[Plasma level and action of sotalol-HCL on the ECG interval after parenteral administration in healthy subjects].
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.
IPHAR Institut für Klinische Pharmakologie GmbH, München.
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Rehm
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Schnelle
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Dyde
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Blümner
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Arendts
D000328:Adult; D001794:Blood Pressure / Q000187:drug effects; D004562:Electrocardiography; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D013015:Sotalol / Q000008:administration & dosage / Q000097:blood / Q000494:pharmacology*
D013015:Sotalol
Plasmaspiegel und Wirkung von Sotalol-HCl auf EKG-Zeitintervalle nach parenteraler Applikation an gesunde Probanden.