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 this product during pregnancy has not been established. Reproduction studies have been performed in rabbits. In the study of administration during organogenesis in rabbits, increased incidences of abortion and late resorption and reduce in fetal weight were observed when latanoprost was given by intravenous administration at a dose that was approximately 80 times the clinical dose (5 μg/kg/day).]
Nursing mothers: Administration to nursing mothers should be avoided. If the use of this product is unavoidable, the patient should discontinue breastfeeding. [Animal studies (rats, i.v.) have shown that latanoprost and its metabolites are excreted in breast milk. Timolol maleate may be excreted in human breast milk.]
Reference information: In a study in which timolol maleate was orally administered to rats during the period of organogenesis at a dose of 500 mg/kg/day, delayed ossification was observed, and in an oral study in mice at a dose of 1000 mg/kg/day and in rabbits at a dose of 200 mg/kg/day, increased numbers of dead fetuses were observed.