Pediatric Ulcerative Colitis—Mesalazine (5-aminosalicylic acid) Weight-Based Dosing
Oral mesalamine is recommended for mild-to-moderate pediatric ulcerative colitis at 50–70 mg/kg/day, with escalation up to 100 mg/kg/day (maximum 4.8 g/day). [1] Rectal mesalamine is recommended for pediatric distal ulcerative colitis/proctitis at 25 mg/kg (maximum 1 g/day). [1]
Oral Mesalamine (Oral Mesalazine) Dosing
- 50–70 mg/kg/day by mouth in 2 divided doses is recommended for induction and is within typical dosing targets for pediatric mild-to-moderate ulcerative colitis. [1]
- Dosing may be escalated up to 100 mg/kg/day by mouth for adequate disease control, with a maximum of 4.8 g/day. [1]
Rectal Mesalamine (Rectal Mesalazine) Dosing
- 25 mg/kg per day rectally is recommended for distal disease, with a maximum of 1 g/day. [1]
Practical Weight-Based Dose Ranges
- Oral (mg/kg/day): multiply patient weight (kg) by 50–70 to obtain the usual daily dose range, with an upper cap at 100 mg/kg/day and 4.8 g/day. [1]
- Rectal (mg/day): multiply patient weight (kg) by 25 to obtain the usual daily dose range, with a maximum cap at 1 g/day. [1]
Formulation Notes
- Weight-based dosing recommendations apply to mesalamine/mesalazine products used for ulcerative colitis induction and are presented as daily dose targets rather than product-specific fixed tablet/suppository counts. [1]
- When rectal therapy is used, the total daily rectal dose target is 25 mg/kg/day with an upper limit of 1 g/day across rectal formulations used in clinical practice. [1]
Source for Dose Selection in Pediatric Care
- The European Society of Paediatric Gastroenterology, Hepatology and Nutrition and European Crohn’s and Colitis Organisation evidence-based consensus guideline provides the weight-based oral and rectal mesalamine dosing ranges used for ambulatory pediatric ulcerative colitis. [1]