Drug Database: Butoconazole Nitrate

What is butoconazole nitrate?

Butoconazole nitrate is an antifungal prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of vulvovaginal candidiasis, which is an infection of the female vulva and vagina. Vulvovaginal candidiasis is a type of mucocutaneous candidiasis.

Vulvovaginal candidiasis can be an opportunistic infection (OI) of HIV. An OI is an infection that occurs more frequently or is more severe in people with weakened immune systems—such as people with HIV—than in people with healthy immune systems. To learn more about OIs, read the HIVinfo What is an Opportunistic Infection? fact sheet.

How is butoconazole nitrate used in people with HIV?

The Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV include recommendations on the use of butoconazole nitrate to treat uncomplicated vulvovaginal candidiasis. The recommended uses may not always be consistent with FDA-approved uses of butoconazole nitrate. See the guidelines for complete information on recommended uses of butoconazole nitrate in adults and adolescents with HIV. Butoconazole nitrate may have other recommended uses not listed above.

What should I tell my health care provider before using butoconazole nitrate?

Before using butoconazole nitrate, tell your health care provider:

• If you are allergic to butoconazole nitrate or any other medicines.
• About any medical conditions you have or have had.
• About anything that could affect your ability to use butoconazole nitrate, such as difficulty with applying a cream to the affected area or trouble with remembering a scheduled dose.
• If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of using butoconazole nitrate during pregnancy. The Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV may include other recommendations on the use of butoconazole nitrate during pregnancy. Please refer to these guidelines for additional information.
• If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Butoconazole nitrate may affect the way other medicines or products work, and other medicines or products may affect how butoconazole nitrate works. Ask your health care provider if there are interactions between butoconazole nitrate and the other medicines you take.

Ask your health care provider about possible side effects from butoconazole nitrate. Your health care provider will tell you what to do if you have side effects.

How should I use butoconazole nitrate?

Use butoconazole nitrate according to your health care provider’s instructions. Your health care provider will tell you how much butoconazole nitrate to use and when to use it. Before you start using butoconazole nitrate and each time you get a refill, read any printed information that comes with your medicine.

How should butoconazole nitrate be stored?

• Store butoconazole nitrate cream at 77°F (25°C). Avoid heat above 86°F (30°C).
• Keep butoconazole nitrate in the container that it came in and keep the container tightly closed.
• Do not use butoconazole nitrate if the original seal over the applicator opening is broken or missing.
• Throw away butoconazole nitrate that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
• Keep butoconazole nitrate and all medicines out of reach of children.

Where can I find more information about butoconazole nitrate?

• Recommendations on the HIV-related use of butoconazole nitrate, from the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV.
• This Patient Version drug summary is based on the following FDA label(s): Cream. The Patient Package Insert includes information for people using butoconazole nitrate.
• The American Hospital Formulary Service (AHFS) Patient Medication Information for butoconazole vaginal cream available from MedlinePlus.
• Butoconazole nitrate-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests. To learn more about the ClinicalTrials.gov search features, please see How to Search.)