Pregnancy Category C.
Since the effects of miconazole nitrate on fetus and newborn growth are not clearly known, women of childbearing potential who will use Micotran should avoid pregnancy with a proper birth control method. There is no sufficient data regarding the use of Micotran in pregnant women. Oral miconazole nitrate application to rats leaded to prolonged gestation but not observed in rabbits. At high doses, toxic effects on fetus and embryo in rats and rabbits, and dystocia in rats are observed. These effects were not observed in intravaginal application. Potential risk is unknown in humans.
There is insufficient data regarding the use of Micotran in the 1st trimester of pregnancy. Therefore, Micotran should not be used in the 1st trimester of pregnancy. In the 2nd and 3rd trimesters, benefit/risk ratio should be evaluated by a physician, should not be used unless it is necessary. It is not certain whether it is hazardous or not in lactation period.