Clotrimazole Pregnancy and Breastfeeding Warnings

Clotrimazole is also known as: Clotrimazole Troche, Mycelex Troche

Clotrimazole Pregnancy Warnings

Pregnancy predisposes patients to the development of vaginal candidiasis due to changes in the vaginal tract. 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 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 reduction, and 6/6 hypospadias. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994) These data do not support an association between first-trimester clotrimazole use and birth defects.

Clotrimazole has been assigned to pregnancy category C by the FDA when given as oral troches, and pregnancy category B when used intravaginally or topically. Animals given high doses intravaginally and orally have not shown evidence of teratogenicity. In clinical trials involving women in their second and third trimester, clotrimazole treatment of vaginal candidiasis has not been associated with fetal harm. Clotrimazole use has not been well studied during the first trimester. Clotrimazole is only recommended for use during pregnancy when benefit outweighs risk.

Clotrimazole Breastfeeding Warnings

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

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