Prednisolone / sulfacetamide sodium ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: AK-Cide, Blephamide, Blephamide S.O.P., Cetapred, Isopto Cetapred, Medasulf, Metimyd, Ocu-Lone C, Sulster, Supred, Vasocidin

Medically reviewed by Drugs.com. Last updated on Aug 4, 2023.

Prednisolone / sulfacetamide sodium ophthalmic Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C (ophthalmic ointment)
US FDA pregnancy category: Not formally assigned to a pregnancy category (ophthalmic suspension and solution)

Animal studies have revealed evidence of teratogenicity with prednisolone at doses 1 to 10 times the human ocular dose. Animal studies with sulfacetamide sodium have not been reported. Kernicterus may occur in infants due to use of systemic sulfonamides during the third trimester of pregnancy. It is not known whether sulfacetamide sodium can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity. 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.

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Prednisolone / sulfacetamide sodium 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:
-Due to limited absorption from the eye, this drug is not expected to cause any adverse effects in breastfed infants.
-Placing pressure over the tear duct by the corner of the eye for at least 1 minute and removing excess solution with an absorbent tissue substantially reduces the amount of drug that reaches breast milk after using eye drops.

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. Systemically administered sulfonamides may produce kernicterus in breastfeeding infants.

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Further information

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