What is the generic name?

SOTALOL HYDROCHLORIDE

What is the Trade Name for SOTALOL HYDROCHLORIDE?

Sorine

What are the Indications for SOTALOL HYDROCHLORIDE?

• 1 INDICATIONS AND USAGE SORINE (sotalol hydrochloride) 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 Avoid use in patients with asymptomatic ventricular premature contraction ( 1.1 ) Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL ( 1.2 ) 1.1 Life-Threatening Ventricular Arrhythmias SORINE (sotalol hydrochloride) tablets are indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (VT) . Limitation of Use : SORINE (sotalol hydrochloride) tablets may not enhance survival in patients with ventricular arrhythmias. Because of the proarrhythmic effects of SORINE (sotalol hydrochloride) tablets, including a 1.5% to 2% rate of Torsade de Pointes (TdP) or new ventricular tachycardia/fibrillation (VT/VF) in patients with either non-sustained ventricular tachycardia (NSVT) or supraventricular arrhythmias (SVT), its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Avoid treatment of patients with asymptomatic ventricular premature contractions [see Warnings and Precautions (5.2) ]. 1.2 Delay in Recurrence of Atrial Fibrillation/Atrial Flutter (AFIB/AFL) SORINE (sotalol hydrochloride) tablets are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of AFIB/AFL) in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Limitation of Use : Because SORINE (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 SORINE (sotalol hydrochloride) tablets.

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