"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"...
Asacol® HD is indicated for the treatment of moderately active ulcerative colitis in adults. Safety and effectiveness of Asacol HD beyond 6 weeks have not been established.
DOSAGE AND ADMINISTRATION
For the treatment of moderately active ulcerative colitis, the recommended dosage 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 grams, for a duration of 6 weeks.
Important Administration Instructions
Swallow Asacol HD tablets whole, do not cut, break or chew the tablets.
One Asacol HD 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets [see CLINICAL PHARMACOLOGY].
Testing Prior To Asacol HD Administration
It is recommended that all patients have an evaluation of renal function prior to initiation of Asacol HD [see WARNINGS AND PRECAUTIONS].
Dosage Forms And Strengths
Asacol HD delayed-release tablets: 800 mg (red-brown, capsule-shaped and imprinted with “WC 800” in black).
Storage And Handling
Asacol® HD (mesalamine) delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “WC 800” in black.
N 0430-0783-27 Bottle of 180 tablets
Store at controlled room temperature 20° to 25° C (68° to 77° F); excursions are permitted 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature]
Manufactured by: Warner Chilcott Deutschland GmbH, D-64331 Weiterstadt, Germany. Marketed by: Warner Chilcott (US), LLC Rockaway, NJ 07866. Revised: Oct 2013This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/25/2016
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.
Find out what women really need.