug Application
SUCRALFATE - SUCRALFATE SUSPENSION PHYSICIANS TOTAL CARE, INC. ---------- SUCRALFATE SUSPENSION 1 G/10 ML R ONLY DESCRIPTION Sucralfate Suspension contains sucralfate and sucralfate is an _α-_D-glucopyranoside β_-_D-fructo- furanosyl-, octakis-(hydrogen sulfate), aluminum complex. Sucralfate Suspension for oral administration contains 1 g of sucralfate per 10 mL. Sucralfate Suspension also contains: colloidal silicon dioxide NF, FD&C Red #40, flavor, glycerin USP, methyl- cellulose USP, methylparaben NF, microcrystalline cellulose NF, purified water USP, simethicone USP, and sorbitol solution USP. 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 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. X CLINICAL TRIALS In a multicenter, double-blind, placebo-controlled study of Sucralfate Suspension, a dosage regimen of 1 g (10 mL) four times daily was demonstrated to be superior to placebo in ulcer healing. R Lestu allt skjalið