Dipsotrex Use In Pregnancy & Lactation

Pregnancy: Teratogenic Effects: Pregnancy Category C Studies of teratogenicity were done by the oral route where bioavailability is expected to be approximately 40-60% of the administered dose. In rabbits, increased maternal and fetal toxicity were noted at a dosage of 12 μg/kg/day (132 μg/m²/day); a dosage of 36 μg/kg/day (396 μg/m²/day) resulted in a significant increase in the incidence of incomplete ossification of the pubic bones and forelimb phalanges of fetuses. In a rate study, a dosage of 54 μg/kg/day (318 μg/m²/day) resulted in a significantly increased incidence of skeletal abnormalities (enlarged fontanelles and extra ribs). The enlarged fontanelles are most likely due to Calcipotriol's effect upon calcium metabolism. The estimated maternal and fetal no-effect exposure levels in the rate (43.2 μg/m²/day) and rabbit (17.6 μg/m²/day) studies are approximately equal to the expected human systemic exposure level (18.5 μg/m²/day) from dermal application. There are no adequate and well-controlled studies in pregnant women. Therefore, Calcipotriol Ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether Calcipotriol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Calcipotriol Ointment, 0.005% is administered to a nursing woman.