Miconazole Nitrate

Name: Miconazole Nitrate

Introduction

Antifungal; azole (imidazole derivative).a

Miconazole Nitrate Dosage and Administration

Administration

Administer topically to skin or intravaginally in appropriate formulations.a

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

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

Topical Administration

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

Do not use on the scalp or nails.a d e f g

Wash hands after applying.b

Shake sprays and lotions well before using.a g h f

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

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

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

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

Intravaginal Topical Administration

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

Use for self-medication only in otherwise healthy, nonpregnant women with recurrent vulvovaginal candidiasis who were previously diagnosed by a clinician.100 c e

Dosage

Pediatric Patients

Dermatophytoses Tinea Corporis or Tinea Cruris Topical

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

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

Tinea Pedis Topical

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

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

Pityriasis (Tinea) Versicolor† Topical

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

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

Cutaneous Candidiasis Topical

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

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

Diaper Dermatitis Topical

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

Continue treatment for 7 days, even if improved.b

Ointment is not a substitute for frequent diaper changes;b do not use for prevention of diaper dermatitis.b (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.100 a Alternatively, applicatorful of 2% intravaginal cream once daily at bedtime for 7 days.100 a May be used for self-medication.100 a

If clinical symptoms do not improve within 3 days, persist for >7 days, or recur within 2 months, discontinue self-medicationand consult a clinician.a Confirm diagnosis and rule out other pathogens and conditions that may predispose a patient to recurrent vaginal fungal infections.100

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.a e

HIV-infected Adolescents Intravaginal

Use same regimen recommended for other patients.100 k Some experts recommend a duration of 3–7 days.k Maintenance regimen of an intravaginal azole can be considered for those with recurrent episodes;k routine primary or secondary prophylaxis (long-term suppressive or chronic maintenance therapy) not recommended.100 k

Complicated Vulvovaginal Candidiasis Recurrent Vulvovaginal Infections Caused by Candida albicans Intravaginal

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).100 j l

Other Complicated Vulvovaginal Infections Intravaginal

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.100 l

Adults

Dermatophytoses Tinea Corporis or Tinea Cruris Topical

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

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

Tinea Pedis Topical

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

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

Pityriasis (Tinea) Versicolor† Topical

Apply once daily for 2 weeks.a

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

Cutaneous Candidiasis Topical

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

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

Uncomplicated Vulvovaginal Candidiasis Intravaginal

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

If clinical symptoms do not improve within 3 days, persist for >7 days, or recur within 2 months, discontinue self-medicationand consult a clinician.a Confirm diagnosis and rule out other pathogens and conditions that may predispose a patient to recurrent vaginal fungal infections.100

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.a e

HIV-Infected Adults Intravaginal

Use same regimen recommended for other patients.100 k Some experts recommend a duration of 3–7 days.k Maintenance regimen of an intravaginal azole can be considered for those with recurrent episodes;k routine primary or secondary prophylaxis (long-term suppressive or chronic maintenance therapy) not recommended.100 k

Complicated Vulvovaginal Candidiasis 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 an appropriate maintenance regimen (6-month regimen of once-weekly oral fluconazole or, alternatively, an intravaginal azole given intermittently).100 j l

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.100 l

Pregnant women: CDC and others recommend a 7-day regimen of an intravaginal azole antifungal (e.g., miconazole).100 l

Prescribing Limits

Pediatric Patients

Diaper Dermatitis Topical

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

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.a

Renal Impairment

No specific dosage recommendations at this time.a

Geriatric Patients

No specific dosage recommendations at this time.a

Interactions for Miconazole Nitrate

Weak inhibitor of CYP2C9.133 134

Drugs Metabolized by Hepatic Microsomal Enzymes

Drugs metabolized by CYP2C9: possible increased plasma concentrations.133 134

Specific Drugs

Drug

Interaction

Comments

Warfarin

Potential for increased plasma warfarin concentrations with intravaginal miconazole133 134

Potential for interaction with miconazole applied topically to skin is unknownb

Do not use intravaginal miconazole forself-medication if taking warfarin132 133 134 c

Miconazole Nitrate Pharmacokinetics

Absorption

Bioavailability

Minimal systemic absorption following topical application to skin.a b

Only small amounts absorbed systemically following intravaginal administration.a

Distribution

Extent

Not known whether systemically absorbed miconazole is distributed into milk.a

Elimination

Elimination Route

Following intravaginal administration, systemically absorbed drug excreted in urine and feces (1% of dose).a

Stability

Storage

Topical

Ointment

20–25°C (may be exposed to 15–30°C).b

Aerosol

2–30°C (Lotrimin AF);f 20–25°C (Desenex).g Do not use near fire or flame; do not expose to temperatures >49°C.f g

Aerosol Powder

2–30°C.h

Cream, Lotion, and Powder

Tight container at 15–30°C.a

Tincture

Protect from freezing; if crystals form, leave at room temperature for 2 days or immerse bottle in warm water for 6 hours until crystals dissolve, then shake well.d

Intravaginal

Cream

15–30°C.a

Suppository

20–25°C.e

Actions and Spectrum

  • Imidazole-derivative azole antifungal.a

  • Usually fungistatic in action; can be fungicidal at high concentrations or against very susceptible organisms (e.g., Candida).a

  • Presumably exerts its antifungal activity by altering cellular membranes, resulting in increased membrane permeability.a Interferes with ergosterol biosynthesis.b

  • Spectrum of antifungal activity includes many fungi, including yeasts and dermatophytes.a Also has in vitro activity against some gram-positive bacteria.a

  • Candida: Active against Candida albicans,a b C. guilliermondii,a and C. tropicalis.a

  • Dermatophytes and other fungi: Active against Epidermophyton floccosum, Microsporum canis, Trichophyton mentagrophytes, and T. rubrum.a

  • Bacteria: Active against Staphylococcus aureus.a

  • Cross-resistance can occur among the azole antifungals.

Side Effects

Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

List Miconazole Nitrate Powder side effects by likelihood and severity.

Precautions

Consult your pharmacist.

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