What is the recommended dose of omeprazole (proton pump inhibitor) in mg/kg for a 3-year-old child weighing 14-15 kg?

Omeprazole Dosing for a 3-Year-Old Child

For a 3-year-old child weighing 14-15 kg with symptomatic GERD or erosive esophagitis, administer omeprazole 10 mg once daily before meals. 1, 2

Standard FDA-Approved Dosing

The FDA-approved weight-based dosing for children aged 2-16 years is straightforward:

• Children weighing 10 to <20 kg: 10 mg once daily 2
• Children weighing ≥20 kg: 20 mg once daily 2

Since your patient weighs 14-15 kg, they fall squarely in the 10 mg once daily category for both symptomatic GERD and erosive esophagitis treatment. 1, 2

Treatment Duration and Monitoring

• Initial treatment course: 4-8 weeks for erosive esophagitis 2
• For symptomatic GERD without esophagitis: up to 4 weeks 2
• If inadequate response after 8 weeks, an additional 4-week course may be considered 2

Dose Escalation for Refractory Cases

If the standard 10 mg daily dose proves insufficient (which occurs in approximately 50% of cases requiring higher doses), consider escalation: 3, 4

• Escalate to 0.7-1.4 mg/kg/day in divided doses for severe or refractory GERD 1, 3
• For a 14-15 kg child, this translates to approximately 10-20 mg daily total 4
• Some children may require up to 2.8 mg/kg/day (approximately 40 mg daily for this weight) 1, 4

For eosinophilic esophagitis specifically, use 1 mg/kg twice daily (approximately 15 mg twice daily for this child, maximum 40 mg/day total) 1

Administration Instructions

For children unable to swallow capsules: 2

• Open the capsule and mix pellets with 1 tablespoon of applesauce (not hot, soft enough to swallow without chewing)
• Swallow immediately with cool water
• Do not chew or crush the pellets
• Do not save mixture for later use

Alternatively, a compounded 6 mg/mL suspension can be prepared by a retail pharmacy. 1

Important Clinical Considerations

Common pitfalls to avoid:

• Do not extrapolate adult dosing to children—always use weight-based pediatric dosing 1
• Administer before meals for optimal efficacy 2
• Antacids may be used concomitantly without interaction 2

Monitoring for adverse effects: 1, 5

• Common side effects include headaches, diarrhea, constipation, and nausea (up to 14% of children) 5
• Long-term use (>2.5 years) may cause enterochromaffin cell hyperplasia in up to 50% of children 1
• Elevated gastrin levels occur but clinical significance in children remains unclear 6

Evidence quality note: While the FDA label and American Academy of Pediatrics guidelines provide clear weight-based dosing, the supporting research evidence is of very low certainty, with most studies showing omeprazole may or may not provide benefit over placebo in infants. 7 However, in older children with documented erosive esophagitis or severe symptoms, clinical experience supports efficacy at these doses. 8, 6