Miconazole (topical)

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Miconazole (topical)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

Miconazole (topical) is an antifungal agent, that is FDA approved for the treatment of candidal vulvovaginitis, tinea. Common adverse reactions include contact dermatitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • For treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), ringworm (tinea corporis).
  • For the treatment of superficial skin infections caused by Yeast (Candida Albicans).
  • Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch.

Dosing

  • Candidal vulvovaginitis: (suppository) 200 mg intravaginally at bedtime for 3 days OR 100 mg intravaginally at bedtime for 7 days OR 1200 mg intravaginally once.
  • Candidal vulvovaginitis: (cream) insert 1 applicatorful (5 g) of 2% cream intravaginally daily for 7 days, or 1 applicatorful (5 g) of 4% cream intravaginally daily for 3 days.
  • Candidal vulvovaginitis: (HIV patients, duration) uncomplicated cases, 3 to 7 days; severe or recurrent, 7 or more days.
  • Tinea, Superficial: apply topically to affected areas twice daily.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Miconazole (topical) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Miconazole (topical) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indication

  • Candidal vulvovaginitis.
  • Tinea, Superficial

Dosage

  • Candidal vulvovaginitis: 12 yr and older, 200 mg vaginally at bedtime for 3 days.
  • Candidal vulvovaginitis: 12 yr and older, 100 mg vaginally at bedtime for 7 days.
  • Candidal vulvovaginitis: 12 yr and older, 1200 mg vaginally once.
  • Tinea, Superficial: (2 yr and older) apply topically to affected areas twice daily

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Miconazole (topical) in pediatric patients.

Non–Guideline-Supported Use

Indication

Contraindications

There is limited information regarding Miconazole (topical) Contraindications in the drug label.

Warnings

Do not use:

  • Do not use on children under 2 years of age unless directed by a doctor.
  • Avoid contact with eyes.
  • For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
  • For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Miconazole (topical) in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Miconazole (topical) in the drug label.

Drug Interactions

There is limited information regarding Miconazole (topical) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Miconazole (topical) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Miconazole (topical) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Miconazole (topical) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Miconazole (topical) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Miconazole (topical) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Miconazole (topical) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Miconazole (topical) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Miconazole (topical) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Miconazole (topical) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Miconazole (topical) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Miconazole (topical) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Topical

Monitoring

There is limited information regarding Monitoring of Miconazole (topical) in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Miconazole (topical) in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Miconazole (topical) in the drug label.

Pharmacology

Template:Px
Template:Px
1 : 1 mixture (racemate)Miconazole
Systematic (IUPAC) name
(RS)-1-(2-(2,4-Dichlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl)-1H-imidazole
Identifiers
CAS number 22916-47-8
ATC code A01AB09 A07AC01 (WHO) D01AC02 (WHO) G01AF04 (WHO) J02AB01 (WHO) S02AA13 (WHO)
PubChem 4189
DrugBank DB01110
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 416.127 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability n/a
Metabolism n/a
Half life n/a
Excretion n/a
Therapeutic considerations
Pregnancy cat.

A(AU) C(US) In Australia, it is category A when used topically. In the US, the pregnancy category is C for oral and topical treatment.

Legal status

Pharmacy Only (S2)(AU) POM(UK) OTC(US) Schedule 2 in Australia for topical formulations, schedule 3 (Aus) for vaginal use and for oral candidiasis, otherwise schedule 4 in Australia

Routes topical, vaginal

Mechanism of Action

There is limited information regarding Miconazole (topical) Mechanism of Action in the drug label.

Structure

There is limited information regarding Miconazole (topical) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Miconazole (topical) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Miconazole (topical) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Miconazole (topical) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Miconazole (topical) in the drug label.

How Supplied

There is limited information regarding Miconazole (topical) How Supplied in the drug label.

Storage

  • Protect from freezing. Avoid excessive heat.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

  • Clean the affected area and dry thoroughly. Apply a layer of cream over affected area twice daily (morning and night) or as directed by a doctor.
  • For athlete's foot and ringworm, use daily for 4 weeks.
  • For jock itch, use daily for 2 weeks.
  • For athlete's foot, pay special attention to spaces between toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily.

KEEP OUT OF REACH OF CHILDREN

  • If swallowed get medical help or contact a Poison Control Center.

Precautions with Alcohol

  • Alcohol-Miconazole (topical) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Miconazole

Look-Alike Drug Names

There is limited information regarding Miconazole (topical) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Concannon P, Gisoldi E, Phillips S, Grossman R (2001). "Diaper dermatitis: a therapeutic dilemma. Results of a double-blind placebo controlled trial of miconazole nitrate 0.25%". Pediatr Dermatol. 18 (2): 149–55. PMID 11358560.

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