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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)
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RECENT MAJOR CHANGES
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WARNINGS AND PRECAUTIONS 08/2010
Bone Fracture (5.3)
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INDICATIONS AND USAGE
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NEXIUM is a proton pump inhibitor indicated for the following:
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Treatment of gastroesophageal reflux disease (GERD) (1.1)
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Risk reduction of NSAID-associated gastric ulcer (1.2)
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H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3)
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Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4)
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DOSAGE AND ADMINISTRATION
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Indication |
Dose |
Frequency |
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Gastroesophageal Reflux Disease (GERD)
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Adults
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20 mg or 40 mg
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Once daily for 4 to 8 weeks
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12 to 17 years
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20 mg or 40 mg
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Once daily for up to 8 weeks
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1 to 11 years
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10 mg or 20 mg
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Once daily for up to 8 weeks
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Risk Reduction of NSAID-Associated Gastric Ulcer
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20 mg or 40 mg
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Once daily for up to 6 months
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H. pylori Eradication (Triple Therapy):
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NEXIUM
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40 mg
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Once daily for 10 days
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Amoxicillin
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1000 mg
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Twice daily for 10 days
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Clarithromycin
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500 mg
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Twice daily for 10 days
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Pathological Hypersecretory Conditions
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40 mg
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Twice daily
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See full prescribing information for administration options (2)
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DOSAGE FORMS AND STRENGTHS
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NEXIUM Delayed-Release Capsules, 20 mg and 40 mg (3)
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NEXIUM For Delayed-Release Oral Suspension, 10 mg, 20 mg, and 40 mg (3)
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CONTRAINDICATIONS
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Patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles (angioedema and anaphylaxis have occurred) (4)
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WARNINGS AND PRECAUTIONS
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Symptomatic response does not preclude the presence of gastric malignancy (5.1)
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Atrophic gastritis has been noted with long-term omeprazole therapy (5.2)
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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)
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Triple therapy for H. pylori – there are risks due to the antibiotics; see separate prescribing information for individual antibiotics (5.4, 5.5)
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ADVERSE REACTIONS
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Most common adverse reactions:
Adult (> 18 years) use (incidence > 1%):
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Headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth (6.1)
Pediatric (1 - 17 years) use (incidence > 1–2%):
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Headache, diarrhea, abdominal pain, nausea, and somnolence (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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DRUG INTERACTIONS
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May affect plasma levels of antiretroviral drugs – use with atazanavir and nelfinavir is not recommended; if saquinavir is used with NEXIUM, monitor for toxicity and consider saquinavir dose reduction (7.1)
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May interfere with drugs for which gastric pH affects bioavailability (e.g., ketoconazole, iron salts, and digoxin) (7.2)
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Combined inhibitor of CYP 2C19 and 3A4 may raise esomeprazole levels (7.3)
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May increase systemic exposure of cilostazol and an active metabolite. Consider dose reduction (7.3)
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USE IN SPECIFIC POPULATIONS
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See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling |
Revised: 02/2011 |
Back to Highlights and Tabs
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FULL PRESCRIBING INFORMATION: CONTENTS* |
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Recent Major Changes
1 INDICATIONS AND USAGE
1.1 Treatment of Gastroesophageal Reflux Disease (GERD)
1.2 Risk Reduction of NSAID-Associated Gastric Ulcer
1.3 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Concurrent Gastric Malignancy
5.2 Atrophic Gastritis
5.3 Bone Fracture
5.4 Risks of Amoxicillin (as Part of H. pylori Triple Therapy)
5.5 Risks of Clarithromycin (as Part of H. pylori Triple Therapy)
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Combination Treatment with Amoxicillin and Clarithromycin
6.3 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Interference with Antiretroviral Therapy
7.2 Drugs for Which Gastric pH Can Affect Bioavailability
7.3 Effects on Hepatic Metabolism/Cytochrome P-450 Pathways
7.4 Combination Therapy with Clarithromycin
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3Nursing Mothers
8.4Pediatric Use
8.5Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Healing of Erosive Esophagitis
14.2 Symptomatic Gastroesophageal Reflux Disease (GERD)
14.3 Pediatric Gastroesophageal Reflux Disease (GERD)
14.4 Risk Reduction of NSAID-Associated Gastric Ulcer
14.5 Helicobacter pylori (H.pylori) Eradication in Patients with Duodenal Ulcer Disease
14.6 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
FDA-APPROVED PATIENT LABELING
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1 Treatment of Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis
NEXIUM 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 to 8 weeks of treatment, an additional 4 to 8 week course of NEXIUM may be considered.
