Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation

Pregnancy
There are no or limited amount of data from the use of dexamethasone and levofloxacin in pregnant women. Corticosteroids cross the placenta. Prolonged or repeated corticosteroid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation, lower birth weight and risk for high blood pressure, vascular disorders and insulin resistance in the adulthood. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Studies in animals with corticosteroids have shown reproductive toxicity and teratogenic effects (including cleft palate; see section 5.3).

Since a relevant systemic corticosteroid exposure cannot be excluded after ocular administration, treatment with Levodesa is not recommended during pregnancy, and especially during the first three months, should only take place after a careful benefit-risk assessment.

Breastfeeding
Systemic corticosteroids and levofloxacin are excreted into human milk. No data are available, to indicate whether relevant amounts of dexamethasone are transferred into human breast milk and which are capable of producing clinical effects in the infant. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Levodesa therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility
Systemically administered corticosteroids may impair male and female fertility by influencing hormonal secretion of the hypothalamus and pituitary gland as well as gametogenesis in testes and ovaries. It is unknown if dexamethasone impairs human fertility after ocular use.

Levofloxacin caused no impairment of fertility in rats at exposures considerably in excess of the maximum human exposure after ocular administration.