Optanep Use In Pregnancy & Lactation

General recommendation: Pregnancy category: C, D in 3rd trimester.
Women of childbearing potential/Contraception: It is recommended that women with childbearing potential use a medically appropriate contraceptive method during their treatment with Nepafenac.
Pregnancy Period: There are no adequate data regarding the use of Nepafenac in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Since the systemic exposure is expected as negligible after treatment with Nepafenac, the risk during pregnancy could be considered low. Nevertheless, as inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryonal/fetal development and/or parturition and/or postnatal development, it is not recommended for use during pregnancy.
Lactation Period: It is unknown whether Nepafenac is excreted in human milk or not. Animal studies have shown the excretion of Nepafenac in the milk of rats. However, no effects on the suckling child are anticipated since the systemic exposure of the breastfeeding woman to Nepafenac is negligible. Nepafenac can be used during the lactation period.
Fertility: There is no data on the effect of Nepafenac on reproductive ability.