Introduction

Antifungal; azole (imidazole derivative).

Uses for Miconazole

Dermatophytoses

Treatment of tinea corporis (body ringworm) and tinea cruris (jock itch) caused by Epidermophyton floccosum, Trichophyton mentagrophytes, or T. rubrum.

Treatment of tinea pedis (athlete’s foot) caused by Epidermophyton floccosum, Trichophyton mentagrophytes, or T. rubrum.

Topical antifungals usually effective for treatment of uncomplicated tinea corporis or tinea cruris. An oral antifungal preferred 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^{† [off-label]} caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale).

Topical treatment usually effective; an oral antifungal (alone or in conjunction with a topical antifungal) may be necessary in patients who have extensive or severe infections or who fail to respond to or have frequent relapses with topical therapy.

Cutaneous Candidiasis

Treatment of cutaneous candidiasis caused by Candida albicans.

Treatment of candidal diaper dermatitis. Treatment of choice is a topical antifungal (e.g., nystatin, clotrimazole, miconazole). Most infants with candidal diaper dermatitis harbor C. albicans in their intestines and infected feces appear to be an important source of the cutaneous infection. Some clinicians recommend that an oral antifungal (e.g., oral nystatin) be administered concomitantly to treat the intestinal infection, but studies have not provided evidence that concomitant oral and topical therapy is more effective than topical therapy alone.

Vulvovaginal Candidiasis

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

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 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.

Miconazole Dosage and Administration

Administration

Administer topically to skin or intravaginally in appropriate formulations.

Topical skin preparations are for external use only and should not be used orally, intravaginally, or near or in eyes or mucous membranes.

Intravaginal preparations are for intravaginal administration only and should not be used orally, topically on the skin, or near or in eyes.

Topical Administration

Administer topically to the skin as a 0.25% ointment, 2% aerosol, 2% aerosol powder, or 2% cream, lotion, powder, or tincture.

Do not use on the scalp or nails.

Wash hands after applying.

Shake sprays and lotions well before using.

Do not use tincture for self-medication in patients with diabetes, circulatory, renal, or hepatic problems.

When treating dermatomycoses or cutaneous candidiasis, apply sparingly to cleansed, dry, infected area.

When treating tinea pedis, pay special attention to spaces between toes. Also, wear well-fitting, ventilated shoes and change shoes and socks at least once daily.

When treating candidal diaper dermatitis, apply at each diaper change. Gently cleanse skin with lukewarm water and pat dry with a soft towel. Gently apply thin layer to diaper area with fingertips; do not rub into skin since this may cause additional irritation.

Intravaginal Topical Administration

Administer intravaginally as a 2% cream or 100- or 200-mg suppository.

Use for self-medication only in otherwise healthy, nonpregnant women with recurrent vulvovaginal candidiasis who were previously diagnosed by a clinician.

Dosage

Pediatric Patients

Dermatophytoses

Tinea Corporis or Tinea Cruris

Children ≥2–11 years of age: Apply twice daily (morning and evening) for 2 weeks.

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

Tinea Pedis

Children ≥2–11 years of age: Apply twice daily (morning and evening) for 1 month.

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

Pityriasis (Tinea) Versicolor† [off-label]

Topical

Children ≥2–11 years of age: Apply once daily for 2 weeks.

If clinical improvement does not occur after 2 weeks of treatment, reevaluate the diagnosis.

Cutaneous Candidiasis

Topical

Children ≥2–11 years of age: Apply twice daily (morning and evening) for 2 weeks.

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

Diaper Dermatitis

Infants ≥4 weeks of age: Apply to affected area at each diaper change for 7 days.

Continue treatment for 7 days, even if improved.

Ointment is not a substitute for frequent diaper changes; do not use for prevention of diaper dermatitis. (See Selection and Use of Antifungals for Diaper Dermatitis under Cautions.)

