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Study Data Show Asacol(R) (Mesalamine) is Effective in Treating All Extents of Ulcerative Colitis Including Isolated Proctitis
Date:12/5/2007

uring a flare, in which the rectum or colon become inflamed, people experience symptoms such as diarrhea, rectal bleeding, abdominal cramping and an urgent need to go to the bathroom. Flares can vary in duration and intensity. While UC is a lifelong condition, medication may help control flares.

UC affects people of all ages, but is often diagnosed during early adulthood. The causes of this condition are unknown, but may involve heredity, infection or the immune system.

About Asacol(R) (mesalamine) Delayed-Release Tablets 400 mg

Asacol is a delayed-release oral mesalamine tablet indicated for the treatment of mildly to moderately active UC (the indicated dosage is two 400 mg tablets to be taken three times a day for six weeks) and for the maintenance of remission of UC (the indicated dosage is 1.6 g/day in divided doses). Asacol is a non-steroidal medication that belongs to the class of agents known as 5-aminosalicylic acids (5-ASAs) and is the number one most prescribed oral 5-ASA therapy for UC, with more than 20 million prescriptions written since its introduction in 1992(3,4).

Asacol was well-tolerated in clinical studies. Overall, the incidence of adverse events with Asacol was comparable to placebo. In pivotal clinical studies of mildly to moderately active UC, the most frequent adverse events reported for Asacol and placebo, respectively, were headache (35 percent vs. 36 percent), abdominal pain (18 percent vs. 14 percent), eructation (16 percent vs. 15 percent), pain (14 percent vs. 8 percent) and nausea (13 percent vs. 15 percent); for the maintenance of remission of UC, the most frequent adverse events were headache (50 percent vs. 50 percent), rhinitis (42 percent vs. 36 percent), diarrhea (35 percent vs. 50 percent), abdominal pain (32 percent vs. 44 percent) and flatulence (24 percent vs. 30 percent).

Asacol is contraindicated in patients with hypersensitivity to salicylates. Caution should be exercised when using Asac
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SOURCE Procter & Gamble Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
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