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Clotrimazole

Generic Name
Clotrimazole
Brand Names
Alevazol, Dermacinrx Therazole Pak, Lotriderm, Lotrimin, Lotrimin AF, Lotrisone, Mycelex
Drug Type
Small Molecule
Chemical Formula
C22H17ClN2
CAS Number
23593-75-1
Unique Ingredient Identifier
G07GZ97H65

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

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.

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
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