What is the recommended omeprazole (Prilosec) dosing and administration for an infant (<12 months) with gastro‑esophageal reflux?

Omeprazole Dosing for Infants (<12 months)

Omeprazole should generally NOT be used in infants under 12 months of age, as PPIs have been shown to be no more effective than placebo in this population while significantly increasing serious adverse events, particularly lower respiratory tract infections. 1, 2

Evidence Against Routine PPI Use in Infants

• A multicenter RCT demonstrated that lansoprazole (a PPI similar to omeprazole) showed no difference in efficacy compared to placebo for GERD symptoms in infants aged 1-12 months, while serious adverse events—particularly lower respiratory tract infections—occurred more frequently with PPI therapy (OR 6.56; 95% CI 1.18-26.25). 1, 3

• The American Thoracic Society, as published in Chest, recommends that PPIs should NOT be used when there are no clinical features of GERD such as recurrent regurgitation, dystonic neck posturing in infants, or clear signs of acid-mediated disease. 1, 2

• FDA approval for omeprazole begins at age 2 years, making use in infants under 12 months off-label with limited safety data. 2

Recommended First-Line Approach for Infant GERD

Before considering any pharmacologic therapy, implement conservative management strategies:

• Smaller, more frequent feedings to reduce gastric distension 2
• Thickening formula if formula-fed (caution in preterm infants due to necrotizing enterocolitis risk) 2
• Maternal elimination diet excluding milk and egg for 2-4 weeks if breastfeeding 2
• Trial of extensively hydrolyzed or amino acid-based formula if formula-fed 2
• Upright positioning when awake and supervised 2, 4

When Omeprazole May Be Considered (Severe, Refractory Cases Only)

If conservative measures fail and there are clear gastrointestinal symptoms (recurrent regurgitation, dystonic neck posturing, failure to thrive), omeprazole dosing would be:

• Starting dose: 0.7 mg/kg/day divided into 2 doses 2, 5, 6
• Dose escalation: Up to 1.4-2.8 mg/kg/day if inadequate response after 14 days 2, 5
• Maximum reported dose: 3.3 mg/kg/day in refractory cases 6, 7

Practical Preparation

• Compound into 6 mg/mL suspension from capsules mixed with applesauce 2
• Administer approximately 30 minutes before meals for optimal effect 4, 3

Treatment Duration and Monitoring

• Limit treatment to 4-8 weeks maximum without further evaluation 2, 3
• Re-evaluate response after 4-8 weeks and discontinue if no clear benefit 2
• Monitor for adverse effects: headaches, diarrhea, constipation, nausea, and particularly respiratory infections 2, 4

Critical Safety Concerns in Infants

• Increased risk of lower respiratory tract infections with PPI use 1, 2, 3
• Potential for community-acquired pneumonia, gastroenteritis, and candidemia 2, 4
• Long-term use (>2.5 years) associated with enterochromaffin cell hyperplasia in up to 50% of children 2, 3

When to Refer to Pediatric Gastroenterology

• Refractory cases despite optimized conservative management 2, 4
• Diagnostic uncertainty or alarm symptoms (poor weight gain, recurrent vomiting, hematemesis) 2, 4
• Before initiating PPI therapy in infants, consider specialist evaluation 2

Common Pitfalls to Avoid

• Do not use PPIs for isolated crying, irritability, or "colic" without clear GERD symptoms 1, 2
• Do not combine H2RAs with PPIs—there is no evidence this improves outcomes and increases medication burden 4
• Do not delay appropriate referral while escalating PPI doses in infants with warning signs 4