What is the appropriate weight‑based dosing regimen for omeprazole in pediatric patients, including maximum daily dose, age considerations, and administration guidelines?

Pediatric Omeprazole Dosing

For children aged 2-16 years with GERD or erosive esophagitis, administer omeprazole 10 mg once daily for those weighing 10 to <20 kg, and 20 mg once daily for those weighing ≥20 kg, taken before meals. 1

FDA-Approved Weight-Based Dosing by Indication

Symptomatic GERD (Ages 2-16 years)

• 10 to <20 kg: 10 mg once daily for up to 4 weeks 1
• ≥20 kg: 20 mg once daily for up to 4 weeks 1

Erosive Esophagitis (Ages 2-16 years)

• 10 to <20 kg: 10 mg once daily for 4-8 weeks 1
• ≥20 kg: 20 mg once daily for 4-8 weeks 1
• If no response after 8 weeks, an additional 4 weeks may be given 1

Maintenance of Healing (Ages 2-16 years)

• 10 to <20 kg: 10 mg once daily 1
• ≥20 kg: 20 mg once daily 1
• Controlled studies do not extend beyond 12 months 1

Dosing for Infants and Children <2 Years

For infants under 2 years with severe or refractory GERD, start with 0.7 mg/kg/day in divided doses, and titrate up to 1.4-2.8 mg/kg/day based on clinical response and pH monitoring when available. 2, 3

Initial Dosing Strategy

• Start at 0.7 mg/kg/day divided into 2 doses 2, 3
• Approximately 50% of infants require doses higher than 0.7 mg/kg/day for adequate acid control 2
• Titrate in increments of 0.7 mg/kg/day every 14 days based on symptoms and pH monitoring 3
• Maximum studied dose: 2.8 mg/kg/day 2, 3

Critical Caveat for Premature Infants

Do NOT extrapolate weight-based dosing to premature infants due to immature renal function and risk of drug accumulation. 2 Premature infants have prolonged elimination half-lives (55-90 hours vs. 30 hours in adults) requiring specialized dosing considerations 2

Special Condition: Eosinophilic Esophagitis

For eosinophilic esophagitis in children, initiate treatment with 1 mg/kg twice daily (maximum 40 mg twice daily) for 8-12 weeks before assessing histological response. 2

Dosing Regimen

• Initial treatment: 1 mg/kg twice daily (up to 40 mg twice daily) 2
• Maintenance: 1 mg/kg/day (maximum 40 mg/day) 2
• Higher dosing (20 mg twice daily or equivalent) demonstrates superior response rates (50.8%) compared to standard doses (35.8%) 2
• Treatment duration should be 8-12 weeks before assessing response 2

Administration Instructions

For Children Who Can Swallow Capsules

• Swallow capsules whole before meals 1
• Do not chew or crush 1
• Antacids may be used concomitantly 1

For Children Unable to Swallow Capsules

Mix the pellets from the capsule with one tablespoon of applesauce and swallow immediately without chewing. 1

1. Place one tablespoon of applesauce (not hot, soft enough to swallow without chewing) into a clean container 1
2. Open the capsule and carefully empty all pellets onto the applesauce 1
3. Mix pellets with applesauce 1
4. Swallow immediately with a glass of cool water 1
5. Do not chew or crush the pellets 1
6. Do not save for future use 1

Compounded Suspension for Infants

For infants requiring liquid formulation, prepare a 6 mg/mL suspension by compounding at a retail pharmacy or mixing pellets with applesauce. 2

• Commercial suspension can be compounded to 6 mg/mL concentration 2
• For a 3 mg daily dose: administer 0.5 mL of 6 mg/mL suspension 2
• A 30-day supply can be prepared using two 20 mg capsules to create approximately 6.7 mL of suspension 2

Comparative Efficacy and Safety Considerations

Superiority Over H2-Receptor Antagonists

Omeprazole demonstrates superior efficacy compared to H2-receptor antagonists for healing erosive esophagitis and symptom relief in pediatric GERD 4

Long-Term Safety Concerns

• Enterochromaffin cell hyperplasia may occur in up to 50% of children receiving PPIs for >2.5 years 4, 2
• Common adverse effects include headaches, diarrhea, constipation, and nausea in up to 14% of patients 4, 2
• Acid suppression may increase risk of lower respiratory tract infections, particularly in infants 4

Important Clinical Pitfall

Avoid overuse in infants with uncomplicated reflux—placebo-controlled trials show no superiority of PPIs over placebo for reducing irritability in infants. 4 Reserve omeprazole for documented erosive esophagitis or severe refractory symptoms 4

Missed Dose Instructions

• If a dose is missed, administer as soon as possible 1
• If the next scheduled dose is due, skip the missed dose 1
• Do not take two doses at one time 1

Monitoring Recommendations

For long-term therapy (>2.5 years), monitor for potential adverse effects including headaches, diarrhea, nausea, and consider periodic assessment for enterochromaffin cell hyperplasia 2