Colazal (Balsalazide) Drug Information: Medication Guide and Patient Information

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May 26, 2012

Colazal

Ulcerative Colitis »

What is Ulcerative Colitis?

Ulcerative colitis is a chronic inflammation of the large intestine (colon). The colon is the part of the digestive system where waste material is stored. The rectum is the end of the colon adjacent to the anus. In patients with ulcerative colitis, ulcers and inflammation of the inner lining of the colon lead to symptoms of abdominal pain, diarrhea, and rectal bleeding.

Ulcerative colitis is closely related to another condition of inflammation of the intestines called Crohn's disease. Together, they are frequently referred to as inflammatory bowel disease (IBD). Ulcerative colitis and Crohn's diseases are chronic conditions that can last years to decades. They affect approximately 500,000 to 2 million people In the United States. Men and women are affected equally. They most commonly begin during adolescence and early adulthood, but they also can begin during childhood and later in life.

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Read the Ulcerative Colitis article »

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PATIENT INFORMATION

Important Precautions Regarding COLAZAL (balsalazide)

Instruct patients not to take COLAZAL (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 COLAZAL (balsalazide) 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 COLAZAL (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 COLAZAL (balsalazide) with Other Medication

Based upon limited studies conducted in a test tube, COLAZAL (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.

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