HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use NEXIUM safely and effectively. See full prescribing information for NEXIUM.
NEXIUM (esomeprazole magnesium) DELAYED-RELEASE CAPSULES
NEXIUM (esomeprazole magnesium) FOR DELAYED-RELEASE ORAL SUSPENSION
Initial U.S. Approval: 1989 (omeprazole)
RECENT MAJOR CHANGES
WARNINGS AND PRECAUTIONS 09/2010

Bone Fracture (5.3)

WARNINGS AND PRECAUTIONS06/2011

Hypomagnesemia (5.6)

WARNINGS AND PRECAUTIONS 06/2011

Concomitant use of NEXIUM with St John’s Wort or Rifampin (5.6)

Interactions with Diagnositc Investigations for Neuroendocrine Tumors (5.7)
INDICATIONS AND USAGE
NEXIUM is a proton pump inhibitor indicated for the following:

Treatment of gastroesophageal reflux disease (GERD) (1.1)

Risk reduction of NSAID-associated gastric ulcer (1.2)

H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3)

Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4)
DOSAGE AND ADMINISTRATION
Indication Dose Frequency
Gastroesophageal Reflux Disease (GERD)
Adults
 20 mg or 40 mg
 Once daily for 4 to 8 weeks
 
12 to 17 years
 20 mg or 40 mg
 Once daily for up to 8 weeks
 
1 to 11 years
 10 mg or 20 mg
 Once daily for up to 8 weeks
 
Risk Reduction of NSAID-Associated Gastric Ulcer
 
 20 mg or 40 mg
 Once daily for up to 6 months
 
H. pylori Eradication (Triple Therapy):
 
NEXIUM
 40 mg
 Once daily for 10 days
 
Amoxicillin
 1000 mg
 Twice daily for 10 days
 
Clarithromycin
 500 mg
 Twice daily for 10 days
 
Pathological Hypersecretory Conditions
 
 40 mg
 Twice daily
 

See full prescribing information for administration options (2)

 
DOSAGE FORMS AND STRENGTHS
NEXIUM Delayed-Release Capsules, 20 mg and 40 mg (3)
NEXIUM For Delayed-Release Oral Suspension, 10 mg, 20 mg, and 40 mg (3)
CONTRAINDICATIONS
Patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles (angioedema and anaphylaxis have occurred) (4)
WARNINGS AND PRECAUTIONS
Symptomatic response does not preclude the presence of gastric malignancy (5.1)

Atrophic gastritis has been noted with long-term omeprazole therapy (5.2)

Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. (5.3)

Triple therapy for H. pylori – there are risks due to the antibiotics; see separate prescribing information for individual antibiotics (5.4, 5.5)

Hypomagnesemia has been reported rarely with prolonged treatment with PPIs (5.6)

Avoid concomitant use of NEXIUM with St John’s Wort or rifampin due to the potential reduction in esomeprazole levels (5.7) (7.3)

Interactions with diagnostic investigations for Neuroendocrine Tumors: Increases in intragastric pH may result in hypergastrinemia and enterochromaffin-like cell hyperplasia and increased chromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors. (5.8, 12.2)
ADVERSE