Crotamiton: Difference between revisions

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|indicationType=treatment
|indicationType=treatment
|indication=scabies (sarcoptes scabiei) and for symptomatic treatment of pruritic skin
|indication=scabies (sarcoptes scabiei) and for symptomatic treatment of pruritic skin
|hasBlackBoxWarning=Yes
|adverseReactions=dermatitis, skin irritation
|adverseReactions=dermatitis, skin irritation
|blackBoxWarningTitle=Title
|blackBoxWarningTitle=Title
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:* Thoroughly massage into the skin of the whole body from the chin down, paying particular attention to all folds and creases. A second application is advisable 24 hours later. Clothing and bed linen should be changed the next morning. A cleansing bath should be taken 48 hours after the last application.
:* Thoroughly massage into the skin of the whole body from the chin down, paying particular attention to all folds and creases. A second application is advisable 24 hours later. Clothing and bed linen should be changed the next morning. A cleansing bath should be taken 48 hours after the last application.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Crotamiton in adult patients.
|offLabelAdultNoGuideSupport======Pediculosis capitis=====
|offLabelAdultNoGuideSupport======Pediculosis capitis=====


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:* Dosage
:* Dosage
 
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Crotamiton in pediatric patients.
|contraindications=* Condition1
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Crotamiton in pediatric patients.
 
|contraindications=Eurax should not be applied topically to patients who develop a sensitivity or are allergic to it or who manifest a primary irritation response to topical medications.
<!--Warnings-->
|warnings=*If severe irritation or sensitization develops, treatment with this product should be discontinued and appropriate therapy instituted.
|warnings=* Description


====Precautions====
====Precautions====


* Description
'''General'''
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
 
=====Body as a Whole=====
 
 
 
 
=====Cardiovascular=====
 
 
 
 
=====Digestive=====
 
 
 
 
=====Endocrine=====
 
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
 
=====Metabolic and Nutritional=====
 
 


 
*Eurax should not be applied in the eyes or mouth because it may cause irritation. It should not be applied to acutely inflamed skin or raw or weeping surfaces until the acute inflammation has subsided.
=====Musculoskeletal=====
|clinicalTrials=*Primary irritation reactions, such as dermatitis, pruritus, and rash, and allergic sensitivity reactions have been reported in a few patients.
 
|drugInteractions=*None known.
 
|FDAPregCat=C
 
|useInPregnancyFDA=*Animal reproduction studies have not been conducted with Eurax. It is also not known whether Eurax can cause fetal harm when applied topically to a pregnant woman or can affect reproduction capacity. Eurax should be given to a pregnant woman only if clearly needed.
 
=====Neurologic=====
 
 
 
 
=====Respiratory=====
 
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
 
=====Special Senses=====
 
 
 
 
=====Urogenital=====
 
 
 
 
=====Miscellaneous=====
 
 
 
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
 
=====Body as a Whole=====
 
 
 
=====Cardiovascular=====
 
 
 
=====Digestive=====
 
 
 
=====Endocrine=====
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
=====Metabolic and Nutritional=====
 
 
 
=====Musculoskeletal=====
 
 
 
=====Neurologic=====
 
 
 
=====Respiratory=====
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
=====Special Senses=====
 
 
 
=====Urogenital=====
 
 
 
=====Miscellaneous=====
 
 
 
<!--Drug Interactions-->
|drugInteractions=* Drug
:* Description
 
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''


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|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|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.
|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.
|useInPed=*Safety and effectiveness in pediatric patients have not been established.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGeri=*Clinical studies with Eurax (crotamiton USP) Lotion/Cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|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.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
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     Clothing and bed linen should be changed the next day. Contaminated clothing and bed linen may be dry-cleaned, or washed in the hot cycle of the washing machine.
     Clothing and bed linen should be changed the next day. Contaminated clothing and bed linen may be dry-cleaned, or washed in the hot cycle of the washing machine.
     A cleansing bath should be taken 48 hours after the last application
     A cleansing bath should be taken 48 hours after the last application
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


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<!--Nonclinical Toxicology-->
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
|nonClinToxic='''Carcinogenesis and Mutagenesis and Impairment of Fertility'''


<!--Clinical Studies-->
*Long-term carcinogenicity studies in animals have not been conducted.
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.


