Butoconazole

The Basics

What is Butoconazole?

Used to treat yeast infections of the vagina.

Brand names for Butoconazole

Femstat, Gynazole

How Butoconazole is classified

Anti-Infective Agents, Antifungal Agents, Dermatologic Agents

Butoconazole During Pregnancy

Butoconazole pregnancy category

Category CNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Butoconazole while pregnant

In pregnant rats administered 6 mg/kg/day of butoconazole nitrate intravaginally during the period of organogenesis, there was an increase in resorption rate and decrease in litter size; however, no teratogenicity was noted. This dose represents a 130- to 353-fold margin of safety based on serum levels achieved in rats following intravaginai administration compared to the serum levels achieved in humans following intravaginai administration of the recommended therapeutic dose of butoconazole nitrate. Butoconazole nitrate has no apparent adverse effect when administered orally to pregnant rats throughout organogenesis at dose levels up to 50 mg/kg/day (5 times the human dose based on mg/m²). Daily oral doses of 100,300 or 750 mg/kg/day (10,30 or 75 times the human dose based on mg/m² respectively) resulted in fetal malformations (abdominal wall defects, cleft palate), but maternal stress was also evident at these higher dose levels. There were, however, no adverse effects on litters of rabbits who received butoconazole nitrate orally, even at maternally stressful dose levels (e.g., 150 mg/kg, 24 times the human dose based on mg/m²). Butoconazole nitrate, like other azole antifungal agents, causes dystocia in rats when treatment is extended through parturition. However, this effect was not apparent in rabbits treated with as much as 100 mg/kg/day orally (16 times the human dose based on mg/m²). There are, however, no adequate and well-controlled studies in pregnant women. GYNAZOLE • 1 ® Butoconazole Nitrate Vaginal Cream USP, 2% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Taking Butoconazole While Breastfeeding

What are recommendations for lactation if you're taking Butoconazole?

Vaginal butoconazole has not been studied during breastfeeding. About 5.5% of a vaginal dose is absorbed and its plasma half-life is 21 to 24 hours. Because there is no published experience with butoconazole during breastfeeding, other agents may be preferred, especially while nursing a newborn or preterm infant.

Maternal / infant drug levels

Vaginal butoconazole has not been studied during breastfeeding. About 5.5% of a vaginal dose is absorbed and its plasma half-life is 21 to 24 hours. Because there is no published experience with butoconazole during breastfeeding, other agents may be preferred, especially while nursing a newborn or preterm infant.

Possible effects of Butoconazole on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Butoconazole

Clotrimazole, Miconazole.