What is the recommended dose of esomeprazole (proton pump inhibitor) for pediatric patients?

Esomeprazole Dosing in Pediatric Patients

For children aged 1-11 years with GERD, esomeprazole should be dosed at 10 mg once daily for those weighing 10 to <20 kg and 20 mg once daily for those weighing ≥20 kg, with higher doses of 0.5-1.0 mg/kg/day used for infants 1-11 months and up to 1 mg/kg twice daily for eosinophilic esophagitis. 1, 2, 3

Weight-Based Dosing for GERD and Erosive Esophagitis (Ages 1-11 Years)

Standard dosing follows a two-tier weight-based approach:

• Children weighing 10 to <20 kg: 10 mg once daily 1
• Children weighing ≥20 kg: 20 mg once daily 1

This dosing strategy has demonstrated 89% erosion resolution rates in children with erosive esophagitis, translating to approximately 0.2-1.0 mg/kg daily 3. The treatment duration is typically 8 weeks for initial therapy 2, 3.

Infant Dosing (Ages 1-11 Months)

For infants with GERD, weight-adjusted dosing is more granular:

• 2.5-10 mg once daily based on individual weight 4
• Alternatively, 0.5 mg/kg for infants 0-1 month and 1.0 mg/kg for infants 1-11 months when using intravenous formulation 5

The evidence shows symptom improvement in 82.7% of infants during open-label treatment, though diagnostic criteria remain challenging in this age group 4.

Dosing for Eosinophilic Esophagitis

For children with eosinophilic esophagitis, substantially higher doses are required:

• Initial treatment: 1 mg/kg twice daily (maximum 40 mg twice daily) 1
• Maintenance therapy: 1 mg/kg/day (maximum 40 mg/day) 1

This represents a critical distinction from standard GERD dosing, as the twice-daily regimen at 1 mg/kg provides the anti-inflammatory effects needed beyond simple acid suppression 6.

Dosing for Adolescents (Ages 12-17 Years)

• 20 mg or 40 mg once daily 5
• The higher 40 mg dose achieved mean AUC of 17.6 μmol·h/L and Cmax of 10.5 μmol/L, demonstrating dose-proportional pharmacokinetics 5

Age-Related Pharmacokinetic Considerations

Younger children (1-5 years) demonstrate approximately 50% higher weight-normalized clearance compared to older children (6-11 years), meaning they metabolize esomeprazole more rapidly per kilogram of body weight 7. Despite this, the standard weight-based dosing adequately compensates for these differences, as evidenced by the 2-fold increase in AUC and Cmax when doubling the dose within each age group 7.

Administration Instructions

For children unable to swallow capsules:

• Mix pellets with applesauce for oral administration 1
• Administer approximately 30 minutes before meals for optimal acid suppression 8

Safety Profile

Esomeprazole demonstrates excellent tolerability in pediatric populations:

• Only 9.3% of patients reported treatment-related adverse events in clinical trials 2
• Most common side effects: diarrhea (2.8%), headache (1.9%), and somnolence (1.9%) 2
• Important caveat: Long-term use exceeding 2.5 years may cause enterochromaffin cell hyperplasia in up to 50% of children 1

Clinical Algorithm for Dose Selection

1. Determine indication: Standard GERD/erosive esophagitis versus eosinophilic esophagitis
2. For standard GERD (ages 1-11 years): Use weight-based dosing (10 mg if <20 kg; 20 mg if ≥20 kg) 1
3. For infants (1-11 months): Start with 2.5-10 mg weight-adjusted dosing 4
4. For eosinophilic esophagitis: Use 1 mg/kg twice daily initially, then reduce to once daily for maintenance 1
5. For adolescents (12-17 years): Use 20-40 mg once daily based on severity 5

Critical pitfall to avoid: Do not use standard GERD dosing for eosinophilic esophagitis, as the pathophysiology requires higher doses for anti-inflammatory effects beyond acid suppression 6, 1.