Revision as of 20:57, 3 October 2014

Crotamiton
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: Deepika Beereddy, MBBS [2]

Disclaimer

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Overview

Crotamiton is a pesticide that is FDA approved for the treatment of scabies (sarcoptes scabiei) and for symptomatic treatment of pruritic skin. Common adverse reactions include dermatitis, skin irritation.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • For eradication of scabies (Sarcoptes scabiei) and for symptomatic treatment of pruritic skin.
Pruritus of skin
  • Dosing Information
  • Massage gently into affected areas until medication is completely absorbed. Repeat as needed.
  • LOTION: Shake well before using.
Scabies
  • Dosing Information
  • Thoroughly massage into the skin of the whole body from the chin down, paying particular attention to all folds and creases. A second application is advisable 24 hours later. Clothing and bed linen should be changed the next morning. A cleansing bath should be taken 48 hours after the last application.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

Pediculosis capitis
  • Dosing Information
  • Dosage

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Crotamiton FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

Eurax should not be applied topically to patients who develop a sensitivity or are allergic to it or who manifest a primary irritation response to topical medications.

Warnings

  • If severe irritation or sensitization develops, treatment with this product should be discontinued and appropriate therapy instituted.

Precautions

General

  • Eurax should not be applied in the eyes or mouth because it may cause irritation. It should not be applied to acutely inflamed skin or raw or weeping surfaces until the acute inflammation has subsided.

Adverse Reactions

Clinical Trials Experience

  • Primary irritation reactions, such as dermatitis, pruritus, and rash, and allergic sensitivity reactions have been reported in a few patients.

Postmarketing Experience

There is limited information regarding Crotamiton Postmarketing Experience in the drug label.

Drug Interactions

  • None known.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

  • Animal reproduction studies have not been conducted with Eurax. It is also not known whether Eurax can cause fetal harm when applied topically to a pregnant woman or can affect reproduction capacity. Eurax should be given to a pregnant woman only if clearly needed.


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Crotamiton in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

  • Safety and effectiveness in pediatric patients have not been established.

Geriatic Use

  • Clinical studies with Eurax (crotamiton USP) Lotion/Cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

In Scabies: Thoroughly massage into the skin of the whole body from the chin down, paying particular attention to all folds and creases. A second application is advisable 24 hours later. Clothing and bed linen should be changed the next morning. A cleansing bath should be taken 48 hours after the last application.

In Pruritus: Massage gently into affected areas until medication is completely absorbed. Repeat as needed.

LOTION: Shake well before using.

DIRECTIONS FOR PATIENTS WITH SCABIES: 

   Take a routine bath or shower. Thoroughly massage Eurax cream or lotion into the skin from the chin to the toes including folds and creases.
   Put Eurax cream or lotion under fingernails after trimming the fingernails short, because scabies are very likely to remain there. A toothbrush can be used to apply the Eurax cream or lotion under the fingernails. Immediately after use, the toothbrush should be wrapped in paper and thrown away. Use of the same brush in the mouth could lead to poisoning.
   A second application is advisable 24 hours later.
   A 60 gram tube or bottle is sufficient for two applications.
   Clothing and bed linen should be changed the next day. Contaminated clothing and bed linen may be dry-cleaned, or washed in the hot cycle of the washing machine.
   A cleansing bath should be taken 48 hours after the last application

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

There is limited information regarding Crotamiton Pharmacology in the drug label.

Mechanism of Action

Structure

File:Crotamiton01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

Carcinogenesis and Mutagenesis and Impairment of Fertility

  • Long-term carcinogenicity studies in animals have not been conducted.

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Crotamiton Storage in the drug label.

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

Eurax

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "http://www.ismp.org". External link in |title= (help)

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