The mechanism of action of mesalamine (5-ASA) is not fully understood but appears to be a local anti-inflammatory effect on colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with ulcerative colitis, and it is possible that 5-ASA diminishes inflammation by blocking the production of arachidonic acid metabolites.

APRISO is an aminosalicylate indicated for the maintenance of remission of ulcerative colitis in adults.

The recommended dosage is 1.5 g (four 0.375 g capsules) once daily in the morning.

Most common adverse reactions (≥3%) are: headache, diarrhea, upper abdominal pain, nausea, and nasopharyngitis

Known or suspected hypersensitivity to salicylates, aminosalicylates, or any component of APRISO capsules.

• Renal Impairment: Assess renal function at the beginning of treatment and periodically during treatment. Evaluate the risks and benefits in patients with known renal impairment or taking nephrotoxic drugs; monitor renal function.
• Mesalamine-Induced Acute Intolerance Syndrome: Symptoms may be difficult to distinguish from an exacerbation of ulcerative colitis; monitor for worsening symptoms; discontinue treatment if acute intolerance syndrome is suspected. See package insert for complete information.