What is the recommended omeprazole dosage for children based on age, weight, and indication (e.g., gastro‑esophageal reflux disease, ulcer disease, erosive esophagitis, or Helicobacter pylori infection)?

Pediatric Omeprazole Dosing

For children aged 2-16 years with GERD or erosive esophagitis, use weight-based dosing: 10 mg once daily for children weighing 10 to <20 kg, and 20 mg once daily for children weighing ≥20 kg. 1

Standard Dosing by Age and Weight

Children 2-16 Years (FDA-Approved)

• Weight 10 to <20 kg: Omeprazole 10 mg once daily 1
• Weight ≥20 kg: Omeprazole 20 mg once daily 1
• These doses apply to both symptomatic GERD and erosive esophagitis 1

Infants and Children <2 Years (Off-Label)

• Initial dose: 0.7 mg/kg/day in divided doses 1, 2, 3
• Dose escalation: Up to 1.4-2.8 mg/kg/day may be required for adequate acid control 1, 3
• Important caveat: Approximately 50% of infants require doses higher than the initial 0.7 mg/kg/day 1
• Critical warning: Do NOT extrapolate term infant dosing to premature infants due to immature renal function and risk of drug accumulation 1

Indication-Specific Dosing

Eosinophilic Esophagitis

• 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
• Evidence for higher dosing: The higher-dose regimen (20 mg twice daily or equivalent) demonstrates superior response rates (50.8%) compared to standard doses (35.8%) 1

Severe or Refractory GERD

• Older children and adolescents: Doses of 0.7-3.5 mg/kg/day have been used successfully 2
• Dose correlation: Required healing dose correlates with severity of esophagitis, not with age or underlying disease 2
• Distribution of effective doses: 44% of children respond to 0.7 mg/kg/day, another 28% require 1.4 mg/kg/day 2

Administration Instructions

For Children Unable to Swallow Capsules

• Mix pellets with applesauce immediately before administration 1
• Compounded suspension: Can be prepared as 6 mg/mL suspension by retail pharmacy 1
• Example for 3 mg daily dose: Administer 0.5 mL of 6 mg/mL suspension 1

Timing

• Administer approximately 30 minutes before meals for optimal acid suppression 4

Clinical Decision Algorithm

Step 1: Determine Age and Severity

• Infants <1 year with uncomplicated reflux: Do NOT use omeprazole—placebo-controlled trials show no benefit over placebo for reducing irritability, and acid suppression increases risk of lower respiratory tract infections 1, 5
• Children 2-16 years with documented GERD or erosive esophagitis: Proceed with weight-based dosing 1

Step 2: Initial Therapy Selection

• Mild-moderate GERD in children ≥2 years: Start with standard weight-based dosing (10 mg if <20 kg, 20 mg if ≥20 kg) 1
• Severe erosive esophagitis: May require higher doses; start with 0.7-1.4 mg/kg/day 2, 3
• Eosinophilic esophagitis: Start with 1 mg/kg twice daily 1

Step 3: Response Assessment and Dose Titration

• Reassess after 2-4 weeks of therapy 4
• If inadequate response: Increase dose incrementally by 0.7 mg/kg/day 3
• Maximum treatment duration without reassessment: 4-8 weeks 4

Step 4: Long-Term Management

• Attempt discontinuation after initial 4-8 week course 4
• If symptoms recur: Consider additional 4-8 week courses with reassessment after each 4
• For chronic therapy >2.5 years: Monitor for enterochromaffin cell hyperplasia (occurs in up to 50% of children) 1

When Omeprazole Should NOT Be Used

Absolute Contraindications to Routine Use

• "Happy spitters" (physiologic reflux) who are thriving—most resolve spontaneously by 12 months 4
• Infants with uncomplicated reflux without erosive esophagitis—no proven benefit and increased infection risk 1, 5
• Chronic cough without clear GERD symptoms (recurrent regurgitation, heartburn, epigastric pain) 4

Red-Flag Signs Requiring Further Evaluation (Not Omeprazole)

• Bilious vomiting 4
• GI bleeding 4
• Forceful/projectile vomiting 4
• Fever with vomiting 4
• Abdominal distension 4
• Poor weight gain or failure to thrive (requires evaluation before treatment) 4

Comparative Efficacy

Omeprazole vs. H2-Receptor Antagonists

• Omeprazole provides superior healing of erosive esophagitis and greater symptom relief compared to H2-receptor antagonists (ranitidine, famotidine) in children 1, 4
• H2-antagonists develop tachyphylaxis within 6 weeks, limiting long-term efficacy 4
• Sequential therapy is preferred: Switch from H2RA to PPI if inadequate response after 2-4 weeks, rather than combining agents 4

Safety Considerations and Monitoring

Common Adverse Effects

• Headache, diarrhea, constipation, and nausea occur in approximately 14-25% of pediatric patients on prolonged therapy 1

Serious Long-Term Risks

• Lower respiratory tract infections: Significantly increased risk, particularly in infants (6.56-fold increased odds with lansoprazole) 1, 5
• Enterochromaffin cell hyperplasia: Occurs in up to 50% of children receiving PPIs for >2.5 years 1
• Other infection risks: Community-acquired pneumonia, gastroenteritis, and candidemia 4

Monitoring Recommendations

• For long-term therapy: Monitor for headaches, diarrhea, nausea, and respiratory infections 1
• Reassess necessity after each 4-8 week treatment course 4
• Consider referral to pediatric gastroenterology for refractory cases or need for chronic therapy 4

Common Pitfalls to Avoid

• Do NOT prescribe omeprazole for uncomplicated infant reflux or "fussiness" without clear GERD symptoms—this exposes infants to unnecessary infection risk without proven benefit 5
• Do NOT combine H2-receptor antagonists with PPIs in initial therapy—no evidence supports improved outcomes and it increases medication burden 4
• Do NOT continue therapy beyond 4-8 weeks without specialist consultation and re-evaluation of diagnosis 4, 5
• Do NOT use adult dosing extrapolated to children—children require higher per-kilogram doses than adults (0.7-3.5 mg/kg/day vs. 20-40 mg/day in adults) 2
• Do NOT delay appropriate therapy in children with warning signs such as poor weight gain or recurrent vomiting 4