API: Fluconazole

What Is Fluconazole and How Does It Work?

Fluconazole belongs to a class of antifungals called triazoles, and can be administered orally or intravenously to treat “yeast” infections of the vagina as well as other fungal infections of the blood, mouth, throat, abdomen, lungs, esophagus, and other organs. The drug essentially works by slowing the growth of the fungus causing the infection and may also be used as a preventive in immunocompromised patients. Additionally, fluconazole can be used to treat meningitis in the brain and spine.

For more information, including a MSDS sheet, please see PNA’s Fluconazole page.


Approved Indications1

Candidases: Fluconazole can be used to treat fungal infections in adults and children caused by Candida and Cryptococcus. Treatable candidasis include vaginal and peritoneal infections, oropharyngeal infection, and esophageal infection. Prevention of candidiasis in bone marrow transplants is also indicated.

Cryptococcal Infections: Fluconazole can also be used to treat cryptococcal meningitis on both adults and children, as well as to suppress cryptococcal meningitis in the case of AIDS relapse.


Side Effects and Drug Interactions

Fluconazole can cause a number of side effects, including2:

  • Headaches
  • Dizziness
  • Stomach pain
  • Heartburn
  • Diarrhea
  • A change in the ability to taste food and drink
  • Flu-like symptoms

Patients who suffer from severity of these common side effects should contact their pharmacist or physician right away. Patients who experience nausea and vomiting, extreme fatigue, unusual bruising or bleeding, loss of appetite, pain in the upper right part of the stomach, jaundice, dark urine or pale stools, seizures, rash, itching, or hives, blistering or peeling skin, or swelling of the face and joints should inform their physician immediately.

Patients who are allergic or sensitive to fluconazole (or any of its excipients) should not take this medication.3 Co-administration of other drugs known to prolong the QT interval in the heart cycle, and those that are metabolized via the enzyme CYP3A4 (such as cisapride, astemizole, erythromycin, pimozide, and quinidine) are contraindicated with fluconazole.

There is currently no information with respect to cross-sensitivity between this drug and other azole agents so caution should be used with the co-administration of azoles. Co-administration of terfenadine should also be treated with caution, especially in the case of multiple doses of 400 mg or higher. The effects of fluconazole in pregnant or breastfeeding women are not well understood.


Latest News and Research

Fluconazole was developed in the late 1980s and is currently on the World Health Organization’s (WHO) List of Essential Medicines.4 This list, which is updated every two years, includes drugs that the WHO defines to “satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in appropriate dosage forms, at a price the community can afford.”

The development of fluconazole was a significant success in the pharmaceutical industry because it marked the first antifungal drug that could be both administered locally for minor infections against Candida species, and intravenously for a more serious systemic infection against cryptococcal meningitis.5 Fluconazole has long been a front line antifungal drug because of its safety profile and ability to defeat most Candida species6, although more recently, some resistance has been observed.7 Among other azoles, and even other antifungal agents, however, fluconazole remains the preferred treatment and is the recommended in the 2016 Clinical Practice Guideline for the Management of Candidiasis issued by the Infectious Diseases Society of America.

Targeted studies of prophylactic fluconazole against fungal infections in low weight preterm neonates also shows a lot of promise.8


Buying Guide

PNA is a recommended bulk supplier of Fluconazole and other APIs. You can learn more about Fluconazole here.

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Resources

Show 8 footnotes

  1. “Diflucan (fluconazole) – Drug Summary,” 2015, http://www.pdr.net/drug-summary/Diflucan-fluconazole-1847
  2. “Fluconazole, November 20, 2015, https://www.nlm.nih.gov/medlineplus/druginfo/meds/a690002.html
  3. “Diflucan,” 2015, http://www.rxlist.com/diflucan-drug/overdosage-contraindications.htm
  4. “WHO Model Lists of Essential Medicines,” August 2015, http://www.who.int/medicines/publications/essentialmedicines/en/
  5. “Origin of drugs in current use: the diflucan story,” http://www.davidmoore.org.uk/Sec04_02.htm
  6. “Antifungal Agents: Mode of Action, Mechanisms of Resistance, and Correlation of These Mechanisms with Bacterial Resistance,” October 1999, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC88922/
  7. “Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America,” November 2, 2015, http://cid.oxfordjournals.org/content/early/2015/12/15/cid.civ933.full
  8. “ADMINISTRATION OF FLUCONAZOLE AS PROPHYLACTIC SYSTEMIC ANTIFUNGAL IN VERY LOW BIRTH WEIGHT PRETERM NEONATES,” July 2012, http://web.b.ebscohost.com/abstract?direct=true&profile=ehost&scope=site&authtype=crawler&jrnl=20754124&AN=80212900&h=OWCaGl5yLsx9YPWYyZDB7qUsc8Xiv%2b50%2fPKYBzVCBiHex8bjBbD%2fmq8gaqq9nuL1rZvHKT5Fo4I6Xa%2fmG%2bw1JA%3d%3d&crl=c&resultNs=AdminWebAuth&resultLocal=ErrCrlNotAuth&crlhashurl=login.aspx%3fdirect%3dtrue%26profile%3dehost%26scope%3dsite%26authtype%3dcrawler%26jrnl%3d20754124%26AN%3d80212900