DOSAGE AND ADMINISTRATION
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 AND USAGE).
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.
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Diluent
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Administer within:
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0.9% Sodium Chloride Injection, USP
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12 hours
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Lactated Ringer’s Injection, USP
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12 hours
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5% Dextrose Injection, USP
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6 hours
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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.
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