When is omeprazole (Proton Pump Inhibitor) indicated for use in pediatrics and adults?

When to Use Omeprazole in Pediatrics and Adults

Adults

Omeprazole is FDA-approved for adults for active duodenal ulcer (4-8 weeks), active benign gastric ulcer (4-8 weeks), symptomatic GERD (up to 4 weeks), erosive esophagitis (4-8 weeks with possible additional 4 weeks if needed), maintenance of healed erosive esophagitis, H. pylori eradication in combination with antibiotics, and pathological hypersecretory conditions including Zollinger-Ellison syndrome. 1

Specific Adult Indications:

• Active Duodenal Ulcer: Short-term treatment with most patients healing within 4 weeks; some require an additional 4 weeks 1

• H. pylori Eradication: Triple therapy (omeprazole + clarithromycin + amoxicillin) or dual therapy (omeprazole + clarithromycin) to reduce duodenal ulcer recurrence risk 1

• Active Benign Gastric Ulcer: 4-8 weeks of treatment 1

• Symptomatic GERD: Treatment of heartburn and related symptoms for up to 4 weeks 1

• Erosive Esophagitis: 4-8 weeks initial treatment; if no response after 8 weeks, an additional 4 weeks may be given 1

• Maintenance of Healed Erosive Esophagitis: Long-term maintenance therapy, though controlled studies do not extend beyond 12 months 1

• Pathological Hypersecretory Conditions: Long-term treatment of Zollinger-Ellison syndrome, multiple endocrine adenomas, and systemic mastocytosis 1

• Eosinophilic Esophagitis (Off-Label): Omeprazole 20 mg twice daily for at least 8-12 weeks prior to histological assessment, with maintenance therapy effective in 73-81% of responders 2

Pediatrics

Omeprazole is FDA-approved for children 2 years and older for symptomatic GERD, erosive esophagitis due to acid-mediated GERD, and maintenance of healing of erosive esophagitis. 1 The safety and effectiveness have NOT been established in infants under 2 years of age. 1

Pediatric Dosing by Indication:

FDA-Approved Uses (Ages 2-16 Years):

• Symptomatic GERD:

  • Children 10 to <20 kg: 10 mg once daily 3, 1
  • Children ≥20 kg: 20 mg once daily 3, 1

• Erosive Esophagitis:

  • Children 10 to <20 kg: 10 mg once daily 3, 1
  • Children ≥20 kg: 20 mg once daily 3, 1

• Maintenance of Healed Erosive Esophagitis: Same weight-based dosing as above 1

Off-Label Pediatric Uses:

• Eosinophilic Esophagitis: Initial treatment is omeprazole 1 mg/kg twice daily (up to 40 mg twice daily) for 8-12 weeks, with maintenance therapy at 1 mg/kg/day (maximum 40 mg/day) showing 70.1% long-term histological remission over 12 months 2, 3

Critical Pediatric Considerations:

Do NOT use omeprazole routinely in infants under 2 years of age. 4, 1 The American Thoracic Society recommends PPIs should NOT be used when there are no clinical features of GERD such as recurrent regurgitation or dystonic neck posturing 4. For severe, refractory GERD in infants with clear gastrointestinal symptoms (off-label), starting dose is 0.7 mg/kg/day, escalating up to 1.4-2.8 mg/kg/day if needed, but this represents off-label use with limited safety data 3, 4.

Important safety concern: Serious adverse events, particularly lower respiratory tract infections, occurred more frequently with PPIs than placebo in infants 4, 5. Long-term use (>2.5 years) may be associated with enterochromaffin cell hyperplasia in up to 50% of children 3, 5.

Administration in Children:

For children unable to swallow capsules, omeprazole can be administered by mixing pellets with applesauce or compounded into a 6 mg/mL suspension 3.

Common Pitfalls to Avoid:

• In pediatrics: Do not diagnose GERD based solely on symptomatic response to PPI without endoscopic confirmation, as symptoms overlap substantially with eosinophilic esophagitis, functional dyspepsia, and recurrent abdominal pain 2

• In eosinophilic esophagitis: Clinical response to PPI does not rule out EoE; histological confirmation is required for diagnosis and monitoring 2

• Duration concerns: If using PPI for EoE, do not reduce to lower doses in primary care; maintain therapeutic dosing (omeprazole 20 mg twice daily in adults) 2

• Infant use: Prioritize non-pharmacologic interventions (smaller frequent feedings, thickening formula, upright positioning, maternal elimination diet if breastfeeding) before considering PPI therapy in infants 4

• Treatment duration in infants: If PPI therapy is deemed necessary for severe refractory GERD in infants, limit duration to 4-8 weeks maximum without further evaluation 4