What is the recommended dose of Lansoprazole (proton pump inhibitor) for pediatric patients?

Lansoprazole Dosing in Pediatric Patients

For children 1-11 years with GERD, lansoprazole should be dosed at 15 mg once daily for those weighing ≤30 kg and 30 mg once daily for those weighing >30 kg, administered for 8-12 weeks. 1

Age-Specific Dosing Guidelines

Infants <1 Year of Age

• Lansoprazole is NOT recommended for infants under 1 year of age 1
• A multicenter, double-blind, placebo-controlled study demonstrated no efficacy difference between lansoprazole and placebo in 162 infants (1 month to <12 months) with symptomatic GERD—both groups showed 54% response rates 1
• Despite pharmacokinetic studies showing adequate drug exposure at doses of 0.2-0.3 mg/kg/day (infants ≤10 weeks) or 1.0-1.5 mg/kg/day (infants >10 weeks), clinical efficacy was not established 1, 2

Children 1-11 Years of Age

Weight-based dosing: 1

• ≤30 kg: 15 mg once daily
• >30 kg: 30 mg once daily
• Duration: 8-12 weeks initially

Dose escalation if needed: 1

• If symptoms persist after 2+ weeks, doses can be increased up to 30 mg twice daily (maximum 60 mg/day)
• In clinical trials, 24 of 66 patients required dose escalation 1

Clinical efficacy data: 1, 3, 4

• 76% of patients showed improvement in overall GERD symptoms
• 100% healing rate for erosive esophagitis by 12 weeks (21/27 healed by 8 weeks)
• Dosing range studied: 0.6-1.3 mg/kg/day 5

Adolescents 12-17 Years of Age

Indication-based dosing: 1

• Non-erosive GERD: 15 mg once daily for 8 weeks
• Erosive esophagitis: 30 mg once daily for 8-12 weeks

Clinical efficacy data: 1, 3

• 63% reduction in symptom frequency and 69% reduction in severity
• 95.5% healing rate for erosive esophagitis (21/22 patients) by 8 weeks

Administration Instructions

Capsule administration: 1

• Administer once daily, preferably 30 minutes before meals for optimal effect 6
• Capsules should be swallowed whole

For patients unable to swallow capsules: 7

• Open capsule and mix granules with applesauce
• Do not crush or chew the granules (they are enteric-coated)

Safety Profile

Common adverse events (≥2% incidence): 1, 5

• Constipation (5% in ages 1-11 years)
• Headache (3% in ages 1-11 years)
• Generally well-tolerated with no treatment discontinuations due to adverse events in clinical trials

Monitoring considerations: 1, 5

• Serum gastrin levels increase during treatment (median 89% increase in children 1-11 years, 42% increase in adolescents), but typically remain within normal range (25-111 pg/mL)
• Long-term use (>2.5 years) may be associated with enterochromaffin cell hyperplasia in up to 50% of children 7

Important safety note: 1

• Do not exceed recommended doses and duration in pediatric patients
• Juvenile animal studies showed heart valve thickening and bone changes at doses higher than maximum recommended equivalent human doses

Clinical Decision Algorithm

Step 1 - Age assessment:

• If <1 year: Do NOT use lansoprazole (not effective) 1
• If 1-11 years: Proceed to weight-based dosing
• If 12-17 years: Proceed to indication-based dosing

Step 2 - Initial dosing (ages 1-11 years):

• Weight ≤30 kg → 15 mg once daily
• Weight >30 kg → 30 mg once daily 1

Step 3 - Initial dosing (ages 12-17 years):

• Non-erosive GERD → 15 mg once daily
• Erosive esophagitis → 30 mg once daily 1

Step 4 - Response assessment at 2 weeks:

• If adequate symptom control → Continue current dose for full 8-12 week course
• If persistent symptoms (ages 1-11 years) → Increase dose incrementally up to 30 mg twice daily 1

Step 5 - Endoscopic reassessment (if erosive esophagitis):

• At 8 weeks for healing confirmation
• If not healed, continue up to 12 weeks total 1

Comparison to Other PPIs

Lansoprazole vs. Omeprazole: 7, 6

• Both PPIs demonstrate superior efficacy compared to H2-receptor antagonists for pediatric GERD
• Omeprazole dosing: 10 mg once daily for children 10 to <20 kg; 20 mg once daily for ≥20 kg (ages 2-16 years)
• Lansoprazole has more robust FDA-approved pediatric data with specific weight-based dosing guidelines 1

Critical Pitfalls to Avoid

• Do not use in infants <1 year despite pharmacokinetic data showing adequate drug levels—clinical efficacy is not established 1
• Do not crush or chew granules as this destroys the enteric coating and reduces efficacy 1
• Do not underdose based on age alone—use weight-based dosing for children 1-11 years 1
• Do not continue indefinitely without reassessment—limit to recommended 8-12 week courses initially 1