Tapcom Use In Pregnancy & Lactation

This product should be used for pregnant women or women who may possibly be pregnant only if the expected therapeutic benefits are judged to outweigh the possible risks associated with the treatment. [The safety of this product for use during pregnancy has not been established. In animal studies, when tafluprost solution was administered intravenously to pregnant rats at a dose of 30 µg/kg/day (2000 times the clinical dose^*), teratogenicity and post-implantation embryonic mortality rate increased; at 10 µg/kg/day (about 670 times the clinical dose^*) adverse effects on fetal development (low body weight and unossification of breast bone in fetuses) was observed. In intravenous administration in pregnant rabbits at 0.1 µg/kg/day (about 6.7 times the clinical dose^*), the miscarriage and mortality rate after implantation increased, and luteal body and implantation decreased; at 0.03 µg/kg/day (2 times the clinical dose^*) teratogenicity was observed. In an intravenous administration study in pregnant and lactating rats at a dose level of 1 µg/kg/day (about 67 times the clinical dose^*), mal-nursing of dams was observed and the 4-day survival rate of new born baby decreased. On the other hand, in the study using uteri isolated from rats, uterine contraction was observed at about 3.3 times the plasma concentration of tafluprost (less than 30 pg/mL), or about 420 times the plasma concentration of unbound tafluprost (less than 0.24 pg/mL), calculated based on the protein binding ratio, estimated after ocular administration of the clinical dosage.].
^*Dosage (0.015 µg/kg/day) when one drop (30 µL) of tafluprost ophthalmic solution 0.0015% is instilled into both eyes at a time for a 60 kg patient.
Avoid administration to nursing mothers. If administration is judged to be essential, the patients should be instructed to stop breast-feeding during treatment. [A study has shown excretion of tafluprost in breast milk after ocular instillation in rats. Timolol maleate may be excreted in human breast milk.].
(Additional information): In animal studies, delayed ossification in the fetuses was observed when timolol maleate was administered orally to pregnant rats during organogenesis at a dose of 500 mg/kg/day. Increased fetal death was observed when timolol maleate was administered orally to mice at a dose of 1000 mg/kg/day and to rabbits at a dose of 200 mg/kg/day.