[Plasma level and action of sotalol-HCL on the ECG interval after parenteral administration in healthy subjects]

Abstract

Sotalol (Sotalex; Sotacor) is a beta-blocker with additional class III antiarrhythmic activity. In this study two intravenous doses of 1.5 mg/kg and 2 mg/kg body weight were administered in 8 healthy volunteers in order to determine the pharmacokinetics and ECG intervals. After a short-term infusion (5 min) plasma levels and the relevant pharmacokinetic parameters were determined. The ECG parameters (QRS, PQ, QT, QTc), blood pressure, heart rate and tolerability were also evaluated. A correlation between the plasma concentration of sotalol, the decrease in heart rate and a prolongation of the real QT interval was found for both dose levels and for a period of 2 h after administration. A prolongation of the QTc-time could only be statistically confirmed for the higher dose. No differences in pharmacokinetic parameters were observed between the two doses.