Sulfacetamide sodium ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: 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

Medically reviewed by Drugs.com. Last updated on Apr 30, 2024.

Sulfacetamide sodium ophthalmic Pregnancy Warnings

AU: Sulfonamides should be avoided during the last month of pregnancy, if possible.
US: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: C

Animal studies have not been reported. There are no controlled data in human pregnancy; unknown if sulfonamides can cause fetal harm when applied topically to pregnant women.

Sulfonamides have been reported to cross the placenta to the fetus during all stages of gestation. Oral sulfonamides have not been reported to pose a significant teratogenic risk; however, kernicterus may occur in the newborn if a pregnant woman is treated with such agents at term. 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.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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.

See references

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: Data not available
Excreted into animal milk: Data not available

Comments:
-Systemic sulfonamides are excreted into breast milk.
-Some systemic sulfonamides are considered compatible with breastfeeding of healthy full-term infants by the American Academy of Pediatrics.

Sulfonamides administered systemically to lactating women may cause kernicterus in their breastfeeding infants.

See references

Further information

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