Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation

Pregnancy
There are limited data from the use of aminoglycosides, including gentamicin, in pregnancy. Gentamicin crosses the placenta, and there is a risk of ototoxicity (vestibulocochlear nerve damage) and/or renal damage in the fetus, as seen in animal studies (see section 5.3). Gentamicin should not be used in pregnancy, except in case of life-threatening situations where expected benefits outweigh possible risks.
In such case, maternal serum gentamicin concentration monitoring is recommended (see section 4.2. Monitoring of hearing and renal function of the infants is also recommended.
Breast-feeding
Gentamicin is excreted in human breast milk and was detected in low concentrations in the serum of breast-fed infants, except in cases where the mucous membrane of the infant's stomach and intestines is severely eroded.
In cases of suspected severe mucosal erosion, if the infant is breast-fed during gentamicin treatment, it is recommended to monitor the serum concentration of gentamicin in the infant (see section 4.2). Animal and human data suggest that if the serum gentamicin concentration in the infant exceeds 1 µg/ml, either breast-feeding or the gentamicin therapy may need to be discontinued, under medical supervision. The following effects of gentamicin on the infant's normal gastrointestinal flora are possible and it is recommended to monitor the infant for possible effects such as diarrhoea, candidiasis and bloody stools.