fosfomycin and Abnormalities--Drug-Induced

The peri- and post-natal examination of fosfomycin-Ca (FOM-Ca) was undertaken in Wistar strain rats. Rats were treated orally at dose levels of 140, 1,400 and 2,800 mg/kg/day from the 14th day of gestation to 21st day after delivery. One-third of pregnant rats in each group were sacrificed on 20th day of gestation and then their fetuses were examined for external, visceral and skeletal observation. The remaining mothers were allowed to deliver naturally, and then their offsprings were examined for postnatal development. No effect of FOM-Ca treatment to rat mothers was found except soft stool was seen in 1,400 and 2,800 mg/kg groups. No effect of FOM-Ca on rat fetuses and newborns was found except fetal body weight and survival rate decreased and skeletal variation increased in maximum dose. Consequently, it can be concluded that FOM-Ca has no effect on rat mothers, fetuses, and newborns treated during peri- and post-natal period.

Topics: Abnormalities, Drug-Induced; Administration, Oral; Animals; Animals, Newborn; Anti-Bacterial Agents; Bone and Bones; Drug Evaluation, Preclinical; Female; Fetus; Fosfomycin; Male; Organ Size; Pregnancy; Pregnancy, Animal; Rats

The fertility study of fosfomycin-Na (FOM-Na) was undertaken in Wistar rats. FOM-Na was administered intraperitoneally at dose levels of 125, 250, 750 and 1,500 mg/kg/day. The male rats were continuously treated with FOM-Na from 63 days before mating and the females were treated from 14 days before mating. The males and females were treated through the mating period and then the pregnant rats were treated until 7 days of gestation. All pregnant rats were sacrificed on day 20 of gestation and then their fetuses were examined for external, visceral and skeletal observation. Mean body weight of males decreased and 6 males and 3 females died in the maximum dose. However, no significant differences were found between treated groups and the control with regard to fertility rate and pregnant rate. External, visceral and skeletal anomalies related with FOM-Na treatment were not observed. In this experiment, no effects of FOM-Na for reproductive performance in rats were observed.

Topics: Abnormalities, Drug-Induced; Animals; Anti-Bacterial Agents; Female; Fertility; Fetus; Fosfomycin; Male; Pregnancy; Rats; Sex Factors

The teratogenicity study of fosfomycin-Ca (FOM-Ca) was undertaken in Wistar strain rats and JW strain rabbits. Rats were treated orally at dose levels of 140,700 and 1,400 mg/kg/day from 7th to 17th day of gestation, and rabbits were treated orally at dose levels of 80, 140 and 420 mg/kg/day from 6th to 18th day of gestation. In the case of rats, two-thirds of pregnant mothers in each group were sacrificed on 20th day of gestation and then their fetuses were examined for external, visceral and skeletal observation. The remaining mothers were allowed to deliver naturally, and then their offsprings were examined for postnatal development. In the case of rabbits, all pregnant mothers were sacrificed on 29th day of gestation and their fetuses were examined. No effect of FOM-Ca treatment to rat and rabbit mothers was found except soft stool was seen with maximum dose in rats. Dead or resorbed rate of fetuses increased, external anomalies (short tail, abdominal hernia) were found and skeletal anomalies slight increased with maximum dose in rats. However, there was no significant difference from the control or background data. While, no effect of FOM-Ca treatment was observed in rabbits and rat offsprings. Consequently, it can be concluded that FOM-Ca has no teratogenicity effects on rats and rabbits.

Topics: Abnormalities, Drug-Induced; Animals; Anti-Bacterial Agents; Calcium; Female; Fetus; Fosfomycin; Growth; Male; Maternal-Fetal Exchange; Pregnancy; Rabbits; Rats; Teratogens