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Dosing and administration


NEXIUM Delayed-Release Capsules


Approved Uses Dose Frequency Duration
Gastroesophageal Reflux Disease (GERD)
Healing of Erosive
Esophagitis
Maintenance of Healing of
Erosive Esophagitis
Symptomatic Gastroesophageal
Reflux Disease


20 mg
or
40 mg
20 mg
20 mg

Once daily
Once daily
Once daily

4-8 weeks*
As long as clinically indicated**
4 weeks***
Pediatric Use
Short-Term Treatment of GERD
in Pediatric Patients
Aged 12 to 17 Years

20 mg
or
40 mg
Once daily
Up to 8 weeks
H. pylori Eradication
to Reduce the Risk of
Duodenal Ulcer Recurrence
Triple Therapy‡ ‡
NEXIUM
Amoxicillin
Clarithromycin





40 mg
1000 mg
500 mg





Once daily
Twice daily
Twice daily





10 days
10 days
10 days

Risk Reduction of
NSAID-Associated Gastric Ulcer

20 mg
or
40 mg
Once daily
Up to 6 months**



Alternate Modes of Administration
NEXIUM Delayed-Release Capsules should be swallowed whole.

For patients who have difficulty swallowing, capsules can be opened and intact pellets may be sprinkled onto 1 tablespoon of applesauce, mixed, and swallowed immediately. Applesauce should not be hot, and pellets should not be chewed or crushed. Do not store for future use.

For patients who have a nasogastric tube in place, NEXIUM Delayed-Release Capsules can be opened and the intact granules emptied into a 60-mL syringe and mixed with 50 mL of water. Replace the plunger and shake the syringe vigorously for 15 seconds. Hold the syringe with the tip up and check for granules remaining in the tip. Attach the syringe to a nasogastric tube and deliver the contents of the syringe through the nasogastric tube into the stomach. After administering the granules, the nasogastric tube should be flushed with additional water. Do not administer pellets if they have dissolved or disintegrated.

The suspension must be used immediately after preparation.

Indication: Pathological Hypersecretory Conditions including Zollinger-Ellison Syndrome
Dose: 40mg
Frequency: Twice Daily‡
Duration: As long as clinically indicated†



*The majority of patients are healed within 4-8 weeks.

**Controlled studies did not extend beyond six months.

***If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.

†The dosage of NEXIUM in patients with pathological hypersecretory conditions varies with the individual patient. Dosage regimens should be adjusted to individual patient needs.

‡Doses up to 240 mg daily may have been administered.

‡ ‡Patients not eradicated of H. pylori following esomeprazole magnesium/amoxicillin/clarithromycin triple therapy will likely have clarithromycin resistant H. pylori isolates. Therefore, clarithromycin susceptibility testing should be done, when possible. Patients with clarithromycin resistant H. pylori should not be treated with a clarithromycin-containing regimen.7




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.

Risk Reduction of NSAID-Associated Gastric Ulcer
NEXIUM is indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered at risk due to their age (≥60 years) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.

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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