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)
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.
DRUG INTERACTIONS
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)
May interfere with drugs for which gastric pH affects bioavailability (e.g., ketoconazole, iron salts, and digoxin) Patients treated with NEXIUM and digoxin may need to be monitored for digoxin toxicity. (7.2)
Combined inhibitor of CYP 2C19 and 3A4 may raise esomeprazole levels (7.3)
May increase systemic exposure of cilostazol and an active metabolite. Consider dose reduction (7.3)
Tacrolimus: NEXIUM may increase serum levels of tacrolimus (7.4)
USE IN SPECIFIC POPULATIONS
Severe liver impairment – do not exceed dose of 20 mg (2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
Revised: 06/2011
Back to Highlights and Tabs
FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
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)
5.6Hypomagnesemia
5.7 Concomitant use of NEXIUM with St John’s Wort or Rifampin
5.8 Interactions with Investigations for Neuroendocrine Tumors
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 Interactions With Investigations of Neuroendocrine Tumors
7.5 Tacrolimus
7.6 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
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
PRINCIPAL DISPLAY PANEL
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
*
[See Clinical Studies (14.1) ]The majority of patients are healed within 4 to 8 weeks. For patients who do not heal after 4 to 8 weeks, an additional 4 to 8 weeks of treatment may be considered.
†
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.
§
Doses over 1 mg/kg/day have not been studied.
¶
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 have been administered [see Drug Interactions (7)].
Indication
Dose
Frequency
Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis
20 mg or 40 mg
Once Daily for 4 to 8 Weeks*
Maintenance of Healing of Erosive Esophagitis
20 mg
Once Daily†
Symptomatic Gastroesophageal Reflux Disease
20 mg
Once Daily for 4 Weeks‡
Pediatric GERD
12 to 17 Year Olds
Short-term Treatment of GERD
20 mg or 40 mg
Once Daily for up to 8 Weeks
1 to 11 Year Olds§
Short-term Treatment of Symptomatic GERD
10 mg
Once Daily for up to 8 Weeks
Healing of Erosive Esophagitis
weight < 20 kg
10 mg
Once Daily for 8 Weeks
weight ≥ 20 kg
10 mg or 20 mg
Once Daily for 8 Weeks
Risk Reduction of NSAID-Associated Gastric Ulcer
20 mg or 40 mg
Once Daily for up to 6 months†
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
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 Including Zollinger-Ellison Syndrome
40 mg¶
# Twice Daily
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 methods of administration for each of these dosage forms are presented below.
Table 2
Administration Options
(See text following table for additional instructions.)
Type
Route
Options
Delayed-Release Capsule
Oral
Capsule can be swallowed whole.
-or-
Capsule can be opened and mixed with applesauce.
Delayed-Release Capsule
Nasogastric Tube
Capsule can be opened and the intact granules emptied into a syringe and delivered through the nasogastric tube.
