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NEXIUM I.V.




Acid control from hospital to home

For the short-term treatment (up to 10 days) of GERD in adult patients with a history of EE as an alternative when oral therapy is not possible or appropriate, NEXIUM I.V. provides:

  • Effective acid control
    Rapid onset of action on day 1 with NEXIUM I.V. 40 mg*19,20

    Data from a randomized, double-blind, 2-way crossover study comparing pharmacodynamic parameters in healthy subjects treated for 5 days with at least a 13-day washout period. All infusions administered over a period of 30 minutes.

    *Administered as an I.V. infusion over 30 minutes. A significantly greater amount of time with intragastric pH>4 (P<0.0001).20
  • Impressive mean duration with pH>419
    —Day 1: 10.1 hours with NEXIUM I.V. 40 mg vs 8.8 hours with NEXIUM oral 40 mg (P=NS)
    —Day 5: 15.9 hours with NEXIUM I.V. 40 mg vs 15.3 hours with NEXIUM oral 40 mg (P=NS)

    THE CORRELATION OF pH DATA TO CLINICAL OUTCOME HAS NOT BEEN DIRECTLY ESTABLISHED.
  • Proven safety profile
    In clinical studies, NEXIUM I.V. and NEXIUM oral were generally well tolerated. NEXIUM I.V. demonstrated a similar safety profile to NEXIUM oral.7,19
  • Convenient storage7
    NO REFRIGERATION REQUIRED
    Store unopened vials away from light. Reconstituted solution should be administered within 12 hours, and may be stored at room temperature, 77°F.
From I.V. to oral treatment

To transition patients from I.V., NEXIUM Delayed-Release Capsules offer continuing acid control for at-home treatment. Learn more about NEXIUM Delayed-Release Capsules.




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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