Exelderm Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk to the fetus.
US FDA pregnancy category: C
Animal studies have revealed evidence of embryotoxicity in rats at doses 125 times the human dose (in mg/kg); this dose given orally to rats led to prolonged gestation and dystocia, and several females died during the perinatal period (likely due to labor complications). Animal studies have failed to reveal evidence of teratogenicity in rats or rabbits at oral doses of 50 mg/kg/day. 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.
See references
Exelderm Breastfeeding Warnings
Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-The effects in the nursing infant are unknown.
-About 11% of dose absorbed after topical use; considered low risk to nursing infants but may prefer other antifungal agents with less absorption, particularly in neonates or preterm infants.
-Application to the nipple area should be avoided.
See references
