Betamethasone / clotrimazole topical Pregnancy and Breastfeeding Warnings

Betamethasone / clotrimazole topical is also known as: Lotrisone

Betamethasone / clotrimazole topical Pregnancy Warnings

Betamethasone-clotrimazole has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity when corticosteroids are administered orally or potent steroids are applied topically. Betamethasone has been shown to be teratogenic when administered intramuscularly in rabbits. There are no controlled data in human pregnancy. Betamethasone has been shown to cross the placenta. Betamethasone-clotrimazole is only recommended for use during pregnancy when benefit outweighs risk.

Following oral administration of betamethasone prior to delivery, the umbilical serum concentration to maternal serum ratio averaged 0.28. Intravaginal clotrimazole use has been studied during pregnancy. Clotrimazole has been used in several clinical trials for the treatment of vaginal candidiasis during the second and third trimester without evidence of fetal harm. One trial included 57 patients in their first trimester. Again no adverse fetal effects were attributed to clotrimazole. In a review of 229,101 deliveries to Michigan Medicaid patients, 2624 first-trimester exposures to clotrimazole and 8590 exposures any time during pregnancy were recorded. A total of 118 birth defects were reported with first trimester exposure (112 expected) and included (observed/expected) 27/26 cardiovascular defects, 3/1 spina bifida, 4/4 oral clefts, 9/6 polydactyly, 1 limb reductions, and 6/6 hypospadias. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994) These data do not support an association between clotrimazole use during pregnancy and birth defects. Animals given high doses of clotrimazole intravaginally and orally have not revealed evidence of teratogenicity. In clinical trials of women in their second and third trimester, clotrimazole treatment of vaginal candidiasis has not been associated with fetal harm.

Betamethasone / clotrimazole topical Breastfeeding Warnings

There are no data on the excretion of betamethasone or clotrimazole into human milk.

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