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COLAZAL – balsalazide disodium

Ulcerative Colitis
Symptoms



Common UC Symptoms

This information is intended for U.S. residents only.

The most common initial symptoms of ulcerative colitis (UC) are bloody diarrhea, diarrhea with mucus, and rectal bleeding. These symptoms may appear alone or may be accompanied by others, which can be associated with more severe disease. Those symptoms include nausea and vomiting, loss of appetite, weight loss, and fever.

Ulcerative colitis symptoms tend to present themselves on a sporadic basis, with long periods of remission between symptoms. These periods can last for months or years, and patients may not experience any UC symptoms at all.

If you experience any of the following symptoms of UC, speak to your healthcare provider:

  • Diarrhea or rectal urgency–some people may have diarrhea 10 to 20 times per day. The urge to go to the bathroom may wake the sufferer up at night
  • Rectal bleeding–ulcerative colitis usually causes bloody diarrhea and mucus in the stool. There may also be rectal pain and an urgent need to empty the bowels
  • Abdominal pain–this symptom may often be described as cramping; the abdomen may be sore when touched
  • Constipation–this symptom may develop depending on what part of the colon is affected. Constipation is much less common than diarrhea
  • Loss of appetite
  • Fever–in severe cases, fever or other symptoms that affect the entire body may develop
  • Weight loss–ongoing (chronic) symptoms, such as diarrhea, can lead to weight loss
  • Too few red blood cells (anemia)–some people develop anemia because of low iron levels caused by bloody stools or intestinal inflammation
  • Other symptoms may also develop, as well as complications outside the digestive tract, such as joint pain, eye problems, skin rash, or liver disease. However, some of these problems are generally more common in Crohn's disease, the other major inflammatory bowel disease

Other conditions with symptoms similar to ulcerative colitis include Crohn's disease, diverticulitis, irritable bowel syndrome (IBS), and colon cancer.



COLAZAL® (balsalazide disodium) Capsules 750 mg are indicated for the treatment of mildly to moderately active Ulcerative Colitis in patients 5 years of age and older. COLAZAL does not relieve symptoms in all patients; your patients' results may vary. In four well-controlled clinical trials, patients receiving a COLAZAL dose of 6.75g/day most frequently reported the following events (reporting frequency > 3%): headache (8%), abdominal pain (6%), diarrhea (5%), nausea (5%), vomiting (4%), respiratory infection (4%), and arthralgia (4%). Withdrawal from therapy due to adverse events was comparable to placebo. In the pediatric trial, patients most frequently reported the following adverse events: headache (15%), abdominal pain upper (13%), abdominal pain (12%), vomiting (10%), diarrhea (9%), colitis ulcerative (6%), nasopharyngitis (6%) and, pyrexia (6%). COLAZAL is contraindicated in patients with a hypersensitivity to salicylates or the components of COLAZAL capsules or balsalazide metabolites. The safety and effectiveness of COLAZAL beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults have not been established.

Consult with your physician to see if this product is right for you.

For complete Prescribing Information, please click here.


For product information, adverse event reports, and product complaint reports please call:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email:

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