Pediatric Pantoprazole Dosing
For children aged 5 years and older with erosive esophagitis (EE) associated with GERD, pantoprazole is dosed based on weight: 20 mg once daily for children weighing 15-40 kg, and 40 mg once daily for children weighing ≥40 kg. 1
FDA-Approved Indications and Dosing
Age and Weight-Based Recommendations
Pantoprazole is FDA-approved only for children 5 years and older because no appropriate dosage strength in an age-appropriate formulation exists for younger children 1
For children 5-16 years with EE associated with GERD:
The effectiveness of pantoprazole for treating symptomatic GERD (without documented EE) has not been established in pediatric patients 1
Critical Safety Considerations
Age Restrictions
Pantoprazole is NOT indicated for infants less than 1 year of age - a randomized controlled trial of 129 infants aged 1-11 months showed no efficacy compared to placebo for symptomatic GERD 1
In the infant trial, adverse events occurred more commonly with pantoprazole including elevated CK, otitis media, rhinitis, and laryngitis (≥4% difference vs placebo) 1
Children 1-5 Years of Age
While pharmacokinetic studies support dosing of approximately 0.6 mg/kg or 1.2 mg/kg once daily in children 1-5 years with EE, there is no commercially available formulation appropriate for this age group 1, 2
In children 1-5 years, the 1.2 mg/kg dose provided systemic exposure similar to adults receiving 40 mg, though with wide interindividual variability 2
Pharmacokinetic Considerations
Exposure and Metabolism
Pantoprazole pharmacokinetics in children 6-16 years are similar to adults when appropriately weight-dosed 3, 4
In children 6-11 years receiving 40 mg, the geometric mean AUC was approximately 39% higher than adults; in adolescents 12-16 years, it was only 10% higher 1
CYP2C19 genetic polymorphism affects pantoprazole exposure - poor metabolizers have 5-7 fold higher AUC values, but no dosage adjustment is recommended 1, 5
Administration Guidelines
Administer pantoprazole approximately 30 minutes before meals for optimal acid suppression (extrapolated from other PPI data) 6
Pantoprazole delayed-release tablets should be swallowed whole and not crushed or chewed 1
For children unable to swallow tablets, pantoprazole granules can be mixed with applesauce (though this formulation may not be commercially available in all regions) 2
Alternative PPI Options
If pantoprazole is unavailable or not appropriate, consider FDA-approved alternatives:
Omeprazole: 10 mg once daily for children 10 to <20 kg; 20 mg once daily for children ≥20 kg (ages 2-16 years) 7
Esomeprazole: 10 mg once daily for children 10 to <20 kg; 20 mg once daily for children ≥20 kg (ages 1-11 years) 8
Lansoprazole: 30 mg once daily for children ≥30 kg (ages 1-11 years) 9
Common Pitfalls to Avoid
Do not extrapolate adult dosing to young children - clearance increases with age and body weight in a non-linear fashion, particularly in children under 3 years 1, 2
Do not use pantoprazole for symptomatic GERD without documented EE - efficacy has not been demonstrated for this indication in pediatric patients 1
Do not exceed 8 weeks of initial treatment without reassessment, as longer durations have not been adequately studied in children 1
Avoid long-term use (>2.5 years) when possible due to risks of enterochromaffin cell hyperplasia, lower respiratory tract infections, vitamin B12 deficiency, and bone fractures 9