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Delzicol

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Delzicol

Indications
Dosage
How Supplied

INDICATIONS

Treatment Of Mildly To Moderately Active Ulcerative Colitis

DELZICOL® (mesalamine) delayed-release capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 12 years of age and older.

Maintenance Of Remission Of Ulcerative Colitis In Adults

DELZICOL® (mesalamine) delayed-release tablets are indicated for the maintenance of remission of ulcerative colitis in adults. The safety and effectiveness of DELZICOL 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 DELZICOL is two 400 mg capsules to be taken three times daily (total daily dose of 2.4 grams), for a duration of 6 weeks [see Clinical Studies].

Pediatrics

For pediatric patients 12 years of age and older, the recommended total daily dose of DELZICOL is weight-based (up to maximum of 2.4 grams/day). DELZICOL capsules are to be taken twice daily for a duration of 6 weeks [see Clinical Studies].

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 the maintenance of remission of ulcerative colitis, the recommended dose of DELZICOL in adults is 1.6 g daily, in divided doses [see Clinical Studies].

Important Administration Instructions

Do not open, crush, break, or chew the capsules. Swallow whole with water.

Before prescribing DELZICOL capsules, children should be assessed for the ability to swallow capsules. DELZICOL should be dosed at least 1 hour before a meal or 2 hours after a meal.

Two DELZICOL 400 mg capsules should not be substituted with one mesalamine delayed-release 800 mg tablet.

Testing Prior To DELZICOL Administration

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

HOW SUPPLIED

Dosage Forms And Strengths

DELZICOL (mesalamine) delayed-release capsules are red capsules containing 400 mg mesalamine and imprinted with “WC 400mg” in white.

Storage And Handling

DELZICOL (mesalamine) delayed-release capsules are available as red capsules containing 400 mg mesalamine and imprinted with “WC 400mg” in white.

NDC 0430-0753-27 Bottle of 180 capsules

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: April 2014

Last reviewed on RxList: 5/9/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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