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BALSALAZIDE DISODIUM capsule


  1. Patient Information
  2. Important Precautions Regarding Balsalazide:
  3. Patients Should Be Instructed To Contact Their Health Care Provider Under The Following Circumstances:
  4. What Patients Should Know About Adverse Reactions:
  5. What Patients Should Know About Taking Balsalazide With Other Medication:

Patient Information 

17.1 Important Precautions Regarding Balsalazide

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

17.2 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.

17.3 What Patients Should Know About Taking Balsalazide with Other Medication

  • Based upon limited studies conducted in a test tube, balsalazide 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.

Manufactured for: Pulaski, TN 38478 Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 03/16 Mfg. Rev. 03/16

AV 06/16 (P)AV 06/16 (P)

Important Precautions Regarding Balsalazide: 

Instruct patients not to take balsalazide 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 balsalazide 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 balsalazide.

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 Balsalazide With Other Medication: 

Based upon limited studies conducted in a test tube, balsalazide 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.

Distr. by:West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

10003708/08

Revised August 2019



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