Brand names: Fungoid Solution, Gyne-Lotrimin, Lotrimin, Mycelex
Drug class: Azoles
VA class: DE102
Chemical name: 1-[(2-chlorophenyl)diphenylmethyl]-1H-imidazole
CAS number: 23593-75-1

Medically reviewed by Drugs.com on Jun 21, 2024. Written by ASHP.

Introduction

Antifungal; azole (imidazole derivative).

Uses for Clotrimazole

Dermatophytoses

Treatment of tinea corporis (body ringworm), tinea cruris (jock itch), and tinea pedis (athlete’s foot) caused by Epidermophyton floccosum, Microsporum canis, Trichophyton mentagrophytes, or T. rubrum. Can be used for self-medication of these conditions.

Treatment (in fixed combination with betamethasone dipropionate) of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis caused by E. floccosum, T. mentagrophytes, or T. rubrum.

Topical antifungals usually effective for treatment of uncomplicated tinea corporis or tinea cruris. An oral antifungal may be necessary when tinea corporis or tinea cruris is extensive, dermatophyte folliculitis is present, infection is chronic or does not respond to topical therapy, or patient is immunocompromised because of coexisting disease or concomitant therapy.

Topical antifungals usually effective for treatment of uncomplicated tinea pedis. An oral antifungal may be necessary for treatment of hyperkeratotic areas on the palms and soles, for chronic moccasin-type (dry-type) tinea pedis, and for tinea unguium (fingernail or toenail dermatophyte infections, onychomycosis).

Pityriasis (Tinea) Versicolor

Treatment of pityriasis (tinea) versicolor caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale).

Topical antifungals generally effective; an oral antifungal (with or without a topical antifungal) may be necessary in patients who have extensive or severe infections or have failed to respond to or have frequent relapses with topical therapy.

Cutaneous Candidiasis

Treatment of cutaneous candidiasis.

Oropharyngeal Candidiasis

Treatment of oropharyngeal candidiasis confirmed by potassium hydroxide microscopic mounts and/or culture.

A drug of choice for the treatment of uncomplicated oropharyngeal candidiasis in HIV-infected patients; ineffective for the treatment of esophageal candidiasis in HIV-infected patients.

Prophylaxis to reduce the incidence of oropharyngeal candidiasis in immunocompromised patients receiving immunosuppressive therapy (e.g., corticosteroids, antineoplastic agents, radiation therapy) for leukemia, solid tumor, or renal transplantation. Efficacy and safety in patients with immunosuppression resulting from primary immunodeficiency or other causes not established.

Not recommended for prophylaxis against oropharyngeal candidiasis in HIV-infected patients.

Vulvovaginal Candidiasis

Treatment of uncomplicated vulvovaginal candidiasis (mild to moderate, sporadic or infrequent, most likely caused by Candida albicans, occurring in immunocompetent women).

Self-medication (OTC use) for treatment of uncomplicated vulvovaginal candidiasis in otherwise healthy, nonpregnant women who have been previously diagnosed by a clinician and are having a recurrence of similar symptoms.

Treatment of complicated vulvovaginal candidiasis, including infections that are recurrent (≥4 times episodes in 1 year), severe (extensive vulvar erythema, edema, excoriation, fissure formation), caused by Candida other than C. albicans, or occurring in women with underlying medical conditions (uncontrolled diabetes mellitus, HIV infection, immunosuppressive therapy, pregnancy). Complicated infections generally require more prolonged treatment than uncomplicated infections.

Optimal regimens for treatment of vulvovaginal candidiasis caused by Candida other than C. albicans (e.g., C. glabrata, C. krusei) not identified. CDC and others state these infections may respond to an intravaginal azole antifungal given for 7–14 days or to a 14-day regimen of intravaginal boric acid (not commercially available in the US).

Treatment of male sexual partners of women with recurrent vulvovaginal candidiasis who have symptomatic balanitis or penile dermatitis. Routine treatment of asymptomatic male sexual partners is not recommended but may be considered in women with recurrent infections.

Clotrimazole Dosage and Administration

Administer topically as oral lozenge; to skin as cream, lotion, or solution; or intravaginally as cream or tablet.

Topical cream, lotion, and solution not intended for ophthalmic use.

Topical preparations containing clotrimazole in fixed combination with betamethasone dipropionate not intended for ophthalmic, oral, or intravaginal use.

Oral Topical Administration

Dissolve oral lozenges slowly in mouth over approximately 15–30 minutes.

Topical Administration

Apply cream, lotion, or solution sparingly in the morning and evening; rub gently into cleansed, affected area and surrounding skin.

Intravaginal Topical Administration

Administer preferably at bedtime.

Dosage

Pediatric Patients

Dermatophytoses

Topical

Apply 1% cream, lotion, or solution twice daily.

If clinical improvement does not occur after 4 weeks of treatment, reevaluate the diagnosis. Some infections (especially tinea pedis) may require up to 8 weeks of therapy for mycological cure.

Self-medication of Tinea Corporis, Tinea Cruris, or Tinea Pedis

Topical

Children ≥2 years of age: Apply topical cream or solution twice daily for 2 weeks (tinea cruris) or 4 weeks (tinea pedis or tinea corporis).

