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Esomeprazole - Pediatric Dosing (IV)

Dosing: Pediatric

Erosive esophagitis associated with GERD:

IV: Note: Indicated only in cases where oral therapy is inappropriate or not possible; safety and efficacy >10 days has not been established.

Infants: 0.5 mg/kg/dose once daily.

Children and Adolescents ≤17 years:

<55 kg: 10 mg once daily.

≥55 kg: 20 mg once daily.


Discontinuation of therapy: Oral: Based on experience in adults, some experts recommend a step-down approach in order to avoid worsening or rebound symptoms. One recommendation is to decrease the dose by 50% over 2 to 4 weeks. If the patient is already on the lowest possible dose, alternate day therapy may be considered. If symptoms worsen during treatment or after discontinuation, patient should be reevaluated (Kim 2018).

Dosing: Renal Impairment: Pediatric

Infants, Children, and Adolescents: Oral, IV: No dosage adjustments necessary.

Dosing: Hepatic Impairment: Pediatric

There are no specific pediatric recommendations; based on experience in adult patients, adjustment suggested in severe impairment.


Preparation for Administration: Pediatric

IV: For IV infusion (10 to 30 minutes): 

    Reconstitute powder (20 mg or 40 mg) with 5 mL of NS, LR, or D5W; 

   further dilute to a final volume of 50 mL to achieve a final concentration of 0.4 mg/mL or 0.8 mg/mL, respectively

Administration: Pediatric

IV: Flush line prior to and after administration with NS, LR, or D5W. Administer desired dose by intermittent infusion over 10 to 30 minutes. The manufacturer recommends that pediatric patients receive intravenous esomeprazole by intermittent infusion only.


Storage/Stability

Powder for injection: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. Per the manufacturer, following reconstitution, solution for injection prepared in NS, and solution for infusion prepared in NS or LR should be used within 12 hours; solution for infusion prepared in D5W should be used within 6 hours. Refrigeration is not required following reconstitution.

Additional stability data: Following reconstitution, solutions for infusion prepared in D5W, NS, or LR in PVC bags are chemically and physically stable for 48 hours at room temperature (25°C) and for at least 120 hours under refrigeration (4°C) (Kupiec 2008).