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 .
Background
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 | |
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 | |
NuCare Pharmaceuticals,Inc. | 68071-2324 | TOPICAL | 10 mg in 1 g | 1/6/2021 |
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 |
---|---|---|---|---|---|
Clotrimazole and Urea Cream | 国药准字H11022580 | 化学药品 | 乳膏剂 | 11/24/2020 | |
Clotrimazole Tablets | 国药准字H37021739 | 化学药品 | 片剂 | 3/20/2025 | |
Clotrimazole Tablets | 国药准字H32020325 | 化学药品 | 片剂 | 9/3/2020 | |
Clotrimazole Tablets | 国药准字H44023710 | 化学药品 | 片剂 | 5/13/2020 | |
Clotrimazole Tablets | 国药准字H21023979 | 化学药品 | 片剂 | 7/23/2024 | |
Clotrimazole Tablets | 国药准字H32021001 | 化学药品 | 片剂 | 8/13/2020 | |
Clotrimazole Tablets | 国药准字H52020001 | 化学药品 | 片剂 | 10/21/2019 | |
Clotrimazole Tablets | 国药准字H14020238 | 化学药品 | 片剂 | 4/10/2020 | |
Clotrimazole Tablets | 国药准字H41023701 | 化学药品 | 片剂 | 5/25/2020 | |
Clotrimazole Tablets | 国药准字H22023252 | 化学药品 | 片剂 | 5/18/2021 |
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 |