Clotrimazole (mucous membrane): Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{SS}}
|authorTag={{SS}}
|OTC=Yes
|genericName=Clotrimazole
|genericName=Clotrimazole
|aOrAn=an
|aOrAn=an
|drugClass=Azole Antifungal
|drugClass=azole antifungal
|indicationType=treatment
|indicationType=treatment
|indication=[[tinea pedis]], [[tinea cruris]], [[tinea corporis]]
|indication=[[tinea pedis]], [[tinea cruris]] and [[tinea corporis]]
|adverseReactions=[[Nausea]], [[Vomiting]]
|adverseReactions=[[nausea]] and [[vomiting]]
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
Line 12: Line 13:


* Dosing information
* Dosing information
:* Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.
:* Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For [[athlete's foot]] and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Clotrimazole in adult patients.
|offLabelAdultGuideSupport=* There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of clotrimazole in adult patients.
|offLabelAdultNoGuideSupport=<h4>[[Candidal vulvovaginitis]]</h4>
|offLabelAdultNoGuideSupport=<h4>Candidal vulvovaginitis</h4>


* Dosing information
* Dosing information
:* '''0.5 grams administered once weekly for 2 weeks'''<ref name="pmid2644595">{{cite journal| author=Sobel JD, Schmitt C, Meriwether C| title=Clotrimazole treatment of recurrent and chronic candida vulvovaginitis. | journal=Obstet Gynecol | year= 1989 | volume= 73 | issue= 3 Pt 1 | pages= 330-4 | pmid=2644595 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=2644595  }} </ref>
:* '''0.5 grams administered once weekly for 2 weeks'''<ref name="pmid2644595">{{cite journal| author=Sobel JD, Schmitt C, Meriwether C| title=Clotrimazole treatment of recurrent and chronic candida vulvovaginitis. | journal=Obstet Gynecol | year= 1989 | volume= 73 | issue= 3 Pt 1 | pages= 330-4 | pmid=2644595 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=2644595  }} </ref>
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Clotrimazole in pediatric patients.
|fdaLIADPed=* There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Clotrimazole in pediatric patients.
|offLabelPedGuideSupport=* There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of clotrimazole in pediatric patients.
|contraindications=Hypersensitivity to clotrimazole.
|offLabelPedNoGuideSupport=* There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of clotrimazole in pediatric patients.
|warnings=For exteranl use only.
|contraindications=[[Hypersensitivity]] to clotrimazole.
|warnings=* For exteranl use only.


If swallowed, get medical help or contact a Poison Control Center right away.
* If swallowed, get medical help or contact a Poison Control Center right away.


Do not use on children under 2 years of age unless directed by a doctor.
* Do not use on children under 2 years of age unless directed by a doctor.


Avoid contact with the eyes.
* Avoid contact with the eyes.


If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor.
* If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor.


Keep out of reach of children
* Keep out of reach of children
|clinicalTrials=Common gastrointestinal: [[nausea]], [[vomiting]].
|clinicalTrials=* Common gastrointestinal: [[nausea]], [[vomiting]].
|postmarketing=FDA Package Insert for Allopurinol contains no information regarding Postmarketing experience.
|postmarketing=* FDA package insert for clotrimazole contains no information regarding Post marketing experience.
|administration=For exteranl use only.
|useInLaborDelivery=* There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|monitoring=FDA Package Insert for Clotrimazole contains no information regarding Drug Monitoring.
|useInNursing=* There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|IVCompat=There is limited information about the IV Compatibility.
|useInPed=* There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|alcohol=Alcohol-Clotrimazole interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|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=* For exteranl use only.
|monitoring=* FDA package insert for clotrimazole contains no information regarding drug monitoring.
|IVCompat=* There is limited information about the IV compatibility.
|drugBox={{Drugbox2
| Watchedfields = changed
| verifiedrevid = 464366359
| IUPAC_name = 1-[(2-Chlorophenyl)(diphenyl)methyl]-1''H''-imidazole
| image = Clotrimazole.png
| width = 200
| image2 = Clotrimazole-xtal-3D-balls.png
 
