What is the dosage and treatment protocol for Mesalamine (Mesalazina) in managing ulcerative colitis and Crohn's disease?

Mesalamine (Mesalazina) Dosage and Treatment Protocol for Ulcerative Colitis and Crohn's Disease

For ulcerative colitis, standard-dose mesalamine (2-3 g/day) is recommended as first-line therapy, with high-dose mesalamine (>3 g/day) being superior for patients with suboptimal response or moderate disease activity. 1

Dosing for Ulcerative Colitis

Adults:

• Induction of remission: 2.4-4.8 g once daily 2
• Maintenance of remission: 2.4 g once daily 2
• Administration: Take with food, swallow tablets whole (do not split or crush), ensure adequate hydration 2

Pediatric patients (based on weight):

• Initial treatment (Week 0-8):
  • 24-35 kg: 2.4 g daily

  • 35-50 kg: 3.6 g daily

  • 50 kg: 4.8 g daily

• After Week 8:
  • 24-35 kg: 1.2 g daily

  • 35-50 kg: 2.4 g daily

  • 50 kg: 2.4 g daily 2

Disease-Specific Protocols

Extensive Mild-Moderate Ulcerative Colitis:

• Start with standard-dose mesalamine (2-3 g/day) 1
• Add rectal mesalamine to oral therapy for improved efficacy 1
• For suboptimal response, increase to high-dose mesalamine (>3 g/day) with rectal mesalamine 1

Left-Sided UC/Proctosigmoiditis:

• Mesalamine enemas preferred over oral therapy alone 1
• If patient prefers oral administration, standard-dose oral mesalamine is acceptable but less effective 1

Ulcerative Proctitis:

• Mesalamine suppositories are strongly recommended 1
• For intolerance or refractoriness to suppositories, rectal corticosteroid therapy is suggested 1

Crohn's Disease:

• Higher dosages (4 g/day) appear more effective than placebo in reducing disease activity 3
• After 16 weeks of treatment with 4 g/day, 64% of patients experienced clinical improvement and 43% attained remission 3
• More effective in preventing relapse in patients with isolated small bowel disease than in those with colonic involvement 3

Monitoring

• Renal function: Evaluate prior to initiation and periodically during therapy (every 3-6 months) 4, 2
• Fecal calprotectin: Monitor every 6-12 months in patients in symptomatic remission 4
• Liver function: Periodic monitoring based on clinical symptoms 4

Treatment Escalation

• If refractory to optimized 5-ASA therapy (including high-dose oral and rectal mesalamine), add oral prednisone or budesonide MMX 1

Administration Tips

• Once-daily dosing is recommended for improved adherence with similar efficacy to divided dosing 1, 4
• Take with food 2
• Drink adequate fluids to prevent nephrolithiasis 4, 2

Common Adverse Effects

• Most common adverse reactions in adults (≥2%): headache, flatulence, abnormal liver function tests, abdominal pain, and diarrhea 2
• Most common adverse reactions in pediatric patients (≥5%): abdominal pain, upper respiratory tract infection, vomiting, anemia, headache, and viral infection 2

Cautions and Contraindications

• Contraindicated: Known or suspected hypersensitivity to salicylates or aminosalicylates 2
• Monitor for: Mesalamine-induced acute intolerance syndrome (may mimic UC flare), hypersensitivity reactions including myocarditis and pericarditis, renal impairment, severe cutaneous adverse reactions 4, 2

Mesalamine is generally well tolerated by about 85% of patients allergic to or intolerant of sulfasalazine, making it a suitable alternative for these patients 5.