What is the recommended dosage and treatment regimen of omeprazole (proton pump inhibitor) for pediatric patients with Gastroesophageal Reflux Disease (GERD)?

Omeprazole Dosing for Pediatric GERD

For pediatric patients aged 2-16 years with GERD, omeprazole should be dosed at 10 mg once daily for children weighing 10 to <20 kg, and 20 mg once daily for children ≥20 kg, administered 30 minutes before meals for 4-8 weeks. 1

Age-Appropriate Dosing Strategy

FDA-Approved Dosing (Ages 2-16 years)

• Weight 10 to <20 kg: 10 mg once daily 1
• Weight ≥20 kg: 20 mg once daily 1
• Treatment duration: 4-8 weeks for erosive esophagitis; up to 4 weeks for symptomatic GERD 1
• Administration timing: 30 minutes before meals for optimal acid suppression 2, 1

Dosing for Refractory Cases

• If inadequate response after 8 weeks, an additional 4 weeks may be given 1
• For severe or refractory esophagitis, doses up to 0.7-3.3 mg/kg/day have demonstrated effectiveness 2, 3
• In children under 2 years (off-label use), dose-finding studies suggest starting at 0.7 mg/kg/day divided twice daily, with potential escalation up to 2.8 mg/kg/day if needed 4

Administration Considerations

For Children Who Cannot Swallow Capsules

• Open the delayed-release capsule and mix pellets with one tablespoon of applesauce 1
• Swallow immediately without chewing the pellets, followed by cool water 1
• Do not save the mixture for later use 1

Maintenance Therapy

• For maintenance of healed erosive esophagitis: 10 mg daily (10 to <20 kg) or 20 mg daily (≥20 kg) 1
• Controlled studies do not extend beyond 12 months 1
• Omeprazole is preferred over H2-receptor antagonists for long-term management due to tachyphylaxis issues with H2 blockers 2

Clinical Decision Algorithm

Initial Treatment Selection

1. Mild, intermittent GERD symptoms: Consider H2-receptor antagonist (famotidine 1 mg/kg/day divided twice daily) as first-line 2
2. Moderate to severe symptoms or erosive esophagitis: Start omeprazole at weight-based dosing 2, 1
3. Refractory to H2-blocker after 2-4 weeks: Switch to omeprazole 2

Treatment Duration and Reassessment

• Limit initial treatment to 4-8 weeks 1
• PPIs should not be used for longer than 4-8 weeks without further evaluation 5
• Reassess response after initial treatment course 5
• If symptoms recur, additional 4-8 week courses may be considered 1

Critical Safety Considerations

Important Precautions

• Do NOT use omeprazole solely for chronic cough without clear GERD symptoms (recurrent regurgitation, heartburn, or epigastric pain) 5
• Infants <1 year: Omeprazole has shown no benefit over placebo and significantly increases serious adverse events, particularly lower respiratory tract infections (OR 6.56; 95% CI 1.18-26.25) 6

Adverse Effects and Monitoring

• Short-term: Generally well-tolerated; potential headaches, diarrhea, constipation, nausea 2
• Increased infection risk: Therapy with gastric acid inhibitors increases risk of acute gastroenteritis and community-acquired pneumonia in children 7
• Long-term use (>2.5 years): Risk of enterochromaffin cell hyperplasia in up to 50% of children 2, 6
• Other long-term risks: Vitamin B12 deficiency, bone fractures, lower respiratory tract infections 6

When to Refer

Consider pediatric gastroenterology referral for:

• Persistent symptoms despite 8-12 weeks of optimized PPI therapy 2, 6
• Need for treatment beyond 12 months 1
• Warning signs: poor weight gain, recurrent vomiting, respiratory symptoms 2
• Infants requiring acid suppression therapy 6

Key Clinical Pitfalls to Avoid

• Do not prescribe omeprazole without clear GERD symptoms (regurgitation, heartburn, epigastric pain) - acid suppression should not be used solely for chronic cough 5
• Avoid use in infants <1 year unless under specialist guidance, given lack of efficacy and increased harm 6
• Do not continue beyond 8-12 weeks without reassessment and consideration of specialist referral 5, 6
• Remember that antacids can be used concomitantly with omeprazole without interference 1