May 19 2022

Classification of the active ingredient amikacin

Risk level in pregnancy: This medicine is classified as Category C.

There are no adequate controlled studies on the use of the drug in pregnant women, although there have been no reported observations on adverse effects of exposure to amikacin. For obvious reasons, if a woman becomes pregnant while taking this drug, should be apprised of the potential risks to the fetus from the use of aminoglycosides.

This group of antibiotics can cause fetal harm when administered to pregnant women. Aminoglycosides cross the placenta and are known several cases of irreversible congenital deafness in children of pregnant women treated with one of these drugs (streptomycin, kanamycin). Although no injuries have been detected with other drugs of the same group, the risk exists.

Studies in laboratory animals have found dose-dependent kidney damage in mothers and fetuses, but no teratogenic effects were detected.

Update 18.07.2009

Meaning of category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.