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Clomaz/Clomaz-Forte Pregnancy |
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Pregnancy predisposes patients to the development of vaginal candidiasis due to changes in the vaginal tract. Clomaz/Clomaz-Forte 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 Clomaz/Clomaz-Forte. In a review of 229,101 deliveries to Michigan Medicaid patients, 2624 first-trimester exposures to Clomaz/Clomaz-Forte 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 Clomaz/Clomaz-Forte use and birth defects.
Clomaz/Clomaz-Forte 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, Clomaz/Clomaz-Forte treatment of vaginal candidiasis has not been associated with fetal harm. Clomaz/Clomaz-Forte use has not been well studied during the first trimester. Clomaz/Clomaz-Forte is only recommended for use during pregnancy when benefit outweighs risk.
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There are no data on the excretion of Clomaz/Clomaz-Forte into human milk.
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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