Pharmacology: Toxicology: Fertility and reproductive toxicity study: 50 mg/kg was given to rats, mating rate, fertility rate as well as the average performance of sperm were reversibly decreased in adult male rats. After the implementation, a loss of embryo and decreased number of survived fetus in females were found. A delay of development such as decrease of the average weight, auditory reflex, late auricle detachments, etc., was found in neonates.
In embryo-fetal development study, when rats were given more than 15 mg/kg, weight loss and frameshift mutation (Differentiation of infant sternebra) were found. And when a dose of 450 mg/kg/day was given to mice, an increase of post implantational embryo death, including total litter loss, decrease of fetal body weights, and an increased incidence of costal cartilage fusion were observed.
In sexually mature male rats exposed to drugs as juveniles, mildly decreased fertility was observed following treatment with linezolid through most of their period of sexual development (50 mg/kg/day from days 7 to 36 of age, and 100 mg/kg/day from days 37 to 55 of age), with exposures up to 1.7 -fold greater than mean AUCs observed in pediatric patients aged 3 months to 11 years. Decreased fertility was not observed with shorter treatment periods, corresponding to exposure in utero through the early neonatal period (gestation day 6 through postnatal day 5), neonatal exposure (postnatal days 5 to 21), or to juvenile exposure (postnatal days 22 to 35). Reversible reductions in sperm motility and altered sperm morphology were observed in rats treated from postnatal day 22 to 35.
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