Sorine

1. INDICATIONS AND USAGE Sotalol hydrochloride tablets are 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 hydrochloride tablets have 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 hydrochloride tablets are indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT). Limitation of Use: Sotalol hydrochloride tablets have 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 hydrochloride tablets are 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 hydrochloride tablets 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 hydrochloride tablets.

Sotalol hydrochloride tablets are 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 hydrochloride tablets are also contraindicated in patients with: Baseline QT interval >450 msec For the treatment of AFIB/AFL or ventricular arrhythmias Sinus bradycardia, 2 nd or 3 rd 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 )