Pityriasis (Tinea) Versicolor

Topical

Apply 1% cream, lotion, or solution twice daily.

If clinical improvement does not occur after 4 weeks of treatment, reevaluate the diagnosis.

Cutaneous Candidiasis

Topical

Apply 1% cream, lotion, or solution twice daily.

If clinical improvement does not occur after 4 weeks of treatment, reevaluate the diagnosis. Some infections (especially tinea pedis) may require up to 8 weeks of therapy for mycological cure.

Oropharyngeal Candidiasis

Treatment

Oral Topical

Children ≥3 years of age: 10 mg (as lozenge) 5 times daily for 14 consecutive days.

Vulvovaginal Candidiasis

If response is inadequate following a course of therapy, reevaluate the diagnosis before instituting another course.

Intravaginal

Two 100-mg tablets or 1 applicatorful of 2% cream once daily for 3 consecutive days or one 100-mg tablet once daily for 7 consecutive days.

Alternatively, 1 applicatorful of 1% cream once daily for 7–14 consecutive days.

Self-medication of Uncomplicated Vulvovaginal Candidiasis

Intravaginal

Children ≥12 years of age: One applicatorful of 1% cream once daily for 7 consecutive days; alternatively, 1 applicatorful of 2% cream once daily for 3 consecutive days.

Topical

For adjunctive relief of external vulvar itching: Apply 1% topical vulvar cream 1 or 2 times daily for up to 7 days as needed.

Adults

Dermatophytoses

Topical

Apply 1% cream, lotion, or solution twice daily. If clinical improvement does not occur after 4 weeks of treatment, reevaluate the diagnosis. Some infections (especially tinea pedis) may require up to 8 weeks of therapy for mycological cure.

If combination (clotrimazole 1% and betamethasone 0.05%) cream is used, apply twice daily for 2 weeks (tinea cruris or tinea corporis) or 4 weeks (tinea pedis); if infection persists beyond this period, discontinue combination preparation and initiate clotrimazole alone.

Self-medication of Tinea Corporis, Tinea Cruris, or Tinea Pedis

Topical

Apply topical cream or solution twice daily for 2 weeks (tinea cruris) or 4 weeks (tinea pedis or tinea corporis).

Pityriasis (Tinea) Versicolor

Topical

Apply 1% cream, lotion, or solution twice daily.

If clinical improvement does not occur after 4 weeks of treatment, reevaluate the diagnosis.

Cutaneous Candidiasis

Topical

Apply 1% cream, lotion, or solution twice daily.

If clinical improvement does not occur after 4 weeks of treatment, reevaluate the diagnosis. Some infections (especially tinea pedis) may require up to 8 weeks of therapy for mycological cure.

Oropharyngeal Candidiasis

Treatment

Oral Topical

10 mg (as lozenge) 5 times daily for 14 consecutive days.

Prophylaxis in Immunocompromised Patients

Oral Topical

10 mg (as lozenge) 3 times daily for the duration of chemotherapy or until corticosteroid therapy is reduced to maintenance levels.

Vulvovaginal Candidiasis

If response is inadequate following a course of therapy, reevaluate the diagnosis before instituting another course.

Intravaginal

Two 100-mg tablets or 1 applicatorful of 2% cream once daily for 3 consecutive days or one 100-mg tablet once daily for 7 consecutive days.

Alternatively, 1 applicatorful of 1% cream once daily for 7–14 consecutive days.

Self-medication of Uncomplicated Vulvovaginal Candidiasis

Intravaginal

One applicatorful of 1% cream once daily for 7 consecutive days; alternatively, 1 applicatorful of 2% cream once daily for 3 consecutive days.

Topical

For adjunctive relief of external vulvar itching: Apply 1% topical vulvar cream 1 or 2 times daily for up to 7 days as needed.

Recurrent Vulvovaginal Infections Caused by Candida albicans

Intravaginal

CDC and others recommend an initial intensive regimen (7–14 days of an intravaginal azole or 3-dose regimen of oral fluconazole) to achieve mycologic remission, followed by a 6-month maintenance regimen of once-weekly oral fluconazole. If the oral maintenance regimen cannot be used, use intravaginal clotrimazole (200 mg twice weekly or 500 mg once weekly) or other intravaginal treatments intermittently.

Other Complicated Vulvovaginal Infections

Intravaginal

CDC and others recommend 7–14 days of an intravaginal azole for vulvovaginal candidiasis that is severe, caused by Candida other than C. albicans, or occurring in women with underlying medical conditions.

Vulvovaginal Candidiasis in HIV-infected Women

Intravaginal

CDC and other clinicians recommend same treatment as in women without HIV infection. Some experts recommend a duration of 3–7 days. Maintenance regimen of an intravaginal azole can be considered for those with recurrent episodes; routine primary or secondary prophylaxis (long-term suppressive or chronic maintenance therapy) not recommended.

Vulvovaginal Candidiasis in Pregnant Women

Intravaginal

CDC and others recommend a 7-day regimen of an intravaginal azole antifungal (e.g., clotrimazole).

