What is the generic name?

SOTALOL HYDROCHLORIDE

What is the Trade Name for SOTALOL HYDROCHLORIDE?

BETAPACE

What are the Indications for SOTALOL HYDROCHLORIDE?

• 1 INDICATIONS AND USAGE Betapace/Betapace AF is an antiarrhythmic indicated for: ‚Ä¢ the treatment of life-threatening ventricular arrhythmias ( 1.1 ) ‚Ä¢ the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) ( 1.2 ) Limitations of Use ‚Ä¢ Betapace has not been shown to enhance survival in patients with life threatening ventricular arrhythmias ( 1.1 ) ‚Ä¢ Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL ( 1.2 ) 1.1 Life-Threatening Ventricular Arrhythmias Betapace/Betapace AF is indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT) . Limitation of Use: Betapace/Betapace 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) Betapace/Betapace 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 Betapace/Betapace 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 Betapace/Betapace AF.

References: https://open.fda.gov/