What is the recommended treatment regimen for mild to moderate ulcerative colitis using Balsalazide (Balsalazide disodium)?

Balsalazide Treatment Regimen for Mild to Moderate Ulcerative Colitis

For adults with mild to moderate ulcerative colitis, the recommended treatment regimen is three 750 mg balsalazide disodium capsules taken 3 times a day (6.75 g per day) for up to 8 weeks, with some patients requiring treatment for up to 12 weeks. 1

Dosage Guidelines

Adult Dosing

• Standard dose: 6.75 g daily (three 750 mg capsules taken three times daily) 1
• Duration: Up to 8 weeks initially, with some patients requiring up to 12 weeks of therapy 1

Pediatric Dosing (ages 5-17 years)

• Option 1: 6.75 g daily (three 750 mg capsules three times daily)
• Option 2: 2.25 g daily (one 750 mg capsule three times daily)
• Duration: Up to 8 weeks (pediatric use beyond 8 weeks has not been evaluated) 1

Administration Methods

• Capsules may be swallowed whole
• Alternatively, capsules can be opened and contents sprinkled on applesauce
  • The mixture should be swallowed immediately
  • Contents may be chewed if necessary
  • Do not store drug/applesauce mixture for future use 1

Efficacy Considerations

• Balsalazide is classified as a diazo-bonded 5-ASA, which is a prodrug converted to 5-ASA in the colon 2
• Balsalazide has demonstrated faster onset of action compared to mesalamine, with a median time to symptomatic remission of 25 days versus 37 days for mesalamine 3
• Significantly more balsalazide patients show improvement in stool frequency, rectal bleeding, and physician's global assessment scores by 14 days compared to mesalamine patients 3

Treatment Optimization

• For patients with suboptimal response to balsalazide alone, consider:
  1. Adding rectal mesalamine therapy (combination oral and rectal 5-ASA therapy is superior to oral therapy alone) 4
  2. Switching to oral prednisone or budesonide MMX if no response is observed after optimized 5-ASA therapy 4

Safety and Monitoring

• Monitor for potential exacerbation of ulcerative colitis symptoms (reported in 3 out of 259 adult patients in clinical trials) 1
• Exercise caution in patients with:
  • Pyloric stenosis (may have prolonged gastric retention of balsalazide)
  • Known renal dysfunction or history of renal disease 1
• Periodic monitoring of renal function is recommended 2
• Contraindicated in patients with hypersensitivity to salicylates or components of balsalazide 1

Common Side Effects

• Balsalazide is generally well-tolerated compared to other 5-ASA formulations
• Most common adverse events are related to gastrointestinal and central/peripheral nervous systems 3
• Teeth and/or tongue staining may occur when using the sprinkle form with food 1

Comparative Efficacy

• Balsalazide has demonstrated similar or superior efficacy to mesalamine in treating active mild-to-moderate ulcerative colitis 3, 5
• Balsalazide has fewer side effects than sulfasalazine at therapeutic doses 5, 6
• Low-dose balsalazide (2.25 g/day) combined with probiotics has shown superior efficacy to medium-dose balsalazide alone or mesalamine in some studies 7

By following this treatment regimen, patients with mild to moderate ulcerative colitis can expect effective symptom control with a favorable safety profile compared to other 5-ASA formulations.