Pharmacokinetics and pharmacodynamics of (+/-)-sotalol in healthy male volunteers

British Journal of Clinical Pharmacology
M KimuraM Nakashima

Abstract

1. We investigated the pharmacokinetics and pharmacodynamics of (+/-)-sotalol administered orally to healthy male volunteers in single doses of 40, 80 and 160 mg and in multiple doses of 80 mg twice daily for 7 consecutive days. 2. In the single dose studies, the half-life of (-)-sotalol (7.2-8.5 h) was significantly (P < 0.01) shorter than that of (+)-sotalol (9.1-11.4 h) while the renal clearance of (-)-sotalol (110.6-126.4 ml min-1) was significantly (P < 0.01) faster than that of (+)-sotalol (102.2-110.1 ml min-1). In the multiple dose studies, similar differences in the pharmacokinetics of (+)- and (-)-sotalol were observed. In addition, the pharmacokinetics of both (+)- and (-)-sotalol on day 4 were shown to be essentially the same as those on day 7. 3. In pharmacodynamic examinations, (+/-)-sotalol prolonged QTc intervals on electrocardiograms dose-dependently after single doses of 80 and 160 mg (3.81 +/- 2.96%, 13.23 +/- 5.66%). The correlation between the plasma concentration of (+/-)-sotalol and prolongation of QTc intervals was nearly linear, and showed no hysteresis. 4. In conclusion, we demonstrated that QTc interval was prolonged with a linear correlation to the plasma concentration of (+/-)-sotalol. In addition, ...Continue Reading

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Citations

Aug 1, 2012·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Rashmi R Shah, Joel Morganroth
Oct 21, 2016·American Journal of Therapeutics·Sahan P Semasinghe BandaralageSelvanayagam Niranjan
Feb 13, 2003·British Journal of Clinical Pharmacology·Christer TannergrenHans Lennernäs
Aug 5, 1998·British Journal of Clinical Pharmacology·G DevereuxD J Hendrick
Jan 18, 2017·Pharmacology Research & Perspectives·Verena GottaPiet H van der Graaf
Jul 1, 1997·The Annals of Pharmacotherapy·C G GustavssonE Pantev
Jun 27, 1998·British Journal of Clinical Pharmacology·V H DeneerJ R Brouwers

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