July 3, 2015
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Asacol

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Asacol




Indications
Dosage
How Supplied

INDICATIONS

Treatment Of Mildly To Moderately Active Ulcerative Colitis

Asacol® (mesalamine) delayed-release tablets are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.

Maintenance Of Remission Of Ulcerative Colitis In Adults

Asacol (mesalamine) delayed-release tablets are indicated for the maintenance of remission of ulcerative colitis in adults. The safety and effectiveness of Asacol for the maintenance of remission of ulcerative colitis in pediatric patients have not been established.

DOSAGE AND ADMINISTRATION

Dosage For Treatment Of Mildly To Moderately Active Ulcerative Colitis

Adults

For adults, the recommended dosage of Asacol is two 400 mg tablets to be taken three times daily with or without food (total daily dose of 2.4 grams), for a duration of 6 weeks [see Clinical Studies].

Pediatrics

For pediatric patients, the recommended total daily dose of Asacol is weight-based (up to maximum of 2.4 grams/day) (see Table 1). Asacol tablets are to be taken twice daily with or without food for a duration of 6 weeks [see Clinical Studies].

Table 1: Pediatric Dosage by Weight

Weight Group (kg) Daily Dose (mg/kg/day) Maximum Daily Dose (grams/day)
17 to < 33 36 to 71 1.2
33 to < 54 37 to 61 2.0
54 to 90 27 to 44 2.4

Dosage For Maintenance Of Remission Of Ulcerative Colitis In Adults

For adults, the recommended dosage of Asacol is 1.6 grams daily, in divided doses, with or without food [see Clinical Studies].

Important Administration Instructions

Swallow Asacol tablets whole. Do not cut, break or chew the tablets.

Two Asacol 400 mg tablets have not been shown to be bioequivalent to one Asacol® HD (mesalamine) delayed-release 800 mg tablet and should not be used interchangeably.

Testing Prior To Asacol Administration

Evaluate renal function prior to initiation of Asacol [see WARNINGS AND PRECAUTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

Asacol (mesalamine) Delayed-Release Tablets: 400 mg (red-brown, capsule-shaped and imprinted with “0752 DR” in black).

Storage And Handling

Asacol (mesalamine) Delayed-Release Tablets are available as red-brown, capsule-shaped tablets containing 400 mg mesalamine and imprinted with “0752 DR” in black.

NDC 0430-0752-27 Bottle of 180 tablets

Store at 20° to 25° C (68° to 77° F); excursions 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

Last reviewed on RxList: 6/8/2015
This monograph has been modified to include the generic and brand name in many instances.

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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