Overview
This drug is a broad spectrum antimycotic or antifungal agent. Clotrimazole's antimycotic properties were discovered in the late 1960s . Clotrimazole falls under the imidazole category of azole antifungals, possessing broad-spectrum antimycotic activity . It is available in various preparations, including creams, pessaries, and troche formulations (slowly dissolving tablets). As well as its antifungal activity, clotrimazole has become a drug of interest in treating several other diseases such as sickle cell disease, malaria and some cancers . The minimal side effect profile of this drug and its uncomplicated metabolic profile have led it to gain widespread acceptance for the treatment of mycotic outbreaks such as vaginal yeast infections as well as athlete's foot .
Indication
Topical preparations Clotrimazole topical cream is indicated for the topical treatment of the following dermal infections , : Tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum Candidiasis due to Candida albicans Tinea versicolor due to Malassezia furfur Diaper rash infected by Candida albicans In some preparations, clotrimazole may be combined with betamethasone dipropionate, a corticosteroid . Oral preparations The oral troche preparation is indicated for the local treatment of oropharyngeal candidiasis . It is also indicated as a prophylactic drug to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions such as chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation . Troche preparations are not indicated for the treatment of any systemic mycoses .
Associated Conditions
- Balanitis candida
- Candidiasis
- Dermatitis
- Erythrasma
- Fungal Vaginal Infections
- Fungal ear infection
- Fungal skin infection
- Genital candidiasis
- Inflammation
- Mixed Vaginal Infections
- Oropharyngeal Candidiasis
- Pityriasis versicolor
- Pyoderma
- Ringworm
- Skin Infections
- Skin candida
- Tinea Corporis
- Tinea Cruris
- Tinea Pedis
- Tinea inguinalis
- Trichophytosis
- Vaginal Candidiasis
- Vaginal Mycosis
- Vulvitis
- Cutaneous candidiasis
- Infection mycotic
- Susceptible Bacterial Infections
- Symptomatic Tinea Corporis caused by Trichophyton mentagrophytes, Trichophyton rubrum, Epidermophyton floccosum
- Symptomatic Tinea Cruris caused by Trichophyton mentagrophytes, Trichophyton rubrum, Epidermophyton floccosum
- Symptomatic Tinea Pedis caused by Trichophyton mentagrophytes, Trichophyton rubrum, Epidermophyton floccosum
- Tinea versicolor caused by Malassezia infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/04/01 | Phase 1 | Completed | Rawalpindi Medical College | ||
2021/04/01 | Not Applicable | UNKNOWN | |||
2021/01/07 | Phase 4 | Completed | Peking University Shenzhen Hospital | ||
2020/03/03 | Not Applicable | UNKNOWN | Second Affiliated Hospital of Wenzhou Medical University | ||
2018/08/15 | Phase 2 | UNKNOWN | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | ||
2018/07/26 | N/A | Completed | |||
2017/04/14 | Phase 2 | Completed | |||
2017/01/18 | Phase 1 | UNKNOWN | |||
2016/12/29 | Phase 2 | Completed | |||
2016/09/20 | Phase 3 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Taro Pharmaceuticals U.S.A., Inc. | 51672-1275 | TOPICAL | 10 mg in 1 g | 1/24/2020 | |
| Rite Aid Corporation | 11822-0351 | TOPICAL | 10 mg in 1 g | 8/12/2025 | |
| Rebel Distributors Corp | 21695-333 | TOPICAL | 10 mg in 1 g | 12/18/2008 | |
| Rite Aid Corporation | 11822-0350 | TOPICAL | 10 mg in 1 g | 3/31/2025 | |
| VIVE HEALTH LLC | 84722-3059 | TOPICAL | 1 g in 100 g | 4/28/2025 | |
| Cardinal Health (Leader) 70000 | 70000-0729 | VAGINAL | 10 mg in 1 g | 4/29/2025 | |
| Proficient Rx LP | 71205-524 | TOPICAL | 10 mg in 1 g | 1/1/2021 | |
| NuCare Pharmaceuticals,Inc. | 68071-2433 | TOPICAL | 10 mg in 1 g | 6/2/2021 | |
| RPK Pharmaceuticals, Inc. | 53002-9741 | TOPICAL | 10 mg in 1 g | 2/17/2020 | |
| Lake Erie Medical DBA Quality Care Products LLC | 55700-524 | TOPICAL | 10 mg in 1 g | 6/6/2017 |
