Balsalazide

Balsalazide Brand Names- Colazal | Giazo

What is Balsalazide

Balsalazide is a diazo-bonded 5-aminosalicylate and is a prodrug; the drug utilizes bacterial azoreduction to release the antiinflammatory agent 5-ASA (also known as mesalamine).

Balsalazide capsules (e.g., Colazal) are indicated for the treatment of mildly to moderately active ulcerative colitis (UC) in adult and pediatric patients 5 years and older.

The tablets (i.e., Giazo) were indicated only in adult male patients with UC but are no longer marketed.

Although there is little evidence to suggest differences in efficacy between the diazo-bonded 5- ASA preparations, balsalazide is the often the preferred diazo-bonded 5-ASA over olsalazine due to its better tolerability.

The guidelines support the use of standard-dose mesalamine (2 to 3 grams/day) or diazo-bonded 5-ASAs (balsalazide or olsalazine) for induction and maintenance of remission in patients with extensive mild to moderate UC.

Those with moderate symptoms may benefit from early use of combination oral and rectal 5-ASA. Use of combined oral and rectal 5-ASA in patients with extensive disease may improve rates of induction of remission, as may escalation to high-dose (more than 3 grams/day) oral with rectal 5-ASA in patients with suboptimal response to standard-dose therapy.

In patients with inadequate response to optimized 5-ASA, consider oral prednisone or budesonide MMX 9 mg/day to induce remission instead of changing to an alternate 5-ASA formulation.

Systemic corticosteroids should not be used for maintenance of remission in patients with UC. In patients with mildly active ulcerative proctitis, rectal 5-ASA at a dose of 1 gram/day should be used to maintain remission rather than oral 5-ASA.

Those patients with suboptimal response or intolerance to rectal mesalamine may opt to use rectal corticosteroids.

Indications

  • ulcerative colitis

For the treatment of mildly to moderately active ulcerative colitis

Side Effects

  1. abdominal pain
  2. alopecia
  3. anaphylactoid reactions
  4. anorexia
  5. arthralgia
  6. back pain
  7. bronchospasm
  8. cholestasis
  9. constipation
  10. cough
  11. diarrhea
  12. dizziness
  13. dyspepsia
  14. elevated hepatic enzymes
  15. eosinophilia
  16. eosinophilic pneumonia
  17. fatigue
  18. fever
  19. flatulence
  20. GI bleeding
  21. headache
  22. hepatic failure
  23. hepatic necrosis
  24. hepatitis
  25. infection
  26. insomnia
  27. interstitial nephritis
  28. jaundice
  29. musculoskeletal pain
  30. myalgia
  31. myocarditis
  32. nausea
  33. pancreatitis
  34. pericarditis
  35. pharyngitis
  36. pleural effusion
  37. pruritus
  38. rash
  39. renal failure (unspecified)
  40. rhinitis
  41. sinusitis
  42. vasculitis
  43. vomiting
  44. xerostomia

Monitoring Parameters

  • serum creatinine

Contraindications

  • 5-aminosalicylates hypersensitivity
  • breast-feeding
  • children
  • colitis
  • hepatic disease
  • infants
  • neonates
  • pregnancy
  • pyloric stenosis
  • renal disease
  • renal failure
  • renal impairment
  • salicylate hypersensitivity

Interactions

  • Amlodipine; Celecoxib
  • Azathioprine
  • Celecoxib
  • Mercaptopurine, 6-MP
  • Thioguanine, 6-TG
  • Warfarin
Scroll to Top