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 ) 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) .]
bayshore pharmaceuticals llc
OVAL BLUE B104
B104 OVAL BLUE
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16 HOW SUPPLIED/STORAGE AND HANDLING
SOTALOL HYDROCHLORIDE Tablets, USP; capsule-shaped light-blue scored tablets, imprinted with the strength and “B104”, “B105”, and “B106” are available as follows: 80 mg strength, bottles of 100 (NDC 76385-114-01) 80 mg strength, bottles of 500 (NDC 76385-114-50) 120 mg strength, bottles of 100 (NDC 76385-115-01) 120 mg strength, bottles of 500 (NDC 76385-115-50) 160 mg strength, bottles of 100 (NDC 76385-116-01) 160 mg strength, bottles of 500 (NDC 76385-116-50) Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].
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