近日，Prism制药公司宣布，美国食品药品管理局(FDA)已批准Nexterone，即抗心律失常药胺碘酮的一种预混静脉注射(IV)剂。Nexterone适合作为采用其他方法治疗无效的频繁复发性心室颤动(VF)和室性心动过速(VT)的初步治疗和预防用药。
导致停止静脉注射胺碘酮治疗的最常见的不良反应是低血压、心脏停搏/心脏骤停/无脉性电活动、VT和心源性休克。其他严重的不良反应包括尖端扭转型室性心动过速、充血性心力衰竭、肺病和肝功检测结果异常
Nexterone
Marketed by: Prism Pharmaceuticals Inc (King of Prussia, PA)
Indication: The FDA approved the supplemental new drug application for Nexterone (amiodarone hydrochloride) Premixed Injection. Nexterone is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. It is the first and only premixed intravenous (IV) bag formulation of the antiarrhythmic agent amiodarone IV.
Dosage Form: 1.5 mg/mL for rapid loading infusion, and 1.8 mg/mL for subsequent infusion
NEXTERONE (Amiodarone HCl) Allows For Immediate Use of Critical Antiarrhythmic Drug in Urgent Care Settings
13, 2011 - Baxter International Inc. (NYSE:BAX) announced today at the American Society of Health-System Pharmacists Summer Meeting and Exhibition that it has launched NEXTERONE® (amiodarone HCl) Premixed Injection, the first and only ready-to-use premixed intravenous (IV) bag version of the antiarrhythmic agent amiodarone in the United States.
In a premixed formulation, NEXTERONE does not require admixing (compounding), making it immediately available for use and also reducing the risk of medication errors associated with compounding. Amiodarone is used for ventricular tachycardia (rapid heart rate) and ventricular fibrillation (abnormal heart rhythm), 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, RPh, MPA, director of Pharmacy, Yuma Regional Medical Center, Yuma, Arizona. "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 U.S. Food and Drug Administration (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 U.S. Medication Delivery.
About Ventricular Tachycardia and Ventricular Fibrillation
Ventricular tachycardia is a rapid heartbeat that may result from serious heart disease and requires prompt treatment. Ventricular fibrillation is an uncontrolled twitching of muscle fibers in the lower chambers of the heart. General symptoms for both include chest pain, feeling the heart race, shortness of breath, dizziness and fainting. If unresolved and untreated, these conditions can lead to myocardial infarction (heart attack), heart failure or sudden death.
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.1 NEXTERONE should be stored in its carton to protect it from light until it is ready-to-use.
The premixed IV bags leverage Baxter's proprietary non-PVC (polyvinyl chloride), non-DEHP (di (2-ethylhexyl) phthalate) and non-latex GALAXY container technology, which is aseptically filled. The NEXTERONE formulations do not contain polysorbate 80 or benzyl alcohol. More information can be found at www.nexterone.com.
Important Risk Information
NEXTERONE (amiodarone HCl) Premixed Injection is contraindicated in patients with known hypersensitivity to any of the components of NEXTERONE, including iodine; cardiogenic shock; marked sinus bradycardia or second- or third-degree atrio-ventricular (AV) block unless a functioning pacemaker is available.
NEXTERONE 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.
If hypotension occurs, treat hypotension initially by slowing the infusion; additional standard therapy may be needed, including: vasopressors, positive inotropic agents and volume expansion.
If bradycardia and AV block occur, treat bradycardia by slowing the infusion rate or discontinuing NEXTERONE.
The most common adverse reactions leading to discontinuation (1-2%) of intravenous amiodarone therapy are hypotension, asystole/cardiac arrest/pulseless electrical activity, VT, and cardiogenic shock.
Other important adverse reactions are torsade de pointes (TdP), congestive heart failure, liver function test abnormalities, pulmonary disorders, and thyroid abnormalities.
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
1Joint Commission Standards BoosterPak for MM.03.01.01: The Joint Commission, 10, Dec. 2009:
