Sotalol Hydrochloride

1. INDICATIONS AND USAGE Sotalol/Sotalol AF is an antiarrhythmic indicated for:

• the treatment of life-threatening ventricular arrhythmias (1.1)
• the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2) Limitations of Use
• Sotalol 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 Arrhythmias Sotalol/Sotalol

AF is indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT). Limitation of Use: Sotalol/Sotalol AF 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) Sotalol/Sotalol

AF is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of AFIB/AFL) in patients with highly symptomatic AFIB/AFL who are currently in sinus rhythm. Limitation of Use: Because Sotalol/Sotalol AF 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 Sotalol/Sotalol AF.

Sotalol/Sotalol AF is contraindicated in patients with: 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, Sotalol/Sotalol AF is also contraindicated in patients with: Baseline QT interval >450 msec For the treatment of AFIB/AFL or ventricular arrhythmias Sinus bradycardia, 2nd or 3rd degree AV block, sick sinus syndrome (4) Congenital or acquired long QT syndrome (4) Serum potassium <4 mEq/L (4) Cardiogenic shock, decompensated heart failure (4) Bronchial asthma or related bronchospastic conditions (4) Hypersensitivity to Sotalol (4) For the treatment of AFIB/AFL also contraindicated for: QT interval >450 msec (4)