(Amiodarone HCl) Tablets are intended for use only in patients with the indicated life-threatening arrhythmias because amiodarone use is accompanied by substantial toxicity.
Amiodarone has several potentially fatal toxicities, the most important of which is pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 10 to 17% in some series of patients with ventricular arrhythmias given doses around 400 mg/day, and as abnormal diffusion capacity without symptoms in a much higher percentage of patients. Pulmonary toxicity has been fatal about 10% of the time. Liver injury is common with amiodarone, but is usually mild and evidenced only by abnormal liver enzymes. Overt liver disease can occur, however, and has been fatal in a few cases. Like other antiarrhythmics, amiodarone can exacerbate the arrhythmia, e.g., by making the arrhythmia less well tolerated or more difficult to reverse. This has occurred in 2 to 5% of patients in various series, and significant heart block or sinus bradycardia has been seen in 2 to 5%. All of these events should be manageable in the proper clinical setting in most cases. Although the frequency of such proarrhythmic events does not appear greater with amiodarone than with many other agents used in this population, the effects are prolonged when they occur.
Even in patients at high risk of arrhythmic death, in whom the toxicity of amiodarone is an acceptable risk, Pacerone
Tablets pose major management problems that could be life-threatening in a population at risk of sudden death, so that every effort should be made to utilize alternative agents first.
The difficulty of using Pacerone
Tablets effectively and safely itself poses a significant risk to patients. Patients with the indicated arrhythmias must be hospitalized while the loading dose of Pacerone
Tablets is given, and a response generally requires at least one week, usually two or more. Because absorption and elimination are variable, maintenance-dose selection is difficult, and it is not unusual to require dosage decrease or discontinuation of treatment. In a retrospective survey of 192 patients with ventricular tachyarrhythmias, 84 required dose reduction and 18 required at least temporary discontinuation because of adverse effects, and several series have reported 15 to 20% overall frequencies of discontinuation due to adverse reactions. The time at which a previously controlled life-threatening arrhythmia will recur after discontinuation or dose adjustment is unpredictable, ranging from weeks to months. The patient is obviously at great risk during this time and may need prolonged hospitalization. Attempts to substitute other antiarrhythmic agents when Pacerone
Tablets must be stopped will be made difficult by the gradually, but unpredictably, changing amiodarone body burden. A similar problem exists when amiodarone is not effective; it still poses the risk of an interaction with whatever subsequent treatment is tried.
Pacerone®(Amiodarone HCl) Tablets are a member of a class of antiarrhythmic drugs with predominantly Class III (Vaughan Williams' classification) effects, available for oral administration in 100 mg and 200 mg strengths of amiodarone hydrochloride.
Because of its life-threatening side effects and the substantial management difficulties associated with amiodarone use (see
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 tablets 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.
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)
Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation [Completed]
This was a prospective, randomized, double blinded study in which patients undergoing a
cardiopulmonary bypass (CPB) with aortic cross clamping were randomly assigned to receive
amiodarone, lidocaine, or saline placebo prior to removal of the aortic cross clamp. (CPB
is a technique that temporarily takes over the function of the heart and lungs during
surgery, maintaining the circulation of blood and the oxygen content of the body.)
Specifically, we will test the hypothesis that amiodarone is superior to both lidocaine and
placebo in the prevention of a severely abnormal heart rhythm when the blood flow is
restored to the heart after the aortic cross clamp is removed.
Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia [Terminated]
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.
Minocycline Plus Amiodarone Versus Amiodarone Alone for the Prevention of Atrial Fibrillation After Cardiac Surgery [Active, not 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.
Withdrawal Versus Continuation of Amiodarone in Successfully Treated Patients With Persistent Atrial Fibrillation [Completed]
Amiodarone is considered to be the most effective antiarrhythmic drug in the prevention of
persistent atrial fibrillation. It can however cause many adverse events, both cardiac and
non-cardiac. Long-term maintenance of sinus rhythm after cardioversion is difficult
especially because of high recurrence rates during the first month after cardioversion.
Duration of atrial fibrillation, type of underlying disease, left ventricular function, left
atrial size and age are associated with maintaining sinus rhythm. Early recurrence of atrial
fibrillation may be related to a highly arrhythmogenic period due to recovery from
electrical remodelling. Late recurrences may be related to other triggers than recovery from
electrical remodelling. In this study the investigators want to investigate the effect of
amiodarone withdrawal on the occurrence of late relapses of persistent atrial fibrillation.
Furthermore, the investigators want to investigate the effect of amiodarone withdrawal on
the occurrence of amiodarone related adverse events as well as adverse events related to
atrial fibrillation or underlying heart disease. The investigators also want to investigate
which patients characteristics are and potential triggers have a prognostic value in the
occurence of late relapses after amiodarone withdrawal.
Safety and Efficacy of Oral Versus Intravenous Amiodarone in the Treatment of AF [Not yet recruiting]
Atrial fibrillation (AF) remains a significant contributor to cardiovascular morbidity.
Amiodarone is a potent antiarrhythmic drug; however, patients receiving IV amiodarone are at
high risk for phlebitis. Phlebitis may lead to infection, additional medical intervention,
delay in treatment, and prolonged hospitalization. Therefore, examining new therapy
approach, aimed to reduce the incidence of phlebitis is a valuable clinical and research
Aim: To evaluate the safety and efficacy of oral versus intravenous (IV) Amiodarone in the
treatment of AF of recent onset (duration < 48 h).
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 >>
Page last updated: 2014-11-30