<!--Clinical data-->
| tradename = Lotrimin, Desenex, Canesten
| Drugs.com = {{drugs.com|monograph|clotrimazole}}
| MedlinePlus = a682753
| pregnancy_AU = A
| pregnancy_category = C (oral) and B (topical) <small>([[United States|US]])</small>
| legal_US = OTC (topical), prescription (oral)
| routes_of_administration = [[topical]], [[troche]]
 
<!--Pharmacokinetic data-->
| bioavailability = Poor oral absorption (troche), negligible absorption through intact skin (topical)
| protein_bound = 90%
| metabolism = [[hepatic]]
| elimination_half-life = 2 hours
 
<!--Identifiers-->
| CASNo_Ref = {{cascite|correct|CAS}}
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number = 23593-75-1
| ATC_prefix = A01
| ATC_suffix = AB18
| ATC_supplemental =  {{ATC|D01|AC01}} {{ATC|G01|AF02}} {{ATCvet|J02|AB90}}
| PubChem = 2812
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = DB00257
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
| ChemSpiderID = 2710
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = G07GZ97H65
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D00282
| ChEBI_Ref = {{ebicite|correct|EBI}}
| ChEBI = 3764
| ChEMBL_Ref = {{ebicite|correct|EBI}}
| ChEMBL = 104
 
<!--Chemical data-->
| C=22 | H=17 | Cl=1 | N=2
| molecular_weight = 344.837 g/mol
| smiles = Clc1ccccc1C(c2ccccc2)(c3ccccc3)n4ccnc4
| InChI = 1/C22H17ClN2/c23-21-14-8-7-13-20(21)22(25-16-15-24-17-25,18-9-3-1-4-10-18)19-11-5-2-6-12-19/h1-17H
| InChIKey = VNFPBHJOKIVQEB-UHFFFAOYAO
| StdInChI_Ref = {{stdinchicite|correct|chemspider}}
| StdInChI = 1S/C22H17ClN2/c23-21-14-8-7-13-20(21)22(25-16-15-24-17-25,18-9-3-1-4-10-18)19-11-5-2-6-12-19/h1-17H
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
| StdInChIKey = VNFPBHJOKIVQEB-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.
|fdaPatientInfo=* There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
|alcohol=* Alcohol-Clotrimazole interaction has not been established. Talk to your doctor about the effects of taking [[alcohol]] with this medication.
|brandNames=3 Day Vaginal Cream
|brandNames=3 Day Vaginal Cream
Clotrim Antifungal
Clotrim Antifungal
Line 50: Line 122:
|fileName=Clotrimazole_label_01.jpg
|fileName=Clotrimazole_label_01.jpg
}}
}}
{{LabelImage
 
|fileName=Clotrimazole_panel_01.png
[[Category:Drug]]
}}

Latest revision as of 19:20, 18 August 2015

Clotrimazole (mucous membrane)
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: Sheng Shi, 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

Clotrimazole (mucous membrane) is an azole antifungal that is FDA approved for the treatment of tinea pedis, tinea cruris and tinea corporis. Common adverse reactions include nausea and vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Anti-Fungal

  • Dosing information
  • Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

  • There is limited information regarding Off-Label Guideline-Supported Use of clotrimazole in adult patients.

Non–Guideline-Supported Use

Candidal vulvovaginitis

  • Dosing information
  • 0.5 grams administered once weekly for 2 weeks[1]

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

  • There is limited information regarding FDA-Labeled Use of Clotrimazole (mucous membrane) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

  • There is limited information regarding Off-Label Guideline-Supported Use of clotrimazole in pediatric patients.

Non–Guideline-Supported Use

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

Contraindications

Hypersensitivity to clotrimazole.

Warnings

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

Adverse Reactions

Clinical Trials Experience

Postmarketing Experience

  • FDA package insert for clotrimazole contains no information regarding Post marketing experience.

Drug Interactions

There is limited information regarding Clotrimazole (mucous membrane) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Clotrimazole (mucous membrane) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Clotrimazole (mucous membrane) in women who are pregnant.

