MedPath

Fluconazole

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

Overview

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.

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

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/04/10
Phase 4
Recruiting
2025/02/26
Phase 1
Completed
2025/02/12
Phase 1
Completed
Ahon Pharmaceutical Co., Ltd.
2025/01/13
Phase 4
Recruiting
2024/11/29
Phase 4
Recruiting
2024/04/03
Phase 1
Completed
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
2024/02/23
Phase 3
Recruiting
2023/12/15
Phase 1
Completed
2023/06/08
Not Applicable
Recruiting
2023/05/17
Phase 1
Completed
Combined Military Hospital Abbottabad

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Chartwell RX, LLC
62135-132
ORAL
150 mg in 1 1
10/11/2023
Glenmark Pharmaceuticals Inc., USA
68462-101
ORAL
50 mg in 1 1
3/28/2024
BluePoint Laboratories
68001-254
ORAL
200 mg in 1 1
10/31/2023
St. Mary's Medical Park Pharmacy
60760-803
ORAL
150 mg in 1 1
1/6/2023
Blenheim Pharmacal, Inc.
10544-855
ORAL
150 mg in 1 1
4/23/2015
AvPAK
50268-339
ORAL
200 mg in 1 1
1/9/2024
Preferred Pharmaceuticals Inc.
68788-8220
ORAL
200 mg in 1 1
6/8/2023
Rebel Distributors Corp
21695-193
ORAL
150 mg in 1 1
8/21/2009
Bryant Ranch Prepack
71335-2268
ORAL
150 mg in 1 1
11/30/2023
Unit Dose Services
50436-1139
ORAL
150 mg in 1 1
3/16/2018

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
FLUCONAZOLE B.BRAUN SOLUTION FOR INFUSION 2MG/ML
SIN14781P
INFUSION, SOLUTION
200mg/100ml
5/12/2015
MEDOFLUCON 50 CAPSULE 50 mg
SIN12600P
CAPSULE
50 mg
10/12/2004
Apo-Fluconazole 150mg Capsule
SIN13329P
CAPSULE
150 mg
8/3/2007
DIFLUCAN CAPSULE 100 mg
SIN06804P
CAPSULE
100 mg
1/31/1992
OMASTIN CAPSULE 50 MG
SIN13067P
CAPSULE
50 MG
3/18/2005
DIFLUCAN CAPSULE 150 mg
SIN04460P
CAPSULE
150 mg
4/17/1990
DIFLUCAN FOR INFUSION 2 mg/ml
SIN05770P
INJECTION
2 mg/ml
4/23/1991
FLUCONAZOLE KABI SOLUTION FOR INFUSION 2MG/ML
SIN15044P
INFUSION, SOLUTION
2mg/ml
7/4/2016
Diflazon Capsule 150mg
SIN13362P
CAPSULE
0.1500 g
10/11/2007
MEDOFLUCON 150 CAPSULE 150 mg
SIN12599P
CAPSULE
150 mg
10/12/2004

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Fluconazole Injection
国药准字H20031322
化学药品
注射剂
9/3/2020
Fluconazole Injection
国药准字H20040739
化学药品
注射剂
7/12/2021
Fluconazole Injection
国药准字H20020370
化学药品
注射剂
5/20/2020
Fluconazole Injection
国药准字H20030973
化学药品
注射剂
9/9/2020
Fluconazole Injection
国药准字H20040360
化学药品
注射剂
8/10/2020
Fluconazole Injection
国药准字H20040664
化学药品
注射剂
11/25/2020
Fluconazole Injection
国药准字H20023393
化学药品
注射剂
7/26/2024
Fluconazole Injection
国药准字H20020461
化学药品
注射剂
7/17/2020
Fluconazole Injection
国药准字H20040523
化学药品
注射剂
7/15/2020
Fluconazole Injection
国药准字H20020236
化学药品
注射剂
4/15/2021

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
FLUCONAL 150 TAB 150MG
N/A
N/A
N/A
9/10/2005
ZEMYC CAP 50MG
N/A
sunray company
N/A
N/A
3/16/2001
MEDOFLUCON CAP 150MG
N/A
N/A
N/A
3/25/2004
FLUCONAZOLE CAPSULES 150MG
N/A
N/A
N/A
3/6/2025
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