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.
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.
Dosage and Administration
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.
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.
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.
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
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.
Advice to Patients
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.
Clotrimazole with Betamethasone Dipropionate Cream (with benzyl alcohol and prophylene glycol)
Altana, Taro
Lotion
1% with Betamethasone Dipropionate 0.05% (of betamethasone)*
Lotrisone® (with benzyl alcohol and prophylene glycol)
Schering
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
Sign up with Facebook
