Nexterone (amiodarone HCl) Premixed Injection is 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. Nexterone also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with Nexterone, patients may be transferred to oral amiodarone therapy. Please read the accompanying full Indication(s) and Important Risk Information, and the Package Insert for full Prescribing Information.
Ready at a Moment’s Notice
Nexterone provides a ready-to-use amiodarone in
150 mg/100 mL and 360 mg/200 mL administration bags. As a premix that is cGMP manufacturer prepared, Nexterone provides an accurately prepared dose to help minimize compounding errors that may occur in urgent situations.
Manufacturer-prepared premixed amiodarone
Ready to administer bags
Two-year shelf life
Extended storage at room temperature
Store in carton to protect from light until ready to use
Selected Important Risk Information
As with all injectable products, there are risks associated with Nexterone, including that it should be administered only by physicians who are experienced in the treatment of life-threatening arrhythmias, who are thoroughly familiar with the risks and benefits of amiodarone therapy, and who have access to facilities adequate for monitoring the effectiveness and side effects of treatment.
Nexterone offers healthcare professionals one less task to perform during stressful situations. Our manufacturer-prepared premix provides an accurately prepared dose that helps minimize errors related to compounding. With Nexterone, there’s no waiting, no admixing—and it may reduce amiodarone waste. Clinicians can just grab the bag for delivery at the point of care.
Intensive Care Unit
Long-Term Acute Care
Emergency Medical Services
Dosing Nexterone (Amiodarone HCl)
The first 24-hour dose may be individualized for each patient; however, in controlled clinical trials, mean daily doses above 2100 mg were associated with an increased risk of hypotension. Do not exceed an initial infusion rate of 30 mg/min.
After the first 24 hours, continue the maintenance infusion rate of 0.5 mg/min by infusing Nexterone (360 mg/200 mL; 1.8 mg/mL) at a rate of 0.278 mL/min. The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression.
In the event of breakthrough episodes of VF or hemodynamically unstable VT, use 150 mg supplemental infusions of Nexterone (amiodarone HCI) Premixed Injection (infused over 10 minutes to minimize the potential for hypotension).
Single-use only. Administer via central venous catheter whenever possible.
Selected Important Risk Information
Nexterone is contraindicated in patients with:
● Known hypersensitivity to any of the components of Nexterone, including iodine
● Cardiogenic shock
● Marked sinus bradycardia
● Second- or third-degree atrio-ventricular (AV) block unless a functioning pacemaker is available
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Indications and Usage
NEXTERONE (amiodarone HCl) Premixed Injection is 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. During or after treatment with NEXTERONE, patients may be transferred to oral amiodarone therapy.
Important Risk Information
NEXTERONE (amiodarone HCl) Premixed Injection should be administered only by physicians who are experienced in the treatment of life-threatening arrhythmias, who are thoroughly familiar with the risks and benefits of amiodarone therapy, and who have access to facilities adequate for monitoring the effectiveness and side effects of treatment.
NEXTERONE is contraindicated in patients with:
- Known hypersensitivity to any of the components of NEXTERONE, including iodine
- Cardiogenic shock
- Marked sinus bradycardia
- Second- or third-degree atrio-ventricular (AV) block unless a functioning pacemaker is available
Hypotension is the most common adverse reaction seen with intravenous amiodarone. Clinically significant hypotension was seen most often in the first several hours of treatment and appeared to be related to the rate of infusion. To treat hypotension, slow the infusion; as needed, add vasopressor drugs, positive inotropic agents, and volume expansion.
Drug-related bradycardia that was not dose‐related occurred while patients were receiving intravenous amiodarone for life-threatening VT/VF. To treat bradycardia, slow the infusion or discontinue NEXTERONE. In some patients, inserting a pacemaker is required.
Carefully monitor patients receiving NEXTERONE for evidence of progressive hepatic injury. In such cases, consider reducing the rate of administration or withdrawing NEXTERONE.
NEXTERONE may cause worsening of existing arrhythmias or precipitate a new arrhythmia sometimes leading to fatal outcomes. Monitor patients for QTc prolongation during infusion with NEXTERONE.
Amiodarone is a substrate for CYP3A and CYP2C8, so inhibitors and inducers affect amiodarone exposure.
Amiodarone inhibits p‐glycoprotein and CYP1A2, CYP2C9, CYP2D6, and CYP3A, increasing exposure to other drugs.
The most important adverse reactions were hypotension, asystole/cardiac arrest/pulseless electrical activity (PEA), cardiogenic shock, congestive heart failure, bradycardia, liver function test abnormalities, VT, AV block, and torsade de pointes.
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.
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