Labor and Delivery

  • There is no FDA guidance on use of Clotrimazole (mucous membrane) during labor and delivery.

Nursing Mothers

  • There is no FDA guidance on the use of Clotrimazole (mucous membrane) with respect to nursing mothers.

Pediatric Use

  • There is no FDA guidance on the use of Clotrimazole (mucous membrane) with respect to pediatric patients.

Geriatic Use

  • There is no FDA guidance on the use of Clotrimazole (mucous membrane) with respect to geriatric patients.

Gender

  • There is no FDA guidance on the use of Clotrimazole (mucous membrane) with respect to specific gender populations.

Race

  • There is no FDA guidance on the use of Clotrimazole (mucous membrane) with respect to specific racial populations.

Renal Impairment

  • There is no FDA guidance on the use of Clotrimazole (mucous membrane) in patients with renal impairment.

Hepatic Impairment

  • There is no FDA guidance on the use of Clotrimazole (mucous membrane) in patients with hepatic impairment.

Females of Reproductive Potential and Males

  • There is no FDA guidance on the use of Clotrimazole (mucous membrane) in women of reproductive potentials and males.

Immunocompromised Patients

  • There is no FDA guidance one the use of Clotrimazole (mucous membrane) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • For exteranl use only.

Monitoring

  • FDA package insert for clotrimazole contains no information regarding drug monitoring.

IV Compatibility

  • There is limited information about the IV compatibility.

Overdosage

There is limited information regarding Clotrimazole (mucous membrane) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Template:Px
Template:Px
Clotrimazole (mucous membrane)
Systematic (IUPAC) name
1-[(2-Chlorophenyl)(diphenyl)methyl]-1H-imidazole
Identifiers
CAS number 23593-75-1
ATC code A01AB18 D01AC01 (WHO) G01AF02 (WHO) Template:ATCvet
PubChem 2812
DrugBank DB00257
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 344.837 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability Poor oral absorption (troche), negligible absorption through intact skin (topical)
Protein binding 90%
Metabolism hepatic
Half life 2 hours
Excretion ?
Therapeutic considerations
Pregnancy cat.

A(AU) C (oral) and B (topical) (US)

Legal status

?(US)

Routes topical, troche

Mechanism of Action

There is limited information regarding Clotrimazole (mucous membrane) Mechanism of Action in the drug label.

Structure

There is limited information regarding Clotrimazole (mucous membrane) Structure in the drug label.

Pharmacodynamics

  • There is limited information regarding Pharmacodynamics of Clotrimazole (mucous membrane) in the drug label.

Pharmacokinetics

  • There is limited information regarding Pharmacokinetics of Clotrimazole (mucous membrane) in the drug label.

Nonclinical Toxicology

  • There is limited information regarding Nonclinical Toxicology of Clotrimazole (mucous membrane) in the drug label.

Clinical Studies

  • There is limited information regarding Clinical Studies of Clotrimazole (mucous membrane) in the drug label.

How Supplied

There is limited information regarding Clotrimazole (mucous membrane) How Supplied in the drug label.

Storage

There is limited information regarding Clotrimazole (mucous membrane) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Clotrimazole (mucous membrane) |?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::Clotrimazole (mucous membrane) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

  • There is limited information regarding Patient Counseling Information of Clotrimazole (mucous membrane) in the drug label.

Precautions with Alcohol

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

Brand Names

3 Day Vaginal Cream Clotrim Antifungal Cruex Prescription Strength Gyne-Lotrimin Gyne-Lotrimin 3 Lotrimin Lotrimin AF Mycelex

Look-Alike Drug Names

There is limited information regarding Clotrimazole (mucous membrane) 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. ↑ Sobel JD, Schmitt C, Meriwether C (1989). "Clotrimazole treatment of recurrent and chronic candida vulvovaginitis". Obstet Gynecol. 73 (3 Pt 1): 330–4. PMID 2644595.

{{#subobject: 

 |Label Page=Clotrimazole (mucous membrane)
 |Label Name=Clotrimazole_label_01.jpg

}}

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