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Sulfacetamide sodium ophthalmic Pregnancy and Breastfeeding Warnings

Sulfacetamide sodium ophthalmic is also known as: AK-Sulf, Bleph-10, Cetamide, Isopto Cetamide, Ocu-Sul 10, Ocu-Sul 15, Ocu-Sul 30, Ocusulf-10, Sodium Sulamyd, Sulf-10, Sulfac 10%, Sulfacet Sodium

Sulfacetamide sodium ophthalmic Pregnancy Warnings

Sodium sulfacetamide ophthalmic has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. 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; although there is a risk of kernicterus in the newborn. With the maternal blood levels expected when the drug is administered by the ophthalmic route, risk to the fetus would be expected to be minimal. Sodium sulfacetamide is only recommended for use during pregnancy when benefit outweighs risk.

Sulfacetamide sodium ophthalmic Breastfeeding Warnings

There are no data on the excretion of sodium sulfacetamide ophthalmic into human milk. Systemic sulfonamides are excreted into breast milk. The manufacturer recommends that due to the potential for the development of kernicterus in neonates, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Some systemic sulfonamides are considered compatible with breast-feeding of healthy full-term infants by the American Academy of Pediatrics.

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