Asacol HD
FDA Approves Simponi to Treat Ulcerative Colitis »
"The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.
Simponi works by blocking tumor necrosis factor (TNF), which plays an important"...
Read the FDA Approves Simponi to Treat Ulcerative Colitis article »
Asacol HD
INDICATIONS
Asacol HD (mesalamine delayed-release tablets, oral) is indicated for the treatment of moderately active ulcerative colitis. Safety and effectiveness of Asacol HD (mesalamine delayed-release tablets, oral) beyond 6 weeks has not been established.
DOSAGE AND ADMINISTRATION
For the treatment of moderately active ulcerative colitis, the recommended dose of Asacol HD (mesalamine delayed-release tablets, oral) 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 6 weeks. Asacol HD (mesalamine delayed-release tablets, oral) use beyond 6 weeks has not been evaluated. Asacol HD (mesalamine delayed-release tablets, oral) should be swallowed whole without cutting, breaking, or chewing. One Asacol HD (mesalamine delayed-release tablets, oral) 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets [see CLINICAL PHARMACOLOGY].
HOW SUPPLIED
Dosage Forms And Strengths
Asacol HD (mesalamine delayed-release tablets, oral) delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “PG 800” in black.
Storage And Handling
Asacol HD tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “PG 800” in black.
NDC 0149-0783-01 Bottle of 180
Store at controlled room temperature 20° to 25°C (68° to 77°F) [See USP].
Procter & Gamble Pharmaceuticals, Inc., Cincinnati, OH 45202, under license from Medeva Pharma Suisse AG. Made in Germany, D-64331 Weiterstadt.
Last reviewed on RxList: 10/23/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Asacol HD Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Women's Health
Find out what women really need.
Updated & New
