Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
Sucralfate (UNII: XX73205DH5) (Sucralfate - UNII:XX73205DH5)
Cardinal Health
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 supplied as follows: NDC 66689-790-01: 10 mL unit dose cup NDC 66689-790-50: Case contains 50 unit dose cups of 10 mL (NDC 66689-790-01), packaged in 5 trays of 10 unit dose cups each. SHAKE WELL BEFORE USING. AVOID FREEZING. Store at 20°-25°C (68°-77°F) [See USP CONTROLLED RM TEMP]
New Drug Application
SUCRALFATE- SUCRALFATE SUSPENSION CARDINAL HEALTH ---------- SUCRALFATE SUSPENSION 1 G/ 10 ML Rx only DESCRIPTION Sucralfate Suspension contains sucralfate and sucralfate is an α-D-glucopyranoside, β- Dfructofuranosyl-, octakis (hydrogen sulfate), aluminum complex. Sucralfate Suspension for oral administration contains 1 gram of sucralfate per 10 mL. Sucralfate Suspension also contains: colloidal silicon dioxide NF, FD&C Red #40, flavor, glycerin USP, methylcellulose 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. 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. 3. 4. 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 Suspension, a dosage regiment of 1 g (10 mL) four times daily was demonstrated to be superior to placebo in ulcer healing. RESULTS FROM CLINICAL TRIALS HEALING RATES FOR ACUTE DUODENAL ULCER TREATMENT N WEEK 2 HEALING RATES WEEK 4 HEALING RATES WEEK 8 HEALING RATES * † ‡ Sucralfate Suspension 145 23( Citiți documentul complet