Maintenance of Healing of Erosive Esophagitis
NEXIUM is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease
NEXIUM is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.
1.2 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 to be at risk due to their age (≥ 60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.
1.3 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy (NEXIUM plus amoxicillin and clarithromycin): NEXIUM, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14) and Dosage and Administration. (2)].
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology (12.4) and the clarithromycin package insert, Clinical Pharmacology, Microbiology].
1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
NEXIUM is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
2 DOSAGE AND ADMINISTRATION
NEXIUM is supplied as delayed-release capsules for oral administration or in packets for preparation of delayed-release oral suspensions. The recommended dosages are outlined in the table below. NEXIUM should be taken at least one hour before meals.
The duration of proton pump inhibitor administration should be based on available safety and efficacy data specific to the defined indication and dosing frequency, as described in the Prescribing Information, and individual patient medical needs. Proton pump inhibitor treatment should only be initiated and continued if the benefits outweigh the risks of treatment.
Table 1
Recommended Dosage Schedule of NEXIUM
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Indication
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Dose
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Frequency
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Gastroesophageal Reflux Disease (GERD)
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Healing of Erosive Esophagitis
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20 mg or 40 mg
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Once Daily for 4 to 8 Weeks
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Maintenance of Healing of Erosive Esophagitis
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20 mg
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Once Daily*
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Symptomatic Gastroesophageal Reflux Disease
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20 mg
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Once Daily for 4 Weeks
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Pediatric GERD
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12 to 17 Year Olds
Short-term Treatment of GERD
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20 mg or 40 mg
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Once Daily for up to 8 Weeks
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1 to 11 Year Olds Short-term Treatment of Symptomatic GERD
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10 mg
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Once Daily for up to 8 Weeks
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Healing of Erosive Esophagitis
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weight < 20 kg
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10 mg
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Once Daily for 8 Weeks
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weight ≥ 20 kg
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10 mg or 20 mg
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Once Daily for 8 Weeks
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Risk Reduction of NSAID-Associated Gastric Ulcer
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20 mg or 40 mg
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Once Daily for up to 6 months*
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H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
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Triple Therapy:
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NEXIUM
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40 mg
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Once Daily for 10 Days
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Amoxicillin
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1000 mg
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Twice Daily for 10 Days
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Clarithromycin
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500 mg
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Twice Daily for 10 Days
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Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
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40 mg
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Twice Daily
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Please refer to amoxicillin and clarithromycin full prescribing information for Contraindications, Warnings, and dosing in elderly and renally-impaired patients.
Special Populations
Geriatric
No dosage adjustment is necessary [see Clinical Pharmacology (12.3)].
Renal Insufficiency
No dosage adjustment is necessary [see Clinical Pharmacology (12.3)].
Hepatic Insufficiency
In patients with mild to moderate liver impairment (Child Pugh Classes A and B), no dosage adjustment is necessary. For patients with severe liver impairment (Child Pugh Class C), a dose of 20 mg of NEXIUM should not be exceeded [see Clinical Pharmacology (12.3)].
Gender
No dosage adjustment is necessary [see Clinical Pharmacology (12.3)].
Administration Options
Directions for use specific to the route and available met
