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Butoconazole

    Brands

    DEA Class; Rx, OTC

    Common Brand Names; Femstat 3, Gynazole 1

    • Antifungals, Vaginal

    Imidazole antifungal agent that is fungicidal in vitro against Candida spp.; available as a vaginal preparation; multiple dose products available OTC; single dose product available by prescription only.

    Indicated for the treatment of vulvovaginal candidiasis (VVC).

    Hypersensitivity to drug

    1st trimester of pregnancy

    Pelvic/abdominal pain or cramping

    Vulvar/vaginal irritation, soreness, and swelling

    Hypersensitivity to other azoles

    Contains mineral oil, which may weaken latex or rubber products

    Consider HIV infection in sexually active women with difficult to eradicate recurrent yeast infection

    Pregnancy Category: C

    Lactation: not known if excreted in breast milk; use caution

    Adults

    1 applicatorful (100 mg butoconazole/5 g cream) intravaginally/day.

    Geriatric

    1 applicatorful (100 mg butoconazole/5 g cream) intravaginally/day.

    Adolescents

    Safety and efficacy have not been established; however, 1 applicatorful (100 mg butoconazole/5 g cream) intravaginally/day has been used off-label.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Butoconazole nitrate

    vaginal cream

    • 2%