INDICATIONS: 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.
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, Lactated Ringer’s Injection, or 5% Dextrose Injection,
both prior to and after administration. 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.
Renal Insufficiency
The pharmacokinetics of esomeprazole in patients with renal impairment are not expected to be altered relative to healthy volunteers as less than 1% of esomeprazole is excreted unchanged in urine.
| Preparations for
use: No refrigeration is required. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. |
| IV
Injection: 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. |
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, Lactated Ringer’s Injection, or 5% Dextrose Injection,
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.
|
Diluent
|
Administer
within:
|
|
5%
Dextrose Injection, USP
|
6
hours
|
|
Lactated
Ringer’s Injection, USP
|
12
hours
|
|
0.9%
Sodium Chloride Injection, USP
|
12
hours
|
|
Storage: Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Protect from light. Store in carton until time of use.
HOW SUPPLIED: NEXIUM I.V. for Injection is supplied as a freeze-dried powder containing 20 mg or 40 mg of esomeprazole per single-use vial.
|
Source: Nexium (package insert).
Willmington, DE: AstraZeneca LP; April 2007.
http://www.astrazeneca-us.com/pi/nexium_iv.pdf |
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