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Colazal®

Brand Name: Colazal®
Active Ingredient:   balsalazide disodium
Strength(s): 750mg
Dosage Form(s):   Capsule
Company Name:    Salix Pharmaceuticals Inc.
Availability:         Prescription only
*Date Approved by the FDA:   July 18, 2000
*Approval by FDA does not mean that a new drugis immediately marketed and available for consumers at this time.




What is Colazal used for?

Colazal is used to treat the signs and symptoms of mild to moderately active ulcerative colitis. The safety and efficacy of Colazal are not known after 12 weeks.

Who should not take Colazal?

You should not take Colazal if you are allergic to medicines containing:

  • salicylates, such as aspirin
  • mesalamine (Rowasa®, Asacol®, or Pentasa®)

General Precautions with Colazal:

Some people experience a worsening of their colitis symptoms possibly related to the use of Colazal.

What should I tell my doctor or health care provider?

Tell your doctor or health care provider if you have kidney disease or a history of kidney problems. Patients taking products that contain the same active ingredient as Colazal have sometimes had kidney problems.

Tell your health care provider if you are trying to become pregnant, are already pregnant, or are breast-feeding.

Tell your health care provider if you have pyloric stenosis, a narrowing of the muscle that controls the emptying of the stomach.

Because certain other medications such as antibiotics may interact with Colazal, review all medications that you are taking with your health care provider, including those that you take without a prescription.

What are some possible side effects of Colazal? (This is NOT a complete list of side effects reported with Colazal. Your health care provider can discuss with you a more complete list of side effects.)  

Common side effects include:

  • Headache
  • Stomach pain
  • Nausea
  • Diarrhea

Reports of patients’ experience with similar products:

In patients taking products that contain the same active ingredient as Colazal (mesalamine), several serious liver-related side effects have been reported, including abnormal liver function tests, jaundice, cirrhosis, liver damage, and liver failure. It is not possible to determine how often these side effects occur or whether these events are directly related to the active ingredient.

For more detailed information about Colazal, ask your health care provider.

http://www.fda.gov/cder/foi/label/2000/20610lbl.pdf    Link to Colazal's Labeling 

Posted: 6/18/01

 

Back to Drug Side Effects


source: FDA


last update: December 2004





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