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 approximately 0.6 mg/kg or 1.2 mg/kg per day, as studied in children ages 1 year to 5 years with endoscopically diagnosed EE. However, the exact dosing may vary depending on the patient's weight, with 15 mg for ≤ 12.5 kg and 20 mg for > 12.5 to < 25 kg being equivalent to a 1.2 mg/kg dose 1.
From the Research
The recommended dose of pantoprazole for pediatric patients is 1.2 mg/kg/day, as this dose has been shown to achieve therapeutic exposures similar to those in adults, according to the study by 2.
Key Considerations
- For children aged 5 years and older, the typical dose is 0.5-1 mg/kg/day, with a maximum daily dose of 40 mg.
- For infants and younger children, dosing typically starts at 0.5 mg/kg once daily.
- Pantoprazole is usually administered once daily, preferably in the morning before breakfast.
- For severe cases or certain conditions like GERD, doses may be increased to 1-2 mg/kg/day divided into two doses.
Mechanism and Efficacy
- The medication works by irreversibly binding to the hydrogen-potassium ATPase enzyme system in gastric parietal cells, reducing stomach acid production.
- This mechanism explains why pantoprazole is effective for acid-related conditions like gastroesophageal reflux disease, peptic ulcers, and gastritis.
Safety and Precautions
- It's essential to note that pantoprazole should be used at the lowest effective dose for the shortest duration necessary, as long-term use in children may be associated with potential risks including vitamin and mineral deficiencies, particularly vitamin B12, calcium, and magnesium.
- A study by 3 found that a weight-tiered approach to dosing achieved pantoprazole exposures within therapeutic ranges without over- or under-prediction for obese children.
- Another study by 4 determined that pantoprazole clearance was significantly influenced by developmental changes, systemic inflammatory syndrome, hepatic dysfunction, and CYP2C19 inhibitors in pediatric intensive care patients.