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About Nexterone

Product Details

  • Available in 150 mg/100 mL and 360 mg/200 mL containers
  • 2-year shelf life at room temperature*
  • No admixing
  • Similar dosage as generic forms of IV amiodarone
  • Can be stored in automated dispensing cabinets / crash carts*
  • Exclusive aseptic bag-filling technology
  • Bar-coded for bedside scanning
  • Non-PVC and non-DEHP GALAXY containers
  • Free of polysorbate 80 and benzyl alcohol cosolvents
  • * Store in carton to protect from light until ready to use.

    Scroll down for Indications, Important Risk Information and Full Prescribing Information

Manufacturer PreparedPremixed Amiodarone Nexterone- Ready to AdministerManufacturer Prepared Premixed Amiodarone Nexterone- Ready to Administer

In the ER. The CCU. The ICU. The Cath Lab. NEXTERONE premixed amiodarone is ready and at your fingertips. Plus, it´s manufacturer prepared so it can help minimize medication errors related to compounding and is ready to deliver to patients without the need for admixing

Two-Year Shelf Life Nexterone- Extended stabilityTwo-Year Shelf Life Nexterone- Extended stability

Currently, admixing generic forms of amiodarone limit you to 2-24 hours of room temperature stability. NEXTERONE premixed amiodarone has a shelf life of 24 months. That´s right, months—not hours. Our proprietary GALAXY containers and cGMP aseptic-fill technology enable us to create an amiodarone formulation that is premixed with a long shelf life.* In addition, GALAXY containers are non-PVC and non-DEHP.

* Store in carton to protect from light until ready to use.

Ready To Use Nexterone- There When You Need ItReady To Use Nexterone- There When You Need It

Extended shelf life means that NEXTERONE Premixed Injection can be stored in crash carts, automated dispensing cabinets…standing by …until the instant it is needed.* And if you're not a 24/7 pharmacy —enough said.

* Store in carton to protect from light until ready to use.

NEXTERONE (amiodarone HCl) Premixed Injection Indications and Important Risk Information (IRI)

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 (IRI)

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.

Download full Prescribing Information