MedPath

Fluconazole

Generic Name
Fluconazole
Brand Names
Diflucan
Drug Type
Small Molecule
Chemical Formula
C13H12F2N6O
CAS Number
86386-73-4
Unique Ingredient Identifier
8VZV102JFY
Background

Fluconazole, commonly known as Diflucan, is an antifungal drug used for the treatment of both systemic and superficial fungal infections in a variety of tissues. It was initially approved by the FDA in 1990. This drug is an azole antifungal, in the same drug family as ketoconazole and itraconazole. Fluconazole has many advantages over the other antifungal drugs including the option of oral administration. The side effect profile of this drug is minimal. It has been demonstrated as an efficacious treatment for vaginal yeast infections in one single dose.

Indication

Fluconazole can be administered in the treatment of the following fungal infections:

1) Vaginal yeast infections caused by Candida

2) Systemic Candida infections

3) Both esophageal and oropharyngeal candidiasis

4) Cryptococcal meningitis

5) UTI (urinary tract infection) by Candida

6) Peritonitis (inflammation of the peritoneum) caused by Candida

A note on fungal infection prophylaxis

Patients receiving bone marrow transplantation who are treated with cytotoxic chemotherapy and/or radiation therapy may be predisposed to candida infections, and may receive fluconazole as prophylactic therapy.

A note on laboratory testing

Obtaining specimens for fungal culture and other important laboratory studies such as serology or pathology is advised before starting fluconazole therapy in order to isolate the organisms to be eliminated through treatment. It is permissible to start therapy before the results are available, however, adjusting the therapy once laboratory results confirm the causative organism may be necessary.

Associated Conditions
Candida intertrigo, Candida pneumonia, Candida urinary tract infection, Candidemia, Candidiasis, Coccidioidomycosis, Esophageal Candidiasis, Fungal Infections, Fungal peritonitis caused by Candida, Meningitis, Cryptococcal, Oropharyngeal Candidiasis, Peritoneal candidiasis, Pneumonia cryptococcal, Pruritus, Skin Irritation, Systemic Candida Infections caused by Candida, Vaginal Candidiasis, Disseminated Candidiasis

Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome

Not Applicable
Completed
Conditions
HIV Infections
Histoplasmosis
First Posted Date
2001-08-31
Last Posted Date
2021-11-02
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
90
Registration Number
NCT00000627
Locations
🇺🇸

Methodist Hosp of Indiana / Life Care Clinic, Indianapolis, Indiana, United States

🇺🇸

San Francisco Veterans Administration Med Ctr, San Francisco, California, United States

🇺🇸

Montefiore Med Ctr / Bronx Municipal Hosp, Bronx, New York, United States

and more 20 locations

A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone

Phase 1
Completed
Conditions
HIV Infections
Candidiasis
First Posted Date
2001-08-31
Last Posted Date
2021-11-03
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
24
Registration Number
NCT00000788
Locations
🇺🇸

Addiction Research and Treatment Corp, Brooklyn, New York, United States

Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients With AIDS

Phase 3
Completed
Conditions
Meningitis, Cryptococcal
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2011-03-14
Lead Sponsor
Pfizer
Target Recruit Count
330
Registration Number
NCT00001017
Locations
🇺🇸

Beth Israel Deaconess - West Campus, Boston, Massachusetts, United States

🇺🇸

SUNY - Stony Brook, Stony Brook, New York, United States

🇺🇸

Duke Univ Med Ctr, Durham, North Carolina, United States

and more 25 locations

Multi-center Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis

Not Applicable
Completed
Conditions
Meningitis, Cryptococcal
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2011-03-14
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
120
Registration Number
NCT00000708
Locations
🇺🇸

Univ of Miami School of Medicine, Miami, Florida, United States

🇺🇸

Julio Arroyo, West Columbia, South Carolina, United States

🇺🇸

Tulane Univ School of Medicine, New Orleans, Louisiana, United States

and more 3 locations

Comparison of Two Treatments to Prevent Invasive Fungal Infections in Patients Who Have Received Liver Transplants

Phase 4
Completed
Conditions
Candidiasis
First Posted Date
2001-08-31
Last Posted Date
2010-08-27
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
500
Registration Number
NCT00001107
Locations
🇺🇸

Mary Ellen Bradley, Birmingham, Alabama, United States

A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems

Phase 3
Completed
Conditions
Candidiasis, Esophageal
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Pfizer
Target Recruit Count
100
Registration Number
NCT00002339
Locations
🇺🇸

Houston Veterans Administration Med Ctr, Houston, Texas, United States

🇺🇸

Los Angeles County - USC Med Ctr, Los Angeles, California, United States

A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.

Not Applicable
Completed
Conditions
Meningitis, Cryptococcal
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Pfizer
Target Recruit Count
64
Registration Number
NCT00002113
Locations
🇺🇸

UCSD Med Ctr - Owen Clinic, San Diego, California, United States

🇺🇸

Los Angeles County - USC Med Ctr, Los Angeles, California, United States

🇺🇸

UCI Med Ctr, Orange, California, United States

A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success With Amphotericin B

Not Applicable
Completed
Conditions
Meningitis, Cryptococcal
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Pfizer
Registration Number
NCT00002306
Locations
🇺🇸

Med College of Georgia, Augusta, Georgia, United States

🇺🇸

Washington Univ School of Medicine, St. Louis, Missouri, United States

🇺🇸

Univ of South Florida, Tampa, Florida, United States

and more 11 locations

A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems

Not Applicable
Completed
Conditions
Candidiasis, Esophageal
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Pfizer
Registration Number
NCT00002304
Locations
🇺🇸

Eisenhower Med Ctr, Rancho Mirage, California, United States

🇺🇸

Univ Hosp, Boston, Massachusetts, United States

🇺🇸

Buckley Braffman Stern Med Associates, Philadelphia, Pennsylvania, United States

and more 39 locations

Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis

Not Applicable
Completed
Conditions
Meningitis, Cryptococcal
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Pfizer
Registration Number
NCT00002075
Locations
🇺🇸

Dr Robert Larsen, Los Angeles, California, United States

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