PLASMASPIEGEL UND WIRKUNG VON SOTALOL-HCl AUF EKG-ZEITINTERVALLE NACH PARENTERALER APPLIKATION AN GESUNDE PROBANDEN

Sotalol (Sotalex®, Sotacor®) is a β-blocker with additional class III antiarrhythmic activity. In this study two intervenous 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 adminitration. 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.