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Sulfanilamide topical Pregnancy and Breastfeeding Warnings

Sulfanilamide topical is also known as: AVC

Sulfanilamide topical Pregnancy Warnings

Sulfanilamide topical has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity at high oral doses (7 to 25 times the human therapeutic oral dose), with an increased incidence of cleft palate and other bony abnormalities observed in rats and mice. There are no controlled data in human pregnancy. The safe use of sulfonamides, including sulfanilamide topical, in pregnancy has not been established. Sulfanilamide topical is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Sulfonamides, including sulfanilamide, readily cross the placental barrier and enter fetal circulation. The concentration in the fetus averages from 50% to 90% of that in the maternal blood and if high enough, can cause toxic effects.

See references

Sulfanilamide topical Breastfeeding Warnings

Sulfanilamide topical is excreted into human milk. Absorbed sulfonamides have caused kernicterus in the newborn. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

See references

References for pregnancy information

  1. "Product Information. AVC Cream (sulfanilamide topical)" Aventis Pharmaceuticals, Swiftwater, PA.

References for breastfeeding information

  1. "Product Information. AVC Cream (sulfanilamide topical)" Aventis Pharmaceuticals, Swiftwater, PA.

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