Miconazole (topical)
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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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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.
- Candidal vulvovaginitis
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
- Diaper rash[1]
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
- 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
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.
- ↑ 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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