Sotalol Hydrochloride 120 MG Oral Tablet
1 INDICATIONS AND USAGE Sotalol hydrochloride tablets are an antiarrhythmic indicated for: • the treatment of life threatening ventricular arrhythmias ( 1.1 ) Limitations of Use • Avoid use in patients with asymptomatic ventricular premature contraction ( 1.1 ) 1.1 Life-Threatening Ventricular Arrhythmias Sotalol hydrochloride tablets are indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (VT) . Limitation of Use Sotalol hydrochloride tablets may not enhance survival in patients with ventricular arrhythmias. Because of the proarrhythmic effects of 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) ].
Eon Labs, Inc.
OVAL BLUE E170
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16 HOW SUPPLIED/STORAGE AND HANDLING Sotalol Hydrochloride Tablets, USP, for oral administration, are available as follows 80 mg blue, capsule shaped tablets, debossed “ E 171” on one side and bisected on the reverse side and supplied as: NDC 0185-0171-09 bottles of 90 NDC 0185-0171-01 bottles of 100 NDC 0185-0171-05 bottles of 500 120 mg blue, capsule-shaped tablets, debossed “ E 170” on one side and bisected on the reverse side and supplied as: NDC 0185-0170-09 bottles of 90 NDC 0185-0170-01 bottles of 100 NDC 0185-0170-05 bottles of 500 160 mg blue, capsule-shaped tablets, debossed “ E 177” on one side and bisected on the reverse side and supplied as: NDC 0185-0177-09 bottles of 90 NDC 0185-0177-01 bottles of 100 NDC 0185-0177-05 bottles of 500 240 mg blue, capsule-shaped tablets, debossed “ E 174” on one side and bisected on the reverse side and supplied as: NDC 0185-0174-09 bottles of 90 NDC 0185-0174-01 bottles of 100 NDC 0185-0174-05 bottles of 500 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Store in a dry place. Avoid excessive heat. KEEP TIGHTLY CLOSED.
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