sotalol hydrochloride 160 mg
1 INDICATIONS AND USAGE Sotalol hydrochloride tablets (AF) 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 (AF) has 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 (AF) are indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT) . Limitation of Use: Sotalol hydrochloride tablets (AF) has 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 (AF) 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 (AF) 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 AF.
aurobindo pharma limited
ROUND ORANGE S 160
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16 HOW SUPPLIED/STORAGE AND HANDLING
SOTALOL HYDROCHLORIDE Tablets, USP (AF) are available containing 80 mg, 120 mg or 160 mg of
SOTALOL HYDROCHLORIDE, USP. The 80 mg tablets are a light orange, approximately 7.938 mm round biconvex tablets debossed with S and 80 one side and score on other side of the tablet. They are available as follows: Bottles of 100 tablets NDC 59651-775-01 The 120 mg tablets are a light orange, approximately 8.731 mm round biconvex tablets debossed with S and 120 one side and score on other side of the tablet. They are available as follows: Bottles of 100 tablets NDC 59651-776-01 The 160 mg tablets are a light orange, approximately 9.525 mm round biconvex tablets debossed with S and 160 one side and score on other side of the tablet. They are available as follows: Bottles of 100 tablets NDC 59651-777-01 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 using a child-resistant closure.
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