From the Guidelines
Omeprazole can be used in pediatric patients for treating gastroesophageal reflux disease (GERD) and erosive esophagitis, with a recommended dose of 0.7-3.3 mg/kg/day for children 1-16 years old, as supported by the American Academy of Pediatrics 1.
Key Considerations
- The dose for children weighing less than 20 kg typically starts at 10 mg daily, while those weighing more than 20 kg start at 20 mg daily.
- For infants 1 month to 1 year, doses of 0.5-1.5 mg/kg once daily are commonly used.
- Treatment duration varies by condition: 4-8 weeks for GERD symptoms and 4-12 weeks for erosive esophagitis.
- Omeprazole works by inhibiting the proton pump in gastric parietal cells, reducing acid production in the stomach, making it effective for acid-related conditions.
- Common side effects include headache, abdominal pain, nausea, diarrhea, and constipation, as noted in studies 1.
Important Safety Information
- Long-term use of omeprazole should be monitored due to potential associations with vitamin B12 deficiency, hypomagnesemia, and increased risk of respiratory infections in some children, highlighting the need for cautious use, especially in infants 1.
- The American Academy of Pediatrics guidelines emphasize the importance of avoiding overprescription of acid suppressants, including proton pump inhibitors like omeprazole, in pediatric patients 1.
From the FDA Drug Label
For children 2 to 16 years of age, omeprazole delayed-release capsules are used: • for up to 4 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD). • for up to 8 weeks to treat gastroesophageal reflux disease (GERD) with acid-related damage to the lining of the esophagus [called erosive esophagitis (or EE) due to acid-mediated GERD] • to maintain healing of the esophagus. It is not known if omeprazole delayed-release capsules are safe and effective when used longer than 12 months (1 year) for this purpose.
Omeprazole use in pediatric patients is approved for children 2 to 16 years of age for the treatment of:
- Gastroesophageal reflux disease (GERD) for up to 4 weeks
- GERD with acid-related damage to the lining of the esophagus (erosive esophagitis) for up to 8 weeks
- Maintenance of healing of the esophagus However, the safety and effectiveness of omeprazole delayed-release capsules for longer than 12 months (1 year) in pediatric patients are not known 2.
From the Research
Omeprazole Use in Pediatric Patients
- Omeprazole has been shown to be effective in the treatment of acid-related diseases in children, including gastroesophageal reflux disease (GERD), peptic ulcer disease, and Helicobacter pylori (HP) infection 3.
- The initial dose of omeprazole most consistently reported to heal esophagitis and provide relief of symptoms of GERD in children is 1 mg/kg per day 3.
- In children under 2 years of age, omeprazole has been found to be effective in treating symptomatic gastroesophageal reflux, with a median dosage of 1.05 mg/kg/day required 4.
- Proton pump inhibitors (PPIs), including omeprazole, are considered better antisecretory agents than H2-receptor antagonists and are the mainstream treatment for GERD in children 5.
Dosage and Administration
- Omeprazole has been administered to children aged 2 months to 18 years at dosages of 5 to 80 mg/d (0.2-3.5 mg/kg/d) for periods ranging from 14 days to 36 months with a low incidence of adverse effects 3.
- In children under 2 years of age, the initial dosage of omeprazole is 0.7 mg/kg/day, with increases in increments of 0.7 mg/kg/day as needed 4.
- The median dosage required to control gastroesophageal reflux in children under 2 years of age is 1.05 mg/kg/day, with some children requiring up to 2.8 mg/kg/day 4.
Safety and Efficacy
- Omeprazole has been found to be effective and well tolerated in the acute and chronic treatment of esophageal and peptic ulcer disease in children 3.
- Long-term gastric acid suppression in children has been linked to increased risks of gastrointestinal and lower respiratory tract infections, bone fractures, and allergy 6.
- PPIs, including omeprazole, are considered safe and effective for the treatment of GERD in children, but their use should be carefully monitored due to potential long-term risks 6.