Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
SUCRALFATE (UNII: XX73205DH5) (SUCRALFATE - UNII:XX73205DH5)
A-S Medication Solutions
ORAL
PRESCRIPTION DRUG
Sucralfate tablets, USP are indicated in: Sucralfate tablets are contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.
Product: 50090-3019 NDC: 50090-3019-0 60 TABLET in a BOTTLE
Abbreviated New Drug Application
SUCRALFATE- SUCRALFATE TABLET A-S MEDICATION SOLUTIONS ---------- SUCRALFATE TABLETS, USP 3892 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. 2. 3. 4. These observations suggest that sucralfate’s antiulcer activity is the result of formation of an ulcer- 3 2 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%. _In vitro_, sucralfate adsorbs bile salts. 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%) Soma hati kamili