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 |
|---|---|---|---|---|---|
| Creobic Cream | SIN10956P | CREAM | 10mg/g | 6/1/1999 | |
| COTREN VAGINAL TABLETS 500 mg | SIN00175P | TABLET | 500 mg | 3/25/1988 | |
| MYCORIL SPRAY 1% | SIN06447P | SPRAY | 1% | 7/15/1991 | |
| CANDID EAR DROPS 1% | SIN04573P | SOLUTION | 1% | 6/2/1990 | |
| CANDID-V3 VAGINAL TABLET 200 mg | SIN03396P | TABLET | 200 mg | 6/16/1989 | |
| CANDID DUSTING POWDER 1% w/w | SIN04582P | POWDER | 1% w/w | 6/4/1990 | |
| CANDID V-1 VAGINAL TABLET 500 mg | SIN03397P | TABLET | 500 mg | 6/16/1989 | |
| CANESTEN GYN 1 DAY THERAPY VAGINAL TABLET 0.5 g | SIN03584P | TABLET | 0.5 g | 7/11/1989 | |
| CANDAZOLE CREAM 1% | SIN10406P | CREAM | 1% | 11/11/1998 | |
| CANDID-V6 VAGINAL TABLET 100 mg | SIN03395P | TABLET | 100 mg | 6/16/1989 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PANECIN CREAM | N/A | N/A | N/A | 1/21/1999 | |
| GENTRISONE CREAM | N/A | N/A | N/A | 11/13/1989 | |
| PERMASOL CREAM | N/A | N/A | N/A | 12/21/1998 | |
| KAMBI CREAM | N/A | N/A | N/A | 1/21/1999 | |
| RAPIDERM CREAM | N/A | N/A | N/A | 8/23/1999 | |
| FORTIN CREAM | N/A | N/A | N/A | 2/23/2000 | |
| TOLNAFU CREAM | N/A | N/A | N/A | 3/16/2011 | |
| TRIDAZINE-FORTE CREAM | N/A | N/A | N/A | 9/28/2009 | |
| XYLOPAN CREAM | N/A | N/A | N/A | 3/11/1999 | |
| JACAPTON CREAM | N/A | N/A | N/A | 5/2/1994 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| CANESTEN 3 DAY INTERNAL CREAM | Bayer Inc | 02150905 | Cream - Vaginal | 2 % / W/W | 12/31/1995 |
| CANESTEN 200 MG VAGINAL INSERTS | miles canada inc. - consumer health care division | 02130211 | Suppository - Vaginal | 200 MG / SUP | 12/31/1994 |
| CANESTEN EXTERNAL CREAM | Bayer Inc | 02311720 | Cream - Topical
,
Vaginal | 1 % | 3/10/2010 |
| CANESTEN SOFT CAPSULE 1 | Bayer Inc | 02547252 | Vaginal Capsule - Vaginal | 500 MG | 2/3/2025 |
| CANESTEN 1 VAGINAL TABLET COMBI-PAK | bayer inc consumer care | 02150948 | Suppository
,
Cream - Topical
,
Vaginal | 1 % / W/W | 12/31/1995 |
| CANESTEN CRM 1% VAG | miles canada inc. - consumer health care division | 02029499 | Cream - Vaginal | 1 % | 12/31/1994 |
| CANESTEN 1 VAGINAL TABLET COMBI-PAK | bayer inc consumer care | 02150948 | Suppository
,
Cream - Topical
,
Vaginal | 500 MG / TAB | 12/31/1995 |
| CLOTRIMADERM TOPICAL SOLUTION 1% USP | 02236746 | Liquid - Topical | 10 MG / ML | N/A | |
| CLOTRIMADERM-FLUCONAZOLE COMBI-PACK | 02445131 | Kit
,
Cream
,
Capsule - Oral
,
Topical | 1 % / W/W | 2/14/2017 | |
| MYCLO-GYNE INSERTS | boehringer ingelheim (canada) ltd ltee | 02131633 | Suppository - Vaginal | 100 MG / SUP | 12/31/1994 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| GINE-CANESTEN 20 MG/G CREMA VAGINAL | Bayer Hellas Α.Β.Ε.Ε. | 11003-29-03-1999IP1 | CREMA VAGINAL | Sin Receta | Commercialized |
| GINE-CANESTEN 100 mg COMPRIMIDOS VAGINALES | Bayer Hispania S.L. | 52624 | COMPRIMIDO VAGINAL | Sin Receta | Commercialized |
| GINE-CANESTEN 20 mg/g CREMA VAGINAL | Bayer Hellas A.E. | 11003-29-03-1999IP | CREMA VAGINAL | Sin Receta | Commercialized |
| CANESPIE CLOTRIMAZOL 10 mg/g CREMA | Bayer Hispania S.L. | 69680 | CREMA | Sin Receta | Commercialized |
| GINE-CANESTEN 500 MG CAPSULA VAGINAL BLANDA | Bayer Hispania S.L. | 78414 | CÁPSULA VAGINAL BLANDA | Sin Receta | Commercialized |
| GINE-CANESTEN 500 mg COMPRIMIDO VAGINAL | Bayer Hispania S.L. | 56755 | COMPRIMIDO VAGINAL | Sin Receta | Commercialized |
| CANESTEN 10 mg/g CREMA | Bayer Hispania S.L. | 52626 | CREMA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| GINE-CANESTEN 20 mg/g CREMA VAGINAL | Bayer Hispania S.L. | 56825 | CREMA VAGINAL | Sin Receta | Commercialized |
| CLOTRIMAZOL GINE-CANESMED 100 MG COMPRIMIDOS VAGINALES EFG | Bayer Hispania S.L. | 62218 | COMPRIMIDO VAGINAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| CLOTRIMAZOL CANESMED 10 mg/g CREMA EFG | Bayer Hispania S.L. | 62221 | CREMA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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