Sotalol Hydrochloride Tablets AF

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) 1.1 Life-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. 1.2 Delay 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.