SOTALOL HYDROCHLORIDE

Warning

Risk of life-threatening proarrhythmia

Contraindications

• Sinus bradycardia
• Sick sinus syndrome
• Congenital or acquired long QT syndromes
• Cardiogenic shock or decompensated heart failure
• Bronchial asthma or related bronchospastic conditions
• Hypersensitivity to sotalol

Adverse Reactions

• Fatigue
• Bradycardia
• Dyspnea
• Proarrhythmia
• Asthenia
• Dizziness

General Guidance

Dose adjustments should be made based on renal function and QTc interval

Pregnancy

• Pregnancy Category B
• No adequate and well-controlled studies in pregnant women
• Sotalol has been shown to cross the placenta and is found in amniotic fluid

Nursing Mothers

• Sotalol is excreted in human milk
• Discontinue nursing on sotalol

Pediatric Use

• The safety and effectiveness of sotalol in children have not been established
• However, the Class III electrophysiologic and beta-blocking effects, the pharmacokinetics, and the relationship between the effects (QTc interval and resting heart rate) and drug concentrations have been evaluated in children aged between 3 days and 12 years old

Geriatric Use

• Age does not significantly alter the pharmacokinetics of sotalol
• Impaired renal function in geriatric patients can increase the terminal elimination half-life, resulting in increased drug accumulation