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.
Recurrent ventricular fibrillation.
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.
Media Articles Related to Pacerone (Amiodarone)
FDA: Bradycardia Risk With Amiodarone Plus Hep-C Antivirals
Source: theheart.org | Medscape Cardiology Headlines [2015.03.23]
The FDA is updating labeling for Harvoni and Savoldi antivirals after the death of one patient, and pacemaker implantation in three others, who were also on the antiarrhythmic agent.
Published Studies Related to Pacerone (Amiodarone)
Effects of dronedarone started rapidly after amiodarone discontinuation. 
HYPOTHESIS: A rapid switch from amiodarone to dronedarone is feasible... CONCLUSION: In this patient population, a switch from amiodarone to dronedarone
Amiodarone significantly decreases atrial fibrillation in patients undergoing
surgery for lung cancer. 
permanent stroke, acute myocardial infarction, and death... CONCLUSIONS: Postoperative prophylaxis with a high dose of oral amiodarone after
Efficacy and Safety of Celivarone, With Amiodarone as Calibrator, in Patients With an Implantable Cardioverter-Defibrillator for Prevention of Implantable Cardioverter-Defibrillator Interventions or Death: The ALPHEE Study. [2011.11.14]
CONCLUSIONS: Celivarone was not effective for the prevention of ICD interventions or sudden death. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT00993382.
Pharmacokinetics of intravenous amiodarone and its electrocardiographic effects on healthy Japanese subjects. [2011.05]
The aim of this phase I, dose-escalating study was to evaluate the pharmacokinetics, electrocardiographic effect and safety of amiodarone after a single intravenous administration in Japanese subjects. Thirty-two healthy Japanese male volunteers (20-32 years) were randomized to three single-dose groups (1.25, 2.5 and 5.0 mg/kg)...
A randomized active-controlled study comparing the efficacy and safety of vernakalant to amiodarone in recent-onset atrial fibrillation. [2011.01.18]
OBJECTIVES: This randomized double-blind study compared the efficacy and safety of intravenous vernakalant and amiodarone for the acute conversion of recent-onset atrial fibrillation (AF). BACKGROUND: Intravenous vernakalant has effectively converted recent-onset AF and was well tolerated in placebo-controlled studies... CONCLUSIONS: Vernakalant demonstrated efficacy superior to amiodarone for acute conversion of recent-onset AF. Both vernakalant and amiodarone were safe and well tolerated in this study. (A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation [AVRO]; NCT00668759). Copyright A(c) 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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]
Minocycline Plus Amiodarone Versus Amiodarone Alone for the Prevention of Atrial Fibrillation After Cardiac Surgery [Recruiting]
Postoperative atrial fibrillation (POAF) is a common complication after heart surgery.
Amiodarone is the drug of choice to treat POAF. Inflammation is considered one of underlying
factor for POAF. Minocycline is an antibiotic with anti-inflammatory properties.
Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia [Not yet recruiting]
Implantable Cardioverter Defibrillators (ICDs) provide a shock or pacing therapy to bring
back a normal heart beat when a patient experiences a dangerous abnormal heart rhythm such
as ventricular tachycardia (VT). ICDs are very successful in bringing back a normal heart
beat when VT occurs, but they do not prevent further dangerous heart rhythms from occurring.
This study is designed to determine the best way to manage patients who have an ICD and who
continue to have episodes of VT. There are two methods for treatment the VT: 1) Ablation,
and 2) Medication.
An ablation procedure involves placing a flexible catheter (insulated wire) in the groin
area and threading it into the heart. After the doctor has located the affected area
responsible for the VT, radiofrequency energy is delivered by the power generator through
the catheter to the inside of the heart. The radiofrequency energy ablates (burns) a small
area of the heart tissue thought to cause the VT.
A medication called Amiodarone is an "anti-arrhythmic" prescribed to prevent abnormal heart
rhythms from recurring.
The purpose of this study is to compare these two different methods for treating VT.
Treatment with ablation and amiodarone are both considered the standard of care for patients
with VT but they have not been compared directly in a study like this before.
Effect of Amiodarone on the Procedure Outcome in Long-standing Persistent Atrial Fibrillation Undergoing Pulmonary Vein Antral Isolation [Recruiting]
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.
Reports of Suspected Pacerone (Amiodarone) Side Effects
Heart Rate Decreased (5),
Acute Respiratory Distress Syndrome (3),
Cardiac Failure Congestive (3),
Pulmonary Toxicity (3),
Blindness (3), more >>