Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation
Fertility
There are no data available on the use of this medicine affecting male or female fertility.
There is limited clinical data to evaluate the effect of dexamethasone on male or female fertility. Dexamethasone was free of adverse effects on fertility in a chorionic gonadotropin primed rat model.

Pregnancy
There are no or limited amount of data from the use of MAXITROL ophthalmic ointment in pregnant women.
3 MAX OIN API SEP20 V4                                                     UK SPC -JUN2020 Aminoglycoside antibiotics, such as neomycin, do cross the placenta after intravenous dosing in pregnant women. Non-clinical and clinical systemic exposure to aminoglycosides has been shown to induce ototoxicity and nephrotoxicity. At the low dose administered via this topical product, neomycin is not expected to cause ototoxicity or nephrotoxicity from in utero exposure. Prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism (See Section 4.4).

Studies in animals with some active components of MAXITROL ophthalmic ointment have shown reproductive toxicity (see section 5.3).

MAXITROL ophthalmic ointment is not recommended during pregnancy.

Lactation
It is unknown whether topical ophthalmic dexamethasone, neomycin or polymyxin B are excreted in human milk. Because systemic corticosteroids and aminoglycosides may be distributed into milk, a risk to the suckling child cannot be excluded.
A decision whether to discontinue/abstain from breast-feeding or to discontinue therapy with MAXITROL ophthalmic ointment taking into account the benefit of breast-feeding for the child and the benefit of the product to the woman.