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Basic Drug Info
Drug Name:TAMBOCOR
Manufacturer:3M Pharmaceuticals
Other Info:

Plasma Level Monitoring: The large majority of patients successfully treated with TAMBOCOR were found to have trough plasma levels between 0.2 and 1.0 ?g/mL.

The probability of adverse experiences, especially cardiac, may increase with higher trough plasma levels, especially when these exceed 1.0 ?g/mL.

Periodic monitoring of trough plasma levels may be useful in patient management.

Plasma level monitoring is required in patients with severe renal failure or severe hepatic disease, since elimination of flecainide from plasma may be markedly slower.

Monitoring of plasma levels is strongly recommended in patients on concurrent amiodarone therapy and may also be helpful in patients with CHF and in patients with moderate renal disease.



Clinical Trials:


Indications and Usage

In patients without structural heart disease, TAMBOCOR is indicated for the prevention of– paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms– paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptomsTAMBOCOR is also indicated for the prevention of– documented ventricular arrhythmias, such assustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening.Use of TAMBOCOR for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital.

The use of TAMBOCOR is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic.Because of the proarrhythmic effects of TAMBOCOR, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks.TAMBOCOR should not be used in patients with recent myocardial infarction.

(See Boxed Warnings.)Use of TAMBOCOR in chronic atrial fibrillation has not been adequately studied and is not recommended.

(See Boxed Warnings.)As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of TAMBOCOR favorably affects survival or the incidence of sudden death.
Heart Diseases -- Pathological conditions involving the HEART including its structural and functional abnormalities.

Paroxysmal supraventricular tachycardia -- An episodic form of supraventricular tachycardia, with abrupt onset and termination.

Atrioventricular Nodal Reentry Tachycardia -- Abnormally rapid heartbeats caused by reentry of atrial impulse into the dual (fast and slow) pathways of ATRIOVENTRICULAR NODE. The common type involves a blocked atrial impulse in the slow pathway which reenters the fast pathway in a retrograde direction and simultaneously conducts to the atria and the ventricles leading to rapid HEART RATE of 150-250 beats per minute.

Atrioventricular Reentrant Tachycardia -- A supraventricular tachycardia due to reentry along a circuit including a concealed AV nodal bypass tract. This tachycardia circuit proceeds in an antegrade fashion through the AV node and then is conducted retrograde through the bypass tract into the atria.

Supraventricular tachycardia -- A generic expression for any tachycardia that originates above the BUNDLE OF HIS.

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

Tachycardia, Ventricular -- An abnormally rapid ventricular rhythm usually in excess of 150 beats per minute. It is generated within the ventricle below the BUNDLE OF HIS, either as autonomic impulse formation or reentrant impulse conduction. Depending on the etiology, onset of ventricular tachycardia can be paroxysmal (sudden) or nonparoxysmal, its wide QRS complexes can be uniform or polymorphic, and the ventricular beating may be independent of the atrial beating (AV dissociation).

Sudden death -- The abrupt cessation of all vital bodily functions, manifested by the permanent loss of total cerebral, respiratory, and cardiovascular functions.

Contraindications

TAMBOCOR is contraindicated in patients with pre-existing second- or third-degree AV block, or with right bundle branch block when associated with a left hemiblock (bifascicular block), unless a pacemaker is present to sustain the cardiac rhythm should complete heart block occur.

TAMBOCOR is also contraindicated in the presence of cardiogenic shock or known hypersensitivity to the drug.
Complete atrioventricular block -- Complete failure of atrial electrical impulse conduction through the AV node to the ventricles.

Right bundle branch block -- An impairment of transmission of the cardiac electrical impulse along the fibers of the right bundle branch. A " complete RBBB pattern" (with QRS duration > 0.11s) does not necessarily reflect the existence of a total conduction block in the right branch. This pattern only indicates that the entire or major parts of both ventricles are activated by the impulse emerging from the left branch. Thus, a significant degree of conduction delay ("high-grade" or "incomplete RBBB") can produce a similar pattern.

Bifascicular block -- An electrocardiographic finding comprising right bundle branch block and left anterior fasicular block, or right bundle branch block and left posterior fasicular block. Defects occuring in two of the three divisions of the conduction system of the heart are considered bifasicular blocks. Technically left bundle branch block may be considered a bifasicular block.

Cardiogenic shock -- Shock resulting from diminution of cardiac output in heart disease.

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


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