What is the recommended dose of omeprazole (Proton Pump Inhibitor) for pediatric patients with conditions like gastroesophageal reflux disease (GERD)?

From the Guidelines

The recommended dose of omeprazole for pediatric patients with GERD is 0.7-3.3 mg/kg/day, often given once daily, with a maximum of 20 mg daily for those weighing less than 20 kg and 40 mg daily for those over 20 kg, as supported by the most recent and highest quality study 1.

Key Considerations

• The dose of omeprazole varies by age and weight, with a typical starting dose of 0.7-3.3 mg/kg/day for children 1-16 years old.
• For infants 1 month to 1 year, the dose is usually 0.5-1.5 mg/kg once daily.
• Treatment duration typically ranges from 4-8 weeks for symptom relief, though some children may require longer therapy under medical supervision.
• Omeprazole works by inhibiting the proton pump in gastric parietal cells, reducing stomach acid production.
• The medication is most effective when given 30 minutes before meals, preferably breakfast.
• For children who cannot swallow capsules, the contents can be mixed with an acidic liquid like apple juice or yogurt, but should not be crushed or chewed.

Important Safety Considerations

• Regular reassessment is necessary to evaluate treatment response and adjust dosing as needed, as prolonged use may be associated with potential side effects including vitamin B12 deficiency, increased risk of infections, and reduced calcium absorption, as noted in 1 and 1.
• The use of PPIs, including omeprazole, should be balanced with the potential risks, including increased risk of lower respiratory tract infections, as highlighted in 1 and 1.

Clinical Guidance

• The American Academy of Pediatrics and other expert guidelines recommend treating GERD in children with symptoms and signs or tests consistent with gastroesophageal pathological reflux, as stated in 1 and 1.
• Acid suppressive therapy, including omeprazole, should not be used solely for chronic cough in children without underlying lung disease, as recommended in 1.

From the FDA Drug Label

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 recommended dose of omeprazole for pediatric patients with conditions like gastroesophageal reflux disease (GERD) is:

• For patients aged 2 to 16 years and weighing 10 to less than 20 kg: 10 mg once daily for up to 4 weeks for symptomatic GERD, and for 4 to 8 weeks for EE due to acid-mediated GERD.
• For patients aged 2 to 16 years and weighing 20 kg and greater: 20 mg once daily for up to 4 weeks for symptomatic GERD, and for 4 to 8 weeks for EE due to acid-mediated GERD. 2

From the Research

Omeprazole Use in Pediatric Patients

• Omeprazole is a proton pump inhibitor (PPI) used to treat acid-related disorders in children, including gastroesophageal reflux disease (GERD) 3.
• The recommended dose of omeprazole for pediatric patients with GERD is 1 mg/kg per day, with a range of 5 to 80 mg/d (0.2-3.5 mg/kg/d) 3.
• Studies have shown that omeprazole is effective in healing esophagitis and providing relief of symptoms of GERD in children, particularly those who had failed to respond to previous treatment with histamine2-receptor antagonists 3, 4.

Safety and Efficacy of Omeprazole in Children

• Long-term use of omeprazole in children has been shown to be safe and effective, with few adverse reactions reported 5.
• A systematic review of randomized controlled trials and crossover studies found that PPIs, including omeprazole, are effective in reducing GERD symptoms in children, but the evidence is limited by the small number of studies and the lack of placebo-controlled trials in older children 6.
• Omeprazole has been shown to be well tolerated in children, with diarrhea, headache, and abdominal pain being the most commonly reported adverse events 4, 7.

Dosage and Administration

• The usual dosage of omeprazole for children is 10 to 20 mg/day, although the dose may vary depending on the specific condition being treated and the age and weight of the child 4, 7.
• Omeprazole can be administered once daily, and the dose may be adjusted based on the response to treatment and the presence of any adverse effects 3, 7.