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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

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

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Title
Posted
Study ID
Phase
Status
Sponsor
2012/01/19
Phase 1
Completed
2012/01/19
Phase 1
Completed
2012/01/04
Phase 3
Completed
2011/10/06
Not Applicable
Completed
2011/05/16
Phase 1
Completed
2011/03/03
Phase 3
Completed
2010/07/26
Phase 1
Completed
Michael Cohen-Wolkowiez
2010/06/30
Phase 1
Completed
2010/03/31
Not Applicable
Completed
2010/01/28
Phase 3
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
MedVantx, Inc.
66116-510
ORAL
150 mg in 1 1
7/31/2012
REMEDYREPACK INC.
70518-4336
ORAL
150 mg in 1 1
5/1/2025
Drug Ocean LLC
70985-013
ORAL
50 mg in 1 1
11/30/2023
NorthStar Rx LLC
16714-696
ORAL
40 mg in 1 mL
1/22/2024
Golden State Medical Supply, Inc.
51407-300
ORAL
100 mg in 1 1
8/15/2023
PD-Rx Pharmaceuticals, Inc.
55289-824
ORAL
200 mg in 1 1
3/12/2024
Slate Run Pharmaceuticals
70436-227
ORAL
40 mg in 1 mL
1/24/2024
A-S Medication Solutions
50090-4425
ORAL
150 mg in 1 1
3/21/2022
Bryant Ranch Prepack
63629-9134
ORAL
100 mg in 1 1
3/25/2021
Roerig
0049-3450
ORAL
1400 mg in 35 mL
3/7/2024

EMA Drug Approvals

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

HSA Drug Approvals

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Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Fluconazole and Sodium Chloride Injection
国药准字H20033746
化学药品
注射剂
8/4/2020
Fluconazole and Sodium Chloride Injection
国药准字H10950033
化学药品
注射剂
11/2/2020
Fluconazole and Sodium Chloride Injection
国药准字H20033069
化学药品
注射剂
9/29/2020
Fluconazole and Sodium Chloride Injection
国药准字H20233575
化学药品
注射剂
5/19/2023
Fluconazole and Sodium Chloride Injection
国药准字H20223962
化学药品
注射剂
12/30/2022
Fluconazole and Sodium Chloride Injection
国药准字H20013092
化学药品
注射剂
2/12/2020
Fluconazole and Sodium Chloride Injection
国药准字H20057492
化学药品
注射剂
11/27/2023
Fluconazole and Sodium Chloride Injection
国药准字H20043442
化学药品
注射剂
7/30/2020
Fluconazole and Sodium Chloride Injection
国药准字H20023554
化学药品
注射剂
9/1/2020
Fluconazole and Sodium Chloride Injection
国药准字H20044185
化学药品
注射剂
4/14/2020

PPB Drug Approvals

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Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
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