Sotalol Hydrochloride 80 MG Oral Tablet
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.
Teva Pharmaceuticals USA, Inc.
OVAL BLUE 93 61
93 61 OVAL BLUE
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16 HOW SUPPLIED/STORAGE AND HANDLING
SOTALOL HYDROCHLORIDE tablets USP, 80 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers “93” and “61” on each side of the score, and plain on the other side. They are available in bottles of 100 (NDC 0093-1061-01).
SOTALOL HYDROCHLORIDE tablets USP, 120 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers “93” and “1060” on each side of the score, and plain on the other side. They are available in bottles of 100 (NDC 0093-1060-01).
SOTALOL HYDROCHLORIDE tablets USP, 160 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers “93” and “62” on each side of the score, and plain on the other side. They are available in bottles of 100 (NDC 0093-1062-01).
SOTALOL HYDROCHLORIDE tablets USP, 240 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers “93” and “63” on each side of the score, and plain on the other side. They are available in bottles of 100 (NDC 0093-1063-01). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children.
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