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.
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 |
|---|---|---|---|---|---|
2013/08/16 | Phase 1 | Completed | |||
2013/07/03 | Phase 2 | Completed | Viamet | ||
2013/04/05 | Phase 3 | Completed | Anna Griffiths, MRC | ||
2013/03/07 | Phase 3 | Completed | |||
2013/01/21 | Phase 1 | Completed | |||
2012/10/29 | Phase 2 | UNKNOWN | |||
2012/09/12 | Phase 2 | Completed | |||
2012/09/07 | N/A | Completed | |||
2012/03/23 | Phase 2 | Terminated | |||
2012/02/17 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Redpharm Drug, Inc. | 67296-1498 | ORAL | 100 mg in 1 1 | 2/3/2023 | |
| REMEDYREPACK INC. | 70518-2087 | ORAL | 150 mg in 1 1 | 6/29/2021 | |
| PD-Rx Pharmaceuticals, Inc. | 43063-642 | ORAL | 150 mg in 1 1 | 6/29/2023 | |
| Aurobindo Pharma Limited | 65862-299 | ORAL | 10 mg in 1 mL | 3/21/2024 | |
| STAT Rx USA LLC | 16590-283 | ORAL | 200 mg in 1 1 | 9/5/2012 | |
| Aurobindo Pharma Limited | 65862-059 | ORAL | 100 mg in 1 1 | 3/15/2024 | |
| Roerig | 0049-3430 | ORAL | 200 mg in 1 1 | 3/7/2024 | |
| DIRECT RX | 61919-282 | ORAL | 150 mg in 1 1 | 6/25/2015 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-104 | ORAL | 200 mg in 1 1 | 3/28/2024 | |
| Rising Pharma Holdings, Inc. | 57237-006 | ORAL | 200 mg in 1 1 | 1/20/2024 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | 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H20044007 | 化学药品 | 注射剂 | 6/15/2020 | |
| Fluconazole and Sodium Chloride Injection | 国药准字H20066748 | 化学药品 | 注射剂 | 12/18/2020 | |
| Fluconazole and Sodium Chloride Injection | 国药准字H20043143 | 化学药品 | 注射剂 | 9/28/2020 | |
| Fluconazole and Sodium Chloride Injection | 国药准字H10960198 | 化学药品 | 注射剂 | 7/22/2020 | |
| Fluconazole and Sodium Chloride Injection | 国药准字H20043404 | 化学药品 | 注射剂 | 6/22/2020 | |
| Fluconazole and Sodium Chloride Injection | 国药准字H20023086 | 化学药品 | 注射剂 | 5/12/2020 | |
| Fluconazole and Sodium Chloride Injection | 国药准字H20033845 | 化学药品 | 注射剂 | 8/4/2020 | |
| Fluconazole and Sodium Chloride Injection | 国药准字H20045543 | 化学药品 | 注射剂 | 7/9/2021 | |
| 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 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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