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 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
FLUCONAZOLE-BAXTER fluconazole 100mg/50mL solution for injection vial | 133463 | Medicine | A | 4/29/2008 | |
CIPLA FEMME FLUCONAZOLE 1 fluconazole 150mg capsule blister pack | 149125 | Medicine | A | 1/14/2008 | |
DIZOLE 200 fluconazole 200 mg capsule blister pack | 132789 | Medicine | A | 11/28/2006 | |
OZOLE fluconazole 150 mg capsule blister pack | 122904 | Medicine | A | 10/6/2006 | |
PHARMACY CARE FEMINA V CAPSULE fluconazole 150mg capsule blister pack | 229564 | Medicine | A | 10/20/2014 | |
PRICELINE PHARMACY FLUCONAZOLE ONE fluconazole 150 mg capsule blister pack (new formulation) | 408242 | Medicine | A | 4/28/2023 | |
MEDREICH FLUCONAZOLE 150 mg capsule blister pack | 160379 | Medicine | A | 3/24/2009 | |
FEMAZOLE DUO fluconazole 150mg capsule blister pack and clotrimazole 10mg/g cream tube composite pack | 174773 | Medicine | A | 8/12/2010 | |
DIFLUCAN fluconazole 200 mg capsule blister pack | 48397 | Medicine | A | 4/21/1994 | |
APOHEALTH FLUCONAZOLE ONE 150 mg capsule blister pack | 152959 | Medicine | A | 6/10/2008 |