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Basic Drug Info
Drug Name:Mexiletine HCl
Manufacturer:Watson Laboratories, Inc.
Other Info:



Clinical Trials:


Indications and Usage

Mexiletine Hydrochloride Capsules are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening.

Because of the proarrhythmic effects of mexiletine, its use with lesser arrhythmias is generally not recommended.

Treatment of patients with asymptomatic ventricular premature contractions should be avoided.Initiation of mexiletine treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
Ventricular arrhythmia -- Irregular heart beat resulting from a pathologic process in the cardiac ventricles.--2004

Sustained Ventricular Tachycardia -- An electrocardiographic finding of ventricular tachycardia greater than 30 seconds in duration.

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

Premature ventricular contractions -- A type of cardiac arrhythmia with premature contractions of the HEART VENTRICLES. It is characterized by the premature QRS complex on ECG that is of abnormal shape and great duration (generally >129 msec). It is the most common form of all cardiac arrhythmias. Premature ventricular complexes have no clinical significance except in concurrence with heart diseases.

Contraindications

Mexiletine hydrochloride is contraindicated in the presence of cardiogenic shock or pre-existing second- or third-degree AV block (if no pacemaker is present). WARNINGS Mortality: In the National Heart, Lung and Blood Institute’s Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multicentered, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than six days but less than two years previously, an excessive mortality or non-fatal cardiac arrest rate (7.7%) was seen in patients treated with encainide or flecainide compared with that seen in patients assigned to carefully matched placebo-treated groups (3.0%).

The average duration of treatment with encainide or flecainide in this study was ten months. The applicability of the CAST results to other populations (e.g.

those without recent myocardial infarction) is uncertain.

Considering the known proarrhythmic properties of mexiletine and the lack of evidence of improved survival for any antiarrhythmic drug in patients without life-threatening arrhythmias, the use of mexiletine as well as other antiarrhythmic agents should be reversed for patients with life-threatening ventricular arrhythmia. Acute Liver Injury: In post-marketing experience abnormal liver function tests have been reported, some in the first few weeks of therapy with mexiletine hydrochloride.

Most of these have been observed in the setting of congestive heart failure or ischemia and their relationship to mexiletine has not been established.
Cardiogenic shock -- Shock resulting from diminution of cardiac output in heart disease.

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

Visual Suppression --

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

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

Myocardial Infarction -- NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION).

Cardiac Arrest -- Cessation of heart beat or MYOCARDIAL CONTRACTION. If it is treated within a few minutes, heart arrest can be reversed in most cases to normal cardiac rhythm and effective circulation.

Congestive heart failure -- complication of heart diseases; defective cardiac filling and/or impaired contraction and emptying, resulting in the heart's inability to pump a sufficient amount of blood to meet the needs of the body tissues or to be able to do so only with an elevated filling pressure.

Ischemia -- A hypoperfusion of the BLOOD through an organ or tissue caused by a PATHOLOGIC CONSTRICTION or obstruction of its BLOOD VESSELS, or an absence of BLOOD CIRCULATION.


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