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Clotrimazole

Pronunciation

Class: Azoles
VA Class: DE102
Chemical Name: 1-[(2-chlorophenyl)diphenylmethyl]-1H-imidazole
CAS Number: 23593-75-1
Brands: Fungoid Solution, Gyne-Lotrimin, Lotrimin, Lotrisone, Mycelex

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.100 126 129 Can be used for self-medication of these conditions.100

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.130 156

Topical antifungals usually effective for treatment of uncomplicated tinea corporis or tinea cruris.143 144 147 148 149 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.143 144 147 148 149

Topical antifungals usually effective for treatment of uncomplicated tinea pedis.143 144 148 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).143 144 148

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Pityriasis (Tinea) Versicolor

Treatment of pityriasis (tinea) versicolor caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale).100 126 129

Topical antifungals generally effective;145 146 148 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.145 146 148

Cutaneous Candidiasis

Treatment of cutaneous candidiasis.126 129

Oropharyngeal Candidiasis

Treatment of oropharyngeal candidiasis confirmed by potassium hydroxide microscopic mounts and/or culture.121 125 128 c

A drug of choice for the treatment of uncomplicated oropharyngeal candidiasis in HIV-infected patients;121 123 128 c ineffective for the treatment of esophageal candidiasis in HIV-infected patients.120 121 c

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.125 Efficacy and safety in patients with immunosuppression resulting from primary immunodeficiency or other causes not established.125

Not recommended for prophylaxis against oropharyngeal candidiasis in HIV-infected patients.122 c

Vulvovaginal Candidiasis

Treatment of uncomplicated vulvovaginal candidiasis (mild to moderate, sporadic or infrequent, most likely caused by Candida albicans, occurring in immunocompetent women).105 106 117 118 129 131 132 135 136 b c d e

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.101 106 108

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).106 118 131 132 134 135 136 142 b c d Complicated infections generally require more prolonged treatment than uncomplicated infections.106 c d

Optimal regimens for treatment of vulvovaginal candidiasis caused by Candida other than C. albicans (e.g., C. glabrata, C. krusei) not identified.106 b 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).106 b d e

Treatment of male sexual partners of women with recurrent vulvovaginal candidiasis who have symptomatic balanitis or penile dermatitis.106 Routine treatment of asymptomatic male sexual partners is not recommended but may be considered in women with recurrent infections.106 133 142

Clotrimazole Dosage and Administration

Administration

Administer topically as oral lozenge;125 to skin as cream, lotion, or solution;100 or intravaginally as cream or tablet.101 106 108

Topical cream, lotion, and solution not intended for ophthalmic use.100

Topical preparations containing clotrimazole in fixed combination with betamethasone dipropionate not intended for ophthalmic, oral, or intravaginal use.156

Oral Topical Administration

Dissolve oral lozenges slowly in mouth over approximately 15–30 minutes.125

Topical Administration

Apply cream, lotion, or solution sparingly in the morning and evening; rub gently into cleansed, affected area and surrounding skin.100

Intravaginal Topical Administration

Administer preferably at bedtime.106

Dosage

Pediatric Patients

Dermatophytoses
Topical

Apply 1% cream, lotion, or solution twice daily.100

If clinical improvement does not occur after 4 weeks of treatment, reevaluate the diagnosis.100 Some infections (especially tinea pedis) may require up to 8 weeks of therapy for mycological cure.a

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).157

Pityriasis (Tinea) Versicolor
Topical

Apply 1% cream, lotion, or solution twice daily.100

If clinical improvement does not occur after 4 weeks of treatment, reevaluate the diagnosis.100

Cutaneous Candidiasis
Topical

Apply 1% cream, lotion, or solution twice daily.100

If clinical improvement does not occur after 4 weeks of treatment, reevaluate the diagnosis.100 Some infections (especially tinea pedis) may require up to 8 weeks of therapy for mycological cure.a

Oropharyngeal Candidiasis
Treatment
Oral Topical

Children ≥3 years of age: 10 mg (as lozenge) 5 times daily for 14 consecutive days.125

Vulvovaginal Candidiasis

If response is inadequate following a course of therapy, reevaluate the diagnosis before instituting another course.100 101 116

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.101 106

Alternatively, 1 applicatorful of 1% cream once daily for 7–14 consecutive days.106

