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Outline
What is the generic name?
SOTALOL HYDROCHLORIDE
What is the Trade Name for SOTALOL HYDROCHLORIDE?
SOTYLIZE
What are the Indications for SOTALOL HYDROCHLORIDE?
- 1 INDICATIONS AND USAGE SOTYLIZE is an antiarrhythmic indicated for: The treatment of life-threatening ventricular arrhythmias ( 1.1 ) The maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation/flutter (AFIB/AFL) ( 1.2 ) 1.1 Documented Life-Threatening Ventricular Arrhythmia SOTYLIZE (sotalol hydrochloride) is indicated for the treatment of ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. Upon initiation of SOTYLIZE, increasing doses, and prior to chronic outpatient use, evaluated response by a suitable method (e.g., PES or Holter monitoring) at steady-state blood levels of drug. Limitation of Use SOTYLIZE may not enhance survival in patients with ventricular arrhythmias. Because of the proarrhythmic effects of SOTYLIZE [see Warnings and Precautions (5.1) ] , including a 1.5 to 2% rate of Torsade de Pointes or new VT/VF in patients with either NSVT or supraventricular arrhythmias, its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. 1.2 Delay in Recurrence of Atrial Fibrillation/Atrial Flutter SOTYLIZE is indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Limitation of Use Because sotalol can cause life-threatening ventricular arrhythmias, reserve it for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB whose AFIB/AFL that is easily reversed (by Valsalva maneuver, for example) should usually not be given SOTYLIZE .
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