Terconazole

Oral Contraceptives: There is no known interaction with the concomitant use of this product and oral contraceptives.

8.1 Pregnancy Risk Summary There are no available data on Terconazole Vaginal Cream use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Available data from observational studies with terconazole use in pregnancy are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies with oral terconazole, no adverse development effects were observed at clinically relevant systemic exposures (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data There was no evidence of malformations when terconazole was administered orally in rats, or rabbits. There was a delay in fetal ossification at an oral dose of 10 mg/kg/day in rats. Higher doses resulted in decreased litter size, decreased number of viable young and reduced fetal weight in rats. There was also a delay in ossification and an increase incidence of skeletal variants.

The dose of 10 mg/kg/day resulted in a mean peak plasma level of terconazole in pregnant rats of 0.176 mcg/mL which exceeds by 30 times the mean peak plasma level (0.006 mcg/mL) seen in normal subjects after intravaginal administration of terconazole vaginal cream 0.8%. This safety assessment does not account for possible exposure of the fetus through direct transfer to terconazole from the irritated vagina by diffusion across amniotic membranes.