Tikosyn Capsules

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved October 1999

Specific Treatments:

For the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter.

Therapeutic Areas

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General Information

Tikosyn (dofetilide) Capsules for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation /atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Tikosyn is also indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Tikosyn has not been shown to be effective in patients with paroxysmal atrial fibrillation.

Side Effects

Because Tikosyn can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation /atrial flutter is highly symptomatic.

Mechanism of Action

Capsules of dofetilide. Approved interim dissolution method, medium, and specification to be: USP Apparatus I (basket) at 100 rpm in 0.001 M hydrochloric acid; Q=[----] at 30 minutes.

Additional Information

Because Tikosyn can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation /atrial flutter is highly symptomatic.