What is the dosing for pediatric omeprazole (proton pump inhibitor)?

From the Guidelines

The recommended dosing for pediatric omeprazole is 0.7–3.3 mg/kg/d, which can be administered by sprinkling the contents of a capsule onto soft foods, for children aged 2–16 years. This dosing guideline is based on the study published in Pediatrics in 2013 1. The study provides a comprehensive overview of the management of gastroesophageal reflux disease (GERD) in pediatric patients, including the use of proton pump inhibitors (PPIs) like omeprazole.

Key Considerations

• The dosing range of 0.7–3.3 mg/kg/d is recommended for children aged 2–16 years, with the medication administered once daily.
• The medication can be given by sprinkling the contents of a capsule onto soft foods, making it easier for children to take.
• It is essential to adjust the dose based on the patient's response and consult current guidelines for specific conditions, such as GERD or peptic ulcers.
• Omeprazole works by reducing stomach acid production, which helps heal the esophagus and stomach lining in conditions like GERD and peptic ulcers.

Administration and Monitoring

• The dose should be administered in the morning before breakfast for optimal effect.
• The medication can be given as capsules or oral suspension, depending on the child's ability to swallow.
• Treatment duration usually ranges from 4-8 weeks for GERD or ulcers, but may be longer for severe cases.
• It is crucial to monitor the patient's response to the medication and adjust the dose as needed, under the guidance of a healthcare professional 1.

From the FDA Drug Label

1. 2 Recommended Pediatric Dosage Regimen by Indication Table 2 shows the recommended dosage of omeprazole in pediatric patients by indication Table 2: Recommended Dosage Regimen of Omeprazole in Pediatric Patients by Indication Indication Omeprazole Dosage Regimen and Duration Patient Age Weight-Based Dose (mg) Regimen and Duration Treatment of Symptomatic GERD 2 to 16 years 10 to less than 20 kg: 10 mg Once daily for up to 4 weeks 20 kg and greater: 20 mg Treatment of EE due to Acid- Mediated GERD 2 to 16 years 10 to less than 20 kg: 10 mg Once daily for 4 to 8 weeks1 20 kg and greater: 20 mg Maintenance of Healing of EE due to Acid-Mediated GERD 2 to 16 years 10 to less than 20 kg: 10 mg Once daily. Controlled studies do not extend beyond 12 months 20 kg and greater: 20 mg

The dosing for pediatric omeprazole is as follows:

• Treatment of Symptomatic GERD:
  • Patients 2 to 16 years old, weighing 10 to less than 20 kg: 10 mg once daily for up to 4 weeks
  • Patients 2 to 16 years old, weighing 20 kg and greater: 20 mg once daily for up to 4 weeks
• Treatment of EE due to Acid-Mediated GERD:
  • Patients 2 to 16 years old, weighing 10 to less than 20 kg: 10 mg once daily for 4 to 8 weeks
  • Patients 2 to 16 years old, weighing 20 kg and greater: 20 mg once daily for 4 to 8 weeks
• Maintenance of Healing of EE due to Acid-Mediated GERD:
  • Patients 2 to 16 years old, weighing 10 to less than 20 kg: 10 mg once daily
  • Patients 2 to 16 years old, weighing 20 kg and greater: 20 mg once daily 2

From the Research

Dosing for Pediatric Omeprazole

The dosing for pediatric omeprazole varies based on the patient's age, weight, and condition being treated.

• For children under 2 years of age, the initial dosage is 0.7 mg/kg/day, with increases up to 2.8 mg/kg/day as needed 3.
• For children with erosive esophagitis, a dose of 0.3 to 3.5 mg/kg once daily (median 1 mg/kg once daily) for at least 12 weeks is effective 4.
• In severe cases of reflux esophagitis, a starting dose of 20 mg daily for children weighing less than 30 kg and 40 mg daily for those weighing over 30 kg has been used 5.
• For intravenous administration, a dose of 40 mg/1.73 m2 is required to maintain a 24-hour gastric pH of more than 4 6.

Administration Forms

Omeprazole can be administered in various forms, including:

• Delayed-release oral suspension 4
• Granule form 7
• Suspension form 7
• Intravenous form 6

Pharmacokinetics

The pharmacokinetics of omeprazole in children have been studied, with results showing:

• Rapid elimination of the drug 6
• Median area under the curve of omeprazole of 0.78 microg/mL/h (range, 0.55-1.64 microg/mL/h) and 3.95 microg/mL/h (range, 1.9-4.9 microg/mL/h) for doses of 20 mg/1.73 m2 and 40 mg/1.73 m2, respectively 6
• No significant differences in systemic clearance between different dosage forms 7