Land: Kanada
Språk: engelska
Källa: Health Canada
SUCRALFATE
APTALIS PHARMA CANADA ULC
A02BX02
SUCRALFATE
1G
TABLET
SUCRALFATE 1G
ORAL
100
Prescription
PROTECTANTS
Active ingredient group (AIG) number: 0114237002; AHFS:
APPROVED
2004-02-02
Page 1 PRODUCT MONOGRAPH PR SULCRATE ® (sucralfate) 1 g Tablets PR SULCRATE ® SUSPENSION PLUS (sucralfate) 1 g/5 mL Oral Suspension Gastro-Duodenal Cytoprotective Agent APTALIS PHARMA CANADA INC. Date of Revision: 597 Laurier Blvd. September 12, 2013 Mont-St-Hilaire, Quebec Canada J3H 6C4 CONTROL NO. 166321 Page 2 PRODUCT MONOGRAPH PR SULCRATE ® (sucralfate) 1 g Tablets PR SULCRATE ® SUSPENSION PLUS (sucralfate) 1 g/5 mL Oral Suspension THERAPEUTIC CLASSIFICATION Gastro-Duodenal Cytoprotective Agent ACTIONS AND CLINICAL PHARMACOLOGY SULCRATE ® (sucralfate) exerts a generalized gastric cytoprotective effect by enhancing natural mucosal defence mechanisms. Studies conducted in animals and clinical trials in humans have demonstrated that sucralfate can protect the gastric mucosa against various irritants such as alcohol, acetylsalicylic acid (ASA), hydrochloric acid, sodium hydroxide or sodium taurocholate. In addition, sucralfate has been demonstrated to have a greater affinity for ulcerated gastric or duodenal mucosa than for non-ulcerated mucosa. Sucralfate produces an adherent and cytoprotective barrier at the ulcer site. This barrier protects the ulcer site from the potential ulcerogenic properties of acid, pepsin and bile. Furthermore, sucralfate blocks acid diffusion across the sucralfate protein barrier and also complexes directly with pepsin and bile. Page 3 The action of sucralfate is non-systemic as the drug is only minimally absorbed from the gastrointestinal tract. The minute amounts of the sulfated disaccharide which are absorbed are primarily excreted in the urine. Each gram of sucralfate contains approximately 200 mg of aluminum. The aluminum moiety can dissociate at low pH and aluminum release in the stomach can be expected; however, aluminum is poorly absorbed from the intact gastrointestinal tract. Following administration of 1 g of sucralfate (tablets or suspension) four times a day to individuals with normal renal function, approximately 0.001% to 0.017% of sucralfate's aluminum content is Läs hela dokumentet