What is ulcerative colitis?
Understanding UC
Ulcerative colitis (UC) is a chronic disease that causes inflammation and sores in the large intestine (colon) and rectum. Ulcers form on the innermost lining of the colon and rectum, and inflammation in the colon makes the colon empty frequently, leading to symptoms such as
- Diarrhea
- Rectal bleeding
- Abdominal pain
- Abdominal cramping
- Frequent, urgent need to have a bowel movement
- Fatigue
Ulcerative colitis 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 do not know the exact cause of UC, 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.
IMPORTANT SAFETY INFORMATION
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. Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of inflammatory bowel disease. Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, and rash. If acute intolerance syndrome is suspected, promptly discontinue treatment with APRISO. 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 and at a rate greater than placebo 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).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch/ or call
1-800-FDA-1088.
Complete Prescribing Information
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Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
E-mail: Salix@medcomsol.com