Asacol is indicated for the treatment of mildly to moderately active ulcerative colitis (UC) and for the maintenance of remission of UC. The recommended dosage for active UC is two 400 mg tablets TID, with or without food, for a total daily dose of 2.4 g for 6 weeks. For the maintenance of remission of UC, the recommended dosage is 1.6 g/day in divided doses.
Asacol HD is indicated for the treatment of moderately active UC. The recommended dose in adults is two 800 mg tablets TID, with or without food, for a total daily dose of 4.8 g. The safety and effectiveness of Asacol HD beyond 6 weeks has not been established.
Selected Safety Information
Asacol and Asacol HD are contraindicated in patients with hypersensitivity to salicylates. Caution should be exercised when using these products 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 and periodically while on Asacol or Asacol HD therapy. Acute exacerbation of colitis symptoms can also occur. Caution should be exercised when administering Asacol or Asacol HD to patients with liver disease. Serious adverse events may occur with Asacol or Asacol HD.
In clinical trials, Asacol and Asacol HD were generally well-tolerated. The most common adverse reactions reported in patients treated with Asacol and Asacol HD were nausea, diarrhea, abdominal pain, eructation, flatulence, exacerbation of UC, headache, rhinitis, nasopharyngitis and pain.
One Asacol HD 800mg tablet has not been shown to be bioequivalent to two Asacol 400mg tablets.
Please see accompanying full Prescribing Information for Asacol HD here.
Please see accompanying full Prescribing Information for Asacol here.
