sotalol hydrochloride
sotalol hydrochloride is listed in the FDA National Drug Code directory with 9 NDC codes, marketed under brand names including BETAPACE AF, BETAPACE, Sotalol hydrochloride. Available dosage form: tablet.
Drug Details
- Generic Name
- sotalol hydrochloride
- Brand Names
- BETAPACE AF, BETAPACE, Sotalol hydrochloride
- 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 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 ) 1.1 Life-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. 1.2 Delay 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.