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Ilevro

Ilevro Use In Pregnancy & Lactation

nepafenac

Manufacturer:

Novartis Indonesia
Full Prescribing Info
Use In Pregnancy & Lactation
Fertility: There are no adequate data regarding the use of Ilevro on human fertility. No significant fertility effects were seen in studies in rats at doses up to 2500 times greater than the maximum recommended human ocular dose.
Ilevro should not be used by women of child bearing potential not using contraception.
Pregnancy: There are no adequate data regarding the use of Ilevro on human pregnancy. No significant teratogenic effects were observed in rats and rabbits orally administered with doses of nepafenac up to 2500 times greater than the maximum recommended human ocular dose. Since human systemic exposure is negligible (< 1ng/mL) after treatment with Ilevro, the risk during pregnancy could be considered low. Nevertheless, inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryonal/foetal development and/or parturition and/or postnatal development.
Ilevro is not recommended during pregnancy unless the benefit outweighs the potential risk.
Breast-feeding: It is unknown whether nepafenac is excreted in human milk after topical ocular administration. Animal studies have shown excretion of nepafenac in the milk of rats after oral administration. While no effects on the suckling child are anticipated since the systemic exposure of the breastfeeding woman to nepafenac is negligible (<1 ng/mL), caution should be exercised when Ilevro is administered to a nursing woman.
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