What is the appropriate dosage and usage of lansoprazole (Proton Pump Inhibitor) for a 5-year-old with Gastroesophageal Reflux Disease (GERD)?

Lansoprazole Dosing for a 5-Year-Old with GERD

For a 5-year-old child with GERD, lansoprazole should be dosed at 15 mg once daily if the child weighs ≤30 kg, or 30 mg once daily if the child weighs >30 kg, administered approximately 30 minutes before meals for 8-12 weeks. 1

Weight-Based Dosing Algorithm

• Children aged 1-11 years weighing ≤30 kg: Start with lansoprazole 15 mg once daily 1
• Children aged 1-11 years weighing >30 kg: Start with lansoprazole 30 mg once daily 1
• Timing: Administer approximately 30 minutes before meals for optimal acid suppression 2
• Duration: Treatment should be limited to 8-12 weeks initially, as lansoprazole has not been studied beyond 12 weeks in this age group 1

Dose Escalation for Refractory Symptoms

• If symptoms persist after 2 or more weeks of initial therapy, the dose may be increased up to a maximum of 30 mg twice daily 1
• In the pivotal FDA trial, 24 of 66 pediatric patients (36%) required dose escalation for persistent symptoms 1
• Consider referral to pediatric gastroenterology if symptoms remain refractory despite dose optimization 2

Expected Clinical Outcomes

• Symptomatic improvement: Approximately 76% of children aged 1-11 years experience improvement in overall GERD symptoms after 8-12 weeks of treatment 1, 3
• Erosive esophagitis healing: 100% healing rate was achieved by 12 weeks in children with erosive esophagitis (78% healed by 8 weeks) 1, 3
• Symptom reduction: Expect approximately 50% reduction in both frequency and severity of GERD symptoms 1

Safety Profile and Monitoring

• Common adverse effects: The most frequently reported treatment-related adverse events are constipation (5%) and headache (3%) 1
• Serious safety concerns with long-term use: Do not exceed recommended duration, as prolonged PPI use (>2.5 years) may cause enterochromaffin cell hyperplasia in up to 50% of children, and is associated with increased risk of lower respiratory tract infections, vitamin B12 deficiency, and bone fractures 4, 5
• Gastrin monitoring: Median fasting serum gastrin levels increase approximately 89% during treatment, though this is generally well-tolerated 1

Administration Instructions

• Lansoprazole delayed-release capsules can be opened and the granules mixed with applesauce for children unable to swallow capsules whole 5
• Ensure administration occurs 30 minutes before a meal for optimal therapeutic effect 2

Critical Pitfalls to Avoid

• Do not use in infants <1 year: Lansoprazole has been shown to be no more effective than placebo in infants while significantly increasing serious adverse events, particularly lower respiratory tract infections (OR 6.56; 95% CI 1.18-26.25) 4, 6
• Do not exceed 12 weeks without re-evaluation: Safety and effectiveness beyond 12 weeks have not been established in children aged 1-11 years 1
• Do not continue without response: If no improvement occurs after 4-8 weeks, re-evaluate the diagnosis and consider alternative etiologies rather than simply escalating therapy 4

When to Consider Alternative PPIs

• If lansoprazole is unavailable or not tolerated, omeprazole (0.7-3.3 mg/kg/day) or esomeprazole (10-20 mg once daily based on weight) are FDA-approved alternatives with similar efficacy profiles 2, 5
• Omeprazole has been shown to be more effective than H2-receptor antagonists for symptom relief and healing of erosive esophagitis 2