Treatment of Gastroesophageal Reflux Disease (GERD) with Erosive Esophagitis

NEXIUM I.V. for Injection is indicated for the short-term treatment of GERD with erosive esophagitis in adults and pediatric patients 1 month to 17 years, inclusively as an alternative to oral therapy when oral NEXIUM is not possible or appropriate.

NEXIUM I.V. 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 NEXIUM I.V. 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 the Table 1 below. No refrigeration is required.

Table 1

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 NEXIUM I.V. for Injection should be discontinued and the therapy should be continued orally.

Special Populations

Hepatic Insufficiency

No dosage adjustment is necessary 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 dose of 20 mg of NEXIUM should not be exceeded [see Use In Specific Populations and CLINICAL PHARMACOLOGY, Pharmacokinetics].

GERD with Erosive Esophagitis

Adults

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 NEXIUM I.V. for Injection as a treatment of GERD patients with erosive esophagitis for more than 10 days have not been demonstrated.

Pediatric

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

Preparations for Use and Administration

Adults

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 an intravenous injection over no less than 3 minutes.

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 solution (admixture) should be administered as an intravenous infusion over a period of 10 minutes to 30 minutes.

The reconstituted solution should be stored at room temperature up to 30 °C (86 °F) and administered within 12 hours after reconstitution. No refrigeration is required.

Pediatric Population

Intravenous Infusion over 10 minutes to 30 minutes (0.5 mg/kg) for patients ages 1 month to less than 1 year of age

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 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 as follows:

40 mg vial: 0.8 mg/mL
20 mg vial: 0.4 mg/mL

Withdraw appropriate amount of volume for desired dose (0.5 mg/kg) and administer as an intravenous infusion over 10 minutes to 30 minutes

Intravenous Infusion (10 mg and 20 mg) over 10 minutes to 30 minutes for Pediatric Patients, ages 1 year to 17 years of age

40 mg vial

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 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.

20 mg dose: Withdraw 25 mL of the final solution and administer as an intravenous infusion over 10 minutes to 30 minutes
10 mg dose: Withdraw 12.5 mL of the final solution and administer as an intravenous infusion over 10 minutes to 30 minutes

20 mg vial

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 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 0.4 mg/mL.

20 mg dose: Administer the final solution (50 mL) as an intravenous infusion over 10 minutes to 30 minutes
10 mg dose: Withdraw 25 mL of the final solution and administer as an intravenous infusion over 10 minutes to 30 minutes

Dosage Forms And Strengths

NEXIUM I.V. for Injection is supplied as a freeze-dried white to off-white powder containing 20 mg or 40 mg of esomeprazole per single-use vial.

Storage And Handling

NEXIUM I.V. for Injection is supplied as a freeze-dried powder containing 20 mg or 40 mg of esomeprazole per single-use vial.

NDC 0186-6020-01 one carton containing 10 vials of NEXIUM I.V. for Injection (each vial contains 20 mg of esomeprazole).

NDC 0186-6040-01 one carton containing 10 vials of NEXIUM I.V. for Injection (each vial contains 40 mg of esomeprazole).

Storage

Store at 25 °C (77 °F); excursions permitted to 15 °-30 °C (59 °86 °F). [See USP Controlled Room Temperature]. Protect from light. Store in carton until time of use.

Following reconstitution and administration, discard any unused portion of esomeprazole solution.

Manufactured for: AstraZeneca LP Wilmington, DE 19850. Revised: January 2012

Last reviewed on RxList: 2/3/2012
This monograph has been modified to include the generic and brand name in many instances.