Prescribing Limits

Pediatric Patients

Oropharyngeal Candidiasis

Oral Topical

Limit therapy to short-term use if possible; limited safety and efficacy data on prolonged therapy.

Adults

Oropharyngeal Candidiasis

Oral Topical

Limit therapy to short-term use if possible; limited safety and efficacy data on prolonged therapy.

Cautions for Clotrimazole

Contraindications

• Known hypersensitivity to clotrimazole or other imidazoles or any ingredient in the formulation.

Warnings/Precautions

Warnings

Systemic Fungal Infections

Do not use lozenges for treatment of systemic fungal infection, including candidiasis.

Diaper Dermatitis

Preparations containing clotrimazole in fixed combination with betamethasone dipropionate not recommended for treatment of diaper dermatitis.

Sensitivity Reactions

If irritation or sensitization occurs, discontinue the drug.

General Precautions

Hepatic Effects

Possible abnormal liver function test results (e.g., increased serum AST) in patients receiving clotrimazole lozenges. Periodic liver function tests recommended during therapy with lozenges, especially in patients with preexisting hepatic impairment.

Self-medication of Vulvovaginal Candidiasis

Self-medicationnot recommended if abdominal pain, fever, or malodorous vaginal discharge occurs or if vaginal pruritus or discomfort is occurring for the first time.

Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Specific Populations

Pregnancy

Category B (topical and intravaginal preparations).

Category C (oral lozenges; topical preparations containing betamethasone dipropionate).

CDC and others state that a 7-day regimen of an intravaginal azole antifungal can be used, if necessary, for treatment of vulvovaginal candidiasis in pregnant women.

Lactation

Not known whether clotrimazole is distributed into milk; use with caution in nursing women.

Pediatric Use

Safety and efficacy of clotrimazole lozenges not established in children <3 years of age; use not recommended in children <3 years of age. Safety and efficacy of prophylactic therapy with lozenges not established in children.

Topical cream or solution not recommended for self-medication in children <2 years of age.

Vaginal cream not recommended for self-medication in children <12 years of age.

Preparations containing clotrimazole in fixed combination with betamethasone dipropionate not recommended for use in children <17 years of age or for diaper dermatitis.

Hepatic Impairment

Periodic liver function tests recommended during therapy with lozenges, especially in patients with hepatic impairment. Potential for abnormal liver function test results (e.g., increased serum AST).

Common Adverse Effects

Topical oral therapy: abnormal liver function test results, nausea, vomiting, unpleasant mouth sensations, pruritus.

Topical application to skin: blistering, erythema, edema, pruritus, burning, stinging, peeling, urticaria, general irritation of skin.

Intravaginal therapy: vaginal burning, erythema, irritation, intercurrent cystitis.

Clotrimazole Pharmacokinetics

Absorption

Bioavailability

Extent of absorption following dissolution of 10-mg lozenge in mouth not determined. Following dissolution, concentrations sufficient to inhibit most species of Candida are present in saliva for up to 3 hours. Long-term effective concentration in saliva apparently related to slow release of drug from oral mucosa.

Minimal systemic absorption following topical application to skin. Highest concentrations present in the stratum corneum; lower concentrations in the stratum spinosum and the papillary and reticular dermis.

About 3–10% of an intravaginal dose reaches systemic circulation, principally as metabolites. Considerable interindividual variation in concentrations of drug in vaginal fluid following administration as vaginal tablets.

Stability

Storage

Oral

Oropharyngeal Topical Lozenge

≤30°C; avoid freezing.

Topical

Cream, Lotion, and Solution

2–30°C.

Intravaginal

Cream

15–30°C; avoid temperatures >30°C.

Tablets

2–30°C.

Actions and Spectrum

• Imidazole-derivative azole antifungal.

• Fungistatic or fungicidal against many fungi, including yeasts and dermatophytes; active against some gram-positive bacteria.

• Binds phospholipids in fungal cell membrane and alters cell membrane permeability. Cell membrane no longer functions as a selective barrier, and potassium and other cellular constituents are lost.

• Active in vitro and in clinical infections caused by most strains of T. rubrum, T. mentagrophytes, E. floccosum, and M. canis. Less active against M. furfur (P. orbiculare), Aspergillus fumigatus, C. albicans. Also active in vitro against Sporothrix, Cryptococcus, Cephalosporium, and Fusarium.

• Cross resistance can occur among the azole antifungals (e.g., clotrimazole, ketoconazole, miconazole). Azole-resistant Candida have been reported.

• Importance of completing full course of therapy.

• Importance of discontinuing therapy (including self-medication) and consulting clinician if adequate response is not achieved after recommended treatment period. Discontinue self-medication for vulvovaginal candidiasis and consult clinician if fever, abdominal pain, or foul-smelling discharge develops; if symptoms do not improve within 3 days; if condition persists beyond 7 days; or if symptoms recur within 2 months.

• Importance of consulting clinician if treated area becomes irritated (redness, itching, burning, blistering, swelling, oozing).

• Importance of avoiding sources of infection.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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Frequently asked questions

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