Miconazole Nitrate

Dermatophytoses

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

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

Topical antifungals usually effective for treatment of uncomplicated tinea corporis or tinea cruris.104 105 106 108 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.104 105 106 108

Topical antifungals usually effective for treatment of uncomplicated tinea pedis.104 105 106 107 108 An oral antifungal may be necessary for treatment of hyperkeratotic areas on the palms and soles,105 108 for chronic moccasin-type (dry-type) tinea pedis,104 105 107 and for tinea unguium (fingernail or toenail dermatophyte infections, onychomycosis).104 105 106 107 108

Pityriasis (Tinea) Versicolor

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

Topical treatment usually effective;104 105 107 110 111 112 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.107 110 111

Cutaneous Candidiasis

Treatment of cutaneous candidiasis caused by Candida albicans.a d

Treatment of candidal diaper dermatitis.b i Treatment of choice is a topical antifungal (e.g., nystatin, clotrimazole, miconazole).i 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.i Some clinicians recommend that an oral antifungal (e.g., oral nystatin) be administered concomitantly to treat the intestinal infection,i but studies have not provided evidence that concomitant oral and topical therapy is more effective than topical therapy alone.i

Vulvovaginal Candidiasis

Treatment of uncomplicated vulvovaginal candidiasis (mild to moderate, sporadic or infrequent, most likely caused by Candida albicans, occurring in immunocompetent women).100 102 113 114 115 118 119 135 j l m A drug of choice.100 102 113 114 115 118 119 135 j l m

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.c e

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).100 k l Complicated infections generally require more prolonged treatment than uncomplicated infections.100 l k

Contraindications

Known hypersensitivity to miconazole or any ingredient in the formulation.a b

Warnings/Precautions

Warnings

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

Sensitivity Reactions

Contact dermatitis reported following topical application of miconazole or other imidazole-derivative azole antifungals.125 126 127 128 129 130

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

Possible cross-sensitization among the imidazoles.125 126 127 128 129 130 a

General Precautions

Prior to use of ointment for adjunctive treatment of diaper dermatitis, confirm diagnosis of candidiasis with microscopic evidence of pseudohyphae and/or budding yeast.b 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.b

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.b Do not use to prevent diaper dermatitis; preventive use may result in development of drug resistance.b

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

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).b

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.100 102

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.100

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.a

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

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

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

Specific Populations

Category C.b

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.100 l

Not known whether miconazole is distributed into milk; use with caution in nursing women.a b

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

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.b (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.a e

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.b

Common Adverse Effects

Irritation, burning, itching.a b

Topical Administration

• Importance of completing full course of therapy, even if symptoms improve.d

• Importance of contacting clinician if condition worsens during treatment or if improvement does not occur after completing full course of therapy.d

• Importance of discontinuing use and consulting clinician if treated area becomes irritated (e.g., itching, burning, blistering, swelling, oozing).d

• Importance of applying topical skin preparations to affected areas as directed and avoiding contact with eyes, nose, mouth, or mucous membranes.b d

• Importance of washing hands after applying miconazole.b

• Importance of consulting a clinician before using tincture if diagnosed with diabetes, circulatory, renal, or hepatic problems.d

• For patients with tinea pedis (athlete’s foot), importance of wearing well-fitting, ventilated shoes and changing socks at least once daily.a d

• For patients with candidal diaper dermatitis, importance of using ointment only for diaper dermatitis complicated by documented candidiasis.b Not for preventative use;b should not be used as a substitute for frequent diaper changes and should not be used long term.b

• For patients with candidal diaper dermatitis, importance of gently cleansing diaper area with lukewarm water or a very mild soap and patting dry with a soft towel before applying ointment.b Importance of not rubbing ointment into skin since this may cause additional irritation.b

• Importance of not using ointment on children for whom it is not prescribed.b

Intravaginal Administration

• Importance of reading and understanding manufacturer’s patient instructions regarding use of applicator for intravaginal administration.c e

• Not for self-medication in women who have never had a vaginal yeast infection diagnosed by a clinician.c e

• Not for intravaginal self-medication in women who think they are pregnant or have been exposed to HIV, unless otherwise directed by a clinician.a c

• Importance of discontinuing self-medication of vulvovaginal candidiasis and consulting clinician if rash or hives, fever, abdominal pain, foul-smelling vaginal discharge, or flu-like symptoms (fever, chills, nausea, vomiting) develop; if symptoms do not improve within 3 days, if condition persists beyond 7 days; or if symptoms recur within 2 months.c e

• Importance of not using latex or rubber products such as condoms or vaginal contraceptive diaphragms within 72 hours following intravaginal miconazole treatment.a c

• Importance of not douching after an intravaginal dose of miconazole.c

• If used during menstruation, importance of using sanitary napkins instead of vaginal tampons.a c e

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and concomitant illnesses, including diabetes mellitus and HIV infection.a c

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

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

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

Consult your pharmacist.

How to use Miconazole Nitrate Powder

Consult your pharmacist.

Consult your pharmacist.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Missed Dose

Consult your pharmacist.

Storage

Consult your pharmacist.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.