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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

Validation Study of Multiple Probe Compounds for Drug Interaction Evaluation

First Posted Date
2009-08-24
Last Posted Date
2018-01-04
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
87
Registration Number
NCT00964106
Locations
🇰🇷

GSK Investigational Site, Seoul, Korea, Republic of

Study of Fluconazole in Children With Autism Spectrum Disorder

Not Applicable
Conditions
Autism Spectrum Disorder
Interventions
First Posted Date
2009-07-09
Last Posted Date
2009-07-09
Lead Sponsor
The Center for Autism and Related Disorders
Target Recruit Count
50
Registration Number
NCT00936182
Locations
🇺🇸

International Child Development Resource Center, Melbourne, Florida, United States

🇺🇸

Thoughtful House, Austin, Texas, United States

🇺🇸

Center for Autism and Related Disorders, Tarzana, California, United States

High-Dose Fluconazole for the Treatment of Cryptococcal Meningitis in HIV-Infected Individuals

Phase 1
Completed
Conditions
Cryptococcal Meningitis
HIV Infections
Interventions
First Posted Date
2009-04-22
Last Posted Date
2021-11-04
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
168
Registration Number
NCT00885703
Locations
🇺🇬

Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site, Kampala, Uganda

🇿🇦

Durban International Clinical Research Site CRS, Durban, KwaZulu-Natal, South Africa

🇺🇸

University of Southern California CRS, Los Angeles, California, United States

and more 7 locations

Drug-Drug Interaction (DDI) w/Ketoconazole or Fluconazole

First Posted Date
2009-03-12
Last Posted Date
2011-01-25
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
30
Registration Number
NCT00860275
Locations
🇺🇸

Ppd Development, Lp, Austin, Texas, United States

Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients

Phase 4
Completed
Conditions
Central Nervous System Fungal Infections
Mycoses
Fungemia
Lung Diseases, Fungal
Interventions
First Posted Date
2009-02-12
Last Posted Date
2014-12-17
Lead Sponsor
University of Pittsburgh
Target Recruit Count
200
Registration Number
NCT00841971
Locations
🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

🇺🇸

UCLA Medical Cente, Los Angeles, California, United States

🇺🇸

University of Washington Medical Center, Seattle, Washington, United States

and more 3 locations

Early Versus Delayed Antiretroviral Therapy (ART) in the Treatment of Cryptococcal Meningitis in Africa

Not Applicable
Completed
Conditions
HIV Infections
Cryptococcal Meningitis
Interventions
Drug: Fixed dose - Stavudine, lamivudine and Nevirapine
Drug: Fixed dose - Stavudine, Lamivudine, Nevirapine
First Posted Date
2009-01-28
Last Posted Date
2016-07-18
Lead Sponsor
University of Zimbabwe
Target Recruit Count
54
Registration Number
NCT00830856
Locations
🇿🇼

University of Zimbabwe, College of Health Sciences, Harare, Zimbabwe

Safety and Efficacy Study of Posaconazole vs. Fluconazole for Prevention of Invasive Fungal Infection (P05387 AM1)(COMPLETED)

Phase 3
Completed
Conditions
Leukopenia
Interventions
First Posted Date
2008-12-19
Last Posted Date
2017-04-07
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
252
Registration Number
NCT00811928

Pharmacokinetics (PK) Study of a Fluconazole Loading Dose in Infants and Toddlers

Phase 1
Completed
Conditions
Candidiasis
Interventions
First Posted Date
2008-11-25
Last Posted Date
2018-11-05
Lead Sponsor
Daniel Benjamin
Target Recruit Count
13
Registration Number
NCT00797420
Locations
🇺🇸

Duke Univeristy Medical Center, Durham, North Carolina, United States

Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis

Phase 3
Completed
Conditions
Candidemia
Interventions
First Posted Date
2008-09-29
Last Posted Date
2019-04-04
Lead Sponsor
Pfizer
Target Recruit Count
70
Registration Number
NCT00761267
Locations
🇧🇷

Hospital Pequeno Principe, Curitiba, PR, Brazil

🇰🇷

Asan Medical Center, Songpa-gu, Seoul, Korea, Republic of

🇺🇸

University of California - Los Angeles - Ronald Reagan UCLA Medical Center, Los Angeles, California, United States

and more 41 locations

Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams Birthweight

Phase 3
Completed
Conditions
Candidiasis
Interventions
Drug: placebo
First Posted Date
2008-08-14
Last Posted Date
2019-03-01
Lead Sponsor
Daniel Benjamin
Target Recruit Count
362
Registration Number
NCT00734539
Locations
🇺🇸

University of California-San Diego, San Diego, California, United States

🇺🇸

Riley Hospital, Indianapolis, Indiana, United States

🇺🇸

West Jersey Hospital - Voorhees, Voorhees, New Jersey, United States

and more 30 locations
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