balsalazide disodium, Colazal

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Pharmacy Author:

Omudhome Ogbru, PharmD

Omudhome Ogbru, PharmD

Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

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Medical and Pharmacy Editor:

Jay W. Marks, MD

Jay W. Marks, MD

Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

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GENERIC NAME: balsalazide disodium

BRAND NAME: Colazal, Giazo

DRUG CLASS AND MECHANISM: 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.

PRESCRIPTION: Yes

GENERIC AVAILABLE: Yes

PREPARATIONS: Capsule: 750 mg; Tablet: 1.1 g

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

PRESCRIBED FOR: Balsalazide is used to treat the signs and symptoms of mild to moderately active ulcerative colitis.

DOSING: 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.

DRUG INTERACTIONS: There are no known drug interactions with balsalazide disodium.

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

NURSING MOTHERS: It is not known if balsalazide disodium is secreted into breast milk. Since many drugs are secreted into breast milk, balsalazide disodium should not be taken by nursing women.

SIDE EFFECTS: The most commonly occurring side effects are headache, abdominal pain, nausea, vomiting, and diarrhea. Fatigue, muscle aches, joint pain, insomnia, and urinary tract reactions also may occur.

Reference: FDA Prescribing Information

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