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