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

A Study to Evaluate the Effect of a Dual CYP2C19 and CYP3A4 Inhibitor, Fluconazole, on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2021-01-11
Last Posted Date
2021-11-29
Lead Sponsor
Celgene
Target Recruit Count
29
Registration Number
NCT04702464
Locations
🇺🇸

PPD Phase 1 Clinic, Austin, Texas, United States

Fluconazol Versus Medical Honey in the Treatment of Recurrent Vulvovaginal Candidiasis

Phase 4
Not yet recruiting
Conditions
Candidiasis, Vulvovaginal
Recurrent Candidiasis of Vagina
Interventions
Other: L-Mesitran
First Posted Date
2020-11-12
Last Posted Date
2020-11-12
Lead Sponsor
Maastricht University Medical Center
Target Recruit Count
252
Registration Number
NCT04626258

Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Participants With B-Cell Malignancies

First Posted Date
2020-09-16
Last Posted Date
2024-10-26
Lead Sponsor
BeiGene
Target Recruit Count
26
Registration Number
NCT04551963
Locations
🇦🇺

Concord Repatriation General Hospital, Concord, New South Wales, Australia

🇦🇺

John Flynn Private Hospital, Tugun, Queensland, Australia

🇦🇺

Royal Adelaide Hospital, Adelaide, South Australia, Australia

and more 4 locations

Bioavailability of Flucanazole

Early Phase 1
Conditions
Candidiasis
Interventions
First Posted Date
2020-08-06
Last Posted Date
2020-08-06
Lead Sponsor
Sutphin Drugs
Target Recruit Count
200
Registration Number
NCT04502277
Locations
🇮🇳

Lifein Multi-Specialty Hospital, Navsari, Gujarat, India

🇺🇸

Sutphin Drugs, Jamaica, New York, United States

Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Fluconazole in Hypercalcicuric Patients With Increased 1.25(OH) 2D Levels

Phase 2
Completed
Conditions
Hypercalciuria
Nephrolithiasis
Nephrocalcinosis
Interventions
Drug: Placebo
First Posted Date
2020-08-03
Last Posted Date
2024-07-12
Lead Sponsor
Hospices Civils de Lyon
Target Recruit Count
56
Registration Number
NCT04495608
Locations
🇫🇷

Service de Néphrologie Rhumatologie Dermatologie Pédiatrique, Bron, France

🇫🇷

CHU de Nantes, Nantes, France

🇫🇷

Hôpital Universitaire Necker-Enfants Malades, Paris, France

and more 8 locations

A Study to Evaluate the Effect of Fluconazole, Bupropion, or Itraconazole on the Drug Levels and Safety of BMS-986235

Phase 1
Withdrawn
Conditions
Healthy Participants
Interventions
First Posted Date
2020-07-09
Last Posted Date
2022-03-25
Lead Sponsor
Bristol-Myers Squibb
Registration Number
NCT04464577
Locations
🇺🇸

Local Institution, Salt Lake City, Utah, United States

Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation

Phase 3
Recruiting
Conditions
Pneumocystis
Invasive Fungal Disease
Prophylaxis of Invasive Fungal Infections
Mycoses
Fungal Infection
Fungemia
Mold Infection
Aspergillus
Candidemia
Invasive Candidiasis
Interventions
Drug: Intravenous Placebo
Drug: Trimethoprim-sulfamethoxazole (TMP/SMX)
Drug: Oral Placebo
First Posted Date
2020-04-30
Last Posted Date
2025-02-03
Lead Sponsor
Mundipharma Research Limited
Target Recruit Count
600
Registration Number
NCT04368559
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

🇺🇸

University of Minnesota Physicians, Minneapolis, Minnesota, United States

🇺🇸

Mary Hitchcock Memorial Hospital Dartmouth-Hitchcock, Lebanon, New Hampshire, United States

and more 48 locations

Generation of Biological Samples Positive to Fluconazole for Anti-Doping Control

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2019-12-16
Last Posted Date
2019-12-16
Lead Sponsor
Parc de Salut Mar
Target Recruit Count
2
Registration Number
NCT04201054
Locations
🇪🇸

IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain

Effect of Fluconazole on PK of Fluzoparib in Healthy Male Subjects

Phase 1
Completed
Conditions
Advanced Cancer
Interventions
First Posted Date
2019-12-10
Last Posted Date
2019-12-10
Lead Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Target Recruit Count
20
Registration Number
NCT04193319
Locations
🇨🇳

Early Cancer Research Center of Hunan Cancer Hospital, Hunan, Hunan, China

Optimized Antibiotic Therapy in Patients With Subarachnoid Haemorrhage (ES) and Cerebral Haemorrhage (EC)

Conditions
Therapeutic Drug Monitoring
Subarachnoid Hemorrhage
Intracerebral Hemorrhage
First Posted Date
2019-10-18
Last Posted Date
2021-07-21
Lead Sponsor
Azienda Sanitaria-Universitaria Integrata di Udine
Target Recruit Count
104
Registration Number
NCT04132115
Locations
🇮🇹

Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD, Udine, Italy

🇮🇹

Terapia Intensiva 1, Udine, Italy

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