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

Comparing the Effectiveness of Fluconazole and a New Medicine (FK463) in Preventing Fungal Infections in Bone Marrow Transplant Patients

Phase 3
Completed
Conditions
Aspergillosis
Candidiasis
Fungemia
Mycoses
First Posted Date
2002-12-10
Last Posted Date
2008-03-04
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
800
Registration Number
NCT00001937
Locations
🇺🇸

National Cancer Institute (NCI), Bethesda, Maryland, United States

Fluconazole Prophylaxis of Thrush in AIDS

Phase 4
Completed
Conditions
Acquired Immunodeficiency Syndrome
Candidiasis
Oral Candidiasis
First Posted Date
2002-05-22
Last Posted Date
2008-03-04
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
80
Registration Number
NCT00001542
Locations
🇺🇸

National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, Maryland, United States

Blood and Marrow Transplant Clinical Research Network

Not Applicable
Completed
Conditions
Bone Marrow Transplantation
Hematopoietic Stem Cell Transplantation
Leukemia
Multiple Myeloma
Myelodysplastic Syndromes
Graft vs Host Disease
Blood Disease
First Posted Date
2001-09-07
Last Posted Date
2016-02-18
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Registration Number
NCT00023530
Locations
🇺🇸

City of Hope National Medical Center, Duarte, California, United States

🇺🇸

University of California at San Diego, La Jolla, California, United States

🇺🇸

Stanford University, Palo Alto, California, United States

and more 13 locations

Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)

Phase 3
Completed
Conditions
Candidiasis
Mycoses
HIV Infections
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
500
Registration Number
NCT00000676
Locations
🇺🇸

Northwestern University CRS, Chicago, Illinois, United States

🇺🇸

Rush Univ. Med. Ctr. ACTG CRS, Chicago, Illinois, United States

🇺🇸

Bmc Actg Crs, Boston, Massachusetts, United States

and more 23 locations

A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients With Recurrent Thrush

Phase 4
Completed
Conditions
Candidiasis, Oral
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2021-10-29
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
948
Registration Number
NCT00000951
Locations
🇺🇸

State of MD Div of Corrections / Johns Hopkins Univ Hosp, Baltimore, Maryland, United States

🇺🇸

Boston Med Ctr, Boston, Massachusetts, United States

🇺🇸

MetroHealth Med Ctr, Cleveland, Ohio, United States

and more 51 locations

A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women

Not Applicable
Completed
Conditions
Candidiasis
Candidiasis, Esophageal
HIV Infections
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
400
Registration Number
NCT00000744
Locations
🇺🇸

Community Consortium of San Francisco, San Francisco, California, United States

🇺🇸

AIDS Research Alliance - Chicago, Chicago, Illinois, United States

🇺🇸

Denver CPCRA / Denver Public Hlth, Denver, Colorado, United States

and more 13 locations

Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites

Phase 1
Completed
Conditions
Bacterial Infections
Mycoses
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2021-10-29
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
48
Registration Number
NCT00000826
Locations
🇺🇸

University of Washington AIDS CRS, Seattle, Washington, United States

🇺🇸

Ucsf Aids Crs, San Francisco, California, United States

An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of 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
NCT00002077
Locations
🇺🇸

Cook County Hosp, Chicago, Illinois, United States

🇺🇸

Saint Michael's Med Ctr, Newark, New Jersey, United States

🇺🇸

Cabrini Med Ctr, New York, New York, United States

and more 1 locations

A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients With AIDS

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
NCT00002294
Locations
🇺🇸

UCI Med Ctr, Orange, California, United States

🇺🇸

Dr Robert Larsen, Los Angeles, California, United States

🇺🇸

UCSD, San Diego, California, United States

and more 2 locations

A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis

Not Applicable
Completed
Conditions
Meningitis, Cryptococcal
HIV Infections
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
400
Registration Number
NCT00000639
Locations
🇺🇸

Ucsf Aids Crs, San Francisco, California, United States

🇺🇸

USC CRS, Los Angeles, California, United States

🇺🇸

Northwestern University CRS, Chicago, Illinois, United States

and more 21 locations
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