Esomeprazole Dosing in Pediatric Patients
Recommended Weight-Based Dosing for GERD and Erosive Esophagitis
For children aged 1-11 years with GERD or erosive esophagitis, administer esomeprazole 10 mg once daily for those weighing 10 to <20 kg and 20 mg once daily for those weighing ≥20 kg. 1
Standard Dosing Algorithm by Weight and Age
Children 1-11 years with GERD:
Adolescents 12-17 years:
- 20 mg or 40 mg once daily depending on severity 2
Infants Under 1 Year
For infants 1-11 months, weight-adjusted dosing ranges from 2.5-10 mg once daily, though efficacy data are limited in this age group 3. The discontinuation rate due to symptom worsening did not differ significantly between esomeprazole and placebo in the overall infant population, though a post-hoc analysis suggested benefit in symptomatic GERD without diagnostic procedures 3.
Special Indication: Eosinophilic Esophagitis
For eosinophilic esophagitis, the dosing strategy differs significantly from standard GERD treatment:
- Initial treatment: 1 mg/kg twice daily (maximum 40 mg twice daily) 1
- Maintenance therapy: 1 mg/kg/day (maximum 40 mg/day) 1
The twice-daily regimen provides anti-inflammatory effects beyond simple acid suppression, which is critical for this condition 1.
Administration Guidelines
Timing and method of administration significantly impact efficacy:
- Administer approximately 30 minutes before meals for optimal acid suppression 1
- For children unable to swallow capsules, open the capsule and mix pellets with applesauce 1
- Do not crush or chew the pellets as this destroys the enteric coating 1
Pharmacokinetic Considerations
Esomeprazole pharmacokinetics are both dose-proportional and age-dependent in children 4. Younger children (1-5 years) demonstrate approximately 50% higher body-weight-normalized clearance compared to older children (6-11 years), suggesting more rapid metabolism per kilogram in younger patients 4. Despite these differences, the weight-based dosing strategy effectively achieves therapeutic exposure similar to adults 2.
Safety Profile and Long-Term Monitoring
Common adverse effects include:
Critical long-term safety concern:
- Long-term use exceeding 2.5 years may cause enterochromaffin cell hyperplasia in up to 50% of children 1
- This necessitates periodic reassessment of the need for continued therapy beyond 2.5 years 1
Efficacy Data
Esomeprazole demonstrates robust efficacy in pediatric populations. In children aged 1-11 years with erosive esophagitis, 89% experienced complete erosion resolution after 8 weeks of treatment 6. Symptom improvement occurs rapidly, with significant reductions in heartburn, acid regurgitation, and epigastric pain within the first 2 weeks of therapy 5.