Pharmacokinetics of sotalol during pregnancy.

Sotalol, a beta-adrenoceptor blocking drug, was administered to 6 healthy pregnant volunteers between 32-36 weeks gestation and when at least 6 weeks post-partum. On both occasions, each volunteer was given sotalol 100 mg intravenously and 400 mg orally in randomised order with at least a 1 week washout period between. Plasma samples were analysed for sotalol using a fluorometric method and the pharmacokinetic profiles investigated. The systemic clearance of sotalol was significantly greater in the antenatal period (2.4 +/- 0.3 ml/min/kg) than in the post-natal phase (1.5 +/- 0.1 ml/min/kg). The apparent volume of distribution was similar in the two periods: the elimination half-life was 6.6 +/- 0.6 h ante-natally and 9.3 +/- 0.7 h post-natally after intravenous drug but the trend for faster elimination was not significant. The elimination half-life after oral administration (about 10 h) and bioavailability (about 90%) were not altered significantly by pregnancy. It is suggested that the more rapid clearance of sotalol in pregnancy may be due to increases in renal plasma flow and glomerular filtration rate.

RCT Entities:   Population Interventions Outcomes