Miconazole (topical): Difference between revisions

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

VisualWikitext

Latest revision as of 16:43, 20 August 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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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

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



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 atom Template:OrganicBox atom Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox atom Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox atom Template:OrganicBox Template:OrganicBox atom Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template: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

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

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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[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]

@@ Line 1: / Line 1: @@
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+|authorTag={{KS}}
+|OTC=Yes
+|genericName=Miconazole nitrate
+|aOrAn=an
+|drugClass=antifungal agent,
 |indicationType=treatment
-|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
+|indication=candidal vulvovaginitis, [[tinea]]
-|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
+|adverseReactions=[[contact dermatitis]]
-|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Miconazole (topical) in adult patients.
+|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
-|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Miconazole (topical) in adult patients.
+|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
-|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Miconazole (topical) in pediatric patients.
-|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Miconazole (topical) in pediatric patients.
+* Content
-|alcohol=Alcohol-Miconazole (topical) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
+<!--Adult Indications and Dosage-->
+<!--FDA-Labeled Indications and Dosage (Adult)-->
+|fdaLIADAdult===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.
+|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
+|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
+|fdaLIADPed===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
+|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
+|offLabelPedNoGuideSupport===Indication==
+* Diaper rash<ref name="pmid11358560">{{cite journal| author=Concannon P, Gisoldi E, Phillips S, Grossman R| title=Diaper dermatitis: a therapeutic dilemma. Results of a double-blind placebo controlled trial of miconazole nitrate 0.25%. | journal=Pediatr Dermatol | year= 2001 | volume= 18 | issue= 2 | pages= 149-55 | pmid=11358560 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=11358560  }} </ref>
+|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.
+|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
+|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
+|useInPregnancyFDA=*
+|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
+There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
+|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
+|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
+|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
+|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
+|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
+|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
+|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
+|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
+|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
+|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
+|administration=* Topical
+|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
+|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
+|overdose=There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
+|drugBox={{Drugbox2
+| Watchedfields = changed
+| verifiedrevid = 461740624
+| IUPAC_name = (''RS'')-1-(2-(2,4-Dichlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl)-1''H''-imidazole
+| image = Miconazole2DCSD.png
+| width = 200px
+| image2 = Miconazole ball-and-stick.png
+| width2 = 200px
+| imagename = 1 : 1 mixture (racemate)
+| drug_name = Miconazole
+<!--Clinical data-->
+| tradename = Desenex, Monistat, Zeasorb-AF
+| Drugs.com = {{drugs.com|monograph|miconazole-nitrate}}
+| MedlinePlus = a601203
+| pregnancy_AU = A
+| pregnancy_US = C
+| pregnancy_category = In Australia, it is category A when used topically. In the US, the pregnancy category is C for oral and topical treatment.
+| legal_AU = S2
+| legal_CA =
+| legal_UK = POM
+| legal_US = OTC
+| legal_status =  Schedule 2 in Australia for topical formulations, schedule 3 (Aus) for vaginal use and for oral [[candidiasis]], otherwise schedule 4 in Australia
+| routes_of_administration = [[topical]], [[vaginal]]
+<!--Pharmacokinetic data-->
+| bioavailability = n/a
+| metabolism = n/a
+| elimination_half-life = n/a
+| excretion = n/a
+<!--Identifiers-->
+| CASNo_Ref = {{cascite|correct|CAS}}
+| CAS_number_Ref = {{cascite|correct|??}}
+| CAS_number = 22916-47-8
+| ATC_prefix = A01
+| ATC_suffix = AB09
+| ATC_supplemental = {{ATC|A07|AC01}} {{ATC|D01|AC02}} {{ATC|G01|AF04}} {{ATC|J02|AB01}} {{ATC|S02|AA13}}
+| PubChem = 4189
+| IUPHAR_ligand = 2449
+| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
+ | DrugBank = DB01110
+| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
+| ChemSpiderID = 4044
+| UNII_Ref = {{fdacite|correct|FDA}}
+| UNII = 7NNO0D7S5M
+| KEGG_Ref = {{keggcite|correct|kegg}}
+| KEGG = D00416
+| ChEBI_Ref = {{ebicite|correct|EBI}}
+| ChEBI = 6923
+| ChEMBL_Ref = {{ebicite|correct|EBI}}
+| ChEMBL = 91
+<!--Chemical data-->
+| C=18 | H=14 | Cl=4 | N=2 | O=1
+| molecular_weight = 416.127 g/mol
+| smiles = Clc1ccc(c(Cl)c1)C(OCc2ccc(Cl)cc2Cl)Cn3ccnc3
+| InChI = 1/C18H14Cl4N2O/c19-13-2-1-12(16(21)7-13)10-25-18(9-24-6-5-23-11-24)15-4-3-14(20)8-17(15)22/h1-8,11,18H,9-10H2
+| InChIKey = BYBLEWFAAKGYCD-UHFFFAOYAA
+| StdInChI_Ref = {{stdinchicite|correct|chemspider}}
+| StdInChI = 1S/C18H14Cl4N2O/c19-13-2-1-12(16(21)7-13)10-25-18(9-24-6-5-23-11-24)15-4-3-14(20)8-17(15)22/h1-8,11,18H,9-10H2
+| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
+| StdInChIKey = BYBLEWFAAKGYCD-UHFFFAOYSA-N
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+|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
+|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
+|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
+|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
+|storage=* Protect from freezing. Avoid excessive heat.
+|fdaPatientInfo=* 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.
+|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
+|brandNames=Miconazole
+|drugShortage=
+}}
+{{PillImage
+|fileName=No image.jpg
+}}
+{{LabelImage
+|fileName=Miconazole ingredients and appearance.png
+}}
+{{LabelImage
+|fileName=Miconazole nitrate.jpg
+}}
+<!--Pill Image-->
+<!--Label Display Image-->
+<!--Category-->
+[[Category:Ethers]]
+[[Category:Drug]]

Miconazole (topical): Difference between revisions

Latest revision as of 16:43, 20 August 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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