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Salix Pharmaceuticals, Inc. Internet Privacy Statement

Salix Pharmaceuticals, Inc. ("Salix"), respects the privacy of visitors to our site (the "Site") and is committed to maintaining your privacy when you visit. Salix will only collect your personally identifiable information when you voluntarily provide it to us. From time to time, we may refer to this information to better understand your needs and how we can improve our services. We may use this information to contact you; however we will not sell the personally identifiable information you provide to us at this Web site to any third parties for their own use.

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Created 7/02

Revised 3/10

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.