General Information
Esomeprazole sodium for injection should not be administered concomitantly with any other medications through the same intravenous site and/or tubing. The intravenous line should always be flushed with either 0.9% Sodium Chloride Injection, USP, Lactated Ringer’s Injection, USP or 5% Dextrose Injection, USP both prior to and after administration of esomeprazole sodium for injection.
The admixture should be stored at room temperature up to 30°C (86°F) and should be administered within the designated time period as listed in Table 1 below. No refrigeration is required.
Table 1 Storage Time for Final (diluted) Product
Diluent
Administer within:
0.9% Sodium Chloride Injection, USP
12 hours
Lactated Ringer’s Injection, USP
12 hours
5% Dextrose Injection, USP
6 hours
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
As soon as oral therapy is possible or appropriate, intravenous therapy with esomeprazole sodium for injection should be discontinued and the therapy should be continued orally.
2.1 GERD with Erosive Esophagitis
Adult Patients
The recommended adult dose is either 20 mg or 40 mg esomeprazole given once daily by intravenous injection (no less than 3 minutes) or intravenous infusion (10 minutes to 30 minutes). Safety and efficacy of esomeprazole sodium for injection as a treatment of GERD patients with erosive esophagitis for more than 10 days have not been demonstrated.
Dosage adjustment is not required in patients with mild to moderate liver impairment (Child Pugh Classes A and B). For patients with severe liver impairment (Child Pugh Class C), a maximum dose of 20 mg once daily of esomeprazole sodium for injection should not be exceeded [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
Pediatric Patients
The recommended doses for children ages 1 month to 17 years, inclusive, are provided below. Dose should be infused over 10 minutes to 30 minutes.
1 year to 17 years:
Body weight less than 55 kg: 10 mg
Body weight 55 kg or greater: 20 mg
1 month to less than 1 year of age: 0.5 mg/kg
2.3 Preparation and Administration Instructions
General Information
The reconstituted solution of esomeprazole sodium for injection should be stored at room temperature up to 30°C (86°F) and administered within 12 hours after reconstitution. (Administer within 6 hours if 5% Dextrose Injection is used after reconstitution). No refrigeration is required [see Dosage and Administration (2), Table 1].
Gastroesophageal Reflux Disease (GERD) with Erosive Esophagitis
Preparation Instructions for Adult Patients
Intravenous Injection (20 mg or 40 mg vial) over no less than 3 minutes
The freeze-dried powder should be reconstituted with 5 mL of 0.9% Sodium Chloride Injection, USP. Withdraw 5 mL of the reconstituted solution and administer as an intravenous injection over no less than 3 minutes.
Preparation Instructions for Pediatric Patients
Intravenous Infusion (20 mg or 40 mg) over 10 minutes to 30 minutes
A solution for intravenous infusion is prepared by first reconstituting the contents of one vial* with 5 mL of 0.9% Sodium Chloride Injection, USP, Lactated Ringer’s Injection, USP or 5% Dextrose Injection, USP and further diluting the resulting solution to a final volume of 50 mL. The resultant concentration after diluting to a final volume of 50 mL is 0.8 mg/mL (for 40 mg vial) and 0.4 mg/mL (for 20 mg vial). The solution (admixture) should be administered as an intravenous infusion over a period of 10 minutes to 30 minutes.
*For patients 1 month to less than 1 year of age, first calculate the dose (0.5 mg/kg) to determine the vial size needed.
