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PRESCRIBING INFORMATION
FOR HEALTHCARE PROFESSIONALS

What is UC?

Understanding UC

Ulcerative colitis (UC) is a chronic disease that causes inflammation and sores in the large intestine (colon) and rectum. The ulcers that form on the innermost lining of the colon and rectum make the colon empty frequently, leading to symptoms such as:

  • Diarrhea
  • Rectal bleeding
  • Stomach pain
  • Cramping
  • Frequent, urgent need to use the bathroom
  • Fatigue

UC affects people at any age, but most are diagnosed in their 20s or 30s. With UC, months can go by without symptoms. These stretches of time are known as remission. However, symptoms can return, and this is called a flare.

Researchers don't know UC's exact cause, but the condition involves an autoimmune response in which the body's defenses react abnormally to substances present in the colon — even if they are beneficial. Currently, there is no cure for UC, but effective treatments are available to reduce symptoms and put patients into remission.

APRISO is a locally acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis in patients 18 years and older. APRISO is contraindicated in patients with hypersensitivity to salicylates or aminosalicylates (sulfasalazine) or to any of the components of APRISO capsules. It is recommended that patients have an evaluation of renal function prior to initiation of APRISO therapy and periodically while on therapy. Exercise caution when using APRISO in patients with known renal dysfunction or a history of renal disease. There have been reports of hepatic failure in patients with pre–existing liver disease who have been administered mesalamine. Caution should be exercised when administering APRISO to patients with liver disease. The recommended dose of APRISO is four 0.375–g capsules once daily in the morning (1.5 g/day) with or without food. Because dissolution of the coating of APRISO granules depends on pH, APRISO should not be coadministered with antacids. Patients with phenylketonuria should be aware that APRISO contains aspartame, equivalent to 2.24 mg of phenylalanine per day. In 2 well–controlled clinical trials, the most common treatment–related adverse events occurring in at least 3% of adult patients taking 1.5 g/day of APRISO were headache (11% vs 8% for placebo), diarrhea (8% vs 7% for placebo), upper abdominal pain (5% vs 3% for placebo), nausea (4% vs 3% for placebo), nasopharyngitis (4% vs 3% for placebo), influenza and influenza–like illness (4% vs 4% for placebo), and sinusitis (3% vs 3% for placebo).

For complete Prescribing Information, please click here.

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