What is the recommended dose of pantoprazole (proton pump inhibitor) for children?

Pantoprazole Dosing in Children

For children aged 5 years and older with erosive esophagitis, use weight-tiered dosing: 20 mg once daily for children weighing 15 kg to <40 kg, and 40 mg once daily for children ≥40 kg. 1

FDA-Approved Dosing by Weight

The FDA label provides clear weight-based dosing for pantoprazole delayed-release tablets in pediatric patients:

• Children weighing ≥15 kg to <40 kg: 20 mg once daily for up to 8 weeks 1
• Children weighing ≥40 kg: 40 mg once daily for up to 8 weeks 1
• Minimum age: 5 years and older 1

Administration Instructions

• Swallow tablets whole with or without food 1
• Do not split, chew, or crush the delayed-release tablets 1
• For patients unable to swallow a 40 mg tablet: Two 20 mg tablets may be taken 1
• Antacids do not affect absorption and can be given concomitantly 1

Important Age Restrictions and Limitations

Pantoprazole is NOT indicated for children under 5 years of age because there is no appropriate dosage strength in an age-appropriate formulation available, despite effectiveness data existing for children as young as 1 year 1

• For infants under 1 year: Pantoprazole was studied but not found to be effective in a randomized controlled trial of 129 infants aged 1-11 months with symptomatic GERD 1
• Neonates and preterm infants showed 103% higher systemic exposure compared to adults, raising safety concerns 1

Clinical Evidence Supporting Weight-Tiered Dosing

Weight-tiered dosing achieves therapeutic exposures in >90% of children regardless of obesity status or CYP2C19 phenotype 2, 3. This approach is superior to:

• 1 mg/kg total body weight dosing 2
• 1.2 mg/kg lean body weight dosing 2

The weight-tiered strategy prevents both under- and over-dosing in obese children, who paradoxically have decreased weight-adjusted clearance of pantoprazole 3.

Pharmacokinetic Considerations

• No dose accumulation occurs with once-daily dosing 4
• Dose-independent pharmacokinetics when dose-normalized 4
• Systemic exposure in children aged 6-16 years is similar to adults when using weight-tiered dosing 4
• CYP2C19 genetic variation affects pantoprazole metabolism but does not require dose adjustment when using weight-tiered dosing 2, 3

Common Pitfalls to Avoid

• Do not empirically increase doses for obese children - weight-tiered dosing already accounts for body size differences 3
• Do not use pantoprazole in infants under 1 year - it has not demonstrated efficacy and has higher systemic exposure 1
• Do not extrapolate adult dosing to younger children - pharmacokinetics differ significantly 1
• Be aware that 3- to 5-fold inter-individual variability in drug exposure persists even with optimal dosing 3

Safety Profile

Pantoprazole was well tolerated in pediatric studies with no serious drug-associated adverse events reported 4. In the infant trial (ages 1-11 months), adverse reactions reported more commonly than placebo included elevated CK, otitis media, rhinitis, and laryngitis 1.

Duration of Therapy

• Initial treatment: Up to 8 weeks 1
• Extended treatment: For adult patients who have not healed after 8 weeks, an additional 8-week course may be considered; similar extension may be reasonable for children though not specifically studied 1
• Controlled pediatric studies did not extend beyond 8 weeks 1