Drug class: Azoles

Medically reviewed by Drugs.com on Apr 10, 2025. Written by ASHP.

Introduction

Antifungal; azole (imidazole derivative).

Uses for Clotrimazole (Topical)

Oropharyngeal Candidiasis

Clotrimazole lozenge is used orally for topical treatment of oropharyngeal candidiasis confirmed by potassium hydroxide smear and/or culture.

Also used for 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. Manufacturer states that safety and efficacy in patients with immunosuppression resulting from primary immunodeficiency or other causes not established.

Not indicated for treatment of systemic fungal infections, including systemic candidiasis.

Oropharyngeal candidiasis can occur in association with HIV infection, diabetes, malignancies, steroid use, radiation therapy, antimicrobial therapy, and denture use. Such infections are largely caused by Candida albicans, either alone or in mixed infections.

Experts recommend systemic therapy with oral fluconazole as the preferred antifungal treatment of choice for oropharyngeal candidiasis in HIV-infected patients, except during pregnancy. Topical therapy with clotrimazole lozenges is recommended as one of several alternative treatment options.

Topical oral therapy with clotrimazole is ineffective for treatment of esophageal candidiasis in HIV-infected patients; if used, a systemic antifungal should also be given.

The Infectious Diseases Society of America (IDSA) guidelines recommend clotrimazole lozenges or miconazole mucoadhesive buccal tablets for treatment of mild oropharyngeal candidiasis; oral fluconazole is recommended for moderate to severe disease.

Dermatophytoses and Cutaneous Candidiasis

Clotrimazole 1% cream and solution are FDA-labeled for topical treatment of candidiasis due to Candida albicans. Also available in OTC topical preparations for treatment of tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm of the body) caused by Trichophyton rubrum, T. mentagrophytes, Epidermophyton floccosum, or Microsporum canis.

Also available in combination with betamethasone dipropionate for topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by T. rubrum, T. mentagrophytes, or E. floccosumin adults.

Clotrimazole 1% cream or solution is considered one of several first-line therapies for tinea pedis, tinea corporis, and tinea cruris; systemic therapy may be required for severe, chronic, or refractory cases.

Pityriasis (Tinea) Versicolor

Clotrimazole 1% cream or solution is used topically for treatment of tinea versicolor due to Malassezia furfur.

Uncomplicated cases of pityriasis (tinea) versicolor generally can be treated with topical agents such as clotrimazole cream, selenium sulfide shampoo or lotion, or other topical azole antifungals (e.g., econazole, ketoconazole, miconazole, oxiconazole), an allylamine antifungal (e.g., terbinafine), ciclopirox, or zinc pyrithione shampoo. Systemic therapies are reserved for more extensive or resistant infections.

Vulvovaginal Candidiasis

Clotrimazole vaginal cream is used for treatment of vulvovaginal candidiasis; only nonprescription (OTC) 1% and 2% vaginal cream preparations are currently available for this use.

CDC and IDSA treatment guidelines recommend topical (i.e., intravaginal) azole antifungal in a single-dose or short-course (generally 1–3 days) regimen or single dose of oral fluconazole for uncomplicated vulvovaginal candidiasis.

For recurrent vulvovaginal candidiasis, prolonged treatment courses recommended, typically with 7–14 days of topical azole antifungal therapy or oral fluconazole administered every 3 days for a total of 3 doses, followed by a maintenance antifungal regimen.

In most people with HIV, vulvovaginal candidiasis is uncomplicated and can be treated with a short course of oral fluconazole, topical azoles (including clotrimazole), or oral ibrexafungerp. Severe or recurrent episodes require longer duration of therapy (at least 7 days).

Clotrimazole (Topical) Dosage and Administration

General

Patient Monitoring

• Periodic assessment of hepatic function is advised, especially in patients with preexisting hepatic impairment.

Administration

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

Also available in combination with betamethasone dipropionate as a cream or lotion; see prescribing information for the combination product for additional details.

Oral Topical Administration

Dissolve oral lozenges slowly in mouth over approximately 30 minutes.

Topical Administration

Apply cream or solution twice daily (in the morning and evening); massage gently into affected area and surrounding skin.

Dosage

Pediatric Patients

Oropharyngeal Candidiasis

Treatment

Oral Topical

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

Dermatophytoses and Cutaneous Candidiasis

Topical

Apply 1% cream or solution twice daily (in the morning and evening).

Clinical improvement and relief of pruritus usually occur within 1 week; if clinical improvement does not occur after 4 weeks of treatment, reevaluate the diagnosis.

Pityriasis (Tinea) Versicolor

Topical

Apply 1% cream or solution twice daily (in the morning and evening).

