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Tobramycin Pregnancy and Breastfeeding Warnings

Tobramycin is also known as: Bethkis, Nebcin, Nebcin Pediatric, TOBI Podhaler, Tobi

Tobramycin Pregnancy Warnings

FDA pregnancy category: D If tobramycin is used during pregnancy or the patient becomes pregnant during therapy, she should be advised of the potential risk to the fetus.

Animal studies have failed to reveal evidence of teratogenicity with subcutaneous administration. There are no controlled data in human pregnancy. Aminoglycosides can cause fetal harm when used in pregnant women. Aminoglycoside antibiotics cross the placenta. Total irreversible bilateral congenital deafness has been reported in children after in utero exposure to streptomycin. Serious side effects to mother, fetus, or newborn have not been reported with use of other aminoglycosides during pregnancy. 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.

Tobramycin Breastfeeding Warnings

Parenteral: The manufacturer makes no recommendation regarding use during lactation. Inhalation: 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 Excreted into animal milk: Unknown Parenteral: Tobramycin has been used without apparent harmful effects in the nursing infant. Inhalation: The effects in the nursing infant are unknown.

Parenteral: Trace amounts of tobramycin have been measured in milk after intramuscular injection. Due to poor oral bioavailability, systemic toxicity in the nursing infant is unlikely; however, the possibility of bowel flora modification and interference with culture results should be considered. Inhalation: It is unknown whether nebulized tobramycin would reach sufficient serum concentrations to be excreted in human milk. Due to poor oral bioavailability, systemic toxicity in the nursing infant is unlikely; however, the manufacturer recommends that due to the potential for ototoxicity and nephrotoxicity in nursing infants, a decision should be made to discontinue nursing or discontinue the drug.

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