API

Drug classification

Aminosalicylates (5-aminosalicylic acid derivative).

Dosage form

Tablet

API strength per dosage

Mesalamine 400mg

Dose

Mechanism of action

Inhibits cyclooxygenase (COX) and lipoxygenase (LOX) enzymes, reducing prostaglandin and leukotriene synthesis; modulates nuclear factor kappa B (NF-κB) activity, decreasing pro-inflammatory cytokine production; scavenges reactive oxygen species, thereby attenuating mucosal inflammation in the colon.

Indications

Mild to moderate ulcerative colitis, maintenance of remission in ulcerative colitis, mild to moderate Crohn’s ileocolitis, maintenance of remission in Crohn’s disease.

Side effects

Pregnancy category

Category B

Precautions

Contraindications