Fluorometholone / sulfacetamide sodium ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: FML-S, FML-S Liquifilm

Fluorometholone / sulfacetamide sodium ophthalmic Pregnancy Warnings

Fluorometholone-sodium sulfacetamide ophthalmic has been assigned to pregnancy category C by the FDA. Animal studies with fluorometholone ophthalmic have revealed evidence of teratogenicity and embryotoxicity following low multiples of the recommended human ophthalmic dose. Sulfonamides have been reported to cross the placenta to the fetus during all stages of gestation. However, even when taken orally, sulfonamides have not been reported to pose a significant teratogenic risk. Systemic sulfonamides have been associated with kernicterus in infants when given during the third trimester. With the maternal blood levels expected when the sodium sulfacetamide is administered by the ophthalmic route, risk to the fetus would be expected to be minimal. There are no controlled data in human pregnancy. Fluorometholone-sodium sulfacetamide ophthalmic is only recommended for use during pregnancy when benefit outweighs risk.

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Fluorometholone / sulfacetamide sodium ophthalmic Breastfeeding Warnings

There are no data on the excretion of fluorometholone-sodium sulfacetamide ophthalmic into human milk. Topically applied steroids have been reported to be absorbed systemically. Sulfonamides are excreted into human milk. However, adverse effects in the nursing infant are unlikely from maternal use of sodium sulfacetamide ophthalmic. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue the drug or to discontinue nursing, taking into account the importance of the drug to the mother.

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Further information

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