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Colazal

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Colazal

INDICATIONS

COLAZAL (balsalazide) is indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Safety and effectiveness of COLAZAL (balsalazide) beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults have not been established.

DOSAGE AND ADMINISTRATION

Adult Dose

For treatment of active ulcerative colitis in adult patients, the usual dose is three 750 mg COLAZAL (balsalazide) capsules to be taken 3 times a day (6.75 g per day) for up to 8 weeks. Some patients in the adult clinical trials required treatment for up to 12 weeks.

Pediatric Dose

For treatment of active ulcerative colitis in pediatric patients, aged 5 to 17 years, the usual dose is EITHER:

  • three 750 mg COLAZAL (balsalazide) capsules 3 times a day (6.75 g per day) for up to 8 weeks;
    OR:
  • one 750 mg COLAZAL (balsalazide) capsule 3 times a day (2.25 g per day) for up to 8 weeks.

Use of COLAZAL (balsalazide) in the pediatric population for more than 8 weeks has not been evaluated in clinical trials. [See Clinical Studies Section]

Administration Alternatives

COLAZAL (balsalazide) capsules may also be administered by carefully opening the capsule and sprinkling the capsule contents on applesauce. The entire drug/applesauce mixture should be swallowed immediately; the contents may be chewed, if necessary, since contents of COLAZAL (balsalazide) are NOT coated beads/granules. Patients should be instructed not to store any drug/applesauce mixture for future use.

If the capsules are opened for sprinkling, color variation of the powder inside the capsules ranges from orange to yellow and is expected due to color variation of the active pharmaceutical ingredient.

Teeth and/or tongue staining may occur in some patients who use COLAZAL (balsalazide) in sprinkle form with food.

HOW SUPPLIED

Dosage Forms And Strengths

COLAZAL is available as beige capsules containing 750 mg balsalazide disodium and CZ imprinted in black.

Storage And Handling

COLAZAL is available as beige capsules containing 750 mg balsalazide disodium and CZ imprinted in black.

NDC 65649-101-02 Bottles of 280 capsules.
NDC 65649-101-50 Bottles of 500 capsules.

Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). See USP Controlled Room Temperature.

Manufactured for Salix Pharmaceuticals, Inc., Morrisville, NC 27560. * COLAZAL® (balsalazide) is a registered trademark of Salix Pharmaceuticals, Inc. FDA Rev date: 7/9/2008

Last reviewed on RxList: 9/3/2008
This monograph has been modified to include the generic and brand name in many instances.

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