What is the safe dosage of Pantaprazole (Proton Pump Inhibitor) as approved by the FDA (Food and Drug Administration) for different age groups?

FDA-Approved Safe Dosages of Pantoprazole for Different Age Groups

The FDA-approved safe dosage of pantoprazole varies by age group, with 40 mg daily for adults, 20-40 mg daily for adolescents 12-16 years, 20-40 mg daily for children 6-11 years, and no FDA approval for children under 5 years of age. 1

Adult Dosing (≥16 years)

• Standard adult dosage is 40 mg once daily for most gastric acid-related disorders 1, 2
• For elderly patients (64-76 years), the same 40 mg daily dose is recommended despite slight to moderate increases in AUC (43%) and Cmax (26%) compared to younger adults 1
• For maintenance therapy of gastroesophageal reflux disease (GERD), 20 mg once daily is effective for most patients 3
• No dosage adjustment is needed based on gender despite modest increases in AUC and Cmax in women 1

Special Adult Populations

• Renal impairment: No dosage adjustment necessary, even in severe renal impairment or patients undergoing hemodialysis 1
• Hepatic impairment:
  • No dosage adjustment needed for mild to severe hepatic impairment (Child-Pugh A to C cirrhosis) 1
  • Doses higher than 40 mg/day have not been studied in hepatically impaired patients 1

Pediatric Dosing

• Children and adolescents 6-16 years:

  • FDA-approved for GERD at doses of 20 mg or 40 mg once daily 1, 4
  • Pharmacokinetic studies show dose-independent (when dose-normalized) behavior similar to adults 4
  • Children 6-11 years have approximately 39% higher AUC than adults at the 40 mg dose 1
  • Adolescents 12-16 years have approximately 10% higher AUC than adults at the 40 mg dose 1

• Children under 6 years:

  • Not FDA-approved for children under 5 years of age 1, 5
  • While research studies have evaluated pantoprazole granules at doses of 0.6 mg/kg and 1.2 mg/kg in infants and children 1 month to <6 years, these formulations and dosages are not FDA-approved 6

Administration Considerations

• Pantoprazole can be taken without regard to timing of meals, though food may delay absorption by up to 2 hours 1
• Proton pump inhibitors like pantoprazole are equivalent at the following doses: pantoprazole 40 mg = omeprazole 20 mg = lansoprazole 30 mg = esomeprazole 20 mg = rabeprazole 20 mg 7

Drug Interactions

• Pantoprazole has fewer drug-drug interactions compared to other PPIs 2, 5
• Coadministration with clopidogrel may reduce the active metabolite of clopidogrel by approximately 14% 1
• Gastric pH changes from pantoprazole may affect absorption of other drugs requiring acidic environment for absorption 1

Safety Considerations

• Children weighing more than 40 kg should be dosed as adults 4
• Pharmacokinetic studies show no evidence of drug accumulation with multiple dosing in pediatric patients 4, 6
• Wide interindividual variability in exposure has been observed, particularly in younger children 6

Always consult the most current FDA labeling for the most up-to-date dosing recommendations, as guidelines may change over time.