Pediatric Pantoprazole Dosing Guidelines
For pediatric patients with GERD, pantoprazole should be dosed at 0.6-1.2 mg/kg once daily for children 1-5 years old and 20-40 mg once daily for children 5-16 years old. 1
Age-Specific Dosing Recommendations
Children 1-5 years old
- Dosage range: 0.6-1.2 mg/kg once daily
- For children ≤12.5 kg: 15 mg once daily
- For children >12.5 to <25 kg: 20 mg once daily
- Administration: Oral, typically 30 minutes before breakfast
Children 5-16 years old
- Dosage range: 20-40 mg once daily
- Weight-based considerations:
- 15-40 kg: 20 mg once daily
40 kg: 40 mg once daily
- Administration: Oral, can be taken without regard to timing of meals
Important Clinical Considerations
Indications
Pantoprazole is FDA-approved for short-term treatment (up to 8 weeks) of erosive esophagitis (EE) associated with GERD in children 5 years and older 1. While it has been studied in children as young as 1 year, there is no commercially available dosage formulation appropriate for patients less than 5 years of age.
Efficacy
- In clinical trials, children ages 1-5 years with endoscopically diagnosed EE treated with pantoprazole at doses of 0.6-1.2 mg/kg showed healing of esophagitis (Hetzel-Dent score of 0 or 1) at 8 weeks 1.
- Pantoprazole has not been found to be effective in infants less than 1 year of age with symptomatic GERD 1.
Pharmacokinetics
- Clearance values in children 1-5 years old with GERD have a median value of 2.4 L/h 1.
- Following a 1.2 mg/kg dose, plasma concentrations are highly variable with median time to peak concentration of 3-6 hours 1.
- The estimated AUC for patients 1-5 years old is approximately 37% higher than for adults receiving a single 40 mg tablet 1.
- Pantoprazole pharmacokinetics are dose-independent (when dose-normalized) and similar to those reported in adult studies 2.
Special Populations
- Obese children: Weight-tiered dosing approach is appropriate without empiric dose escalation, as obese children show decreased weight-adjusted clearance of pantoprazole 3.
- Neonates and infants <1 year: Pantoprazole is not recommended as it has not shown efficacy in this population 1.
Administration Considerations
- Pantoprazole delayed-release tablets can be used in children 6-16 years to provide systemic exposure similar to adults 2.
- For younger children who cannot swallow tablets, pantoprazole granules have been studied but may not be commercially available in all regions 4.
- Food may delay absorption up to 2 hours or longer; however, the maximum concentration and extent of absorption are not altered 1.
Safety Profile
- Pantoprazole is generally well-tolerated in pediatric patients 4.
- Common adverse events include elevated CK, otitis media, rhinitis, and laryngitis 1.
- No evidence of drug accumulation has been observed with multiple dosing 4.
- Long-term safety data in pediatric patients are limited, and the safety and effectiveness for pediatric uses other than EE have not been established 1.
Clinical Pitfalls to Avoid
Avoid use in neonates or infants <1 year: Pantoprazole has not shown efficacy in this population and systemic exposure is significantly higher 1.
Don't overtreat mild GERD: Consider non-pharmacological approaches first for mild symptoms, as PPIs may be overprescribed in pediatric patients 5.
Monitor for drug interactions: Although pantoprazole has fewer drug interactions compared to other PPIs 6, be aware of potential interactions, especially in patients on multiple medications.
Don't exceed recommended treatment duration: Pantoprazole is indicated for short-term treatment (up to 8 weeks) of EE associated with GERD in pediatric patients 1.
Consider CYP2C19 genotype in variable response: Significant differences in pantoprazole exposure have been observed between CYP2C19 extensive metabolizers with different numbers of functional alleles 7.
By following these evidence-based dosing guidelines and considering the specific characteristics of pediatric patients, clinicians can optimize the use of pantoprazole for the management of GERD in children, focusing on improving outcomes related to morbidity, mortality, and quality of life.