Olsalazine
- Atc Codes:A07EC03
- CAS Codes:6054-98-4#15722-48-2
- PHARMGKB ID:6054-98-4#15722-48-2
Table of contents
- Brand Names
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Caution and personalized dose adjustment in patients with the following genotypes
- Drug Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
- Special Considerations
Brand Names
Europe
Austria: Dipentum; Cyprus: Dipentum; Denmark: Dipentum; Finland: Dipentum; France: Dipentum; Germany: Dipentum; Hungary: Dipentum; Ireland: Dipentum; Italy: Dipentum; Netherlands: Dipentum; Portugal: Dipentum; Sweden: Dipentum; UK: Dipentum.
North America
Canada: Dipentum; USA: Dipentum.
Drug combinations
Chemistry
Olsalazine Sodium: C~14~H~8~N~2~Na~2~O~6~. Mw: 346.20. (1) Benzoic acid, 3,3′-azobis[6-hydroxy-, disodium salt; (2) C.I. Mordant Yellow 5, disodium salt; (3) Disodium 5,5′-azodisalicylate. CAS-6054-98-4; CAS-15722-48-2 (olsalazine)(1987).
Pharmacologic Category
Gastrointestinal Drugs; Anti-inflammatory Agents; 5-Aminosalicylic Acid Derivative. (ATC-Code: A07EC03).
Mechanism of action
A sodium salt of a salicylate compound that is effectively bioconverted by colonic bacteria to mesalamine (5-aminosalicylic acid, 5-ASA), active component of olsalazine. Mechanism of action of mesalamine unknown. Thought to modulate local chemical mediators of inflammatory response, especially leukotrienes, and also postulated to be a free radical scavenger or inhibitor of tumor necrosis factor. Exerts local (not systemic) anti-inflammatory effects in GI tract. May reduce inflammation in colon by inhibiting cyclooxygenase and lipoxygenase, which catalyze formation of prostaglandin precursors (endoperoxides) and of leukotrienes and hydroxyeicosatetraenoic acids, respectively, from arachidonic acid and/or its metabolites.
Therapeutic use
Maintenance of remission of ulcerative colitis in patients intolerant to sulfasalazine.
Pregnancy and lactiation implications
Animal studies demonstrated fetal toxicities. There are no well-controlled studies in pregnant women. Use during pregnancy only if clearly necessary. Enters breast milk (not recommended in nursing women). Diarrhea reported in breast-fed infants whose mothers took olsalazine.
Unlabeled use
Contraindications
Hypersensitivity to olsalazine, salicylates, or any component of the formulation.
Warnings and precautions
May exacerbate symptoms of colitis. A common adverse effect is diarrhea. Use with caution in severe allergies or asthma. Use with caution in hepatic/renal impairment. Use with caution in the elderly. May produce increased ALT, AST, GGT, LDH, alkaline phosphatase, and bilirubin.