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Pregnant women: This product should be used in pregnant women or women who may be pregnant only if the expected therapeutic benefits outweigh the possible risks associated with treatment. [The safety of administration during pregnancy has not been established. In animal studies, teratogenicity was observed when 10 μg/kg per day (250 times the clinical dose*) was intravenously administered to pregnant rats. And, an increase in post implantation losses and a decrease in fetal viability were observed when 1 μg/kg per day (25 times the clinical dose*) was subcutaneously administered to pregnant mice as well as when 10 μg/kg per day (250 times the clinical dose*) was intravenously administered to pregnant rats. In pregnant rabbits, moreover, death of whole embryos/fetuses was observed when 0.1 μg/kg per day (2.5 times the clinical dose*) was intravenously administered or 0.003% ophthalmic solution (equivalent to 10 times the clinical dose a t a dose per body weight) was administered. When 0.12 μg/kg per day (3 times the clinical dose*) or a higher dose was subcutaneously administered to pregnant/lactating rats from Day 7 of pregnancy to Day 21 of lactation, adverse effects (such as increased postnatal mortality, inhibition of neonatal body weight gain, delayed eye opening) were observed in the development and differentiation of offspring. In an experiment conducted by using isolated uterus of rats, dose-dependent uterine contraction occurred in a manner at the concentration (0.3 nmol/L) approximately 6 times higher than the maximum plasma concentration of this product (0.025 ng/mL=0.05 nmol/L) observed in healthy Japanese adults.]
*) Comparison with the dose (0.04 μg/kg per day) calculated assuming that the body weight of the patient is 50 kg, and 1 drop (25 μL) each of 0.004% travoprost solution is instilled in both eyes at a time.
Nursing mothers: Administration of this product should be avoided in breastfeeding mothers. If the use of this product is unavoidable, the patient should discontinue breastfeeding. [An animal study (rat: subcutaneous administration) has shown that the drug is excreted in breast milk.]
