Baxter launches first ready-to-use IV amiodarone

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Baxter International launched Nexterone (amiodarone HCl) premixed injection, the first and only ready-to-use premixed intravenous bag version of the antiarrhythmic agent amiodarone in the United States.

In a premixed formulation, Nexterone does not require admixing, what makes it immediately available for use and also reduces the risk of medication errors associated with compounding. Amiodarone is used for ventricular tachycardia and ventricular fibrillation, and currently available vial forms of the drug must be manually admixed, even in urgent care situations.

With its premixed formulation and two-year room temperature shelf life, Nexterone can be stored in automated dispensing cabinets and the crash carts of emergency rooms, intensive care units or critical care units, ready for use during acute, time sensitive and life-threatening situations.

“Rapid heart rate can be life-threatening in critically ill patients and, if left untreated, can progress into a heart attack,” said Tom Van Hassel, director of Pharmacy, Yuma Regional Medical Center, Yuma, Arizona, USA. “Having a premixed treatment available will enable clinicians to treat patients at a moment’s notice, by eliminating preparation steps prior to administration.”

The Nexterone premixed IV formulations were approved by the FDA in two ready-to-use dosage forms: 150 mg in a 100 mL flexible container for rapid 10-minute loading infusion and 360 mg in a 200 mL flexible container for subsequent loading and maintenance infusions.

“As an industry leader in injectable drugs offering enhanced packaging, we are pleased to introduce the first ready-to-use version of amiodarone as a complement to our already robust premix portfolio” said David Bonderud, Baxter’s president of US Medication Delivery.

About Nexterone

Nexterone (amiodarone HCl) premixed injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

The premixed formulations of Nexterone are the first commercially-prepared versions of ready-to-use amiodarone, produced according to FDA’s Current Good Manufacturing Practices. These ready-to-use formats align with the Joint Commission Medication Management guidelines, which recommend using medications in the most ready to administer forms commercially available.