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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use NEXTERONE safely and effectively. See full prescribing information for NEXTERONE.
NEXTERONE (amiodarone HCl) Premixed Injection for intravenous use
Initial U.S. Approval: 1985
RECENT MAJOR CHANGES
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Dosage and Administration ( 2) March 2015
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Warnings and Precautions ( 5) March 2015
INDICATIONS AND USAGE
NEXTERONE is an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. (1)
DOSAGE AND ADMINISTRATION
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•The recommended starting dose is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen (2):
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oInitial Load: 150 mg in 100 mL infused over 10 minutes
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oFollowed by: 1 mg/min for 6 hours
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oFollowed by: 0.5 mg/min thereafter
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•For breakthrough episodes of VF or hemodynamically unstable VT , repeat the Initial Load (2)
DOSAGE FORMS AND STRENGTHS
Injection, 1.5 mg/mL (150 mg/100 mL) Premixed in Dextrose (3)
Injection, 1.8 mg/mL (360 mg/200 mL) Premixed in Dextrose (3)
CONTRAINDICATIONS
NEXTERONE is contraindicated in patients with (4):
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•Known hypersensitivity to any of the components of NEXTERONE, including iodine
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•Cardiogenic shock
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•Marked sinus bradycardia
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•Second- or third-degree atrio-ventricular (AV) block unless a functioning pacemaker is available.
WARNINGS AND PRECAUTIONS
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•Hypotension: Slow the infusion; as needed, add vasopressor drugs, positive inotropic agents, and volume expansion. (5.1)
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•Bradycardia and AV block: Slow the infusion or discontinue. ( 5.2)
ADVERSE REACTIONS
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•The most common adverse reactions (1-2%) leading to discontinuation of intravenous amiodarone therapy are hypotension, asystole/cardiac arrest/pulseless electrical activity, VT, and cardiogenic shock. (6)
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•Other important adverse reactions are torsade de pointes, congestive heart failure, and liver function test abnormalities. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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•Amiodarone is a substrate for CYP3A and CYP2C8, so inhibitors and inducers affect amiodarone exposure ( 7)
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•Amiodarone inhibits p-glycoprotein and CYP1A2, CYP2C9, CYP2D6, and CYP3A, increasing exposure to other drugs ( 7)
USE IN SPECIFIC POPULATIONS
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•Pregnancy: Use NEXTERONE during pregnancy only if the potential benefit to the mother justifies the risk to the fetus (8.1).
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•Nursing mothers: Advise mothers to discontinue breast feeding ( 8.3).
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•Pediatric use: Safety and efficacy have not been established (8.4).
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 8/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
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