Sotylize

SOTYLIZE is an antiarrhythmic indicated for: The treatment of life-threatening ventricular arrhythmias ( 1.1 ) The maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation/flutter (AFIB/AFL) ( 1.2 ) Limitations of Use SOTYLIZE has not been shown to enhance survival in patients with life threatening ventricular arrhythmias ( 1.1 ) Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL ( 1.2 )

1.1Life-Threatening Ventricular Arrhythmia

SOTYLIZE is indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia. Limitation of Use SOTYLIZE has not been shown to enhance survival in patients with life-threatening ventricular arrhythmias.

1.2Delay in Recurrence of Atrial Fibrillation/Atrial Flutter (AFIB/AFL)

SOTYLIZE is indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with highly symptomatic AFIB/AFL who are currently in sinus rhythm. Limitation of Use Because sotalol can cause life-threatening ventricular arrhythmias, reserve its use for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB that is easily reversed (by Valsalva maneuver, for example) should usually not be given SOTYLIZE .

For the treatment of AFIB/AFL or ventricular arrhythmias, SOTYLIZE is contraindicated in patients with: Baseline QT interval ˃450 msec Sinus bradycardia, sick sinus syndrome, second and third degree AV block, unless a functioning pacemaker is present Congenital or acquired long QT syndromes Cardiogenic shock or decompensated heart failure Serum potassium <4 mEq/L Bronchial asthma or related bronchospastic conditions Hypersensitivity to sotalol For the treatment of AFIB/AFL or ventricular arrhythmias Baseline QT interval ˃450 msec ( 4 ) Sinus bradycardia, 2 nd or 3 rd degree AV block, sick sinus syndrome ( 4 ) Congenital or acquired long QT syndromes ( 4 ) Serum potassium ˂4 mEq/L ( 4 ) Cardiogenic shock, decompensated heart failure ( 4 ) Bronchial asthma or related bronchospastic conditions ( 4 ) Hypersensitivity to sotalol ( 4 )