What are the recommended omeprazole doses for children of different ages and weights for treating gastro‑esophageal reflux disease or ulcer disease?

Omeprazole Pediatric Dosing

For children aged 2–16 years with GERD or erosive esophagitis, give omeprazole 10 mg once daily if weight is 10 to <20 kg, or 20 mg once daily if weight ≥20 kg, administered 30 minutes before meals for 4–8 weeks. 1

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FDA-Approved Weight-Based Dosing (Ages 2–16 Years)

Standard dosing by indication:

• Symptomatic GERD:

  • 10–<20 kg: 10 mg once daily for up to 4 weeks 2, 1
  • ≥20 kg: 20 mg once daily for up to 4 weeks 2, 1

• Erosive esophagitis (EE) due to acid-mediated GERD:

  • 10–<20 kg: 10 mg once daily for 4–8 weeks 2, 1
  • ≥20 kg: 20 mg once daily for 4–8 weeks 2, 1

• Maintenance of healing of EE:

  • Same weight-based doses (10 mg or 20 mg once daily); controlled studies do not extend beyond 12 months 1

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Dosing for Infants and Children <2 Years (Off-Label)

Omeprazole should NOT be used routinely in infants with uncomplicated reflux ("happy spitters"), as placebo-controlled trials show no benefit over placebo and significantly increased risk of lower respiratory tract infections. 2, 3

Reserve omeprazole for infants with documented erosive esophagitis or severe, refractory GERD after failure of conservative measures (feeding modifications, maternal diet elimination, thickened formula, upright positioning). 2, 3

When indicated in infants <2 years:

• Starting dose: 0.7 mg/kg/day in 2 divided doses 2, 4
• Dose escalation: Up to 1.4–2.8 mg/kg/day in divided doses if inadequate response after 2 weeks, guided by clinical symptoms and pH monitoring when available 2, 4
• Approximately 50% of infants require doses >0.7 mg/kg/day to achieve adequate acid control 2

Critical caveat: Do NOT extrapolate weight-based dosing to premature infants due to immature renal function and risk of drug accumulation 2

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Special Condition: Eosinophilic Esophagitis

Initial treatment: 1 mg/kg twice daily (maximum 40 mg twice daily) for 8–12 weeks 2

Maintenance therapy: 1 mg/kg/day (maximum 40 mg/day) 2

Higher-dose regimens (20 mg twice daily or equivalent) demonstrate superior histologic response rates (50.8%) compared to standard doses (35.8%) 2

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Administration Instructions

Timing: Administer 30 minutes before meals for optimal acid suppression 5

For children unable to swallow capsules: 2, 1

1. Place 1 tablespoon of room-temperature applesauce in a clean container
2. Open capsule and empty all pellets onto applesauce
3. Mix pellets with applesauce
4. Swallow immediately with cool water without chewing or crushing pellets
5. Do not save mixture for later use

Alternative for infants: Compound a 6 mg/mL suspension from omeprazole capsules (prepared by retail pharmacy); for a 3 mg daily dose, administer 0.5 mL daily 2

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Treatment Duration and Monitoring

Standard course: 4–8 weeks for erosive esophagitis 1

If no response after 8 weeks: Consider additional 4-week course, then reassess diagnosis and refer to pediatric gastroenterology 2, 1

Recurrent symptoms: Additional 4–8 week courses may be given, but do not continue beyond 4–8 weeks without specialist consultation 5

Long-term monitoring (>2.5 years): Watch for enterochromaffin cell hyperplasia (occurs in up to 50% of children), headaches, diarrhea, constipation, and nausea 2

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Clinical Decision Algorithm

Step 1 – Initial assessment:
Confirm GERD diagnosis with clear symptoms (recurrent regurgitation with distress, heartburn, dysphagia, feeding refusal, poor weight gain) and rule out red-flag signs (bilious vomiting, GI bleeding, fever, abdominal distension) 5

Step 2 – Conservative measures (2–4 weeks):
For infants: smaller/more frequent feedings, thickened formula (if formula-fed), maternal elimination diet (milk/egg if breastfeeding), extensively hydrolyzed or amino acid formula trial, upright positioning when awake and supervised 2, 3

Step 3 – Pharmacotherapy criteria:
Initiate omeprazole ONLY if symptoms persist despite Step 2 AND complications are present (erosive esophagitis, failure to thrive, respiratory symptoms attributable to reflux) 2

Step 4 – Dose selection:

• Ages 2–16 years: Use FDA weight-based dosing (10 mg if <20 kg; 20 mg if ≥20 kg) 1
• Ages <2 years: Start 0.7 mg/kg/day divided twice daily; escalate to 1.4–2.8 mg/kg/day if needed 2, 4

Step 5 – Reassessment:
Evaluate response after 4–8 weeks; discontinue if no clear benefit or refer to pediatric gastroenterology 2, 5

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Common Pitfalls to Avoid

Do NOT prescribe omeprazole for:

• Uncomplicated infant reflux ("happy spitters") thriving without distress—most resolve spontaneously by 12 months 2, 3
• Chronic cough without clear GERD symptoms (heartburn, regurgitation, epigastric pain) 5
• Infants solely for irritability—placebo-controlled trials show no benefit and 6.56-fold increased odds of lower respiratory tract infections 3

Do NOT combine omeprazole with H2-receptor antagonists (famotidine, ranitidine)—no evidence of improved outcomes and increases medication burden 5

Do NOT continue therapy beyond 4–8 weeks without re-evaluating diagnosis and considering specialist referral 2, 5

Do NOT use adult dosing extrapolated to children—pediatric patients require higher per-kilogram doses (0.7–3.5 mg/kg/day) than adults 6, 7

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Comparative Efficacy

Omeprazole demonstrates superior healing of erosive esophagitis and greater symptom relief compared to H2-receptor antagonists (famotidine, ranitidine) in children with GERD 2, 5

H2-receptor antagonists develop tachyphylaxis (loss of effect) within 6 weeks, limiting long-term efficacy 5

For refractory cases on H2-receptor antagonists, switch to omeprazole rather than adding a second acid suppressor 5