TRANSFER OF FOSFOMYCIN SODIUM TO THE PELVIC ORGANS

To confirm efficacy and safety of fosfomysin sodium (FOM-Na) in the field of obstetrics and gynecology, hemodynamics and pelvic transferrence were analyzed using so-called three-compartment model in adult women treated with the drug at a dose of 2g either as an one shot injection or an intravenous infusion over 1 hour. Following results were obtained. 1.Hemodynamics in these patients were similar to those obtained in healthy adult males, although there was a tendency that levels reached were lower and elimination was more rapid in cases of genital cancer. 2.As to drug concentration of dead cavity fluid, Tmax appeared at 1.75 hours after completion of administration irrespective of administration methods, with Cmaxbeing 67.8μg/ml and 50.5μg/ml of intravenous injection and intravenous infusion, respectively.Thereafter, there was no difference between two administration methods. 3.Uterine tissue concentration reached to its Tmax.at 15 to 30 minutes after intravenous injection and within 10 minutes after completion of intravenous infusion, Cmax being higher than 90μg/g.Even at 5 hours, 15 to 25μg/g of the drug was detected. From these results and from susceptibilities of clinical isolates to the drug, it was considered that FOM-Na at a dose level of 2g is highly effective in the treatment of various infections in the field of obstetrics and gynecology including intrapelvic infections, uterine infections and adnexitis.