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.101 a

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.158

Adults

Dermatophytoses
Topical

Apply 1% cream, lotion, or solution twice daily.100 If clinical improvement does not occur after 4 weeks of treatment, reevaluate the diagnosis.100 Some infections (especially tinea pedis) may require up to 8 weeks of therapy for mycological cure.a

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.a 156

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).157

Pityriasis (Tinea) Versicolor
Topical

Apply 1% cream, lotion, or solution twice daily.100

If clinical improvement does not occur after 4 weeks of treatment, reevaluate the diagnosis.100

Cutaneous Candidiasis
Topical

Apply 1% cream, lotion, or solution twice daily.100

If clinical improvement does not occur after 4 weeks of treatment, reevaluate the diagnosis.100 Some infections (especially tinea pedis) may require up to 8 weeks of therapy for mycological cure.a

Oropharyngeal Candidiasis
Treatment
Oral Topical

10 mg (as lozenge) 5 times daily for 14 consecutive days.125 c

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.125

Vulvovaginal Candidiasis

If response is inadequate following a course of therapy, reevaluate the diagnosis before instituting another course.100 101 116

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.101 106

Alternatively, 1 applicatorful of 1% cream once daily for 7–14 consecutive days.106

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.101 a

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.158

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.106 b d 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.106

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.106 d

Vulvovaginal Candidiasis in HIV-infected Women
Intravaginal

CDC and other clinicians recommend same treatment as in women without HIV infection.106 136 142 Some experts recommend a duration of 3–7 days.c Maintenance regimen of an intravaginal azole can be considered for those with recurrent episodes;c routine primary or secondary prophylaxis (long-term suppressive or chronic maintenance therapy) not recommended.106 c

Vulvovaginal Candidiasis in Pregnant Women
Intravaginal

CDC and others recommend a 7-day regimen of an intravaginal azole antifungal (e.g., clotrimazole).106 d

Prescribing Limits

Pediatric Patients

Oropharyngeal Candidiasis
Oral Topical

Limit therapy to short-term use if possible; limited safety and efficacy data on prolonged therapy.125

Adults

Oropharyngeal Candidiasis
Oral Topical

Limit therapy to short-term use if possible; limited safety and efficacy data on prolonged therapy.125

Cautions for Clotrimazole

Contraindications

  • Known hypersensitivity to clotrimazole or other imidazoles or any ingredient in the formulation.100 125 156

Warnings/Precautions

Warnings

Systemic Fungal Infections

Do not use lozenges for treatment of systemic fungal infection, including candidiasis.125 156

Diaper Dermatitis

Preparations containing clotrimazole in fixed combination with betamethasone dipropionate not recommended for treatment of diaper dermatitis.156

Sensitivity Reactions

If irritation or sensitization occurs, discontinue the drug.100 156

General Precautions

Hepatic Effects

Possible abnormal liver function test results (e.g., increased serum AST) in patients receiving clotrimazole lozenges.125 Periodic liver function tests recommended during therapy with lozenges, especially in patients with preexisting hepatic impairment.125

Self-medication of Vulvovaginal Candidiasis

Self-medication not recommended if abdominal pain, fever, or malodorous vaginal discharge occurs or if vaginal pruritus or discomfort is occurring for the first time.101 158

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).100 159

Category C (oral lozenges; topical preparations containing betamethasone dipropionate).125 156

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.106 d

Lactation

Not known whether clotrimazole is distributed into milk; use with caution in nursing women.100 129

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.125 Safety and efficacy of prophylactic therapy with lozenges not established in children.125

Topical cream or solution not recommended for self-medication in children <2 years of age.157

Vaginal cream not recommended for self-medication in children <12 years of age.a 101

Preparations containing clotrimazole in fixed combination with betamethasone dipropionate not recommended for use in children <17 years of age or for diaper dermatitis.156

Hepatic Impairment

Periodic liver function tests recommended during therapy with lozenges, especially in patients with hepatic impairment.125 Potential for abnormal liver function test results (e.g., increased serum AST).125

Common Adverse Effects

Topical oral therapy: abnormal liver function test results, nausea, vomiting, unpleasant mouth sensations, pruritus.125

Topical application to skin: blistering, erythema, edema, pruritus, burning, stinging, peeling, urticaria, general irritation of skin.100

Intravaginal therapy: vaginal burning, erythema, irritation, intercurrent cystitis.111 a

