What is the recommended liquid proton pump inhibitor (PPI) formulation and dosage for pediatric patients, particularly those with difficulty swallowing capsules or tablets?

Liquid PPI Formulations for Pediatric Patients

For pediatric patients requiring liquid PPI formulations, lansoprazole orally disintegrating tablets (ODT) are the preferred option, as they can be dissolved in water and administered orally or via nasogastric tube with superior bioavailability and delivery compared to other formulations. 1, 2

Available Liquid/Alternative Formulations

Lansoprazole Orally Disintegrating Tablet (First-Line Choice)

• Lansoprazole ODT demonstrates 86.2% mean recovery of active ingredient when administered through 8 French nasogastric tubes, making it the most reliable liquid-alternative formulation. 1
• The tablet disintegrates rapidly on the tongue and can be swallowed with saliva without water, or dissolved in 5 mL water with a 10 mL flush to deliver the full dose through feeding tubes. 1, 2
• Bioavailability is comparable to lansoprazole capsules at both 15 mg and 30 mg doses. 2
• Administer approximately 30 minutes before meals for optimal acid suppression. 3, 4

Omeprazole Compounded Suspension (Second-Line)

• The American Academy of Pediatrics recommends preparing a compounded 6 mg/mL suspension from omeprazole capsules, which can be mixed with applesauce or compounded by a retail pharmacy. 5
• For patients unable to swallow capsules, open the capsule and sprinkle intact pellets on one tablespoon of applesauce, ENSURE pudding, cottage cheese, yogurt, or strained pears, then swallow immediately. 5
• Warning: Omeprazole capsules show only 3.9% mean recovery when administered through 8 French nasogastric tubes and should NOT be used via this route. 1

Esomeprazole (Third-Line)

• Esomeprazole demonstrates 36.9% mean recovery through 8 French nasogastric tubes—better than omeprazole but inferior to lansoprazole ODT. 1
• Best administration conditions are 5 mL water volume with 5 mL rinse, though only half of administered microgranules are typically recovered. 1

Weight-Based Dosing for Liquid Formulations

Children 1-11 Years (Symptomatic GERD/Erosive Esophagitis)

• ≤30 kg: 15 mg once daily 4
• >30 kg: 30 mg once daily 4
• Maximum treatment duration: 12 weeks initially; not studied beyond this timeframe in this age group. 3, 4

Children 12-17 Years

• Non-erosive GERD: 15 mg once daily for up to 8 weeks 4
• Erosive esophagitis: 30 mg once daily for up to 8 weeks 4

Infants <1 Year

• PPIs are NOT recommended as first-line therapy in infants <1 year, as lansoprazole has been shown to be no more effective than placebo while significantly increasing serious adverse events, particularly lower respiratory tract infections (OR 6.56; 95% CI 1.18-26.25). 3
• If severe/refractory GERD requires treatment in infants, omeprazole starting dose is 0.7 mg/kg/day, with potential escalation to 1.4-2.8 mg/kg/day in divided doses. 5
• Approximately 50% of infants require doses higher than 0.7 mg/kg/day for adequate acid control. 5

Critical Administration Pitfalls

Nasogastric Tube Considerations

• All 6 French tubes become obstructed by PPIs—only use 8 French or larger tubes. 1
• Lansoprazole capsules and omeprazole capsules deliver insufficient active ingredient through nasogastric tubes (7.1% and 3.9% recovery respectively) and should be avoided. 1
• Lansoprazole ODT with 5 mL diluent and 10 mL flush-through water is the only formulation ensuring full dose delivery. 1

Timing and Food Interactions

• Administer all PPIs approximately 30 minutes before meals for optimal acid suppression. 3, 4
• Take at least 30 minutes prior to sucralfate if used concomitantly. 4
• Antacids may be used concomitantly without timing restrictions. 4

Safety Monitoring for Long-Term Use

• Prolonged PPI use (>2.5 years) may cause enterochromaffin cell hyperplasia in up to 50% of children. 3
• Monitor for vitamin B12 deficiency, bone fracture risk, and increased susceptibility to lower respiratory tract infections with extended therapy. 3
• Common adverse effects include headaches, diarrhea, constipation, and nausea. 3

Special Population Considerations

• Premature infants: Weight-based dosing for term infants should NOT be extrapolated to premature infants due to immature renal function and risk of drug accumulation. 5
• Severe hepatic impairment (Child-Pugh C): Reduce lansoprazole dose to 15 mg daily. 4
• Neonates have prolonged elimination half-lives (55-90 hours vs. 30 hours in adults) requiring careful dose titration. 5