Nexium (Esomeprazole) Dosing for Infants 1-12 Months Old
For infants aged 1-11 months weighing ≥3 kg with GERD, esomeprazole should be dosed at 1.0 mg/kg once daily, based on FDA-approved weight-based dosing that has demonstrated effective acid suppression and tolerability in this age group. 1
Weight-Based Dosing Algorithm
For infants 1-11 months old:
- Dose: 1.0 mg/kg once daily 1
- This dosing achieves therapeutic drug exposure (AUC and Cmax) comparable to effective adult doses 1
- Pharmacokinetic studies demonstrate dose-proportional exposure related to both weight and age in this population 1
Practical Dosing Examples
For a typical infant weight range:
- 5 kg infant: 5 mg once daily
- 7 kg infant: 7 mg once daily
- 10 kg infant: 10 mg once daily
The commercially available esomeprazole granules can be mixed with water or administered via nasogastric tube if needed 1.
Clinical Efficacy Evidence
Treatment duration and expected outcomes:
- In infants with erosive esophagitis, 8 weeks of esomeprazole treatment resulted in 89% erosion resolution 2
- For symptomatic GERD in infants 1-11 months, esomeprazole demonstrated significant symptom improvement compared to placebo in post-hoc analysis 3
- Weight-adjusted doses of 2.5-10 mg once daily were well-tolerated during clinical trials 3
Important Clinical Considerations
Diagnostic challenges in this age group:
- The distinction between physiologic reflux and GERD requiring treatment remains controversial in infants 3, 4
- Improved diagnostic criteria are needed to identify which infants truly benefit from acid suppression therapy 3
- Consider endoscopic or histologic confirmation when feasible, as infants with documented erosive esophagitis show clearer treatment benefit 3
Safety profile:
- Esomeprazole was well-tolerated in clinical trials of infants 1-11 months old 3, 1
- Serious adverse events in pediatric studies were generally unrelated to treatment 1
- The very low-certainty evidence base means long-term safety data remain limited 4
Critical Pitfall to Avoid
Do not extrapolate dosing for infants <1 month old from the 1-11 month dosing. Neonates 0-1 month require a lower dose of 0.5 mg/kg once daily due to immature drug clearance mechanisms 1. Using the higher 1.0 mg/kg dose in neonates could result in excessive drug exposure.
When to Reconsider Treatment
If symptoms do not improve after 2 weeks of appropriate dosing, reassess the diagnosis—many infants have physiologic reflux that does not require pharmacologic intervention 3. Non-pharmacologic interventions and parental reassurance should be attempted first in most cases, reserving esomeprazole for infants with documented erosive disease or severe symptoms unresponsive to conservative management 4.