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

DELZICOL is an aminosalicylate indicated for:
• Treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.
• Maintenance of remission of ulcerative colitis in adults.

Important Administration Instructions:
• Two DELZICOL 400 mg capsules have not been shown to be interchangeable or substitutable with one mesalamine delayed-release 800 mg tablet.
• Evaluate renal function prior to initiation of DELZICOL.
• Take with or without food.
•Swallow the capsules whole; do not cut, break, crush, or chew.
• For patients who are unable to swallow the capsules, the capsules can be opened and the inner tablets swallowed.
• Drink an adequate amount of fluids. Treatment of Mildly to Moderately Active Ulcerative Colitis: 
• Adults: 800 mg (two 400 mg capsules) three times daily for 6 weeks
• Pediatric Patients 5 years or older: See the weight-based dosing table in the full prescribing information; twice daily dosing for 6 weeks. Maintenance of Remission of Ulcerative Colitis:
• Adults: 1.6 grams (four 400 mg capsules) daily, in two to four divided doses.

The most common adverse reactions (≥5%) are:
• Adults: eructation, abdominal pain, constipation, dizziness, rhinitis, back pain, and rash.
• Pediatrics: nasopharyngitis, headache, abdominal pain, dizziness, sinusitis, rash, cough and diarrhea.

Known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of DELZICOL capsules.

Renal Impairment: Assess renal function at the beginning of treatment and periodically during treatment. Evaluate the risks and benefits of using DELZICOL 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 ulcerative colitis exacerbation; monitor for worsening symptoms while on treatment; discontinue treatment, if acute intolerance syndrome is suspected.
• Hypersensitivity Reactions, including myocarditis and pericarditis: Evaluate patients immediately and discontinue DELZICOL, if a hypersensitivity reaction is suspected.
• Hepatic Failure: Evaluate the risks and benefits of using DELZICOL in patients with known liver impairment. See package insert for complete information.