Uncomplicated Vulvovaginal Candidiasis

Intravaginal

Children ≥12 years of age: 100-mg suppository at bedtime for 7 days or 200-mg suppository at bedtime for 3 days. Alternatively, applicatorful of 2% intravaginal cream once daily at bedtime for 7 days. May be used for self-medication.

If clinical symptoms do not improve within 3 days, persist for >7 days, or recur within 2 months, discontinue self-medicationand consult a clinician. Confirm diagnosis and rule out other pathogens and conditions that may predispose a patient to recurrent vaginal fungal infections.

Topical

For adjunctive relief of external vulvar itching: Apply 2% topical vulvar cream twice daily (morning and evening) for up to 7 days as needed.

HIV-infected Adolescents

Use same regimen recommended for other patients. 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.

Complicated Vulvovaginal Candidiasis

Recurrent Vulvovaginal Infections Caused by Candida albicans

Adolescents: 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 an appropriate maintenance regimen (6-month regimen of once-weekly oral fluconazole or, alternatively, an intravaginal azole given intermittently).

Other Complicated Vulvovaginal Infections

Adolescents: 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.

Adults

Dermatophytoses

Tinea Corporis or Tinea Cruris

Apply twice daily (morning and evening) for 2 weeks.

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

Tinea Pedis

Apply twice daily (morning and evening) for 1 month.

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

Pityriasis (Tinea) Versicolor† [off-label]

Topical

Apply once daily for 2 weeks.

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

Cutaneous Candidiasis

Topical

Apply twice daily (morning and evening) for 2 weeks.

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

Uncomplicated Vulvovaginal Candidiasis

Intravaginal

100-mg suppository at bedtime for 7 days or 200-mg suppository at bedtime for 3 days. Alternatively, applicatorful of 2% intravaginal cream once daily at bedtime for 7 days. May be used for self-medication.

If clinical symptoms do not improve within 3 days, persist for >7 days, or recur within 2 months, discontinue self-medicationand consult a clinician. Confirm diagnosis and rule out other pathogens and conditions that may predispose a patient to recurrent vaginal fungal infections.

Topical

For adjunctive relief of external vulvar itching: Apply 2% topical vulvar cream twice daily (morning and evening) for up to 7 days as needed.

HIV-Infected Adults

Use same regimen recommended for other patients. 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.

Complicated Vulvovaginal Candidiasis

Recurrent Vulvovaginal Infections Caused by Candida albicans

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 an appropriate maintenance regimen (6-month regimen of once-weekly oral fluconazole or, alternatively, an intravaginal azole given intermittently).

Other Complicated Vulvovaginal Infections

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.

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

Prescribing Limits

Pediatric Patients

Diaper Dermatitis

Topical

Infants ≥4 weeks of age: Maximum treatment duration is 7 days; safety of longer treatment not known.

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.

Renal Impairment

No specific dosage recommendations at this time.

Geriatric Patients

No specific dosage recommendations at this time.

Contraindications

Known hypersensitivity to miconazole or any ingredient in the formulation.

Warnings/Precautions

Warnings

Use of Latex or Rubber Products

Miconazole vaginal suppositories contain petroleum base that can weaken latex or rubber products (including condoms and vaginal contraceptive diaphragms). Concurrent use not recommended. Consider use of miconazole vaginal cream as an alternative to the suppositories.

Sensitivity Reactions

Hypersensitivity Reactions

Contact dermatitis reported following topical application of miconazole or other imidazole-derivative azole antifungals.

If irritation or sensitivity occurs, discontinue the drug and contact a clinician.

Possible cross-sensitization among the imidazoles.

General Precautions

Selection and Use of Antifungals for Diaper Dermatitis

Prior to use of ointment for adjunctive treatment of diaper dermatitis, confirm diagnosis of candidiasis with microscopic evidence of pseudohyphae and/or budding yeast. A positive fungal culture for C. albicans is not adequate evidence of candidal infection since colonization with C. albicans can result in a positive culture.

