Pharmacokinetic changes of theophylline and amikacin through the menstrual cycle in healthy women.

Author(s): Matsuki S, Kotegawa T, Tsutsumi K, Nakamura K, Nakano S

Affiliation(s): Department of Clinical Pharmacology and Therapeutics, Oita Medical University, Japan.

Publication date & source: 1999-12, J Clin Pharmacol., 39(12):1256-62.

Publication type: Clinical Trial; Randomized Controlled Trial

The objective of this open-label, single-dose study was to clarify the influence of the menstrual cycle on the pharmacokinetics of theophylline (n = 10) and amikacin (n = 8) in young healthy Japanese women with regular menstrual cycles. Each subject received an intravenous infusion of theophylline or amikacin sulfate at four different phases--mid-follicular (phase I), peri-ovulatory (phase II), mid-luteal (phase III), and premenstrual days (phase IV). In the theophylline study, there were no significant differences in the pharmacokinetic parameters among the four phases studied. In the amikacin study, CLtot was 15% higher in phase III than in phase I (p < 0.01). Vd beta was 35% higher in phase III than in phase I (p < 0.05). The other pharmacokinetic parameters of amikacin were not significantly altered during the menstrual cycle. Evidence suggests that the phase of the menstrual cycle may be a factor in determining the pharmacokinetics of amikacin.