Overview
Miconazole is a broad-spectrum azole antifungal with some activity against Gram-positive bacteria as well. It is widely used to treat mucosal yeast infections, including both oral and vaginal infections; although intravenous miconazole is no longer available, a wide variety of suppositories, creams, gels, and tablet-based products are available. Miconazole is thought to act primarily through the inhibition of fungal CYP450 14α-lanosterol demethylase activity. Miconazole was first synthesized in 1969 and first granted FDA approval on January 8, 1974, for sale by INSIGHT Pharmaceuticals as a topical cream. It is currently available as a variety of prescription and over the counter products. Despite having been in clinical use for an extended period, resistance to miconazole among susceptible organisms is relatively low.
Background
Miconazole is a broad-spectrum azole antifungal with some activity against Gram-positive bacteria as well. It is widely used to treat mucosal yeast infections, including both oral and vaginal infections; although intravenous miconazole is no longer available, a wide variety of suppositories, creams, gels, and tablet-based products are available. Miconazole is thought to act primarily through the inhibition of fungal CYP450 14α-lanosterol demethylase activity. Miconazole was first synthesized in 1969 and first granted FDA approval on January 8, 1974, for sale by INSIGHT Pharmaceuticals as a topical cream. It is currently available as a variety of prescription and over the counter products. Despite having been in clinical use for an extended period, resistance to miconazole among susceptible organisms is relatively low.
Indication
Miconazole is indicated for the local treatment of oropharyngeal candidiasis in adult patients and for the adjunctive treatment of diaper dermatitis complicated by candidiasis in immunocompetent patients aged four weeks and older. Miconazole is available as both a suppository and cream for the treatment of vaginal yeast infections and the relief of associated vulvar itching and irritation. Lastly, miconazole cream is effective in treating athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm infections (tinea corporis), pityriasis (formerly tinea) versicolor, and cutaneous candidiasis.
Associated Conditions
- Acne Vulgaris
- Dermatophytosis
- Dermatophytosis of nail
- Diaper Dermatitis
- Excessive sweating and body odor
- Fungal skin infection
- Gastrointestinal candidiasis
- Infection, Mixed
- Infections, Fungal of the Skin Folds
- Nail candida
- Oropharyngeal Candidiasis
- Pityriasis versicolor
- Ringworm
- Seborrheic Dermatitis
- Skin candida
- Tinea Capitis
- Tinea Corporis
- Tinea Cruris
- Tinea Pedis
- Vaginal Candidiasis
- Cutaneous candidiasis
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2013/01/16 | Phase 4 | Completed | |||
2012/11/22 | Phase 1 | Completed | |||
2012/08/09 | Phase 4 | UNKNOWN | |||
2006/10/20 | Phase 3 | Completed | |||
2005/09/19 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Dechra Veterinary Products | 17033-175 | TOPICAL | 20 mg in 1 mL | 6/6/2025 | |
Sun Pharmaceutical Industries, Inc. | 51672-2035 | VAGINAL | 20 mg in 1 g | 5/27/2025 | |
