The pharmacokinetics of oral indoramin during pregnancy
The pharmacokinetics of indoramin (Baratol; Wyeth) and its active metabolite 6-hydroxyindoramin administered to 13 women as a single 37.5 mg dose of indoramin were compared under pregnant and post-partum conditions. No significant differences were observed between values determined under pregnant and post-partum conditions, for any pharmacokinetic parameter. C(max) and AUC values in individual subjects differed, in most cases, by no more than two-fold, i.e. the same order of magnitude as intra-subject variation seen in volunteers dosed repeatedly with indoramin. Median values of C(max), AUC(0,24) and t( 1/2 ,z) were of a similar order to values seen previously in normal volunteers after a single 37.5 mg dose. It is concluded that in treating hypertension associated with pregnancy, this study does not provide evidence to depart from the usual clinical practice of titrating indoramin dosage with control of blood pressure as the end-point, keeping in mind the restriction of the dose-limiting side-effect of sedation.