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COLAZAL- balsalazide disodium capsule


  1. Patient Information
  2. Distributed By:
  3. Manufactured By:

Patient Information 

Important Precautions Regarding COLAZAL

Instruct patients not to take COLAZAL if they have a hypersensitivity to salicylates (e.g., aspirin).
Patients should be instructed to contact their health care provider under the following circumstances:
o
If they experience a worsening of their ulcerative colitis symptoms.
o
If they are diagnosed with pyloric stenosis, because COLAZAL capsules may be slow to pass through their digestive tract.
o
If they are diagnosed with renal dysfunction. Damage to the kidney has been observed in people given medications similar to COLAZAL.

What Patients Should Know About Adverse Reactions

In adult clinical trials the most common adverse reactions were headache, abdominal pain, diarrhea, nausea, vomiting, respiratory infection, and arthralgia.
In the pediatric clinical trial the most common adverse reactions were headache, abdominal pain, vomiting, diarrhea, ulcerative colitis, nasopharyngitis, and pyrexia.
Inform patients that this listing of adverse reactions is not complete and not all adverse reactions can be anticipated. If appropriate, a more comprehensive list of adverse reactions can be discussed with patients.

What Patients Should Know About Taking COLAZAL with Other Medication

Based upon limited studies conducted in a test tube, COLAZAL is not believed to interfere with other drugs by preventing how the liver functions. However, as the studies were limited in scope, you should always consult your doctor and discuss potential interactions prior to initiating any new drug.

Distributed By: 

Salix Pharmaceuticals, a division of

Bausch Health US, LLC

Bridgewater, NJ 08807 USA

Manufactured By: 

Nexgen Pharma

Irvine, CA 92614 USA

U.S. Patent Numbers: 7,452,872 and 7,625,884

COLAZAL is a trademark of Salix Pharmaceuticals, Inc. or its affiliates.

2019 Salix Pharmaceuticals, Inc. or its affiliates

9462602



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