From the FDA Drug Label
The children ages 1 year to 5 years with endoscopically diagnosed EE (defined as an endoscopic Hetzel-Dent score ≥ 2) were treated once daily for 8 weeks with one of two dose levels of pantoprazole (approximating 0.6 mg/kg or 1.2 mg/kg). Following a 1.2 mg/kg equivalent dose (15 mg for ≤ 12.5 kg and 20 mg for > 12.5 to < 25 kg), the plasma concentrations of pantoprazole were highly variable and the median time to peak plasma concentration was 3 to 6 hours. In a population pharmacokinetic analysis, the systemic exposure was higher in patients less than 1 year of age with GERD compared to adults who received a single 40 mg dose (geometric mean AUC was 103% higher in preterm infants and neonates receiving single dose of 2.5 mg of pantoprazole, and 23% higher in infants 1 through 11 months of age receiving a single dose of approximately 1.2 mg/kg).
The recommended dose of pantoprazole for pediatric patients is approximating 0.6 mg/kg or 1.2 mg/kg per day for patients 1 year to 5 years of age, as stated in the drug label 1. For patients 1 through 11 months of age, the dose is approximately 1.2 mg/kg per day. However, it's essential to note that the effectiveness of pantoprazole for treating symptomatic GERD in pediatric patients has not been established, and the use of pantoprazole for patients less than 1 year of age is not indicated.
- Key points:
- Dose for patients 1 year to 5 years of age: 0.6 mg/kg or 1.2 mg/kg per day
- Dose for patients 1 through 11 months of age: approximately 1.2 mg/kg per day
- Effectiveness for symptomatic GERD in pediatric patients has not been established
- Use in patients less than 1 year of age is not indicated
From the Research
The recommended dose of pantoprazole for pediatric patients is 1.2 mg/kg/day for children under 5 years, as this dose has been shown to achieve similar exposure to that in adults receiving 40 mg of pantoprazole 2.
Key Considerations
- For children 5 years and older weighing 15-40 kg, the typical dose is 20 mg once daily, while those over 40 kg generally receive the adult dose of 40 mg once daily.
- Treatment duration should be limited to 8-12 weeks for most conditions, though longer courses may be needed for certain disorders.
- Pantoprazole should be administered before meals, preferably in the morning.
- The medication works by irreversibly binding to the hydrogen-potassium ATPase enzyme (the proton pump) in gastric parietal cells, reducing stomach acid production.
Important Factors
- Age and weight are significant factors in determining the dose of pantoprazole for pediatric patients.
- The presence of systemic inflammatory syndrome, hepatic dysfunction, and CYP2C19 inhibitors can influence the disposition of pantoprazole in pediatric intensive care patients 3.
- A population-based pharmacokinetic model approach has been used to evaluate appropriate pantoprazole dosing strategies for obese pediatric patients, and the results support the use of a weight-tiered approach 4.
Potential Side Effects
- Headache, diarrhea, and abdominal pain are potential side effects of pantoprazole in pediatric patients.
- Long-term use of pantoprazole in pediatric patients should be monitored due to potential risks of vitamin B12 deficiency, hypomagnesemia, and increased risk of infections.
Pharmacokinetics
- Pantoprazole clearance is significantly influenced by developmental changes, systemic inflammatory syndrome, hepatic dysfunction, and CYP2C19 inhibitors 3.
- A two-compartment model with zero-order infusion and first-order elimination has been used to characterize the pharmacokinetics of intravenous pantoprazole in pediatric intensive care patients 3.