Balsalazide capsules for mildly to moderately active ulcerative colitis

Balsalazide disodium capsules are an oral prescription medicine used to treat mildly to moderately active ulcerative colitis in patients aged 5 years and older. It is formulated as 750 mg capsules intended to deliver the active ingredient to the colon to reduce inflammation associated with this condition.

Balsalazide disodium capsules are approved for the treatment of mildly to moderately active ulcerative colitis in both pediatric patients (5 to 17 years old) and adults. The safety and effectiveness beyond 8 weeks of treatment in children and 12 weeks in adults have not been established.

Balsalazide disodium

Balsalazide is converted in the colon to mesalamine, an active moiety that works by reducing inflammation in the colon lining. This anti-inflammatory effect helps manage the symptoms of ulcerative colitis by controlling the immune response in the gastrointestinal tract.

Administration Instructions

• Evaluate renal function before starting therapy.
• Swallow capsules whole; do not cut, break, crush, or chew.
• For patients unable to swallow capsules, the capsule contents can be sprinkled on approximately 10 mL of applesauce and then chewed and swallowed immediately. Do not store the mixture. Note that teeth or tongue staining may occur with this method.
• Take with or without food.
• Drink an adequate amount of fluids during treatment.

Recommended Dosage

• Adults: 2.25 g (three 750 mg capsules) three times daily for up to 8 weeks; some adults may require treatment up to 12 weeks.
• Pediatric patients (5 to 17 years): Either 2.25 g (three capsules) three times daily or 750 mg (one capsule) three times daily for up to 8 weeks.

Balsalazide disodium capsules are contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, balsalazide components, or to mesalamine metabolites.

Key Warnings and Precautions

• Renal impairment: Assess renal function before and periodically during treatment. Discontinue if renal function worsens.
• Mesalamine-induced acute intolerance syndrome: Watch for symptoms similar to worsening ulcerative colitis, including cramping, abdominal pain, bloody diarrhea, fever, headache, and rash. Discontinue if suspected.
• Hypersensitivity reactions: Some patients allergic to sulfasalazine may react to balsalazide, including rare myocarditis, pericarditis, nephritis, hepatitis, pneumonitis, and blood abnormalities. Discontinue immediately if suspected.
• Hepatic failure: Exercise caution in patients with pre-existing liver disease.
• Severe skin reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, and AGEP have been reported. Stop at first signs of rash or hypersensitivity.
• Gastrointestinal obstruction: Avoid in patients with pyloric stenosis or other upper GI tract obstructions.
• Photosensitivity: Patients with pre-existing skin conditions should avoid sun exposure and use protective measures.
• Nephrolithiasis: Mesalamine-containing kidney stones have been reported; stones are radiographically undetectable. Maintain adequate hydration.
• Lab test interference: May cause false elevations in urinary normetanephrine tests; consider alternative assays.

Common Side Effects

Adverse reactions occurring in 3% or more of patients include headache, abdominal pain, diarrhea, nausea, vomiting, respiratory infection, and joint pain (arthralgia). Pediatric patients showed similar patterns.

Less Common but Serious Side Effects

• Hypersensitivity reactions (including myocarditis, pericarditis)
• Renal impairment and nephritis
• Severe cutaneous adverse reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis
• Hepatic failure in patients with pre-existing liver disease
• Nephrolithiasis
• Respiratory issues including pneumonia and pleural effusion (postmarketing reports)

Concomitant use with nephrotoxic drugs requires careful monitoring of renal function. Mesalamine metabolites may interfere with urinary normetanephrine assays, leading to false elevated results; alternative testing methods should be considered.