Gentamicin Pregnancy and Breastfeeding Warnings

Brand names: Cidomycin, Garamycin, Septopal

Medically reviewed by Drugs.com. Last updated on Aug 3, 2023.

Gentamicin Pregnancy Warnings

Animal studies have failed to reveal evidence of fetotoxicity, fetal harm, or impaired fertility with this drug. There are reports of total irreversible, bilateral congenital deafness in children whose mothers used streptomycin during pregnancy. Evidence of (probably reversible) damage to immature nephrons of the fetal kidney associated with use, and eighth cranial nerve damage associated with aminoglycoside exposure in utero have been reported. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US 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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: D
US FDA pregnancy category: D

Comments:
-Therapeutic blood levels in the mother do not equate with safety for the fetus.
-Some experts recommend: Aminoglycosides should be considered potentially ototoxic and nephrotoxic to the fetus.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

See references

Gentamicin Breastfeeding Warnings

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-The American Academy of Pediatrics considers this drug compatible with breastfeeding.
-The WHO considers this drug compatible with breastfeeding; breastfed infants should be monitored for thrush and diarrhea.
-Breastfed infants should be monitored for candidiasis and gastrointestinal side effects (e.g., diarrhea, thrush, diaper rash, antibiotic-associated colitis).

See references

Further information

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