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Pediatric patient profile




Go Inside the Wave: The NEXIUM Story

Lucy, hypothetical NEXIUM patient
14-year-old female patient with moderate heartburn and mild regurgitation

What aspects of care would you consider for Lucy?

Safety profile

Symptom relief

NEXIUM for the next generation

NEXIUM 20 mg QD and NEXIUM 40 mg QD are approved for the short-term treatment (up to 8 weeks) of GERD in patients aged 12 to 17 years.

  • Safety data: In patients aged 12 to 17 years, the most frequently reported adverse events include headache, diarrhea, abdominal pain, and nausea. No new safety concerns were identified in the pediatric clinical trial.7
  • Efficacy: The use of NEXIUM in adolescents is supported by extrapolation of results, already included in the approved labeling, from adequate and well-controlled studies that supported the approval of NEXIUM for adults and safety and pharmacokinetic studies in patients aged 12 to 17 years.7
  • Symptom relief: Secondary endpoint from safety study showed symptom improvement at week 8 with NEXIUM in patients aged 12 to 17 years with moderate-to-severe symptoms of GERD.8

Please see Important Safety Information and full Prescribing Information for NEXIUM.

Lucy, hypothetical NEXIUM patient
Lucy, hypothetical NEXIUM patient

Age/Lifestyle:
14-year-old female; rides her bike to school; plays the flute; loves pepperoni pizza

 

Prescription Plan:
Coverage is provided by her father's prescription plan

 

Previous Treatment/Symptoms:
Has taken an H2-receptor antagonist in the past
Has made changes to her diet, in combination with a PPI
Moderate heartburn
Mild regurgitation

Could she benefit from PPI therapy?







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.

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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