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Dosing and administration


NEXIUM I.V. (esomeprazole sodium)

Prepare and administer in 2 easy steps—no filter needed.7

3-minute intravenous injection (20 mg or 40 mg) following reconstitution7

To reconstitute: Draw up 5 mL of 0.9% Sodium Chloride Injection, USP, into a syringe and inject solution into a 20-mg or 40-mg vial of NEXIUM I.V. Mix thoroughly. Use within 12 hours of reconstitution.

To administer: Withdraw the reconstituted solution (5 mL) into a syringe and inject through an I.V. port over no less than 3 minutes.

10- to 30-minute intravenous infusion (20 mg or 40 mg) following reconstitution7

To reconstitute: Draw up 5 mL of 0.9% Sodium Chloride Injection, USP, Lactated Ringer’s Injection, USP, or 5% Dextrose Injection, USP, from a 50-mL bag into a syringe and inject into the vial of NEXIUM I.V. Mix thoroughly.

To administer: Withdraw the reconstituted solution (5 mL) into a syringe and inject back into the 50-mL bag. Administer as an I.V. infusion over 10 to 30 minutes. Stability times: NSS/12 hours, LR/12 hours, and D5W/6 hours.

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.

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

Store unopened vials away from light. Unopened vials may be stored at 77°F with excursions permitted from 59° F to 86° F.




Important Information

Approved Uses

Healing of EE
NEXIUM (esomeprazole magnesium) is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically-confirmed erosive esophagitis.

For those patients who have not healed after 4-8 weeks of treatment, an additional 4-8 week course of NEXIUM may be considered.

Maintenance of EE Healing
NEXIUM is indicated for the maintenance of healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.

Symptomatic GERD
NEXIUM is indicated for treatment of heartburn and other symptoms associated with GERD.

Pathological Hypersecretory Conditions
NEXIUM is indicated for the long-term treatment of pathological hypersecretory conditions. Dosage regimens should be adjusted to individual patient needs.

I.V. Indication
NEXIUM I.V. for Injection is indicated for the short-term treatment (up to 10 days) of GERD adult 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.

 

Important Safety Information
NEXIUM and NEXIUM I.V. are contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles.

The most frequently reported adverse events with NEXIUM include headache, diarrhea, and abdominal pain. Injection site reactions have also been reported with NEXIUM I.V.

In patients aged 12 to 17 years, the most frequently reported adverse events with NEXIUM include headache, diarrhea, abdominal pain, and nausea.

Symptomatic response to therapy does not preclude the presence of gastric malignancy.

Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which NEXIUM is an enantiomer.

As with all PPIs, patients treated concomitantly with warfarin may need to be monitored for increases in INR and prothrombin time. Like other proton pump inhibitors, esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, iron salts, and digoxin).

Concomitant administration of esomeprazole may reduce the plasma levels of atazanavir.

NEXIUM and NEXIUM I.V. should be used only for the conditions, dosages, and durations specified in the Prescribing Information. Please see full Prescribing Information for NEXIUM and NEXIUM I.V.

 
 

NEXIUM and the color purple as applied to the capsule are registered trademarks and Purple Plus is a trademark of the AstraZeneca group of companies.
238402 5/07
Copyright © 2007 AstraZeneca LP. All rights reserved.

This product information is intended for US healthcare professionals only.
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© 2006 AstraZeneca
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