Sotalol Hydrochloride

SOTALOL HYDROCHLORIDE

Manufacturer: Bryant Ranch Prepack

Score: 144.0

Quick Summary

Sotalol hydrochloride is an antiarrhythmic medication used to treat life-threatening ventricular arrhythmias and maintain normal sinus rhythm in patients with atrial fibrillation or flutter. It has both beta-adrenoreceptor blocking and cardiac action potential duration prolongation properties. The initial dose for adults is 80 mg twice daily, with increments of 80 mg/day every 3 days to a maximum of 320 mg/day. For pediatric patients, dosing depends on age and renal function. Important safety information includes the risk of life-threatening proarrhythmia, and contraindications include sinus bradycardia, sick sinus syndrome, and congenital or acquired long QT syndromes. Adverse reactions include fatigue, bradycardia, dyspnea, and proarrhythmia.

Key Clinical Findings and Indications

Treatment of life-threatening ventricular arrhythmias
Maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter
Has both beta-adrenoreceptor blocking and cardiac action potential duration prolongation properties

Important Safety Information

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

Dosing Recommendations

General Guidance

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

Ventricular arrhythmias

Adult Dose

80 mg twice daily, with increments of 80 mg/day every 3 days to a maximum of 320 mg/day

Pediatric Dose

Depends on age and renal function

Atrial fibrillation or flutter

Adult Dose

80 mg twice daily, with increments of 80 mg/day every 3 days to a maximum of 320 mg/day

Pediatric Dose

Depends on age and renal function

Special Population Considerations

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

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