What is the recommended pediatric omeprazole dose, including weight‑based dosing and maximum limits for infants under 1 year and children over 1 year?

Omeprazole Dosing for Pediatric Patients

For children aged 2-16 years with GERD or erosive esophagitis, the American Academy of Pediatrics recommends 10 mg once daily for those weighing 10 to <20 kg and 20 mg once daily for those weighing ≥20 kg. 1

Age-Specific Dosing Guidelines

Infants Under 1 Year

• Omeprazole should be reserved only for documented erosive esophagitis or severe, refractory GERD symptoms in this age group 1
• Start with 0.7 mg/kg/day for severe or refractory GERD 1
• Approximately 50% of infants require dose escalation; titrate up to 1.4-2.8 mg/kg/day in divided doses based on clinical response 1, 2
• Critical caveat: Do NOT extrapolate weight-based dosing to premature infants due to immature renal function and prolonged elimination half-lives (55-90 hours vs. 30 hours in adults) 1
• Avoid routine use in uncomplicated reflux: Placebo-controlled trials show no benefit over placebo for reducing irritability in infants with uncomplicated reflux 1
• Safety concern: Acid suppression in infants increases risk of lower respiratory tract infections (OR 6.56,95% CI 1.18-26.25) 3

Children 2-16 Years (Standard GERD/Erosive Esophagitis)

• Weight 10 to <20 kg: 10 mg once daily 1
• Weight ≥20 kg: 20 mg once daily 1
• Omeprazole demonstrates superior efficacy compared to H2-receptor antagonists for healing erosive esophagitis and symptom relief 1

Eosinophilic Esophagitis (All Pediatric Ages)

• Initial treatment: 1 mg/kg twice daily (maximum 40 mg twice daily) 1
• Maintenance therapy: 1 mg/kg/day (maximum 40 mg/day) 1
• Higher dosing regimens (20 mg twice daily or equivalent) show superior response rates (50.8%) compared to standard doses (35.8%) 1
• Treat for 8-12 weeks before assessing histological response 1

Administration Techniques

For Children Unable to Swallow Capsules

• Mix pellets from capsules with applesauce 1
• Alternative: Compound into a 6 mg/mL suspension by retail pharmacy 1
• Example for 3 mg daily dose: Administer 0.5 mL of 6 mg/mL suspension 1

Dose Titration Strategy

The majority of children respond to initial dosing, but individualized titration is essential:

• Start at recommended weight-based dose 1
• If inadequate response after 2 weeks, increase by 0.7 mg/kg/day increments 2
• Maximum doses up to 3.5 mg/kg/day have been used safely in clinical studies 4, 5
• The healing dose correlates with severity of esophagitis but not with age or underlying disease 5

Long-Term Safety Monitoring

For therapy exceeding 2.5 years, monitor for:

• Enterochromaffin cell hyperplasia (occurs in up to 50% of children) 1
• Common adverse effects: headache, diarrhea, constipation, nausea (approximately 14% overall incidence) 1
• Increased risk of lower respiratory tract infections, particularly in infants 1

Clinical Decision Algorithm

1. Confirm diagnosis of GERD or erosive esophagitis (endoscopy when indicated) 3
2. For infants <1 year: Implement lifestyle modifications first (smaller frequent feedings, thickening formula, positioning); consider H2-receptor antagonists (famotidine 1 mg/kg/day divided in 2 doses) before PPIs 3
3. For children ≥2 years: Use weight-based dosing as outlined above 1
4. For eosinophilic esophagitis: Use higher dosing regimen (1 mg/kg twice daily) 1
5. Reassess at 8-12 weeks with endoscopy for erosive disease or eosinophilic esophagitis 1
6. Note: Relapse occurs in approximately 60% of patients after discontinuation, so maintenance therapy may be necessary 6