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

Pantoprazole Dosing for Children

For children aged 5 years and older with erosive esophagitis, pantoprazole should be dosed at 20 mg once daily for children weighing 15 kg to <40 kg, and 40 mg once daily for children weighing ≥40 kg, administered for up to 8 weeks. 1

FDA-Approved Weight-Based Dosing

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

• Children ≥15 kg to <40 kg: 20 mg once daily 1
• Children ≥40 kg: 40 mg once daily 1
• Treatment duration: Up to 8 weeks for erosive esophagitis 1

This dosing applies specifically to children 5 years and older, as there is no commercially available age-appropriate formulation for younger children despite some evidence of efficacy in the 1-5 year age group. 1

Administration Guidelines

• Swallow tablets whole with or without food—do not split, chew, or crush 1
• For patients unable to swallow a 40 mg tablet, two 20 mg tablets may be substituted 1
• Administer approximately 30 minutes before meals for optimal acid suppression 2
• Antacids do not affect absorption and can be given concomitantly 1

Age-Specific Limitations and Considerations

Infants <1 year: Pantoprazole is not recommended in this age group. A treatment-withdrawal study in 129 infants aged 1-11 months showed no efficacy compared to placebo for symptomatic GERD, and systemic exposure was significantly higher (103% higher in preterm infants/neonates, 23% higher in infants 1-11 months) compared to adults. 1

Children 1-5 years: While clinical trial data showed healing of erosive esophagitis in 4 out of 4 patients treated with pantoprazole (approximating 0.6-1.2 mg/kg), there is no commercially available age-appropriate formulation for this population. 1 The FDA label explicitly states pantoprazole is indicated only for children 5 years and older. 1

Dosing in Children with Obesity

Use weight-tiered dosing (as per FDA label) rather than total body weight-based calculations. Recent pharmacokinetic studies demonstrate that:

• Lean body weight (LBW)-based dosing at 1.2 mg/kg LBW provides comparable systemic exposure between children with and without obesity 3
• Weight-tiered dosing (per FDA label) results in >90% of children achieving appropriate pantoprazole exposures regardless of obesity status or CYP2C19 phenotype 4
• Total body weight-based dosing leads to 50% reduced drug clearance and excessive systemic exposure in children with obesity 3

Pharmacokinetic Profile

Pantoprazole pharmacokinetics in children aged 6-16 years are:

• Dose-independent when dose-normalized 5
• Similar to adult PK parameters with no evidence of drug accumulation with multiple dosing 5
• Not affected by CYP2C19 genetic variation when using weight-tiered dosing, which compensates for metabolic differences 4

Common Pitfalls to Avoid

• Do not extrapolate adult dosing to children <5 years—the pharmacokinetics differ significantly, particularly in infants where systemic exposure is substantially higher 1
• Do not use total body weight for dosing calculations in children with obesity—this leads to overdosing 3
• Do not crush or split tablets—this destroys the delayed-release coating essential for drug stability and absorption 1
• Do not prescribe for infants with symptomatic GERD—evidence shows no benefit over placebo 1

Alternative PPI Options

If pantoprazole is not suitable, consider:

• Omeprazole: 10 mg once daily for children 10 to <20 kg; 20 mg once daily for children ≥20 kg (ages 2-16 years) 6
• Lansoprazole: 30 mg once daily for children ≥30 kg (ages 1-11 years) 2

Safety Considerations

Pantoprazole is generally well-tolerated in children aged 5-16 years with no serious drug-associated adverse events reported in clinical trials. 7, 5 However, long-term safety data beyond 12 months in pediatric maintenance therapy are limited. 1