Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation


Pregnancy
The safety of amikacin in pregnancy has not yet been established. Amikacin should be administered to pregnant women and neonatal infants only when clearly needed and under medical supervision (see section 4.4).
There are limited data on use of aminoglycosides in pregnancy. Aminoglycosides can cause foetal harm. Aminoglycosides cross the placenta and there have been reports of total, irreversible, bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Adverse effects on the foetus or newborns have been reported in pregnant women treated with other aminoglycosides, therefore, the potential for harm exists. If amikacin is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the foetus.


Breast-feeding
Amikacin is excreted in human milk. A decision should be made whether to discontinue breast- feeding or to discontinue therapy.
Fertility
In reproduction toxicity studies in mice and rats no effects on fertility or foetal toxicity were reported.