Pediatric Omeprazole Dosing Guidelines
The recommended dosage of omeprazole for pediatric patients is 0.7-3.3 mg/kg/day, with specific weight-based dosing of 10 mg daily for children 10 to <20 kg and 20 mg daily for children ≥20 kg (ages 2-16 years). 1
FDA-Approved Dosing by Indication
For treatment of symptomatic GERD in children 2-16 years:
- 10 mg once daily for children weighing 10 to <20 kg
- 20 mg once daily for children weighing ≥20 kg
- Treatment duration: up to 4 weeks 1
For treatment of erosive esophagitis due to acid-mediated GERD in children 2-16 years:
- 10 mg once daily for children weighing 10 to <20 kg
- 20 mg once daily for children weighing ≥20 kg
- Treatment duration: 4-8 weeks 1
For maintenance of healing of erosive esophagitis in children 2-16 years:
- 10 mg once daily for children weighing 10 to <20 kg
- 20 mg once daily for children weighing ≥20 kg
- Treatment duration: controlled studies do not extend beyond 12 months 1
Dosing for Special Conditions
For eosinophilic esophagitis in children:
- Initial treatment: omeprazole 1 mg/kg twice daily (up to 40 mg twice daily)
- Treatment duration: 8-12 weeks before assessing histological response
- Maintenance therapy: 1 mg/kg/day (maximum 40 mg/day) 2
For severe or refractory GERD in infants under 2 years:
- Starting dose: 0.7 mg/kg/day
- May require dose escalation up to 1.4-2.8 mg/kg/day in divided doses
- Titrate based on clinical response and pH monitoring 3
Administration Instructions
- Administer omeprazole before meals 1
- For children unable to swallow capsules:
- Place one tablespoon of applesauce in a clean container
- Open the capsule and carefully empty all pellets onto the applesauce
- Mix the pellets with the applesauce
- Have child swallow immediately with water
- Do not chew or crush the pellets 1
Clinical Considerations
- Higher doses (1-2 mg/kg/day) may be required for infants and young children under 2 years of age 3
- For severe esophagitis refractory to H2-receptor antagonists, doses up to 3.3 mg/kg/day have been used effectively 4
- Omeprazole has demonstrated superior efficacy compared to H2-receptor antagonists for pediatric GERD 5
- Long-term use (>2.5 years) may be associated with enterochromaffin cell hyperplasia in up to 50% of children 5
Monitoring
- For long-term therapy, monitor for potential side effects including headaches, diarrhea, and nausea 5
- Consider monitoring gastrin levels in children on long-term therapy, as levels may become elevated to 3-5.5 times the upper limit of normal 4
- Reassess the need for continued therapy periodically, especially for maintenance treatment beyond 12 months 1
Common Pitfalls
- Underdosing in infants and young children - they often require higher mg/kg doses than older children 3
- Failure to administer properly - pellets must not be chewed or crushed as this destroys the enteric coating 1
- Not reassessing therapy - if no response after 8 weeks, consider an additional 4 weeks of treatment or alternative approaches 1
- Using adult dosing in children without appropriate weight-based adjustments 6