Land: Kanada
Språk: engelska
Källa: Health Canada
MESALAZINE
AXCAN PHARMA INC
A07EC02
MESALAZINE
250MG
SUPPOSITORY
MESALAZINE 250MG
RECTAL
30
Prescription
ANTI-INFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0116808003; AHFS:
CANCELLED POST MARKET
2006-09-12
PRODUCT MONOGRAPH Pr SALOFALK7 Mesalamine (5-aminosalicylic acid) Suppositories, 250, 500 and 1000 mg LOWER GASTROINTESTINAL TRACT ANTI-INFLAMMATORY AXCAN PHARMA Date of Preparation: 597, Laurier Boulevard July 15, 1994 Mont St. Hilaire (Québec) CANADA J3H 4X8 Date of Revision: September 10, 2004 Control #: 092435 1 NAME OF DRUG Pr SALOFALK 7 Mesalamine (5-aminosalicylic acid) Suppositories, 250, 500 and 1000 mg THERAPEUTIC CLASSIFICATION Lower Gastrointestinal Tract Anti-Inflammatory ACTIONS AND CLINICAL PHARMACOLOGY SALOFALK7 suppositories contain mesalamine (5-aminosalicylic acid, 5-ASA), the active principle of the prodrug sulfasalazine (SAS) 1, 5, 6, 14 . Although its mode of action is not clear, 5-ASA is thought to affect the inflammatory process through its ability to inhibit prostaglandin synthesis 37, 38 , interfere with leukotriene synthesis and consequent leukocyte migration 16-18 as well as act as a potent scavenger of free radicals 50 . Regardless of the mode of action, 5-ASA appears to be active only topically. SALOFALK7 suppositories are inserted into the rectum thus providing topical application to the affected area. Rectal administration, either as 250, 500 or 1000 mg suppositories or as 4g/60g or 2g/60g rectal suspension of mesalamine (5-aminosalicylic acid) allows for direct targeting of free 5-ASA to the sites of inflammation along the mucosal lumen of the rectum, sigmoid and distal large bowel. Systemic absorption of rectally administered 5-ASA is low as shown by urinary and rectal recoveries which range from 5 to 35% of the amount given 19,24,33 . Rectally administered 5-ASA with minimal systemic absorption thus acts locally on the recto-sigmoidal colon. Plasma concentrations are low, peaking at about 10 µ g/mL for daily rectal dosing of 4 grams 25 and are negligible 24 hours after administration 26 . 5-ASA and its major metabolite N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA) are short 2 lived in the serum with a half-life reported at between 5-10 hours 42 and 24 hours 29, 43, 47 . N-acetyl Läs hela dokumentet