Use ointment as part of a treatment regimen that includes measures directed at the underlying diaper dermatitis; the ointment is not a substitute for frequent diaper changes. Do not use to prevent diaper dermatitis; preventive use may result in development of drug resistance.

Safety and efficacy of ointment for treatment of diaper dermatitis in immunocompromised patients not established.

Safety and efficacy of ointment have not been evaluated in incontinent adults; do not use in an attempt to prevent occurrence of diaper dermatitis (e.g., in adult institutional settings).

Selection and Use of Antifungals for Vulvovaginal Candidiasis

Prior to initial use in a woman with signs and symptoms of vulvovaginal candidiasis, confirm the diagnosis by potassium hydroxide (KOH) microscopic mounts and/or cultures.

Candida identified by culture in the absence of symptoms is not an indication for antifungal treatment since approximately 10–20% of women harbor Candida or other yeasts in the vagina.

If clinical symptoms persist, repeat tests to rule out other pathogens, to confirm the original diagnosis, and to rule out other conditions that may predispose a patient to recurrent vaginal fungal infections.

Do not use for self-medication in women who have never had a vaginal yeast infection diagnosed by a clinician, in women who are or think they may be pregnant, or in women with HIV infection or exposure.

Other Administration Precautions

Topical skin preparations are for external use only. Do not administer orally or intravaginally. Avoid contact with eyes, nose, mouth, and other mucous membranes.

Intentional misuse by deliberately concentrating and inhaling the contents of the aerosols can be harmful or fatal.

Specific Populations

Pregnancy

Category C.

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 miconazole is distributed into milk; use with caution in nursing women.

Pediatric Use

Topical skin preparations: Use in children <2 years of age only if directed by a clinician. Use in children ≥2–11 years of age only under adult supervision.

Ointment for candidal diaper dermatitis: Safety and efficacy not established in infants <4 weeks of age (premature or term) or very-low-birth weight infants. (See Selection and Use of Antifungals for Diaper Dermatitis under Cautions.)

Intravaginal preparations: Safety and efficacy for self-medication not established in children <12 years of age.

Geriatric Use

Clinical studies evaluating miconazole ointment for treatment of candidal diaper dermatitis did not include any adults ≥65 years of age; safety and efficacy of the ointment have not been evaluated in geriatric adults.

Common Adverse Effects

Irritation, burning, itching.

Administration

Administer topically to skin or intravaginally in appropriate formulations.

Topical skin preparations are for external use only and should not be used orally, intravaginally, or near or in eyes or mucous membranes.

Intravaginal preparations are for intravaginal administration only and should not be used orally, topically on the skin, or near or in eyes.

Topical Administration

Administer topically to the skin as a 0.25% ointment, 2% aerosol, 2% aerosol powder, or 2% cream, lotion, powder, or tincture.

Do not use on the scalp or nails.

Wash hands after applying.

Shake sprays and lotions well before using.

Do not use tincture for self-medication in patients with diabetes, circulatory, renal, or hepatic problems.

When treating dermatomycoses or cutaneous candidiasis, apply sparingly to cleansed, dry, infected area.

When treating tinea pedis, pay special attention to spaces between toes. Also, wear well-fitting, ventilated shoes and change shoes and socks at least once daily.

When treating candidal diaper dermatitis, apply at each diaper change. Gently cleanse skin with lukewarm water and pat dry with a soft towel. Gently apply thin layer to diaper area with fingertips; do not rub into skin since this may cause additional irritation.

Intravaginal Topical Administration

Administer intravaginally as a 2% cream or 100- or 200-mg suppository.

Use for self-medication only in otherwise healthy, nonpregnant women with recurrent vulvovaginal candidiasis who were previously diagnosed by a clinician.

Dosage

Pediatric Patients

Dermatophytoses

Tinea Corporis or Tinea Cruris

Children ≥2–11 years of age: Apply twice daily (morning and evening) for 2 weeks.

