Pronunciation: bal-SAL-a-zide die-SO-dee-um
Class: GI agent
- Capsule 750 mg
Reduces inflammation of colon by preventing local production of substances such as arachidonic acid that are involved in inflammatory process.
Very low systemic absorption. T max is approximately 1 to 2 h.
At least 99% protein bound.
In the colon, bacterial azoreductases cleave the balsalazide compound to release 5-aminosalicylic acid (5-ASA) (active) and 4-aminobenzoyl-beta-alanine.
Less than 1% as parent compound, 5-ASA, or 4-aminobenzoyl-beta-alanine; up to 25% as N-acetylated metabolites.Feces
65% as 5-ASA, 4-aminobenzoyl-beta-alanine, and N-acetylated metabolites; less than 1% as parent compound.
Special PopulationsUlcerative colitis
May have increased AUC.
Indications and Usage
Treatment of mildly to moderately active ulcerative colitis.
Hypersensitivity to salicylates, or any of the components of balsalazide capsules, or balsalazide metabolites.
Dosage and AdministrationAdults
PO 2.25 g (eg, three 750 mg capsules) 3 times daily (eg, 6.75 g/day) for 8 wk; some patients may require up to 12 wk of treatment.
- Capsules can be opened and contents sprinkled on applesauce. Entire mixture should be swallowed immediately and not stored for future use. If necessary, contents may be chewed.
Store at 59° to 86°F.
None well documented.
Laboratory Test Interactions
None well documented.
Headache (8%); fatigue, insomnia (2%); dizziness (1%).
Pharyngitis, rhinitis (2%).
Abdominal pain (6%); diarrhea, nausea (5%); vomiting (4%); anorexia, dyspepsia, flatulence, rectal bleeding (2%); constipation, dry mouth, frequent stools (1%).
Cholestatic jaundice, cirrhosis, hepatocellular damage (including liver necrosis and liver failure), hepatotoxicity (including elevated ALT, AST, gamma-glutamyl-transferase, LDH), jaundice, Kawasaki-like syndrome that included hepatic function changes (postmarketing).
Arthralgia (4%); back pain (2%); myalgia (1%).
Respiratory infection (4%); coughing (2%); sinusitis (1%).
Fever, pain (2%); cramps, flu-like disorder (1%).
Assess patient's colitis symptoms, including the following: rectal bleeding, stool frequency and character, abdominal pain, and overall functional status.
Category B .
Safety and efficacy not established.
Use with caution in patients with known renal function impairment or history of renal disease.
Some patients may develop exacerbation of colitis symptoms.
Patients with pyloric stenosis may have prolonged gastric retention of capsules.
No case of overdose has occurred.
- Advise patient that capsules can be opened and contents sprinkled on applesauce. Entire mixture should be swallowed immediately and not stored for future use. If necessary, contents may be chewed.
- Advise patient that usual course of therapy is 8 to 12 wk.
- Advise patient to report worsening of colitis symptoms to health care provider.
- Advise patients to inform the health care provider if experiencing adverse reactions such as headache, stomach pain, nausea, or diarrhea.
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