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

Bioavailability Study of Fluconazole Tablets 200 mg Under Fed Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2012-01-19
Last Posted Date
2012-01-19
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
15
Registration Number
NCT01511757
Locations
🇨🇦

MDS Pharma Services, Cohen street, saint-laurent, montreal (quebec), Canada

Bioavailability Study of Fluconazole Tablets 200 mg Under Fasting Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2012-01-19
Last Posted Date
2012-01-19
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
17
Registration Number
NCT01511770
Locations
🇨🇦

MDS Pharma Services, Cohen street, saint-laurent, montreal (quebec), Canada

Caspofungin Acetate, Fluconazole, or Voriconazole in Preventing Fungal Infections in Patients Following Donor Stem Cell Transplant

Phase 3
Completed
Conditions
Fungal Infection
Hematopoietic and Lymphoid Cell Neoplasm
Interventions
First Posted Date
2012-01-04
Last Posted Date
2024-10-16
Lead Sponsor
Children's Oncology Group
Target Recruit Count
292
Registration Number
NCT01503515
Locations
🇺🇸

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States

🇺🇸

UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States

🇨🇦

Hospital for Sick Children, Toronto, Ontario, Canada

and more 46 locations

Pharmacogenetics of Warfarin Induction and Inhibition

Not Applicable
Completed
Conditions
Healthy
Interventions
First Posted Date
2011-10-06
Last Posted Date
2018-11-14
Lead Sponsor
University of Minnesota
Target Recruit Count
39
Registration Number
NCT01447511
Locations
🇺🇸

Clinical and Translational Science Institute, Minneapolis, Minnesota, United States

Study of Paroxetine and Fluconazole for the Treatment of HIV Associated Neurocognitive Disorder

Phase 1
Completed
Conditions
HIV Associated Neurocognitive Disorder
Interventions
First Posted Date
2011-05-16
Last Posted Date
2017-06-09
Lead Sponsor
Johns Hopkins University
Target Recruit Count
45
Registration Number
NCT01354314
Locations
🇺🇸

The Johns Hopkins Institute for Clinical and Translational Research, Adult Outpatient Clinical Research Unit, Baltimore, Maryland, United States

Caspofungin Versus Fluconazole in Preventing Invasive Fungal Infections (IFI) in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia

Phase 3
Completed
Conditions
Acute Myeloid Leukemia
Adult Acute Monoblastic Leukemia
Adult Acute Monocytic Leukemia
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With Maturation
Adult Acute Myeloid Leukemia With Minimal Differentiation
Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1
Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A
Interventions
Other: Laboratory Biomarker Analysis
First Posted Date
2011-03-03
Last Posted Date
2021-03-30
Lead Sponsor
Children's Oncology Group
Target Recruit Count
517
Registration Number
NCT01307579
Locations
🇺🇸

Valley Children's Hospital, Madera, California, United States

🇺🇸

Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States

🇺🇸

Children's Hospital Los Angeles, Los Angeles, California, United States

and more 176 locations

Pharmacokinetics/Pharmacodynamics (PK/PD) of Fluconazole in Children on Extracorporeal Membrane Oxygenation (ECMO)

Phase 1
Completed
Conditions
Cardiopulmonary Arrest
Fungal Infection
Interventions
First Posted Date
2010-07-26
Last Posted Date
2017-11-22
Lead Sponsor
Michael Cohen-Wolkowiez
Target Recruit Count
21
Registration Number
NCT01169402
Locations
🇺🇸

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

Relative Bioavailability of Olodaterol and Fluconazole

Phase 1
Completed
Conditions
Healthy
Pulmonary Disease, Chronic Obstructive
Interventions
First Posted Date
2010-06-30
Last Posted Date
2014-06-10
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
35
Registration Number
NCT01153724
Locations
🇩🇪

1222.48.1 Boehringer Ingelheim Investigational Site, Berlin, Germany

Effects of Urocortins on Forearm Arterial Blood Flow in Healthy Volunteers (Protocol 3)

Not Applicable
Completed
Conditions
Vascular Disease
Heart Disease
Interventions
First Posted Date
2010-03-31
Last Posted Date
2012-05-15
Lead Sponsor
University of Edinburgh
Target Recruit Count
10
Registration Number
NCT01096706
Locations
🇬🇧

Wellcome Trust Clinical Research Facility, Royal Infirmary of Edinburgh, Edinburgh, Mid Lothian, United Kingdom

Liver Transplant European Study Into the Prevention of Fungal Infection

Phase 3
Completed
Conditions
Liver Transplantation
Mycoses
Interventions
First Posted Date
2010-01-28
Last Posted Date
2024-11-18
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
350
Registration Number
NCT01058174
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