What is the mg/kg dosage of omeprazole (proton pump inhibitor) for pediatric patients?

Pediatric Omeprazole Dosing Guidelines

The recommended dosage of omeprazole for pediatric patients is weight-based: 0.7-3.3 mg/kg/day, with specific FDA-approved dosing of 10 mg daily for children weighing 10 to <20 kg and 20 mg daily for children ≥20 kg aged 2-16 years. 1, 2

FDA-Approved Dosing by Weight and Indication

• For treatment of symptomatic GERD in children 2-16 years:

  • 10 mg once daily for children weighing 10 to <20 kg 2, 1
  • 20 mg once daily for children weighing ≥20 kg 2, 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 2, 1
  • 20 mg once daily for children weighing ≥20 kg 2, 1

Dosing for Special Conditions

• For eosinophilic esophagitis in children:

  • Initial treatment: 1 mg/kg twice daily (maximum 40 mg twice daily) 3, 2
  • Maintenance therapy: 1 mg/kg/day (maximum 40 mg/day) 2

• For severe or refractory GERD:

  • Starting dose: 0.7 mg/kg/day 2, 4
  • Dose may be escalated up to 1.4-2.8 mg/kg/day in divided doses if needed 2, 4

• For infants under 2 years with severe GERD (off-label use):

  • Starting dose: 0.7 mg/kg/day 2, 4
  • May require dose titration based on clinical response 4

Dosing Based on Clinical Evidence

• Clinical studies have shown effectiveness with dosages ranging from 0.7-3.3 mg/kg/day (mean 1.9 mg/kg/day) for treatment of severe reflux esophagitis in children 4

• For children with severe esophagitis who failed treatment with H2-receptor antagonists, effective dosing has been:

  • 20 mg daily for children <30 kg 5
  • 40 mg daily for children ≥30 kg 5

Administration Instructions

• Omeprazole should be taken before meals 1
• For children unable to swallow capsules:
  • Open the capsule and mix pellets with one tablespoon of applesauce 1, 2
  • Ensure the applesauce is not hot 1
  • Have the child swallow the mixture immediately without chewing 1
  • Follow with a glass of cool water 1
  • Do not save the mixture for future use 1

Treatment Duration

• For symptomatic GERD: Up to 4 weeks 1
• For erosive esophagitis: 4-8 weeks 1
• For maintenance of healing of erosive esophagitis: Controlled studies do not extend beyond 12 months 1

Monitoring and Safety Considerations

• Monitor for potential side effects including headaches, diarrhea, and nausea 2
• Long-term use (>2.5 years) may be associated with enterochromaffin cell hyperplasia in up to 50% of children 2, 6

Clinical Pearls

• Omeprazole has demonstrated superior efficacy compared to H2-receptor antagonists for pediatric GERD 2, 6
• For critically ill pediatric patients requiring stress ulcer prophylaxis, nasogastric administration of omeprazole suspension has shown variable efficacy, with some patients requiring significant dose adjustments or not responding at all 7
• Suspension formulation (2 mg/ml prepared with sodium bicarbonate) shows comparable blood levels to granule formulation in pediatric patients 8