What are the FDA approved age-based safety and dosing guidelines for pantoprazole (Proton Pump Inhibitor)?

FDA Approved Age-Based Safety and Dosing of Pantoprazole

Pantoprazole is FDA approved for children 5 years and older for short-term treatment (up to 8 weeks) of erosive esophagitis associated with GERD, with dosing based on weight, while it is not approved or recommended for children under 5 years of age due to lack of efficacy data and potential adverse effects. 1

Adult Dosing

• Short-term treatment of erosive esophagitis: 40 mg once daily for up to 8 weeks
• Maintenance of healing of erosive esophagitis: 40 mg once daily
• Pathological hypersecretory conditions (including Zollinger-Ellison Syndrome): 40 mg twice daily (doses up to 240 mg daily have been administered) 1

Pediatric Dosing

FDA Approved Indications and Dosing:

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

Important Safety Considerations:

• Children under 5 years: No appropriate dosage strength in an age-appropriate formulation is available 1
• Children 1-5 years: Although clinical trials have been conducted using doses approximating 0.6 mg/kg or 1.2 mg/kg, pantoprazole is not commercially available in appropriate dosage forms for this age group 1
• Infants under 1 year: Pantoprazole was not found to be effective in a multicenter, randomized, double-blind, placebo-controlled study of infants 1-11 months of age 1

Administration Instructions

• Pantoprazole delayed-release tablets should be swallowed whole, with or without food
• Do not split, chew, or crush the tablets
• For patients unable to swallow a 40 mg tablet, two 20 mg tablets may be taken 1

Special Populations

Pregnancy

• FDA pregnancy category C
• No evidence of impaired fertility or harm to the fetus in animal studies, but no adequate and well-controlled studies in pregnant women 1

Breastfeeding

• Pantoprazole has been detected in breast milk after a single 40 mg oral dose
• The relative dose to the infant was estimated to be 7.3 mcg (0.14% of the weight-adjusted maternal dose)
• No adverse events in breastfed infants have been reported 1

Elderly

• No dosage adjustment is required based on age alone
• The clearance of pantoprazole is only slightly affected by age, with half-life being approximately 1.25 hours in the elderly 2

Pharmacokinetics in Children

• In children 5-16 years, the pharmacokinetic profile is similar to that in adults and is dose-independent when dose-normalized 3
• For children 2-16 years receiving intravenous pantoprazole, pharmacokinetic values were similar to those previously obtained in adults 4

Safety Concerns and Monitoring

• The American Academy of Pediatrics expresses significant concern about the dramatic increase in PPI prescriptions for infants, noting lack of efficacy and potential risks 5
• Adverse effects in children may include headaches, diarrhea, constipation, and nausea (up to 14% of children) 5
• Long-term adverse effects may include increased risk of lower respiratory tract infections, especially in infants 5

Clinical Pearls

• Always prioritize ruling out other causes of symptoms and trying conservative measures before initiating acid suppression therapy in children 5
• For children weighing more than 40 kg, adult dosing can be used 1
• Pantoprazole 40 mg is equivalent to omeprazole 20 mg, lansoprazole 30 mg, esomeprazole 20 mg, or rabeprazole 20 mg 6