Land: Canada
Sprog: engelsk
Kilde: Health Canada
MESALAZINE
TEVA CANADA LIMITED
A07EC02
MESALAZINE
400MG
TABLET (ENTERIC-COATED)
MESALAZINE 400MG
ORAL
100/500
Prescription
ANTI-INFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0116808001; AHFS:
CANCELLED PRE MARKET
2015-08-06
PRODUCT MONOGRAPH PR NTP-5-AMINOSALICYLIC ACID (5-aminosalicylic acid) 400 mg Enteric Coated Tablets Lower Gastrointestinal, Anti-inflammatory Teva Canada Limited 30 Novopharm Court Toronto, Ontario Canada, M1B 2K9 Submission Control No: 165695 Date of Preparation: June 21, 2013 2 PRODUCT MONOGRAPH PR NTP-5-AMINOSALICYLIC ACID (5-aminosalicylic acid) 400 mg Enteric Coated Tablets THERAPEUTIC CLASSIFICATION Lower Gastrointestinal, Anti-inflammatory ACTION AND CLINICAL PHARMACOLOGY NTP-5-AMINOSALICYLIC ACID (5-aminosalicylic acid) is thought to be the major active component of sulphasalazine for the treatment of inflammatory bowel disease. Its mechanism of action is not fully elucidated, however, evidence suggests that it has a topical anti-inflammatory effect on the colon, where it may inhibit prostaglandin and leukotriene synthesis. NTP-5-AMINOSALICYLIC ACID tablets have an acrylic based resin coating, which does not allow the drug to be released below pH 5.5. Thus the coating delays release of the 5- aminosalicylic acid until it reaches the terminal ileum and colon. Once released in the colon, 5- aminosalicylic acid is minimally absorbed and plasma levels are similar to those found following rectal administration. The absorbed drug is rapidly acetylated through the gut mucosal wall and by the liver. The drug is excreted mainly by the kidney as N-acetyl-5-aminosalicylic acid. A randomized, double-blind, parallel, multi-center clinical study was conducted in 201 patients diagnosed with ulcerative colitis of mild to moderate intensity to compare the efficacy and safety of two oral formulations of 5-aminosalicylic 400 mg enteric coated tablet products. The study demonstrated therapeutic equivalence of NTP-5-AMINOSALICYLIC ACID 400 mg tablets and ASACOL ® 400 mg tablets when administered at a daily dose of 3.2 gm for up to 8 weeks. Both treatments were well tolerated and there was no evidence of a difference between the two treatments for intercurrent events in nature, severity, or frequency. INDICATIONS NTP-5-AMINO Læs hele dokumentet