Pacerone (Amiodarone Hydrochloride) - Summary

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.

1. Recurrent ventricular fibrillation.
2. 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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NEWS HIGHLIGHTS

Media Articles Related to Pacerone (Amiodarone)

Sleep Disorders Linked to Arrhythmias
Source: MedicineNet Sleep Apnea Specialty [2009.06.24]
Title: Sleep Disorders Linked to Arrhythmias
Category: Health News
Created: 6/24/2009 7:00:00 AM
Last Editorial Review: 6/24/2009

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Published Studies Related to Pacerone (Amiodarone)

Comparative efficacy of dronedarone and amiodarone for the maintenance of sinus rhythm in patients with atrial fibrillation. [2009.09.15]
OBJECTIVES: We sought to compare the efficacy and safety of dronedarone versus amiodarone for the prevention of recurrent atrial fibrillation (AF). BACKGROUND: Dronedarone is a noniodinated amiodarone congener developed to maintain sinus rhythm. Few data are available to directly compare the efficacy and safety of dronedarone versus amiodarone... CONCLUSIONS: Dronedarone is less effective than amiodarone for the maintenance of sinus rhythm, but has fewer adverse effects. For every 1,000 patients treated with dronedarone instead of amiodarone, we estimate approximately 228 more recurrences of AF in exchange for 9.6 fewer deaths and 62 fewer adverse events requiring discontinuation of drug.

A randomized trial evaluating amiodarone for prevention of atrial fibrillation after pulmonary resection. [2009.09]
BACKGROUND: Atrial fibrillation (AF) occurs commonly after anatomic pulmonary resection. In this study, the efficacy of amiodarone for prevention of post-pulmonary resection AF was investigated... CONCLUSIONS: Amiodarone prophylaxis significantly reduces the incidence of AF after anatomic pulmonary resection, and is associated with a significant reduction in length of intensive care unit stay.

Intravenous diltiazem is superior to intravenous amiodarone or digoxin for achieving ventricular rate control in patients with acute uncomplicated atrial fibrillation. [2009.07]
OBJECTIVES: To compare the clinical efficacy of intravenous diltiazem, digoxin, and amiodarone for acute ventricular rate (VR) control in patients with acute symptomatic atrial fibrillation (AF) necessitating hospitalization... CONCLUSIONS: As compared with digoxin and amiodarone, intravenous diltiazem was safe and effective in achieving VR control to improve symptoms and to reduce hospital stay in patients with acute AF.

Bioequivalence of 2 intravenous amiodarone formulations in healthy participants. [2009.04]
Intravenous amiodarone is an effective agent for the treatment of recurrent ventricular fibrillation and hemodynamically unstable ventricular tachycardia. PM101 is a new formulation of intravenous amiodarone that uses a cyclodextrin to maintain amiodarone in the aqueous phase... No safety concerns unique to PM101 were identified.

Prevention of atrial fibrillation after coronary artery bypass grafting via atrial electromechanical interval and use of amiodarone prophylaxis. [2009.04]
In our previous study, we defined a cut-off point of 120 ms for atrial electromechanical interval (AEMi) to determine the risk of atrial fibrillation (AF) occurrence. Accordingly, the present study sought to investigate whether or not a prophylactic perioperative administration of amiodarone could reduce the incidence of AF in a high-risk group (AEMi >120 ms) undergoing coronary artery bypass grafting (CABG)...

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Clinical Trials Related to Pacerone (Amiodarone)

Effect of Prophylaxy of Amiodarone and Propranolol and Amiodarone With Propranolol in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft [Completed]

Concentrations of Amiodarone in Fat Tissue During Chronic Treatment [Completed]
The objective of this study is to determine if concentrations of amiodarone in fat tissue increase constantly over time during chronic treatment with this drug, and if blood concentrations reflect accurately the concentrations in fat tissue or not. This is because excessive concentrations of this drug in tissues can produce adverse effects.

Continuous Versus Episodic Amiodarone Treatment for the Prevention of Permanent Atrial Fibrillation [Completed]
Our hypothesis is that episodic amiodarone treatment (i. e. amiodarone treatment 1 month prior until 1 month after cardioversion) is associated with a lower morbidity and a higher quality of life compared to continuous prophylactic amiodarone treatment while atrial fibrillation is still effectively suppressed. The latter means that at the end of the study permanent atrial fibrillation is prevented in comparable percentage of patients (70%) in both treatment strategies. However, this will be accomplished at the cost of a higher number of electrical cardioversions (2-3) in the episodic treatment group compared to the continuous treatment group.

A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation [Recruiting]
The primary objective of the study is to demonstrate the superiority of vernakalant injection over amiodarone injection in the conversion of atrial fibrillation (AF) to sinus rhythm (SR) within 90 minutes of the start of drug administration. The secondary objective is to compare the safety of vernakalant to amiodarone.

Study of Amiodarone Given Before Lung Surgery to Prevent Atrial Fibrillation After Lung Resection [Recruiting]
Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation. We propose a randomized controlled trial to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.

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