What is the recommended dosage of Pantoprazole (Proton Pump Inhibitor) for a 13-year-old patient?

From the Guidelines

The recommended dosage of Pantoprazole for a 13-year-old patient is 40 mg once daily, usually taken in the morning before eating, as this is the standard dose for adolescents aged 12 and older, according to the available evidence 1. When considering the dosage of Pantoprazole for a 13-year-old patient, it's essential to note that the medication should be used under the guidance of a pediatrician or gastroenterologist.

• The dosage may vary depending on the child's weight and medical condition, and it's crucial to individualize the treatment plan.
• The study suggests that an 8-week course of Pantoprazole at a regular dose twice daily (40 mg, BID) or double dose once daily has been proposed as sufficient to assess a response to PPI therapy 1.
• However, for adolescents, the typical dosage is 40 mg once daily, and treatment duration depends on the condition being treated, generally ranging from 2-8 weeks.
• It's also important to monitor for potential side effects, such as headache, diarrhea, or stomach pain, and adjust the treatment plan as needed.
• As the evidence supporting the recommendations for pediatric patients is poor and conflicting, it's vital to consult with a medical professional to determine the best course of treatment for the individual child 1.

From the FDA Drug Label

Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets Indication Dose Frequency Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once daily for up to 8 weeks ≥ 40 kg 40 mg The recommended dosage of Pantoprazole for a 13-year-old patient is 40 mg once daily, assuming the patient weighs ≥ 40 kg 2.

• The dosage is based on the patient's weight.
• For patients who weigh ≥ 15 kg to < 40 kg, the recommended dosage is 20 mg once daily. However, since the patient is 13 years old, it is likely that they weigh ≥ 40 kg, but the exact weight should be confirmed to determine the appropriate dosage.

From the Research

Recommended Dosage of Pantoprazole for a 13-year-old Patient

The recommended dosage of Pantoprazole for a 13-year-old patient can be determined based on the available studies.

• According to the study 3, oral pantoprazole 20 mg given once daily for 28 days was effective in reducing esophageal acid exposure time and improving symptoms of reflux esophagitis in pediatric patients aged 6 to 13 years.
• Another study 4 characterized the pharmacokinetic profile of single and multiple doses of pantoprazole delayed-release tablets in pediatric patients with GERD aged 6 to 16 years, and found that pantoprazole 20 or 40 mg once daily was safe and effective.
• The study 4 also found that pantoprazole PK was dose independent and similar to PK reported from adult studies, with no evidence of accumulation with multiple dosing or reports of serious drug-associated adverse events.

Key Findings

• Pantoprazole 20 mg once daily is an effective maintenance therapy for patients with gastro-oesophageal reflux disease 5, 6.
• Oral pantoprazole 20 mg daily provided gastric acid control in pediatric patients with reflux esophagitis with partial clinical improvement of symptoms after 28 days of treatment 3.
• Pantoprazole 20 or 40 mg once daily was safe and effective in pediatric patients with GERD aged 6 to 16 years 4.

Dosage Considerations

• The dosage of pantoprazole for a 13-year-old patient may be similar to that for adults, based on the study 4 which found that pantoprazole PK was similar to PK reported from adult studies.
• However, the study 3 used a dosage of 20 mg once daily for pediatric patients aged 6 to 13 years, which may be considered for a 13-year-old patient.