What is the weight-based dose of omeprazole (proton pump inhibitor) for a baby?

Weight-Based Omeprazole Dosing for Infants

For infants under 2 years with GERD, start omeprazole at 0.7 mg/kg/day in divided doses, with dose escalation up to 1.4-2.8 mg/kg/day based on clinical response and pH monitoring when available. 1

Standard Dosing by Age and Weight

Infants Under 2 Years (Off-Label)

• Starting dose: 0.7 mg/kg/day divided into two doses 1, 2
• Dose escalation: Increase in increments of 0.7 mg/kg/day if inadequate response 1, 2
• Maximum dose: Up to 2.8 mg/kg/day in divided doses for severe or refractory cases 1, 2
• Clinical reality: Approximately 50% of infants require doses higher than the initial 0.7 mg/kg/day to achieve adequate acid control 1

Children 2-16 Years (FDA-Approved)

• Weight 10 to <20 kg: 10 mg once daily 1, 3
• Weight ≥20 kg: 20 mg once daily 1, 3
• Treatment duration: 4-8 weeks for erosive esophagitis; up to 4 weeks for symptomatic GERD 3

Preparation for Infants Unable to Swallow Capsules

Compounded suspension method: 1

• Mix omeprazole capsule pellets with applesauce immediately before administration 1, 3
• Alternatively, have a retail pharmacy compound a 6 mg/mL suspension 1
• For 3 mg daily dose: Administer 0.5 mL of 6 mg/mL suspension 1
• 30-day supply preparation: Two 20 mg capsules create approximately 6.7 mL of 6 mg/mL suspension (provides 40 mg total, sufficient for 13 days at 3 mg/day) 1

Special Considerations for Neonates and Premature Infants

Critical pharmacokinetic differences: 1, 4

• Infants have prolonged elimination half-lives (55-90 hours vs. 30 hours in adults) 1
• Neonates are "immature children" with developing drug elimination pathways, not simply small adults 4
• Premature infants: Weight-based dosing recommendations for term infants should NOT be extrapolated to premature infants due to immature renal function and risk of drug accumulation 5

Dosing for Eosinophilic Esophagitis (Higher Dose Indication)

• Initial treatment: 1 mg/kg twice daily (maximum 40 mg twice daily) 1
• Maintenance therapy: 1 mg/kg/day (maximum 40 mg/day) 1
• Treatment duration: 8-12 weeks before assessing histological response 1

Administration Timing and Instructions

• Timing: Administer before meals 3
• Capsule administration: Swallow whole; do not chew or crush 3
• For patients unable to swallow: Open capsule, mix pellets with one tablespoon of soft applesauce (not hot), swallow immediately with cool water without chewing pellets 3
• Antacids: May be used concomitantly 3

Monitoring and Dose Titration

Essential clinical approach: 1, 2

• Dose titration is essential based on clinical response 1
• pH monitoring, when available, guides optimal dosing 2
• Reassess after 14 days of therapy and adjust dose if symptoms persist 2
• Long-term use (>2.5 years) may be associated with enterochromaffin cell hyperplasia in up to 50% of children 1

Evidence Quality and Clinical Caveats

Important limitations: 6

• Very low-certainty evidence exists for omeprazole efficacy in infants based on Cochrane review 6
• One study showed omeprazole may provide no additional benefit over placebo for cry/fuss time in infants 3-12 months (mean difference 10 minutes/day lower, 95% CI -89.1 to 69.1) 6
• Despite limited evidence, omeprazole remains widely used when nonmedical interventions fail 6

Alternative routes: 7

• Rectal omeprazole at 1 mg/kg results in similar serum exposure and efficacy as oral administration in infants with pathological GERD 7
• This may be considered when oral administration is challenging 7