Meningitis: What It Is and How to Avoid It Watch Video

Miconazole (Topical)


VA CLASSIFICATION
Primary: DE102
{05}
Commonly used brand name(s): Micatin; Monistat-Derm; Zeasorb-AF.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antifungal (topical)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Candidiasis, cutaneous (treatment)—Miconazole is indicated in the topical treatment of cutaneous candidiasis caused by Candida albicans . {08}

Tinea corporis (treatment)
Tinea cruris (treatment) or
Tinea pedis (treatment)—Miconazole is indicated in the topical treatment of tinea corporis (ringworm of the body), tinea cruris (ringworm of the groin; jock itch), and tinea pedis (ringworm of the foot; athlete's foot) caused by Trichophyton rubrum , T. mentagrophytes , and Epidermophyton floccosum . {08}

Tinea versicolor (treatment)—Miconazole is indicated in the topical treatment of tinea versicolor (pityriasis versicolor; ``sun fungus'') caused by Malassezia furfur (Pityrosporon orbiculare) . {08}

[Paronychia (treatment)]{01}
[Tinea barbae (treatment)] or{01}
[Tinea capitis (treatment)]—Miconazole is used in the topical treatment of paronychia, tinea barbae, and tinea capitis. {01}

—Not all species or strains of a particular organism may be susceptible to miconazole.


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    479.15 {15}

Mechanism of action/Effect:

Fungistatic; may be fungicidal, depending on concentration; inhibits biosynthesis of ergosterol or other sterols, damaging the fungal cell wall membrane and altering its permeability; as a result, loss of essential intracellular elements may occur; also inhibits biosynthesis of triglycerides and phospholipids by fungi; in addition, inhibits oxidative and peroxidative enzyme activity, resulting in intracellular buildup of toxic concentrations of hydrogen peroxide, which may contribute to deterioration of subcellular organelles and cellular necrosis. In Candida albicans , inhibits transformation of blastospores into invasive mycelial form. {18}


Precautions to Consider

Pregnancy/Reproduction

Problems in humans have not been documented.

Breast-feeding

Problems in humans have not been documented.

Pediatrics

Appropriate studies on the relationship of age to the effects of topical miconazole have not been performed in the pediatric population. However, no pediatrics-specific problems have been documented to date.


Geriatrics


Appropriate studies on the relationship of age to the effects of topical miconazole have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problem exists
Sensitivity to topical miconazole


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention {08}
    
Blistering, burning, redness, skin rash, or other sign of skin irritation not present before therapy




Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Miconazole (Topical).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to topical miconazole

Proper use of this medication
» Avoiding contact with the eyes

Applying sufficient medication to cover affected area, and rubbing in gently

Proper administration technique for topical aerosol powder, topical powder, and topical aerosol solution

» Not applying occlusive dressing over this medication unless directed to do so by physician

» Compliance with full course of therapy

» Proper dosing
Missed dose: Applying as soon as possible; not applying if almost time for next dose

» Proper storage

Precautions while using this medication
Checking with physician or pharmacist if no improvement within 4 weeks


Side/adverse effects
Signs of potential side effects, especially blistering, burning, redness, skin rash, or other sign of skin irritation not present before therapy


General Dosing Information
Use of topical antifungals may lead to skin sensitization, resulting in hypersensitivity reactions with subsequent topical or systemic use of the medication.

The lotion is preferred for use on intertriginous areas; if the cream is used, it should be used sparingly and massaged in well to avoid maceration effects. {08}

When this medication is used in the treatment of candidiasis, occlusive dressings should be avoided since they provide conditions that favor growth of yeast and release of its irritating endotoxin.

To reduce the possibility of recurrence, Candida infections, tinea cruris, and tinea corporis should be treated for 2 weeks and tinea pedis for 1 month. {08}


Topical Dosage Forms

MICONAZOLE NITRATE TOPICAL AEROSOL POWDER

Usual adult and adolescent dose
Tinea corporis or
Tinea cruris or
Tinea pedis
Topical, to the skin, two times a day, morning and evening. {12}


Usual pediatric dose
See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—


2% (OTC) [Micatin (alcohol 10%)]{12}{24}

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Shake well.
   • For external use only.
   • Continue medication for full time of treatment.
   • Store away from heat and direct sunlight.


