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  • Title: Sex-related differences in the pharmacokinetics of oral ciprofloxacin.
    Author: Overholser BR, Kays MB, Forrest A, Sowinski KM.
    Journal: J Clin Pharmacol; 2004 Sep; 44(9):1012-22. PubMed ID: 15317829.
    Abstract:
    The oral pharmacokinetics of ciprofloxacin were studied in healthy volunteers to assess the influence of sex on its disposition. Subjects (8 males, 7 females) received a single oral dose of ciprofloxacin 750 mg, blood and urine samples were collected, and ciprofloxacin concentrations were determined. A two-compartment open-model with two or three absorption phases, each one having a fitted independent lag time, best fit the data using a weighted least squares estimator. Univariate and multivariate regression analyses were performed to determine the influence of renal function, weight, and subject sex on the oral clearance (CL(S)/F) and apparent steady-state volume of distribution (V(ss)/F) of ciprofloxacin. Females had a median C(max) of ciprofloxacin that was 30% greater than males and a significantly smaller median (range) V(ss)/F: 81.1 (44.8-111.6) versus 170.9 (140.9-213.4), respectively (p < 0.01). In addition, females had increased exposure to ciprofloxacin, with a slower median (range) CL(S)/F of 28.3 L/h (24.5-33.4) compared to 44.4 L/h (41.4-53.7) for males (p < 0.01). Regression analyses revealed that subject sex was the only significant predictor of CL(S)/F (p < 0.001), but both body weight (p = 0.04) and subject sex (p < 0.005) were significant predictors of V(ss)/F. Fixed oral doses of ciprofloxacin will lead to higher maximum concentration and total drug exposure in females compared to males and do not appear to be solely related to weight-based differences.
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