VIVE HEALTH LLC | 84722-3060 | TOPICAL | 2 g in 100 g | 4/28/2025 | |
Physicians Total Care, Inc. | 54868-6246 | TOPICAL | 2.5 mg in 1 g | 4/20/2011 | |
Rida LLC | 83004-025 | TOPICAL | 2 g in 100 mL | 5/28/2025 | |
Mylan Pharmaceuticals Inc. | 0378-8222 | TOPICAL | 2.5 mg in 1 g | 8/14/2018 | |
Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-007 | TOPICAL | 0.1 g in 100 g | 5/28/2025 | |
Preferred Pharmaceuticals Inc. | 68788-8845 | TOPICAL | 2 g in 100 g | 3/24/2025 | |
Chain Drug Marketing Association | 83324-233 | TOPICAL | 20 mg in 1 g | 5/1/2025 |
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 |
---|---|---|---|---|---|
DAKTARIN ORAL GEL 2% | SIN01115P | GEL | 2% w/w | 5/12/1988 | |
NEO-PENOTRAN PESSARY | SIN11180P | SUPPOSITORY | 100 mg | 10/7/1999 | |
DAKTARIN CREAM 20 mg/g | SIN02028P | CREAM | 20 mg/g | 6/23/1988 | |
MICON-H CREAM | SIN06454P | CREAM | 2% w/w | 7/17/1991 | |
RESOLVE PLUS 1.0 | SIN11900P | CREAM | 2% w/w | 4/26/2002 | |
MINAZOL POWDER 2% w/w | SIN07023P | POWDER | 2% w/w | 6/3/1992 | |
ZARIN CREAM 2% | SIN00962P | CREAM | 2.00% w/w | 5/10/1988 | |
DAKTARIN POWDER 2% | SIN01114P | POWDER | 20 mg/g | 5/12/1988 | |
ZARICORT CREAM | SIN03840P | CREAM | 2% w/w | 2/10/1990 | |
DTC Anti-Fungal & White Spot Cream | SIN13771P | CREAM | 2% w/w | 3/2/2010 |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Miconazole Nitrate Vaginal Soft Capsules | 国药准字J20140135 | 生物制品 | 胶囊剂 | 9/5/2019 | |
Miconazole Nitrate Vaginal Soft Capsules | 国药准字HJ20160008 | 化学药品 | 胶囊剂 | 11/17/2020 | |
Miconazole Nitrate Vaginal Soft Capsules | H20140489 | 化学药品 | 胶囊剂 | 7/3/2019 | |
Miconazole Nitrate Vaginal Soft Capsules | 国药准字H20173400 | 化学药品 | 胶囊剂 | 9/20/2022 | |
Miconazole Nitrate Vaginal Soft Capsules | 国药准字H20058234 | 化学药品 | 软胶囊剂 | 5/12/2020 | |
Miconazole Nitrate Vaginal Soft Capsules | 国药准字HJ20160007 | 化学药品 | 胶囊剂 | 11/17/2020 | |
Miconazole Nitrate Vaginal Soft Capsules | H20140488 | 化学药品 | 胶囊剂 | 7/3/2019 | |
Miconazole Nitrate Vaginal Soft Capsules | 国药准字H20163009 | 化学药品 | 胶囊剂 | 1/6/2021 | |
Miconazole Nitrate Vaginal Soft Capsules | 国药准字H20173399 | 化学药品 | 胶囊剂 | 9/20/2022 | |
Miconazole Nitrate Cream | 国药准字H20074079 | 化学药品 | 乳膏剂 | 7/11/2022 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
MEYERSKIN CREAM | N/A | N/A | N/A | 4/30/2002 | |
MXM CREAM | N/A | N/A | N/A | 12/29/2004 | |
FUOCORTE-F CREAM | N/A | N/A | N/A | 1/30/2003 | |
KENDERM CREAM | N/A | N/A | N/A | 1/7/2005 | |
PHARMASERVE CREAM | N/A | N/A | N/A | 9/30/2008 | |
XATIM CREAM | N/A | N/A | N/A | 1/14/1997 | |
ROCO CREAM | N/A | N/A | N/A | 12/2/2004 | |
ELLAWON CREAM | N/A | N/A | N/A | 1/14/1997 | |
PINOCINE KENIL CREAM | N/A | N/A | N/A | 1/14/1997 | |
CHI-CREAM | N/A | N/A | N/A | 1/14/1997 |
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
RESOLVE PLUS 1.0 cream tube | 75601 | Medicine | A | 8/30/2000 | |
DAKTARIN CREAM FOR ATHLETE'S FOOT miconazole nitrate 20mg/g tube | 13284 | Medicine | A | 8/28/1991 | |
RESOLVE JOCK-ITCH miconazole nitrate 2% w/w CREAM TUBE | 90588 | Medicine | A | 8/19/2002 | |
MICONEO ORAL GEL miconazole 2% w/w oral gel tube | 384702 | Medicine | A | 2/25/2022 | |
DAKTARIN TINCTURE miconazole 20mg/mL bottle | 13289 | Medicine | A | 8/28/1991 |