What is the pediatric dose of pantaprazole (Protonix) for children?

From the Guidelines

Pantoprazole dosing for children is not explicitly indicated, but based on available evidence, a dose of 0.5-1 mg/kg once daily can be considered for children under 5 years, while adolescents (12-16 years) may receive adult dosing of 40 mg once daily, as suggested by 1.

Important Considerations

• The medication should be taken 30 minutes before meals, and tablets should be swallowed whole, not crushed or chewed.
• For young children who cannot swallow tablets, oral suspension formulations may be available.
• As with all proton pump inhibitors, the lowest effective dose should be used for the shortest duration necessary to minimize potential long-term side effects.

Age-Based Dosing

• Children under 5 years: approximately 0.5-1 mg/kg once daily.
• Children 5 years and older: the typical dose is 20 mg once daily for most conditions, which can be increased to 40 mg daily for severe cases.
• Adolescents (12-16 years) with GERD: may receive adult dosing of 40 mg once daily, as per 1.

Mechanism of Action

Pantoprazole works by inhibiting the proton pump in gastric parietal cells, reducing stomach acid production, as mentioned in 1.

Treatment Duration

Treatment duration generally ranges from 8-12 weeks for most conditions, though maintenance therapy may be needed for chronic conditions. It is essential to consult the latest clinical guidelines and expert opinions for the most up-to-date recommendations on pantoprazole dosing in children, considering the potential risks and benefits, as highlighted in 1 and 1.

From the FDA Drug Label

The safety and effectiveness of pantoprazole for short-term treatment (up to eight weeks) of erosive esophagitis (EE) associated with GERD have been established in pediatric patients 1 year through 16 years of age. For children ages 1 year to 5 years with endoscopically diagnosed EE, pantoprazole was administered once daily for 8 weeks with one of two dose levels of pantoprazole (approximating 0.6 mg/kg or 1.2 mg/kg). In a population pharmacokinetic analysis, 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.

The pediatric dose of pantoprazole for children 1 year to 5 years is approximately 0.6 mg/kg or 1.2 mg/kg once daily for 8 weeks, and for children 5 years and older, the dose is not explicitly stated in the label, but it is indicated for the short-term treatment of EE associated with GERD.

• For children 1 to 5 years, the dose can be 15 mg for ≤ 12.5 kg and 20 mg for > 12.5 to < 25 kg.
• For children less than 1 year of age, pantoprazole was not found to be effective. 2

From the Research

Pediatric Dose of Pantaprazole

The pediatric dose of pantaprazole for children can be determined based on various studies.

• The optimal dose for children is not explicitly stated in the same terms as for adults, but studies suggest that pantoprazole 20 or 40 mg/day is effective and well tolerated in the treatment of acid-related disorders in children and adolescents 3.
• A study on children and adolescents aged 6 through 16 years with gastroesophageal reflux disease (GERD) used pantoprazole 20 or 40 mg once daily, showing that the drug's pharmacokinetic profile is similar to that in adults 4.
• For children with obesity, a physiologically-based pharmacokinetic modeling study suggested that weight-tiered dosing results in the most children having pantoprazole exposures in the reference range, regardless of obesity status or CYP2C19 phenotype 5.
• Single-dose pharmacokinetics of oral and intravenous pantoprazole in children and adolescents showed that the pharmacokinetic values were similar in patients from ages 2 to 16 years and to those previously obtained in adults 6.
• In neonates, preterm infants, and infants aged 1 through 11 months with a clinical diagnosis of GERD, pantoprazole was administered at ~0.6 or ~1.2 mg/kg once daily, with the high dose providing significant improvements in pH-metry parameters 7.

Dosage Recommendations

Based on the available evidence:

• Children aged 6 to 16 years with GERD may be treated with pantoprazole 20 or 40 mg once daily 4.
• For children with obesity, weight-tiered dosing may be used to achieve optimal exposure 5.
• In younger children, such as neonates, preterm infants, and infants aged 1 through 11 months, pantoprazole may be administered at ~0.6 or ~1.2 mg/kg once daily, with the high dose being more effective 7.