Pantoprazole Dosing for Pediatric Patients
Pantoprazole is FDA-approved for children ≥5 years old at 20 mg once daily for those weighing 15 to <40 kg, and 40 mg once daily for those ≥40 kg, for treatment of erosive esophagitis associated with GERD for up to 8 weeks. 1
FDA-Approved Dosing by Weight and Age
For children 5 years and older:
Critical caveat: Pantoprazole has no FDA pediatric indication for children under 5 years of age 2, 1. The American Academy of Pediatrics guidelines explicitly state that pantoprazole lacks pediatric approval for younger children 2.
Administration Instructions
- Tablets must be swallowed 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 3
- Antacids may be given concomitantly without affecting absorption 1
Pharmacokinetic Evidence Supporting Dosing
Research demonstrates that pantoprazole pharmacokinetics in children aged 6-16 years are dose-independent and similar to adults, with no drug accumulation after multiple doses 4. In younger children (1 month to <6 years), the 1.2 mg/kg dose provides exposure comparable to the adult 40 mg dose 5. Population pharmacokinetic modeling shows that when allometrically scaled, pantoprazole clearance reaches adult levels by approximately 1 year of age 6.
Alternative PPI Options for Younger Children
If treating children under 5 years, consider FDA-approved alternatives:
Omeprazole (ages 2-16 years): 2, 7
- 10 mg once daily for children 10 to <20 kg
- 20 mg once daily for children ≥20 kg
Lansoprazole (ages 1-17 years): 2
- Weight-based dosing: 0.7-3 mg/kg/day
- 30 mg once daily for children ≥30 kg
Esomeprazole (ages 1-17 years): 2
- Weight-based dosing: 0.7-3.3 mg/kg/day
Safety Considerations
Common pitfalls to avoid:
- Do not use pantoprazole in children <5 years—it lacks FDA approval and safety data in this population 2, 1
- Prolonged PPI use (>2.5 years) may cause enterochromaffin cell hyperplasia in up to 50% of children 8
- Long-term PPI therapy increases risk of lower respiratory tract infections, vitamin B12 deficiency, and bone fractures 8
- Treatment should be limited to 8-12 weeks initially; consider pediatric gastroenterology referral if symptoms remain refractory 8
Dosing for Special Populations
Pantoprazole was safe and well tolerated in clinical trials of children aged 2-16 years, with no serious drug-related adverse events reported 9. However, CYP2C19 poor metabolizers exhibit reduced clearance (>70% lower than typical values), though dose adjustment is not routinely recommended 6.