Butoconazole

Vulvovaginal Candidiasis

Treatment of uncomplicated vulvovaginal candidiasis (mild to moderate, sporadic or infrequent, most likely caused by Candida albicans, occurring in immunocompetent women).1 4 6 7 24 29 30 31 48 51 A drug of choice.7 29 34 35 36 37 39 40 41 48 51

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.29 47

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).7 29 35 36 37 41 46 Complicated infections generally require more prolonged treatment than uncomplicated infections.29 49 50

Optimal regimens for treatment of vulvovaginal candidiasis caused by Candida other than C. albicans (e.g., C. glabrata, C. krusei) not identified.29 48 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).29 48 51

• Imidazole-derivative azole antifungal.1 2 3

• Usually fungistatic in action;3 8 16 22 can be fungicidal at high concentrations or against very susceptible organisms (e.g., Candida).1 3 8 16 22

• Presumably exerts its antifungal activity by altering cellular membranes,1 8 9 17 22 resulting in increased membrane permeability, secondary metabolic effects, and growth inhibition.1 9 17 22 Interferes with ergosterol synthesis probably via inhibition of C-14 demethylation of sterol intermediates (e.g., lanosterol).1 3 9 16 17

• Spectrum of antifungal activity includes many fungi, including yeasts and dermatophytes.2 15 17 23 Also has in vitro activity against some gram-positive bacteria.15 23

• Candida: Active in vitro and in vivo against C. albicans15 23 , C. glabrata,23 and C. tropicalis.23

• Dermatophytes and other fungi: Active in vitro against Trichophyton concentricum, T. mentagrophytes, T. rubrum, T. tonsurans, Epidermophyton floccosum, Microsporum canis, and M. gypseum.15 23 Also active in vitro against Aspergillus2 and Cryptococcus.23

• Cross-resistance can occur among the azole antifungals.2

• If you have an allergy to butoconazole or any other part of butoconazole.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad vaginal irritation.
• Very bad belly pain.
• Upset stomach or throwing up.

• Butoconazole Nitrate

Vulvovaginal candidiasis: Local treatment of vulvovaginal candidiasis due to Candida albicans

Intravaginal: Use applicator provided by manufacturer. Insertion should be as far as possible into the vagina without causing discomfort.

Progesterone: Antifungal Agents (Vaginal) may diminish the therapeutic effect of Progesterone. Avoid combination

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Summary of Use during Lactation

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.

Drug Levels

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

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

Effects in Breastfed Infants

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

Effects on Lactation and Breastmilk

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

Alternate Drugs to Consider

Clotrimazole, Miconazole

References

LactMed Record Number

543

Last Revision Date

20130907

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.