Bacitracin, neomycin, and polymyxin b ophthalmic Pregnancy Warnings
Animal studies have not been reported. There are no controlled data in human pregnancy.
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.
This drug should be used during pregnancy only if clearly needed.
US FDA pregnancy category: Not assigned.
Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.
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Bacitracin, neomycin, and polymyxin b ophthalmic Breastfeeding Warnings
Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-Bacitracin and polymyxin B are poorly absorbed after topical application; both components are considered low risk to nursing infants.
-Ophthalmic neomycin should result in very low levels in breast milk; this should present negligible risk to nursing infants.
See references