Miconazole nitrate: Difference between revisions

Miconazole nitrate
	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

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Revision as of 19:09, 14 January 2015

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

Disclaimer

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Overview

Miconazole nitrate is an antifungal agent, anti-infective agent that is FDA approved for the treatment of candidal vulvovaginitis, tinea, superficial. 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 nitrate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Miconazole nitrate 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 nitrate in pediatric patients.

Non–Guideline-Supported Use

Indication

Diaper rash^[1]

Contraindications

There is limited information regarding Miconazole nitrate 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 nitrate in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Miconazole nitrate in the drug label.

Drug Interactions

There is limited information regarding Miconazole nitrate 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 nitrate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Miconazole nitrate during labor and delivery.

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

Oral

Intravenous

Monitoring

There is limited information regarding Monitoring of Miconazole nitrate in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Miconazole nitrate in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Miconazole nitrate in the drug label.

Pharmacology

There is limited information regarding Miconazole nitrate Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Miconazole nitrate Mechanism of Action in the drug label.

Structure

There is limited information regarding Miconazole nitrate Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Miconazole nitrate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Miconazole nitrate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Miconazole nitrate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Miconazole nitrate in the drug label.

How Supplied

Storage

There is limited information regarding Miconazole nitrate Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Miconazole nitrate |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Miconazole nitrate |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Miconazole nitrate in the drug label.

Precautions with Alcohol

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

Brand Names

There is limited information regarding Miconazole nitrate Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Miconazole nitrate 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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[pmid11358560-1] 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.

[1]

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@@ Line 20: / Line 21: @@
 * Relieves [[itching]], scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch.
+* Candidal vulvovaginitis
 ==Dosing==
-* 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.
+* 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.
-* For jock itch, use daily for 2 weeks.
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+* Candidal vulvovaginitis.
+* Tinea, Superficial
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+==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
 |offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
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+|warnings='''Do not use''':
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+* Avoid contact with eyes.
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+* For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
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@@ Line 80: / Line 76: @@
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-<!--Administration and Monitoring-->
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@@ Line 86: / Line 82: @@
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 <!--IV Compatibility-->
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-* Description
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-<!--Drug Shortage Status-->
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Miconazole nitrate: Difference between revisions

Revision as of 19:09, 14 January 2015

Disclaimer

Overview

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Dosing

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Non–Guideline-Supported Use

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indication

Dosage

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Non–Guideline-Supported Use

Indication

Contraindications

Warnings

Adverse Reactions

Clinical Trials Experience

Postmarketing Experience

Drug Interactions

Use in Specific Populations

Pregnancy

Labor and Delivery

Nursing Mothers

Pediatric Use

Geriatic Use

Gender

Race

Renal Impairment

Hepatic Impairment

Females of Reproductive Potential and Males

Immunocompromised Patients

Administration and Monitoring

Administration

Monitoring

IV Compatibility

Overdosage

Pharmacology

Mechanism of Action

Structure

Pharmacodynamics

Pharmacokinetics

Nonclinical Toxicology

Clinical Studies

How Supplied

Storage

Images

Drug Images

Package and Label Display Panel

Patient Counseling Information

Precautions with Alcohol

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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