ST LOUIS (MD Consult) - On November 18, 2010, Prism Pharmaceuticals announced that the US Food and Drug Administration has approved Nexterone, a premixed intravenous (IV) formulation of the antiarrhythmic agent amiodarone. Nexterone is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and ventricular tachycardia (VT) in patients whose conditions have been refractory to other therapy.

The most common adverse reactions leading to discontinuation of intravenous amiodarone therapy are hypotension, asystole/cardiac arrest/pulseless electrical activity, VT, and cardiogenic shock. Other important adverse reactions include torsade de pointes, congestive heart failure, pulmonary disorders, and abnormal liver-function test results.

Nexterone is contraindicated in patients with known iodine hypersensitivity, as well as in patients with cardiogenic shock, marked sinus bradycardia, and second- or third-degree atrioventricular (AV) block—unless a functioning pacemaker is available. If hypotension occurs during therapy with Nexterone, patients should be initially treated by slowing the infusion. Additional standard therapy may be needed, including vasopressor drugs, positive inotropic agents, and volume expansion. The development of bradycardia and AV block during Nexterone therapy should be treated by slowing the infusion rate or by drug discontinuation.

Nexterone is approved in 2 ready-to-use dosage forms with strengths of 1.5 mg/mL (150 mg/100 mL) for rapid loading infusion and 1.8 mg/mL (360 mg/200 mL) for subsequent infusion.

圣路易斯(MD Consult)——2010年11月18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禁用于已知对碘过敏的患者和心源性休克、严重窦性心动过缓、II度或III度房室(AV)传导阻滞的患者——可使用功能性起搏器的患者除外。若患者在使用Nexterone治疗期间发生低血压，则最初应通过减慢注射速度来治疗，可能还需要辅以血管加压药、正性肌力药和扩充血容量等标准治疗。若Nexterone治疗期间发生心动过缓和AV传导阻滞，则应该通过减慢注射速度或停用该药进行治疗。

目前有2种即用剂型Nexterone获得批准，分别为用于快速注射的1.5 mg/ml (150 mg/100 ml)剂型和用于后续注射的1.8 mg/ml (360 mg/200 ml)剂型。