Miconazole nitrate: Difference between revisions

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{{DrugProjectFormSinglePage
#REDIRECT[[Miconazole (topical)]]
|authorTag={{KS}}
|OTC=Yes
|genericName=Miconazole nitrate
|aOrAn=an
|drugClass=antifungal agent,
|indicationType=treatment
|indication=candidal vulvovaginitis, [[tinea]]
|adverseReactions=[[contact dermatitis]]
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
 
* Content
 
<!--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
}}
|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:Drug]]

Latest revision as of 23:06, 25 May 2015