Butoconazole
Class: Azoles
ATC Class: G01AF15
VA Class: GU300
Chemical Name: (±)-1-[4-(4-Chlorophenyl)-2-[2,6-dichlorophenyl) thio]butyl]-1H-imidazole mononitrate
Molecular Formula: C19H17Cl3N2S•HNO3
CAS Number: 64872-77-1
Brands: Gynazole-1, Mycelex-3
Introduction
Antifungal; azole (imidazole derivative).
Uses for Butoconazole
Vulvovaginal Candidiasis
Treatment of uncomplicated vulvovaginal candidiasis (mild to moderate, sporadic or infrequent, most likely caused by Candida albicans, occurring in immunocompetent women). A drug of choice.
Self-medication (OTC use) for treatment of uncomplicated vulvovaginal candidiasis in otherwise healthy, nonpregnant women who have been previously diagnosed by a clinician and are having recurrence of similar symptoms.
Treatment of complicated vulvovaginal candidiasis, including infections that are recurrent (≥4 episodes in 1 year), severe (extensive vulvar erythema, edema, excoriation, fissure formation), caused by Candida other than C. albicans, or occurring in women with underlying medical conditions (uncontrolled diabetes mellitus, HIV infection, immunosuppressive therapy, pregnancy). Complicated infections generally require more prolonged treatment than uncomplicated infections.
Optimal regimens for treatment of vulvovaginal candidiasis caused by Candida other than C. albicans (e.g., C. glabrata, C. krusei) not identified. CDC and others state these infections may respond to an intravaginal azole antifungal given for 7–14 days or to a 14-day regimen of intravaginal boric acid (not commercially available in the US).
Butoconazole Dosage and Administration
Administration
Intravaginal Topical Administration
Administer intravaginally as a cream using the prefilled applicator provided by the manufacturer.
Vaginal cream is for intravaginal administration only and should not be administered orally. Contact with the eyes should be avoided.
Dosage
Pediatric Patients
Uncomplicated Vulvovaginal Candidiasis
Intravaginal
Mycelex-3: Children ≥12 years of age: One applicatorful of 2% cream (approximately 100 mg of the drug) once daily at bedtime for 3 consecutive days. May be used for self-medication.
Adults
Uncomplicated Vulvovaginal Candidiasis
Intravaginal
Gynazole-1: One applicatorful of 2% cream (approximately 100 mg of the drug) as a single dose.
Mycelex-3: One applicatorful of 2% cream (approximately 100 mg of the drug) once daily at bedtime for 3 consecutive days. May be used for self-medication.
If clinical symptoms persist, tests should be repeated to rule out other pathogens, to confirm the original diagnosis, and to rule out other conditions that may predispose a patient to recurrent vaginal fungal infections.
