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Gentamicin Pregnancy and Breastfeeding Warnings

Gentamicin is also known as: Cidomycin, Garamycin, Septopal

Gentamicin Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity; however, nephrotoxicity occurred in fetal rats. There are no controlled data in human pregnancy. If gentamicin is used during pregnancy or if a woman becomes pregnant during therapy, she should be advised of the potential risk to the fetus. Aminoglycosides can cause fetal harm when given to pregnant women. Aminoglycosides cross the placenta and there are reports of fetal eighth cranial nerve toxicity with permanent bilateral deafness after in utero exposure to streptomycin. Serious side effects to mother, fetus, or newborn have not been reported in pregnant women treated with other aminoglycosides. FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

FDA pregnancy category: D Safety of gentamicin has not been established; potential benefit should outweigh the potential risk.

Gentamicin Breastfeeding Warnings

Gentamicin is excreted into breast milk in small amounts. At 1 and 7 hours following a dose of gentamicin, serum concentrations averaged 3.9 and 1.1 mcg/mL, respectively, while milk concentrations averaged 0.4 and 0.4 mcg/mL. The milk:plasma ratio averaged 0.11 and 0.44, respectively. Infants were fed one hour after administration of gentamicin. Gentamicin was detected in the serum of 5 of 10 infants with an average serum concentration of 0.4 mcg/mL. The five other infants had undetectable levels (below 0.27 mcg/mL). Gentamicin is considered compatible with breast-feeding by the American Academy of Pediatrics.

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