What are the indications for esomeprazole (proton pump inhibitor) in neonates?

From the Guidelines

Esomeprazole is not indicated for neonates, as the Food and Drug Administration has approved its use for people 1 year and older, and there is limited evidence to support its safety and efficacy in neonates.

Indications and Dosage

When considering the use of esomeprazole in pediatric patients, including neonates, it is essential to weigh the potential benefits against the risks. The typical dosage for pediatric patients is 0.7-3.3 mg/kg/d, with treatment duration generally ranging from 4-8 weeks depending on the condition being treated and clinical response 1. However, this dosage is not approved for neonates.

Mechanism of Action and Administration

Esomeprazole works by inhibiting the hydrogen-potassium ATPase enzyme system (the proton pump) in gastric parietal cells, reducing gastric acid production and providing relief from acid-related symptoms. When administering to pediatric patients, the medication can be given as an oral suspension prepared from granules, with careful attention to proper dilution. It should be given at least 30 minutes before feeding for optimal absorption.

Safety and Efficacy

Potential side effects of esomeprazole include headache, abdominal pain, constipation, diarrhea, and rarely, vitamin B12 deficiency with prolonged use. Regular monitoring of symptoms and adjustment of dosage may be necessary. Long-term use should be avoided when possible due to concerns about potential effects on bone density, risk of infections, and other adverse effects in developing pediatric patients.

Clinical Considerations

In clinical practice, the decision to use esomeprazole in pediatric patients, including neonates, should be made on a case-by-case basis, taking into account the individual patient's needs and the potential risks and benefits of treatment. It is essential to carefully evaluate the evidence and consult with a pediatric specialist before initiating treatment with esomeprazole in neonates. Some key points to consider when evaluating the evidence include:

• The lack of approval for use in neonates 1
• The potential risks and benefits of treatment, including the risk of adverse effects and the potential for improved symptoms and quality of life 1
• The importance of careful monitoring and adjustment of dosage to minimize the risk of adverse effects 1

From the Research

Indications of Esomeprazole in Neonates

• Esomeprazole is used to treat gastroesophageal reflux disease (GERD) in neonates, as studied in 2 and 3.
• The study 2 evaluated the efficacy and safety of esomeprazole in neonates with signs and symptoms of GERD, and found that esomeprazole reduced esophageal acid exposure and the number of acidic reflux events.
• Another study 3 assessed the benefits and harms of proton pump inhibitors, including esomeprazole, for the treatment of preterm infants with diagnosed or suspected GERD, but found insufficient data to determine the safety and efficacy of esomeprazole in this population.
• A study 4 evaluated the efficacy and safety of esomeprazole in infants ages 1 to 11 months with GERD, and found that esomeprazole was well tolerated and improved symptom improvement in infants with symptomatic GERD.

Dosage and Administration

• The study 2 used a dosage of 0.5 mg/kg of esomeprazole once daily for up to 14 days in neonates.
• The study 4 used a weight-adjusted dose of esomeprazole (2.5-10 mg) once daily for 2 weeks in infants ages 1 to 11 months.

Safety and Tolerability

• Esomeprazole was found to be well tolerated in neonates and infants, with a similar adverse event profile to placebo 2, 4.
• The most common adverse events reported in infants and children taking esomeprazole were diarrhea, headache, and somnolence 5.