Recommended Dosage of Mesalamine for Treating Ulcerative Colitis
For patients with mild-to-moderate ulcerative colitis, the standard recommended dose of oral mesalamine is 2-3 grams per day, with dosing adjustments based on disease extent, severity, and response to treatment. 1
Oral Mesalamine Dosing by Disease Presentation
Initial Treatment
- For patients with extensive mild-moderate ulcerative colitis, use standard dose mesalamine (2-3 grams/day) or diazo-bonded 5-ASA rather than low dose mesalamine, sulfasalazine, or no treatment 1
- For induction of remission in adults, FDA recommends 2.4 g to 4.8 g (two to four 1.2-g tablets) once daily 2
- For maintenance of remission in adults, FDA recommends 2.4 g (two 1.2-g tablets) once daily 2
- Once-daily dosing is as effective as multiple times per day dosing and may improve adherence 1, 3
Suboptimal Response or Moderate Disease
- For patients with suboptimal response to standard-dose mesalamine or with moderate disease activity, use high-dose mesalamine (>3 grams/day) with rectal mesalamine 1, 4
- High-dose mesalamine (4.0 g/day) has shown 66% clinical improvement in patients who relapsed under low-dose maintenance therapy (1.5-2.25 g/day) 4
- High-dose mesalamine appears to have a similar safety profile as low dose and is not associated with greater risk of adverse events 5
Disease-Specific Recommendations
Extensive or Left-Sided Disease
- Add rectal mesalamine to oral 5-ASA therapy for better outcomes 1
- Combination of topical and oral therapy is more effective than either treatment alone 6
Proctosigmoiditis or Proctitis
- Use mesalamine enemas (or suppositories) rather than oral mesalamine alone 1
- For proctitis specifically, mesalamine suppositories (1 gram once daily) are strongly recommended over other formulations 6, 2
- For patients who choose rectal therapy over oral therapy, use mesalamine enemas rather than rectal corticosteroids 6
Treatment Escalation
- For patients refractory to optimized oral and rectal 5-ASA, add either oral prednisone or budesonide MMX 1
- For patients intolerant of or refractory to mesalamine suppositories, consider rectal corticosteroid therapy 1
Pediatric Dosing
- For pediatric patients weighing at least 24 kg who can swallow tablets whole 2:
- 24-35 kg: 2.4 g daily for weeks 0-8, then 1.2 g daily for maintenance
35-50 kg: 3.6 g daily for weeks 0-8, then 2.4 g daily for maintenance
50 kg: 4.8 g daily for weeks 0-8, then 2.4 g daily for maintenance
Administration Guidelines
- Evaluate renal function prior to initiation and periodically during therapy 2
- Swallow mesalamine delayed-release tablets whole; do not split or crush 2
- Administer mesalamine delayed-release tablets with food 2
- Ensure adequate fluid intake 2
Common Pitfalls to Avoid
- Not escalating to high-dose mesalamine (>3 g/day) when response to standard dose is suboptimal 1, 4
- Failing to combine oral and rectal therapy for better outcomes, especially in left-sided disease 1, 6
- Not considering once-daily dosing, which has similar efficacy to divided doses and may improve adherence 1, 3
- Inadequate monitoring for adverse events, particularly renal function 2, 5