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

Vulvovaginal Candidiasis

Intravaginal

Children >12 years of age: 1 applicatorful of 1% cream once daily for 7–14 consecutive days or 1 applicatorful of 2% cream once daily for 3 consecutive days.

Adults

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.

Dermatophytoses and Cutaneous Candidiasis

Topical

Apply 1% cream or solution twice daily (in the morning and evening).

Clinical improvement and relief of pruritus usually occur within 1 week; if clinical improvement does not occur after 4 weeks of treatment, reevaluate the diagnosis.

If combination (clotrimazole 1% and betamethasone 0.05%) cream or lotion is used for tinea corporis or tinea cruris, apply twice a day for 1 week; do not use more than 45 g of cream or 45 mL of lotion per week and do not use with occlusive dressing. If clinical improvement does not occur within 1 week of treatment, reevaluate the diagnosis. Do not use for longer than 2 weeks.

If combination (clotrimazole 1% and betamethasone 0.05%) cream or lotion is used for tinea pedis, apply twice a day for 2 weeks; do not use more than 45 g of cream or 45 mL of lotion per week and do not use with occlusive dressing. If clinical improvement does not occur within 2 weeks of treatment, reevaluate the diagnosis. Do not use for longer than 4 weeks.

Pityriasis (Tinea) Versicolor

Topical

Apply 1% cream or solution twice daily (in the morning and evening).

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

Vulvovaginal Candidiasis

Intravaginal

1 applicatorful of 1% cream once daily (preferably at bedtime) for 7–14 consecutive days or 1 applicatorful of 2% cream once daily for 3 consecutive days.

Cautions for Clotrimazole (Topical)

Contraindications

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

Warnings/Precautions

Administration Precautions

Clotrimazole topical solution and cream are not for ophthalmic use.

Clotrimazole lozenges are not indicated for treatment of systemic mycoses, including systemic candidiasis.

Patients receiving clotrimazole lozenges must be of an appropriate age and physical and/or mental condition to comprehend and follow administration instructions.

Sensitivity Reactions

If irritation or sensitization occurs, discontinue the drug.

Hepatic Effects

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

Lack of Response

If there is a lack of response to clotrimazole, appropriate microbiological studies should be repeated to confirm the diagnosis and rule out other pathogens before instituting another course of antifungal therapy.

Use of Fixed Combinations

When clotrimazole is used in fixed combination with other drugs (e.g., betamethasone), consider cautions, precautions, contraindications, and interactions associated with the concomitant agent(s).

Specific Populations

Pregnancy

No adequate and controlled studies of clotrimazole lozenges in pregnant women; use during pregnancy only if potential benefits justify potential risks to fetus.

In clinical trials, intravaginal clotrimazole in pregnant women in second and third trimester was not associated with adverse effects; no adequate and well-controlled studies in first trimester.

In animal reproductive studies, embryotoxic effects demonstrated.

Lactation

Not known whether clotrimazole is excreted in human milk; use caution in nursing woman.

Pediatric Use

Safety and efficacy of lozenges not established 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 <3 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 in children <17 years of age or for diaper dermatitis.

Geriatric Use

Insufficient number of patients ≥65 years of age in clinical studies with lozenges to determine whether geriatric patients respond differently from younger patients; other reported clinical experience did not find any differences in response between these patients.

Common Adverse Effects

Lozenge: nausea, vomiting, unpleasant mouth sensations, pruritus.

Topical cream or solution: blistering, erythema, edema, pruritus, burning, stinging, peeling, urticaria, general irritation of skin.

Clotrimazole (Topical) 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.

Stability

Storage

Oral

Topical Lozenge

20–25°C; avoid freezing.

Topical

Cream and Solution

20–25°C.

Actions

• Imidazole-derivative azole antifungal.

• Broad-spectrum antifungal agent that exerts antifungal activity by interfering with the biosynthesis of ergosterol, a major component of the fungal cell membrane. Generally considered to be fungistatic, but exerts fungicidal effects at higher concentrations.

• Active in vitro and in clinical infections caused by most strains of Trichophyton rubrum, T. mentagrophytes, Epidermophyton floccosum, Microsporum canis, and Candida albicans.

• Cross resistance can occur among the azole antifungals (e.g., clotrimazole, ketoconazole, miconazole).

Advice to Patients

• Advise patients to use clotrimazole topical cream or solution for the full treatment time even if symptoms improve. Advise patients to notify their physician if there is no improvement after 4 weeks of treatment.

• Advise patients to inform their physician if the area of application of clotrimazole topical cream or solution shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing) indicative of possible sensitization. Avoid the use of occlusive wrappings or dressings, and avoid sources of infection or reinfection.

• Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.

• Advise patients to inform their clinician if they are or plan to become pregnant or plan to breast-feed.

• Inform patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

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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