balsalazide disodium (Colazal, Giazo)

Balsalazide disodium is an oral anti-inflammatory drug that is used for the treatment of ulcerative colitis. It is a form of mesalamine (5-aminosalicyclic acid) that is activated by colonic bacteria when it reaches the colon. The exact mechanism of action of mesalamine is not known but is believed to be by reducing inflammation in the colon. Ulcerative colitis and other inflammatory diseases cause excessive production of chemicals, for example, prostaglandins, that produce inflammation in the colon. Prostaglandins are produced by the enzymes, cyclooxygenase and lipoxygenase. These enzymes are over-active in individuals with ulcerative colitis. Mesalamine may work by blocking the activity of cyclooxygenase and lipoxygenase, thereby, reducing the production of prostaglandins. Reduced production of prostaglandins decreases inflammation in the colon and the symptoms associated with ulcerative colitis. Other branded, mesalamine-containing drugs include mesalamine (Pentasa, Rowasa, and Asacol). Balsalazide disodium was approved by the FDA in July 2000.

What brand names are available for balsalazide disodium?

Colazal, Giazo

Is balsalazide disodium available as a generic drug?

GENERIC AVAILABLE: Yes

Do I need a prescription for balsalazide disodium?

Yes

Balsalazide disodium is a locally acting aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Safety and effectiveness of balsalazide disodium beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults have not been established.

Contact your doctor if:

• You experience a worsening of your ulcerative colitis symptoms.
• You are diagnosed with pyloric stenosis, because balsalazide disodium capsules may be slow to pass through your digestive tract.
• You are diagnosed with renal dysfunction. Damage to the kidney has been observed in people given medications similar to balsalazide disodium.
• You are diagnosed with liver disease. Worsening liver disease has been observed in some people given medications similar to balsalazide disodium.

In adult clinical trials the most common side effects were:

• headache,
• abdominal pain,
• diarrhea,
• nausea,
• vomiting,
• respiratory infection, and
• arthralgia.

In the pediatric clinical trial the most common side effects were:

• headache,
• abdominal pain,
• vomiting,
• diarrhea,
• ulcerative colitis,
• nasopharyngitis, and
• pyrexia.

This is not a complete list of side effects. Discuss potential side effects with your doctor.

The usual dose is 2250 mg (three 750 mg capsules) taken three times daily for 8 to 12 weeks or three 1.1 g tablets two times a day for up to 8 weeks.

Do not take balsalazide disodium if you have a hypersensitivity to salicylates such as aspirin.

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

Animal studies have not demonstrated any adverse effects on the fetus; however, there have been no studies in pregnant women. Balsalazide disodium should only be used during pregnancy if the benefit outweighs the risks.

It is not known if balsalazide disodium is secreted into breast milk. Since many drugs are secreted into breast milk, nursing women should not take balsalazide disodium.

What preparations of balsalazide disodium are available?

PREPARATIONS: Capsule: 750 mg; Tablet: 1.1 g

How should I keep balsalazide disodium stored?

Balsalazide disodium should be stored between 15 C to 30 C (59 F to 86 F)