MICONAZOLE NITRATE TOPICAL AEROSOL SOLUTION

Usual adult and adolescent dose
See Miconazole Nitrate Topical Aerosol Powder. {12}

Usual pediatric dose
See Miconazole Nitrate Topical Aerosol Powder.

Strength(s) usually available
U.S.—


2% (OTC) [Micatin (alcohol 17%)]{11}{24}

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • Shake well.
   • For external use only.
   • Continue medication for full time of treatment.
   • Store away from heat and direct sunlight.


MICONAZOLE NITRATE CREAM USP

Usual adult and adolescent dose
Candidiasis, cutaneous or
Tinea corporis or
Tinea cruris or
Tinea pedis
Topical, to the skin, two times a day, morning and evening.



Tinea versicolor {08}
Topical, to the skin, once a day.


Usual pediatric dose
See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—


2% (Rx/OTC) [Micatin] [Monistat-Derm][Generic]{08}{19}{22}{23}{24}

Canada—


2% (Rx) [Micatin] [Monistat-Derm]{09}{10}{21}

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a collapsible tube or tight container. Protect from freezing.

Auxiliary labeling:
   • For external use only.
   • Continue medication for full time of treatment.


MICONAZOLE NITRATE LOTION

Usual adult and adolescent dose
See Miconazole Nitrate Cream USP.

Usual pediatric dose
See Miconazole Nitrate Cream USP.

Strength(s) usually available
U.S.—


2% (Rx) [Monistat-Derm]{08}

Canada—


2% (Rx) [Micatin]{10}

Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • Shake well.
   • For external use only.
   • Continue medication for full time of treatment.


MICONAZOLE NITRATE TOPICAL POWDER USP

Usual adult and adolescent dose
Tinea corporis or
Tinea cruris or
Tinea pedis
See Miconazole Nitrate Topical Aerosol Powder.{12}


Usual pediatric dose
See Miconazole Nitrate Topical Aerosol Powder.

Strength(s) usually available
U.S.—


2% (OTC) [Micatin] [Zeasorb-AF]{20}{24}

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Auxiliary labeling:
   • For external use only.
   • Continue medication for full time of treatment.
   • Keep container tightly closed.
   • Keep in a dry place.



Revised: 07/25/94



References
  1. Indications Index review, 1986.
  1. Hold
  1. Micatin package insert (Advanced Care—US), Rev 83, Rec 2/86.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc, 1986: 577.
  1. VA Medication Classification System, USP DI 1989: 2472.
  1. Hold
  1. Hold
  1. Monistat-Derm (Ortho). In: PDR Physicians' desk reference. 43rd ed. 1989. Oradell, NJ: Medical Economics Company, 1989: 1516.
  1. Monistat Derm (Ortho). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 23rd ed. Ottawa: Canadian Pharmaceutical Association, 1988: 564.
  1. Micatin (McNeil). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 23rd ed. Ottawa: Canadian Pharmaceutical Association, 1988: 549.
  1. Micatin package insert (Advanced Care—US), Rec 11/88.
  1. Micatin package insert (Advanced Care—US), Rec 10/88.
  1. Hold
  1. Hold
  1. Fleeger CA, editor. USAN 1989. USAN and the USP dictionary of drug names. Rockville, MD: The United States Pharmacopeial Convention, Inc., 1989: 359.
  1. Hold
  1. Hold
  1. McEvoy GK, editor. AHFS Drug information 90. Bethesda, MD: American Society of Hospital Pharmacists, 1988: 2000.
  1. Monistat-Derm package insert (Ortho Pharm—US), Rev 1/92, Rec 7/93.
  1. Zeasorb-AF package insert (Stiefel—US), Rev 8/91, Rec 8/93.
  1. Micatin (McNeil). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 724-5.
  1. Monistat-Derm (Ortho Pharm). In: PDR Physicians' desk reference. 47th ed. 1994. Oradell, NJ: Medical Economics Data Production Company, 1994: 1710.
  1. Miconazole Nitrate (Taro). In: PDR Physicians' desk reference. 47th ed. 1994. Oradell, NJ: Medical Economics Data Production Company, 1994: 2388.
  1. Micatin (Ortho Pharm). In: PDR Physicians' desk reference for nonprescription drugs. 14th ed. 1993. Montvale, NJ: Medical Economics Data Production Co, 1993: 106.
Hide
(web5)