Sotalol HCl Tablet 160 mg 100/bottle

d, l- N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl] methanesulfonamide monohydrochloride

Sotalol hydrochloride tablets (AF) are 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. Because sotalol hydrochloride tablets (AF) can cause life-threatening ventricular arrhythmias, it should be reserved 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 sotalol hydrochloride tablets (AF).

In general, antiarrhythmic therapy for AFIB/AFL aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients.

Sotalol hydrochloride tablets (AF) are also indicated for the treatment of documented life-threatening ventricular arrhythmias and is marketed under the brand name Betapace . Sotalol hydrochloride tablets, however, must not be substituted for sotalol hydrochloride tablets (AF) because of significant differences in labeling (i.e., patient package insert, dosing administration and safety information).

308.8

C12H20N2O3S•HCl

white, crystalline solid

Betapace Af

160 mg

42806-123-01

100