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Prednisolone / sulfacetamide sodium ophthalmic Pregnancy and Breastfeeding Warnings

Prednisolone / sulfacetamide sodium ophthalmic is also known as: AK-Cide, Blephamide, Blephamide S.O.P., Cetapred, Isopto Cetapred, Medasulf, Metimyd, Ocu-Lone C, Sulster, Supred, Vasocidin

Prednisolone / sulfacetamide sodium ophthalmic Pregnancy Warnings

Prednisolone-sodium sulfacetamide ophthalmic has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of an increased incidence of cleft palates in offspring when prednisolone ophthalmic was administered in therapeutic doses. Prednisolone has been reported to be teratogenic in rabbits, hamsters, and mice. Animal studies have not been reported for sulfacetamide sodium. 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. Prednisolone-sodium sulfacetamide ophthalmic is only recommended for use during pregnancy when benefit outweighs risk.

See references

Prednisolone / sulfacetamide sodium ophthalmic Breastfeeding Warnings

There are no data on the excretion of prednisolone-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.

See references

References for pregnancy information

  1. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  2. "Product Information. Blephamide Ophthalmic Suspension (prednisolone-sodium sulfacetamide ophthalmic)." Allergan Inc, Irvine, CA.

References for breastfeeding information

  1. "Product Information. Blephamide Ophthalmic Suspension (prednisolone-sodium sulfacetamide ophthalmic)." Allergan Inc, Irvine, CA.

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