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For your patients with GERD




Go Inside the Wave: The NEXIUM Story

Number of hours - per 24 hours - intragastric pH>4

(n=34; P≤.0004)‡

Day 5 data from a randomized, open-label, comparative, 5-treatment, 5-way crossover study comparing mean pharmacodynamic parameters in patients with symptoms of GERD treated once daily for 5 days with at least a 10-day washout period.

NEXIUM 20 mg was not evaluated in this study. Study involved oral capsule and tablet formulations only.

Adapted from Miner et al, 2003 and Miner et al, 2006.
‡All pair-wise comparisons vs. NEXIUM.

Controlling acid in patients

NEXIUM:

Controlling acid for more hours than 4 other branded PPIs

In intragastric pH studies, NEXIUM provides more hours of acid control vs 4 other branded PPIs.9-15

In 11 different studies* NEXIUM outperformed 4 other branded PPIs in gastric acid control.9-15

*Individual studies of oral formulations with varying designs, dosing, and comparators in GERD patients and healthy volunteers.

THE CORRELATION OF pH DATA TO CLINICAL OUTCOME HAS NOT BEEN DIRECTLY ESTABLISHED.

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Acid control - intragastric pH>4 - around meals and overnight

(n=36)

NEXIUM 40 mg Delayed-Release Capsule administered
at 8:00 am

Day 5 data from a randomized, double-blind, comparative, 3-treatment, 3-way crossover study comparing pharmaco- dynamic parameters in patients with symptoms of GERD
treated for 5 days with oral doses of NEXIUM 40 mg,
NEXIUM 20 mg, or omeprazole 20 mg once daily with at
least a 14-day washout period.

Adapted from Lind et al.

Controlling acid in patients

Acid control—intragastric pH>4—around meals and overnight.12

THE CORRELATION OF pH DATA TO CLINICAL OUTCOME HAS NOT BEEN DIRECTLY ESTABLISHED.

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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.

Pediatric Use
NEXIUM is approved for the short-term treatment (up to 8 weeks) of GERD in patients aged 12 to 17 years. Safety and effectiveness for the treatment of symptomatic GERD in patients less than 12 years of age have not been established. Safety and effectiveness for other pediatric uses have not been established.

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

 
 

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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