ResoundingHealth
Search
  
Basic Drug Info
Drug Name:Amiodarone Hydrochloride
Manufacturer:Teva Pharmaceuticals USA
Other Info:

This product’s label may have been revised after this insert was used in production.

For further product information and current package insert, please call 1-888-838-2872, MEDICAL AFFAIRS.



Clinical Trials:


Indications and Usage

Because of its life-threatening side effects and the substantial management difficulties associated with its use (see WARNINGS), amiodarone hydrochloride 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 hydrochloride tablets favorably affects survival.Amiodarone 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 amiodarone should be carried out in the hospital.
Adverse effects -- Problems that occur when treatment affects tissues or organs other than the ones meant to be affected by the treatment. Common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.

Ventricular arrhythmia -- Irregular heart beat resulting from a pathologic process in the cardiac ventricles.--2004

cardiac arrhythmia -- any variation from the normal rhythm or rate of the heart beat.

Contraindications
Amiodarone hydrochloride tablets are contraindicated in patients with cardiogenic shock; severe sinus-node dysfunction, causing marked sinus bradycardia; second- or third-degree atrioventricular block; and when episodes of bradycardia have caused syncope (except when used in conjunction with a pacemaker).Amiodarone hydrochloride tablets are contraindicated in patients with a known hypersensitivity to the drug or to any of its components, including iodine.
Sinus Node Dysfunction -- A derangement in the normal functioning of the sinoatrial node. Typically, SA node dysfunction is manifest as sinoatrial exit block or sinus arrest, but may present as an absolute or relative bradycardia in the presence of a stressor. It may be associated with bradycardia-tachycardia syndrome

Complete atrioventricular block -- Complete failure of atrial electrical impulse conduction through the AV node to the ventricles.

Syncope -- A transient loss of consciousness and postural tone caused by diminished blood flow to the brain (i.e., BRAIN ISCHEMIA). Presyncope refers to the sensation of lightheadedness and loss of strength that precedes a syncopal event or accompanies an incomplete syncope. (From Adams et al., Principles of Neurology, 6th ed, pp367-9)

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Amiodarone is intended for use only in patients with the indicated life-threatening arrhythmias because its 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, amiodarone poses 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 amiodarone effectively and safely itself poses a significant risk to patients.

Patients with the indicated arrhythmias must be hospitalized while the loading dose of amiodarone 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 amiodarone 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.
Branded Drugs
The following US Branded drugs contain Amiodarone Hydrochloride


CORDARONE -- WYETH PHARMACEUTICALS INC

NEXTERONE -- PRISM PHARMACEUTICALS INC

PACERONE -- UPSHER SMITH LABORATORIES INC


This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.