Clotrimazole Pharmacokinetics

Absorption

Bioavailability

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

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

About 3–10% of an intravaginal dose reaches systemic circulation, principally as metabolites.103 104 Considerable interindividual variation in concentrations of drug in vaginal fluid following administration as vaginal tablets.102 103 104

Stability

Storage

Oral

Oropharyngeal Topical Lozenge

≤30°C; avoid freezing.125

Topical

Cream, Lotion, and Solution

2–30°C.100

Intravaginal

Cream

15–30°C; avoid temperatures >30°C.101

Tablets

2–30°C.158

Actions and Spectrum

  • Imidazole-derivative azole antifungal.a

  • Fungistatic or fungicidal against many fungi, including yeasts and dermatophytes; active against some gram-positive bacteria.100 a

  • Binds phospholipids in fungal cell membrane and alters cell membrane permeability.a Cell membrane no longer functions as a selective barrier, and potassium and other cellular constituents are lost.100 a

  • Active in vitro and in clinical infections caused by most strains of T. rubrum, T. mentagrophytes, E. floccosum, and M. canis.100 Less active against M. furfur (P. orbiculare), Aspergillus fumigatus, C. albicans.a Also active in vitro against Sporothrix, Cryptococcus, Cephalosporium, and Fusarium.a

  • Cross resistance can occur among the azole antifungals (e.g., clotrimazole, ketoconazole, miconazole).160 Azole-resistant Candida have been reported.156

Advice to Patients

  • Importance of completing full course of therapy.100

  • Importance of discontinuing therapy (including self-medication) and consulting clinician if adequate response is not achieved after recommended treatment period.100 157 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.a 101

  • Importance of consulting clinician if treated area becomes irritated (redness, itching, burning, blistering, swelling, oozing).100

  • Importance of avoiding sources of infection.100

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.100

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

  • 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.

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

Clotrimazole

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder*

Oral (Topical Use Only)

Lozenges

10 mg*

Clotrimazole Lozenge (with povidone)

Paddock, Roxane

Mycelex Troche (with povidone)

Alza

Topical

Cream

1%*

Lotrimin (with benzyl alcohol 1%)

Schering

Lotrimin AF (with benzyl alcohol 1%)

Schering-Plough

Lotrim AF Jock Itch Cream (with benzyl alcohol 1%)

Schering-Plough

Lotion

1%

Lotrimin AF (with benzyl alcohol 1%)

Schering-Plough

Solution

1%*

Fungoid Solution

Pedinol

Lotrimin

Schering

Lotrimin AF

Schering-Plough

Vaginal

Cream

1%*

Gyne-Lotrimin (with benzyl alcohol)

Schering-Plough

Mycelex-7 (with benzyl alcohol; with or without disposable applicators)

Bayer

2%

GyneLotrimin 3 (with benzyl alcohol)

Schering-Plough

Kit

7 g Cream, topical, Clotrimazole 1% (Gyne-Lotrimin (with benzyl alcohol)

3 Tablets, vaginal, Clotrimazole 200 mg (Gyne-Lotrimin (with povidone)

Gyne-Lotrimin 3 Combination Pack

Schering-Plough

Tablets

100 mg*

200 mg

Gyne-Lotrimin-3 (with povidone)

Schering-Plough

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

Clotrimazole Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

1% with Betamethasone Dipropionate 0.05% (of betamethasone)*

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

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Clotrimazole 1% Cream (PERRIGO): 15/$15.99 or 45/$32.97

Clotrimazole 1% Cream (PERRIGO): 28/$34.99 or 84/$79.97

Clotrimazole 1% Cream (TARO): 30/$35.99 or 90/$89.97

Clotrimazole 1% Cream (TARO): 45/$39.99 or 90/$69.97

Clotrimazole 1% Solution (TEVA PHARMACEUTICALS USA): 10/$17.99 or 30/$33.97

Clotrimazole 1% Solution (TEVA PHARMACEUTICALS USA): 30/$24.99 or 90/$53.97

Clotrimazole-Betamethasone 1-0.05% Cream (FOUGERA): 15/$28.99 or 60/$105.97

Clotrimazole-Betamethasone 1-0.05% Lotion (TARO): 30/$73.99 or 90/$209.96

Lotrisone 1-0.05% Lotion (SCHERING): 30/$91.83 or 90/$252.53

Mycelex 10MG Troches (MCNEIL): 70/$122.99 or 210/$356.98

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions July 1, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

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