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.

Complicated Vulvovaginal Candidiasis

Vulvovaginal Candidiasis in HIV-infected Women

Use same intravaginal regimen recommended for women without HIV infection; however some experts recommend a duration of 3–7 days. Maintenance regimen of an intravaginal azole can be considered for those with recurrent episodes; routine primary or secondary prophylaxis (long-term suppressive or chronic maintenance therapy) not recommended.

Recurrent Vulvovaginal Infections Caused by Candida albicans

CDC and others recommend an initial intensive regimen (7–14 days of an intravaginal azole or 3-dose regimen of oral fluconazole) to achieve mycologic remission, followed by an appropriate maintenance regimen (6-month regimen of once-weekly oral fluconazole or, alternatively, an intravaginal azole given intermittently).

Other Complicated Vulvovaginal Infections

CDC and others recommend 7–14 days of an intravaginal azole for vulvovaginal candidasis that is severe, caused by Candida other than C. albicans, or occurring in women with underlying medical conditions.

Contraindications

• Known hypersensitivity to butoconazole or any ingredient in the formulation.

Warnings/Precautions

Warnings

Use of Latex or Rubber Products

Butoconazole vaginal cream contains mineral oil that can weaken latex or rubber products (including condoms and vaginal contraceptive diaphragms). Use of such products within 72 hours following intravaginal butoconazole treatment not recommended.

General Precautions

Selection and Use of Antifungals for Vulvovaginal Candidiasis

Prior to initial use of butoconazole in a woman with signs and symptoms of vulvovaginal candidiasis, confirm the diagnosis by demonstrating yeast or pseudohyphae with direct microscopic examination of vaginal discharge (saline or 10% potassium hydroxide [KOH] wet mount or Gram stain) or by culture.

Candida identified by culture in the absence of symptoms is not an indication for antifungal treatment since approximately 10–20% of women harbor Candida or other yeasts in the vagina.

If clinical symptoms persist after treatment or recur within 2 months, 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 (e.g., pregnancy, HIV infection).

Do not use for self-medication in women who have never had a vaginal yeast infection diagnosed by a clinician, in women who are or think they may be pregnant, or in women with diabetes, HIV infection, or HIV exposure.

Specific Populations

Pregnancy

Category C.

CDC states that a 7-day regimen of an intravaginal azole antifungal can be used, if necessary, for treatment of vulvovaginal candidiasis in pregnant women.

Lactation

Not known whether intravaginal butoconazole is distributed into milk; use with caution in nursing women.

Pediatric Use

Gynazole-1: Safety and efficacy not established in children.

Mycelex-3: Safety and efficacy not established in children <12 years of age.

Common Adverse Effects

Vulvar/vaginal burning, itching, soreness and swelling, pelvic or abdominal pain or cramping.

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.

Complicated Vulvovaginal Candidiasis

Vulvovaginal Candidiasis in HIV-infected Women

Use same intravaginal regimen recommended for women without HIV infection; however some experts recommend a duration of 3–7 days. Maintenance regimen of an intravaginal azole can be considered for those with recurrent episodes; routine primary or secondary prophylaxis (long-term suppressive or chronic maintenance therapy) not recommended.

Recurrent Vulvovaginal Infections Caused by Candida albicans

CDC and others recommend an initial intensive regimen (7–14 days of an intravaginal azole or 3-dose regimen of oral fluconazole) to achieve mycologic remission, followed by an appropriate maintenance regimen (6-month regimen of once-weekly oral fluconazole or, alternatively, an intravaginal azole given intermittently).

Other Complicated Vulvovaginal Infections

CDC and others recommend 7–14 days of an intravaginal azole for vulvovaginal candidasis that is severe, caused by Candida other than C. albicans, or occurring in women with underlying medical conditions.