Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
SUCRALFATE (UNII: XX73205DH5) (SUCRALFATE - UNII:XX73205DH5)
Major Pharmaceuticals
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. WARNINGS Fatal complications, including pulmonary and cerebral emboli have occurred with inappropriate intravenous administration of Sucralfate Oral Suspension. Administer Sucralfate Oral Suspension only by the oral route. Do not administer intravenously.
Sucralfate Oral Suspension, 1 g/10 mL is a pink suspension with cherry flavor supplied in the following dosage forms: NDC 0904-7269-66: 10 mL unit dose cup. Case contains 40 unit-dose cups of 10 mL (NDC 0904-7269-18), packaged in 4 trays of 10 unit-dose cups each. SHAKE WELL BEFORE USING. AVOID FREEZING. Store at controlled room temperature 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
Abbreviated New Drug Application
SUCRALFATE- SUCRALFATE SUSPENSION MAJOR PHARMACEUTICALS ---------- SUCRALFATE- SUCRALFATE SUSPENSION MAJOR® PHARMACEUTICALS RX ONLY DESCRIPTION SUCRALFATE ORAL SUSPENSION CONTAINS SUCRALFATE AND SUCRALFATE IS AN Α-D- GLUCOPYRANOSIDE, Β-D-FRUCTOFURANOSYL-, OCTAKIS-(HYDROGEN SULFATE), ALUMINUM COMPLEX. 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%. 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 In a multicenter, double-blind, placebo-controlled study of Sucralfate Oral Suspension, a dosage regimen of 1 gram (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 Oral Suspension 14523 (16%)* 66 (46%)† 95 (66%)‡ Placebo 14710 (7%) 39 (27%) 58 (39%) *P=0.016 †P=0.001 ‡P=0.0001 Equivalence of sucralfate oral suspension to sucralfate Belgenin tamamını okuyun