Gentamicin ophthalmic Pregnancy Warnings
Animal studies have revealed evidence of decreased body weights, kidney weights, and medial glomerular counts in pups after maternal exposure to daily ophthalmic doses 500 times the maximum recommended human dose. 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
Use is recommended only if clearly needed and the benefit outweighs the risk.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.
Risk Summary: There are no adequate data available on use of this formulation in pregnant women to inform a drug-related risk.
Comments:
-Therapeutic blood levels in the mother do not equate with safety for the fetus.
-Some experts state that 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 ophthalmic Breastfeeding Warnings
Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-The WHO considers this drug compatible with breastfeeding.
-Some experts state that eye drop formulations present little risk to the nursing infant.
-Systemically circulating levels of this drug may be decreased by placing pressure over the tear duct in the corner of the eye over at least 1 minute; excess solution should be removed with tissues.
See references
