PACERONE SUMMARY
Pacerone® (Amiodarone HCl) Tablets are a member of a new class of antiarrhythmic drugs with predominantly Class III (Vaughan Williams' classification) effects.
Because of its life-threatening side effects and the substantial management difficulties associated with amiodarone use (see " WARNINGS " below), Pacerone® (Amiodarone HCl) Tablets are indicated only for the treatment of the following documented, life-threatening recurrent ventricular arrhythmias when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated.
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Recurrent ventricular fibrillation.
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Recurrent hemodynamically unstable ventricular tachycardia.
As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of amiodarone HCl favorably affects survival.
Pacerone® (Amiodarone HCl) Tablets should be used only by physicians familiar with and with access to (directly or through referral) the use of all available modalities for treating recurrent life-threatening ventricular arrhythmias, and who have access to appropriate monitoring facilities, including in-hospital and ambulatory continuous electrocardiographic monitoring and electrophysiologic techniques. Because of the life-threatening nature of the arrhythmias treated, potential interactions with prior therapy and potential exacerbation of the arrhythmia, initiation of therapy with Pacerone® (Amiodarone HCl) Tablets should be carried out in the hospital.
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