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TIKOSYN®(dofetilide)

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TIKOSYN® Quick Finder

To minimize the risk of induced arrhythmia, patients initiated or re-initiated on TIKOSYN should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac...

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INDICATIONS AND USAGE

Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence)

TIKOSYN is indicated for the maintenance of normal sinus rhythm (delay in time to...

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DOSAGE AND ADMINISTRATION

  • Therapy with TIKOSYN must be initiated (and, if necessary, re-initiated) in a setting that provides continuous electrocardiographic (ECG) monitoring and in the presence of personnel trained in the management...
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CONTRAINDICATIONS

TIKOSYN is contraindicated in patients with congenital or acquired long QT syndromes. TIKOSYN should not be used in patients with a baseline QT interval or QTc >440 msec (500 msec in patients with...

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WARNINGS

Ventricular Arrhythmia

TIKOSYN (dofetilide) can cause serious ventricular arrhythmias, primarily Torsade de Pointes (TdP) type ventricular...

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ADVERSE REACTIONS

The TIKOSYN clinical program involved approximately 8,600 patients in 130 clinical studies of normal volunteers and patients with supraventricular and ventricular arrhythmias. TIKOSYN was administered to 5,...

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OVERDOSAGE

There is no known antidote to TIKOSYN; treatment of overdose should therefore be symptomatic and supportive. The most prominent manifestation of overdosage is likely to be excessive prolongation of the QT interval...

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DESCRIPTION

TIKOSYN® (dofetilide) is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its empirical formula is C19H...

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CLINICAL PHARMACOLOGY

Mechanism of Action

Dofetilide shows Vaughan Williams Class III antiarrhythmic activity. The mechanism of action is blockade of the cardiac ion...

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CLINICAL STUDIES

Chronic Atrial Fibrillation and/or Atrial Flutter

Two randomized, parallel, double-blind, placebo-controlled, dose-response trials evaluated the...

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HOW SUPPLIED

TIKOSYN 125 mcg (0.125 mg) capsules are supplied as No. 4 capsules with a light orange cap and white body, printed with TKN 125 PFIZER, and are available in:

TIKOSYN 250 mcg (0.25 mg) capsules are supplied...

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MEDICATION GUIDE

TIKOSYN® (Tee' ko sin)
(dofetilide) Capsules

Read the Medication Guide before you start taking TIKOSYN and each time you get a refill. This...

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Rx only

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LAB-0067-10.0

Revised August 2019

...
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