What are the guidelines for using omeprazole (proton pump inhibitor) in pediatric patients?

Omeprazole Guidelines for Pediatric Patients

Omeprazole is effective and safe for pediatric patients at doses of 0.7-3.3 mg/kg/day, with FDA approval for children 1 year and older for treatment of symptomatic GERD, erosive esophagitis, and maintenance of healing of erosive esophagitis. 1, 2, 3

Dosing Guidelines

Age-Based Dosing

• Children 1-16 years:
  • 10 to <20 kg: 10 mg once daily
  • ≥20 kg: 20 mg once daily 3
  • For more severe cases, weight-based dosing of 0.7-3.3 mg/kg/day may be required 1, 2

Condition-Specific Treatment Duration

• Symptomatic GERD: Up to 4 weeks 3
• Erosive Esophagitis: 4-8 weeks (may extend additional 4 weeks if needed) 3
• Maintenance of Healing: Ongoing (controlled studies do not extend beyond 12 months) 3

Administration Instructions

• Administer before meals 2
• For children unable to swallow capsules:
  1. Place 1 tablespoon of applesauce in a clean container
  2. Open capsule and empty all pellets onto applesauce
  3. Mix pellets with applesauce
  4. Have child swallow mixture immediately with water
  5. Do not chew or crush pellets 3

Clinical Considerations

Efficacy

• Healing rates for erosive esophagitis reach 84% after 8 weeks and 95% after 12 weeks of treatment 4
• Higher doses may be required for more severe esophagitis grades 5
• Studies show that children often require higher per-kilogram doses than adults to achieve therapeutic effect 5

Safety Profile

• Common side effects (occurring in up to 14% of children):
  • Headaches
  • Diarrhea
  • Constipation
  • Nausea 1, 2

Important Cautions

• Tachyphylaxis can develop within 6 weeks of initiating treatment 1
• Long-term PPI use has been associated with:
  • Enterochromaffin cell hyperplasia (in up to 50% of children on PPIs >2.5 years) 1, 2
  • Increased risk of community-acquired pneumonia, gastroenteritis, and candidemia 1, 2
  • PPIs have not demonstrated superiority over placebo for reducing irritability in infants 1

Special Populations

Infants

• Use caution in infants as PPIs have not demonstrated superiority over placebo for reduction in irritability 1
• For infants with confirmed GERD by pH monitoring, starting doses of 0.7 mg/kg/day with potential need to increase to 1.4 mg/kg/day or higher may be required 6

Neurologically Impaired Children

• May require higher doses (up to 3.5 mg/kg/day) due to severity of reflux disease 5

Comparative Effectiveness

• PPIs are more effective than H2-receptor antagonists (H2RAs) for symptom relief and healing of erosive esophagitis 1
• When H2RAs are used instead, they should be administered 2-3 times daily due to their shorter duration of action (6 hours) 1

Monitoring Recommendations

• Assess symptom improvement after 2 weeks
• For patients with erosive esophagitis, consider follow-up endoscopy after 8-12 weeks of treatment in non-responders 2
• For long-term therapy, monitor for potential adverse effects including risk of infections 2

PPIs represent a significant advancement in the treatment of pediatric acid-related disorders, but their use should be targeted to children with documented GERD or erosive esophagitis rather than for non-specific symptoms, especially in infants.