Patolop Use In Pregnancy & Lactation

General recommendation: Pregnancy category: C.
Women of childbearing potential/Contraception: There is no sufficient data on the use of olopatadine in pregnant women. Women of childbearing potential should have effective contraception during treatment.
Pregnancy period: There are no clinical data obtained from the pregnant patients for olopatadine.
Studies on animals are insufficient in terms of the effects on pregnancy and/or embryonal/fetal development and/or birth and/or post-natal development. The potential risk for humans is unknown.
Olopatadine Hydrochloride should not be used unless it is necessary in the pregnancy period. During pregnancy, it should be used only if the potential benefit is more than the potential fetal risk.
Caution should be exercised when prescribing this product to pregnant women.
Lactation period: Olopatadine Hydrochloride is not recommended for breastfeeding mothers.
Olopatadine has been detected in the milk of lactating rats following oral administration. Studies in animals have shown reduced growth of breastfed pups of she-dogs receiving systemic doses of olopatadine well in excess of the maximum level recommended for human ocular use. It is not known whether or not topical ocular administration in humans will lead to systemic absorption at a level that can be passed into breast milk.
It is not known whether topical olopatadine is excreted in human milk or not. Excretion of topical olopatadine in milk has not been studied on animals. When deciding whether breastfeeding will be stopped or not or whether Olopatadine Hydrochloride treatment will be stopped or not whether to avoid treatment or not, the benefit of breastfeeding for the child and the benefit of Olopatadine Hydrochloride treatment for the mother should be taken into consideration.
Reproductive ability/Fertility: There is no known effect on reproductive ability (fertility).