Drug Class: Opportunistic Infections and Coinfections
What Is Fluconazole?
Fluconazole is an antifungal prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of esophageal candidiasis, oropharyngeal candidiasis, vaginal candidiasis, and cryptococcal meningitis. It is also approved to decrease the chance of candidiasis in people undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
Esophageal candidiasis (Infection of the esophagus), oropharyngeal candidiasis (infection of part of the throat), and vaginal candidiasis (infection of the vagina) are all examples of mucocutaneous candidiasis (also called mucosal candidiasis). Cryptococcal meningitis is an infection and inflammation of the tissues covering the brain and spinal cord. Mucocutaneous candidiasis and cryptococcal meningitis are opportunistic infections of HIV. An opportunistic infection is an infection that occurs more frequently or is more severe in people with weakened immune systems -- such as those infected with HIV -- than in people with healthy immune systems. To learn more about opportunistic infections, read the AIDS_info_ What is an Opportunistic Infection? fact sheet.
Fluconazole can also be used off-label to prevent and treat other opportunistic infections of HIV infection. Off-label use refers to use of an FDA-approved medicine in a manner different from that described on the medicine label. Good medical practice and the best interests of a patient sometimes require that a medicine be used off-label.
How Is Fluconazole Used in People With HIV?
The Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, prepared by the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the HIV Medicine Association of the Infectious Diseases Society of America (IDSA-HIVMA), includes recommendations on the HIV-related uses of fluconazole to:
- Coccidioidomycosis from occurring the first time (called primary prophylaxis) and from recurring. (This is an off-label use.)
- Cryptococcal meningitis from recurring.
- Histoplasmosis (also known as Histoplasma capsulatum infection) from recurring. (This is an off-label use.)
- Penicilliosis (also known as Penicillium marneffei infection) from occurring the first time. (This is an off-label use.)
- Mucocutaneous candidiasis, including esophageal candidiasis, oropharyngeal candidiasis, and vulvovaginal candidiasis, from recurring (called secondary prophylaxis or maintenance therapy). (This is an off-label use.)
- Coccidioidomycosis. (This is an off-label use.)
- Histoplasmosis. (This is an off-label use.)
- Mucocutaneous candidiasis, including esophageal candidiasis, oropharyngeal candidiasis, and vulvovaginal candidiasis.
The above list may not include all of the HIV-related uses of fluconazole recommended in the Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents. Some recommended uses, such as uses in certain rare circumstances, may have been omitted.
What Should I Tell My Health Care Provider Before Taking Fluconazole?
Before taking fluconazole, tell your health care provider:
- If you are allergic to fluconazole or any other medicines.
- About any medical conditions you have or have had, for example, diabetes or liver problems.
- About anything that could affect your ability to take medicines, such as difficulty swallowing pills, difficulty remembering to take pills, or any health conditions that may prevent your use of intravenous medicines.
- If you are pregnant or plan to become pregnant. Fluconazole may cause birth defects. A few cases of birth defects in children born to women who received high dose fluconazole during pregnancy have been reported. Talk to your health care provider about possible risks with taking fluconazole when pregnant.
- If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV.
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Fluconazole may affect the way other medicines or products work, and other medicines or products may affect how fluconazole works. Ask your health care provider if there are interactions between fluconazole and the other medicines you take.
Ask your health care provider about possible side effects from fluconazole. Your health care provider will tell you what to do if you have side effects.
How Should I Take Fluconazole?
Take fluconazole according to your health care provider's instructions. Your health care provider will tell you how much fluconazole to take and when to take it. Before you start fluconazole and each time you get a refill, read any printed information that comes with your medicine.
How Should Fluconazole Be Stored?
- Store fluconazole tablets below 86°F (30°C).
- Store fluconazole powder for oral suspension below 86°F (30°C).
- Store reconstituted fluconazole suspension between 41°F and 86°F (5°C to 30°C) and throw away the unused portion after 2 weeks. Protect from freezing.
- Store plastic containers of fluconazole for intravenous infusion between 41°F and 77°F (5°C to 25°C). Brief exposure up to 104°F (40°C) does not adversely affect the medicine. Protect from freezing and avoid excessive heat.
- Do not use fluconazole if the original seal over the container opening is broken or missing.
- Throw away fluconazole that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
- Keep fluconazole and all medicines out of reach of children.
Where Can I Find More Information About Fluconazole?
More information about fluconazole is available:
- Recommendations on the HIV-related uses of fluconazole, from the Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, prepared by CDC, NIH, and IDSA-HIVMA
- Fluconazole-related research studies, from the AIDS_info_ database of ClinicalTrials.gov study summaries