ASACOL® (mesalamine) Delayed-Release Tablets
Asacol is indicated for the treatment of mildly to moderately active ulcerative colitis (the indicated dosage is two 400 mg tablets three times a day for 6 weeks) and for the maintenance of remission of ulcerative colitis (the indicated dosage is 1.6 g/day in divided doses).
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% vs. 36%), abdominal pain (18% vs. 14%), and eructation (16% vs. 15%); for the maintenance of remission of UC, the most frequent adverse events reported were headache (50% vs. 50%), rhinitis (42% vs. 36%), and diarrhea (35% vs. 50%).
Asacol is contraindicated in patients with a hypersensitivity to salicylates. Caution should be exercised when using Asacol in patients with known renal dysfunction or history of renal disease. It is recommended that all patients have an evaluation of renal function prior to initiation of Asacol tablets and periodically while on Asacol therapy. As with other mesalamine-containing products, serious adverse events may occur with Asacol.
- Asacol is proven effective in mildly to moderately active UC
Patients on Asacol experienced improvement in stool frequency and in rectal bleeding at 3 weeks of therapy.1
In a six-week clinical study of mildly to moderately active UC, Asacol was evaluated for its ability to reduce UC symptoms, including rectal bleeding, number of bowel movements, and abdominal pain. At 3 weeks of therapy, rectal bleeding and number of bowel movements were significantly reduced.1
- Asacol is proven effective for the maintenance of remission.
70% of patients on Asacol remained in remission at 6 months.2
- In clinical studies,1,2 Asacol was well tolerated:
- Patients who received either the active or maintenance dose of Asacol had discontinuation rates due to adverse events comparable to placebo.
- The overall incidence of adverse events for Asacol was comparable to placebo.
- Asacol has an excellent safety profile2,3
Asacol has an excellent safety profile based on the pivotal six-month maintenance study.2
Results included:
- No clinically significant trends in renal laboratory profiles, including BUN, serum creatinine, creatinine clearance, or other markers than may be reflective of early renal damage.*
- No clinically significant trends in hematologic or hepatic profiles.
- No patients withdrew from this study as a result of an abnormal lab test.
- The number of patients taking Asacol who withdrew from this study as a result of adverse events was low (less than 4%) and comparable to those taking placebo.
Renal impairment, including minimal change nephropathy, and acute and chronic interstitial nephritis, has been reported in patients taking Asacol tablets as well as in patients taking other mesalamine products. It is recommended that all patients have an evaluation of renal function prior to initiation of Asacol tablets and periodically while on Asacol therapy.
Details of the Maintenance Study
- Multicenter, double-blind, placebo-controlled, randomized
- 264 patients (177 randomized to Asacol)
- 6-month treatment duration
- Adverse events collected via case report forms and daily patient diaries
- Published in the Annals of Internal Medicine, January, 1996
1. Data on file, Procter & Gamble Pharmaceuticals.
2. The Mesalamine Study Group. An oral preparation of mesalamine as long-term maintenance therapy for ulcerative colitis. Ann Intern Med. 1996;124:204-211.
3. Asacol Package Insert, March 2004.
* Including Beta2-microglobulin, alanine aminopeptidase, and N-acetyl-Beta-D-glucosaminidase
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