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

Tinea Pedis

Children ≥2–11 years of age: Apply twice daily (morning and evening) for 1 month.

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

Pityriasis (Tinea) Versicolor† [off-label]

Topical

Children ≥2–11 years of age: Apply once daily for 2 weeks.

If clinical improvement does not occur after 2 weeks of treatment, reevaluate the diagnosis.

Cutaneous Candidiasis

Topical

Children ≥2–11 years of age: Apply twice daily (morning and evening) for 2 weeks.

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

Diaper Dermatitis

Infants ≥4 weeks of age: Apply to affected area at each diaper change for 7 days.

Continue treatment for 7 days, even if improved.

Ointment is not a substitute for frequent diaper changes; do not use for prevention of diaper dermatitis. (See Selection and Use of Antifungals for Diaper Dermatitis under Cautions.)

Uncomplicated Vulvovaginal Candidiasis

Intravaginal

Children ≥12 years of age: 100-mg suppository at bedtime for 7 days or 200-mg suppository at bedtime for 3 days. Alternatively, applicatorful of 2% intravaginal cream once daily at bedtime for 7 days. May be used for self-medication.

If clinical symptoms do not improve within 3 days, persist for >7 days, or recur within 2 months, discontinue self-medicationand consult a clinician. Confirm diagnosis and rule out other pathogens and conditions that may predispose a patient to recurrent vaginal fungal infections.

Topical

For adjunctive relief of external vulvar itching: Apply 2% topical vulvar cream twice daily (morning and evening) for up to 7 days as needed.

HIV-infected Adolescents

Use same regimen recommended for other patients. 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.

Complicated Vulvovaginal Candidiasis

Recurrent Vulvovaginal Infections Caused by Candida albicans

Adolescents: 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 an appropriate maintenance regimen (6-month regimen of once-weekly oral fluconazole or, alternatively, an intravaginal azole given intermittently).

Other Complicated Vulvovaginal Infections

Adolescents: 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.

Adults

Dermatophytoses

Tinea Corporis or Tinea Cruris

Apply twice daily (morning and evening) for 2 weeks.

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

Tinea Pedis

Apply twice daily (morning and evening) for 1 month.

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

Pityriasis (Tinea) Versicolor† [off-label]

Topical

Apply once daily for 2 weeks.

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

Cutaneous Candidiasis

Topical

Apply twice daily (morning and evening) for 2 weeks.

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

Uncomplicated Vulvovaginal Candidiasis

Intravaginal

100-mg suppository at bedtime for 7 days or 200-mg suppository at bedtime for 3 days. Alternatively, applicatorful of 2% intravaginal cream once daily at bedtime for 7 days. May be used for self-medication.

If clinical symptoms do not improve within 3 days, persist for >7 days, or recur within 2 months, discontinue self-medicationand consult a clinician. Confirm diagnosis and rule out other pathogens and conditions that may predispose a patient to recurrent vaginal fungal infections.

Topical

For adjunctive relief of external vulvar itching: Apply 2% topical vulvar cream twice daily (morning and evening) for up to 7 days as needed.

HIV-Infected Adults

Use same regimen recommended for other patients. 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.

Complicated Vulvovaginal Candidiasis

Recurrent Vulvovaginal Infections Caused by Candida albicans

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 an appropriate maintenance regimen (6-month regimen of once-weekly oral fluconazole or, alternatively, an intravaginal azole given intermittently).

Other Complicated Vulvovaginal Infections

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.

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

Prescribing Limits

Pediatric Patients

Diaper Dermatitis

Topical

Infants ≥4 weeks of age: Maximum treatment duration is 7 days; safety of longer treatment not known.

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.

Renal Impairment

No specific dosage recommendations at this time.

Geriatric Patients

No specific dosage recommendations at this time.

Weak inhibitor of CYP2C9.

Drugs Metabolized by Hepatic Microsomal Enzymes

Drugs metabolized by CYP2C9: possible increased plasma concentrations.

Specific Drugs