Pantoprazole Dosing in Pediatric Patients
According to the American Academy of Pediatrics guidelines, pantoprazole does not have an established pediatric per kilogram dosing recommendation as it lacks FDA approval for children under 5 years of age. 1
Current Approval Status and Dosing
- Pantoprazole is not FDA-approved for children under 5 years of age
- For children 5 years and older, pantoprazole is only indicated for short-term treatment (up to 8 weeks) of erosive esophagitis associated with GERD 2
- The FDA label does not provide weight-based dosing recommendations for pantoprazole 2
Available Evidence on Pediatric Dosing
While pantoprazole lacks official weight-based dosing recommendations, pharmacokinetic studies have provided some guidance:
- In children 1-5 years with endoscopically proven GERD, doses approximating 0.6 mg/kg or 1.2 mg/kg once daily have been studied 2
- For children 6-16 years with GERD, studies have used fixed doses of 20 mg or 40 mg once daily, similar to adult dosing 3
- Pharmacokinetic studies show that pantoprazole demonstrates dose-independent (when dose-normalized) and linear pharmacokinetics in children 6-16 years, similar to adults 3
Comparative PPI Dosing in Pediatrics
For context, other PPIs with established pediatric dosing include:
- Omeprazole: 0.7-3.3 mg/kg/day
- Lansoprazole: 0.7-3 mg/kg/day
- Esomeprazole: 0.7-3.3 mg/kg/day 1
Clinical Considerations
- For infants 1-11 months, pharmacodynamic studies have shown that ~1.2 mg/kg once daily (high dose) significantly improved gastric pH parameters 4
- In preterm infants and neonates, a dose of 2.5 mg has been studied but resulted in higher systemic exposure compared to adults 2
- Clearance values in children 1-5 years with GERD had a median value of 2.4 L/h 2
Important Caveats
- Caution regarding overuse: The American Academy of Pediatrics expresses concern about the dramatic increase in PPI prescriptions for pediatric patients, particularly infants 1
- Placebo-controlled trials in infants have not demonstrated superiority of PPIs over placebo for reduction in irritability 1
- Potential adverse effects include headaches, diarrhea, constipation, and nausea (reported in up to 14% of older children) 1
- Long-term use may be associated with increased risk of lower respiratory tract infections, especially in infants 1
Practical Approach to Pantoprazole Dosing in Pediatrics
Based on the available evidence:
- For children 5 years and older: Use fixed doses of 20 mg (for smaller children) or 40 mg (for larger children/adolescents) once daily
- For children 1-5 years: If treatment is absolutely necessary, approximately 0.6-1.2 mg/kg once daily has been studied, though this age group lacks FDA approval
- For infants under 1 year: Pantoprazole is not recommended as studies show lack of efficacy and potential for adverse effects
Remember that pantoprazole should only be used for short-term treatment (up to 8 weeks) of erosive esophagitis associated with GERD in pediatric patients, and not for other acid-related disorders where efficacy has not been established.