With Asacol HD, you can offer an appropriate dose of therapy for the appropriate patient.

Indication: for the treatment of moderately active ulcerative colitis
Recommended dosage: two 800 mg tablets three times daily, with or without food, for a total daily dose of 4.8 g
Duration: six weeks

Indications and Usage

Asacol HD is indicated for the treatment of moderately active ulcerative colitis. Safety and effectiveness of Asacol HD beyond six weeks has not been established.

Dosage and Administration

For the treatment of moderately active ulcerative colitis, the recommended dose of Asacol HD in adults is two 800 mg tablets to be taken three times daily with or without food, for a total daily dose of 4.8 g, for a duration of six weeks. Asacol HD use beyond six weeks has not been evaluated. Asacol HD should be swallowed whole without cutting, breaking, or chewing. One Asacol HD 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets.

Dosage Forms and Strengths

Asacol HD delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg of mesalamine and imprinted with “PG 800” in black.

Contraindications

Asacol HD is contraindicated in patients with hypersensitivity to salicylates, or aminosalicylates, or any of the components of Asacol HD tablets.

Warnings and Precautions

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 also can occur. Caution should be exercised when administering Asacol or Asacol HD to patients with liver disease. Patients with pyloric stenosis may have prolonged gastric retention of Asacol or Asacol HD tablets. Serious adverse events may occur with Asacol or Asacol HD. In pregnant women, Asacol HD may cause fetal harm based on animal data for dibutyl phthalate (inactive ingredient in Asacol HD enteric coating). Caution should be exercised when using these products in nursing women.

Prescribing Information