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PRESCRIBING INFORMATION

FOR HEALTHCARE PROFESSIONALS

About APRISO

Bringing the benefits of APRISO to UC patients.

APRISO is a type of medication called a 5–aminosalicylic acid or 5–ASA.
5–ASAs are anti-inflammatory medications that reduce irritation of the colon. APRISO is a once-daily 5–ASA that features INTELLICOR™ delayed– and extended–release delivery — for the successful long-term (6 months) management of ulcerative colitis (UC).

Studies show APRISO provides extended relief from key ulcerative colitis (UC) symptoms for up to six months, including:

Rectal bleeding
Diarrhea
Flare-ups

Benefits include:

Protection. APRISO works throughout the colon.
Simplicity. APRISO is taken once a day.
Convenience. APRISO may be taken with or without meals.
Targeting. The delayed– and extended–release delivery releases mesalamine at a pH≥6, gradually distributing it throughout the colon.

Please see accompanying full Prescribing Information.

References: 1. APRISO [prescribing information]. Morrisville, NC: Salix Pharmaceuticals, Inc.; 2008. 2. Safdi A, Pieniaszek H, Grigston A, Forbes W. Multiple-dose pharmacokinetics of granulated mesalamine, a unique formulation providing delayed and extended release of 5-ASA. Poster presented at: American College of Gastroenterology Annual Scientific Meeting; October 3-8, 2008; Orlando, FL. 3. Data on file. Salix Pharmaceuticals, Inc.

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.