What is the recommended dose of Salofalk (mesalazine) for a patient with chronic colitis?

Salofalk (Mesalazine) Dosing for Chronic Colitis

For chronic ulcerative colitis, the recommended dose of Salofalk (mesalazine) is 2-4 grams daily orally for active disease, with higher doses (up to 4.8 grams daily) providing superior efficacy, particularly in patients with extensive disease or left-sided colitis. 1, 2

Dosing by Disease Extent and Activity

Active Left-Sided or Extensive Colitis

• Standard dose: 2-4 grams daily orally for mild to moderately active disease as first-line therapy 1
• High dose: 4.8 grams daily should be considered for patients with moderate activity or suboptimal response to standard dosing 2
• Once daily dosing is as effective as divided doses and improves adherence 2, 3
• Adding rectal mesalazine (at least 1 gram daily as enema) to oral therapy improves efficacy in extended colitis 2

Active Distal Colitis (Proctosigmoiditis)

• Combination therapy is superior to monotherapy: topical mesalazine 1 gram daily PLUS oral mesalazine 2-4 grams daily 1, 2
• This combined approach is more effective than either oral or topical therapy alone 1
• For left-sided disease specifically, use mesalazine enema (at least 1 gram/day) plus oral mesalazine (at least 2.4 grams/day) 2

Active Proctitis (Rectum Only)

• First-line: Mesalazine 1 gram suppository once daily 4, 2
• Suppositories are preferred over enemas as they better target the site of inflammation 4
• If combination therapy is needed, add oral mesalazine 2-4 grams daily to topical therapy 4

Maintenance Therapy Dosing

• Standard maintenance: 2.4 grams daily is effective for most patients 2, 5
• Higher maintenance dose: 4.8 grams daily is significantly more effective in specific populations:
  • Patients under 40 years of age (90.5% vs 50% remission maintenance) 5
  • Patients with extensive disease (90.9% vs 46.7% remission maintenance) 5
  • Patients with frequent relapses 5

Treatment Escalation Algorithm

When Standard Dose Fails (After 10-14 Days of Rectal Bleeding or 40 Days Without Complete Remission):

1. First escalation: Increase mesalazine to 4.0-4.8 grams daily if not already at this dose 2, 6
2. Second escalation: Add oral prednisone 40 mg daily OR budesonide MMX 9 mg daily 1, 2
3. Taper corticosteroids gradually over 8 weeks 1
4. For steroid-dependent disease: Consider azathioprine 1.5-2.5 mg/kg/day or mercaptopurine 0.75-1.5 mg/kg/day 1

Critical Practical Considerations

Dosing Optimization

• Doses below 2 grams daily are less effective than 2 grams or more 2
• Once daily dosing (3 grams OD) is therapeutically equivalent to three times daily dosing (1 gram TID) with better patient preference (80% prefer OD) 3
• Patients who relapse on low-dose maintenance (1.5-2.25 grams/day) respond well to dose escalation to 4.0 grams/day (66% achieve clinical improvement) 6

Common Pitfalls to Avoid

• Underdosing: Using less than 2 grams daily reduces efficacy 2
• Oral monotherapy in distal disease: Always use combination oral + rectal therapy for left-sided colitis and proctosigmoiditis 1, 2
• Delayed escalation: Do not wait beyond 40 days without improvement before adding corticosteroids 2
• Ignoring proximal constipation: Treat with stool bulking agents or laxatives in patients with distal disease 1, 4
• Using topical corticosteroids as first-line for distal disease: Topical mesalazine is more effective than topical steroids 1, 4

Safety and Monitoring

• Monitor renal function periodically due to rare risk of interstitial nephritis 1
• Approximately 85% of patients intolerant to sulfasalazine tolerate mesalazine well 7
• No gradual dose reduction needed when stopping mesalazine (unlike corticosteroids), but stopping may lead to relapse 2