sotalol hydrochloride
Drug Details
- Generic Name
- sotalol hydrochloride
- Brand Names
- BETAPACE AF, Sotalol hydrochloride, BETAPACE
- Application Number
- NDA019865
- Sponsor
- Legacy Pharma USA, Inc.
- NDC Codes
- 9
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- SOTALOL HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Sotalol hydrochloride/Sotalol hydrochloride AF 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 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 hydrochloride/Sotalol hydrochloride AF tablets are indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT). Limitation of Use: Sotalol hydrochloride/Sotalol hydrochloride 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 hydrochloride/Sotalol hydrochloride AF 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/sotalol hydrochloride AF 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/sotalol hydrochloride AF tablets.