NEXIUM I.V. for Injection is indicated for the short-term treatment (up to 10 days) of GERD patients with a history of erosive esophagitis as an alternative to oral therapy in patients when therapy with NEXIUM Delayed-Release Capsules is not possible or appropriate.

When oral therapy is possible or appropriate, intravenous therapy with NEXIUM I.V. for Injection should be discontinued and the therapy should be continued orally.

GERD with a history of Erosive Esophagitis

The recommended adult dose is either 20 or 40 mg esomeprazole given once daily by intravenous injection (no less than 3 minutes) or intravenous infusion (10 to 30 minutes).

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.

Treatment with NEXIUM I.V. for Injection should be discontinued as soon as the patient is able to resume treatment with NEXIUM Delayed-Release Capsules.

Safety and efficacy of NEXIUM I.V. for Injection as a treatment of GERD patients with a history of erosive esophagitis for more than 10 days have not been demonstrated (see INDICATIONS).

Special Populations

Geriatric: No dosage adjustment is necessary. (See CLINICAL PHARMACOLOGY, Pharmacokinetics.)

Renal Insufficiency: No dosage adjustment is necessary. (See CLINICAL PHARMACOLOGY, Pharmacokinetics.)

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 CLINICAL PHARMACOLOGY, Pharmacokinetics.)

Gender: No dosage adjustment is necessary. (See CLINICAL PHARMACOLOGY, Pharmacokinetics.)

Preparations for use

Intravenous Injection (20 or 40 mg) 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.

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.

Intravenous Infusion (20 or 40 mg) over 10 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 to 30 minutes.

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 below. No refrigeration is required.

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.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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.

NEXIUM is a registered trademark of the AstraZeneca group of companies. AstraZeneca, LP Wilmington, DE 19850. Rev. 04/07. FDA Rev date: 4/27/2007

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