Bacitracin, hydrocortisone, neomycin, and polymyxin b (ophthalmic) Pregnancy Warnings
Animal studies with this combination drug have not been reported. Corticosteroids have been found to be teratogenic in rabbits when applied topically at concentrations of 0.5% and 15%. There are no controlled data in human pregnancy.
US FDA pregnancy 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.
This drug should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
US FDA pregnancy category: C
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Bacitracin, hydrocortisone, neomycin, and polymyxin b (ophthalmic) Breastfeeding Warnings
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: Unknown
Excreted into animal milk: Data not available
Comments: The effects in the nursing infant are unknown.
It is unknown whether topically administered corticosteroids could result in sufficient systemic absorption to produce detectable levels in breast milk; however, systemically administered corticosteroids may appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause untoward effects.
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