May 27, 2016
Recommended Topic Related To:

Asacol HD

"An experimental oral lymphocyte trafficking agent, ozanimod (Receptos), showed modest activity against ulcerative colitis (UC) in a small, early-stage clinical trial.

In the double-blind, placebo-controlled phase 2 trial in adults wit"...

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Asacol HD




Indications
Dosage
How Supplied

INDICATIONS

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

Dosage Information

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].

HOW SUPPLIED

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 2013

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/25/2016

Indications
Dosage
How Supplied

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.


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