Crotamiton: Difference between revisions

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|drugClass=pesticide
|drugClass=pesticide
|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
|adverseReactions=dermatitis, skin irritation
|adverseReactions=[[dermatitis]], skin irritation
|blackBoxWarningTitle=Title
|blackBoxWarningTitle=Title
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
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<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult=*For eradication of scabies (Sarcoptes scabiei) and for symptomatic treatment of pruritic skin.
|fdaLIADAdult=*For eradication of [[scabies]] (Sarcoptes scabiei) and for symptomatic treatment of pruritic skin.


=====Pruritus of skin=====
=====Pruritus of skin=====
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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.
|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.
|offLabelPedGuideSupport=*There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Crotamiton in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Crotamiton in pediatric patients.
|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.
|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.
|warnings=*If severe irritation or sensitization develops, treatment with this product should be discontinued and appropriate therapy instituted.


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*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.
*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.
|clinicalTrials=*Primary irritation reactions, such as dermatitis, pruritus, and rash, and allergic sensitivity reactions have been reported in a few patients.
|clinicalTrials=*Primary irritation reactions, such as [[dermatitis]], [[pruritus]], and [[rash]], and allergic sensitivity reactions have been reported in a few patients.
|drugInteractions=*None known.
|drugInteractions=*None known.
|FDAPregCat=C
|FDAPregCat=C
Line 52: Line 52:
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|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.
*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.
|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=*Safety and effectiveness in pediatric patients have not been established.
|useInPed=*Safety and effectiveness in pediatric patients have not been established.
|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.
|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.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|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.
|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.
|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.
|useInImmunocomp=*There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.


<!--Administration and Monitoring-->
<!--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.
|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.
*In Pruritus: Massage gently into affected areas until medication is completely absorbed. Repeat as needed.


LOTION: Shake well before using.
*LOTION: Shake well before using.


DIRECTIONS FOR PATIENTS WITH SCABIES:
'''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.
*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.
*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 second application is advisable 24 hours later.
    A 60 gram tube or bottle is sufficient for two applications.
*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.
*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.


* Description
* Description


<!--IV Compatibility-->
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
|IVCompat=*There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.


<!--Overdosage-->
<!--Overdosage-->
|overdose=There is no specific information on the effect of overtreatment with repeated topical applications in humans. A death was reported but cause was not confirmed.
|overdose=*There is no specific information on the effect of overtreatment with repeated topical applications in humans. A death was reported but cause was not confirmed.


Accidental oral ingestion may be accompanied by burning sensation in the mouth, irritation of the buccal, esophageal and gastric mucosa, nausea, vomiting, abdominal pain.
*Accidental oral ingestion may be accompanied by burning sensation in the mouth, irritation of the buccal, esophageal and gastric mucosa, nausea, vomiting, abdominal pain.


If accidental ingestion occurs, call your Poison Control Center.
*If accidental ingestion occurs, call your Poison Control Center.
|drugBox=[[File:Crotamiton image.png|600px|thumbnail|left]]
|drugBox=[[File:Crotamiton image.png|600px|thumbnail|left]]
{{clear}}
{{clear}}


|mechAction=*Eurax has scabicidal and antipruritic actions. The mechanisms of these actions are not known.  
|mechAction=*Eurax has scabicidal and antipruritic actions. The mechanisms of these actions are not known.  
|structure=Eurax (crotamiton USP) is a scabicidal and antipruritic agent available as a cream or lotion for topical use only. Eurax provides 10% (w/w) of the synthetic, crotamiton USP, in a vanishing-cream or emollient-lotion base containing: carbomer-934, cetyl alcohol, diazolidinylurea, dimethicone, fragrance, laureth-23, magnesium aluminum silicate, magnesium nitrate, methylchloroisothiazolinone, methylisothiazolinone, petrolatum, propylene glycol, sodium hydroxide, steareth-2, and water. In addition, the cream contains glyceryl stearate.
|structure=*Eurax (crotamiton USP) is a scabicidal and antipruritic agent available as a cream or lotion for topical use only. Eurax provides 10% (w/w) of the synthetic, crotamiton USP, in a vanishing-cream or emollient-lotion base containing: carbomer-934, cetyl alcohol, diazolidinylurea, dimethicone, fragrance, laureth-23, magnesium aluminum silicate, magnesium nitrate, methylchloroisothiazolinone, methylisothiazolinone, petrolatum, propylene glycol, sodium hydroxide, steareth-2, and water. In addition, the cream contains glyceryl stearate.


Crotamiton is N-ethyl-N-(o-methylphenyl)-2-butenamide and its structural formula is:
*Crotamiton is N-ethyl-N-(o-methylphenyl)-2-butenamide and its structural formula is:


[[File:Crotamiton structure.png|600px|thumbnail|left]]
[[File:Crotamiton structure.png|600px|thumbnail|left]]
{{clear}}
{{clear}}


Crotamiton USP is a colorless to slightly yellowish oil, having a faint amine-like odor. It is miscible with alcohol and with methanol. Crotamiton is a mixture of the cis and trans isomers. Its molecular weight is 203.28.
*Crotamiton USP is a colorless to slightly yellowish oil, having a faint amine-like odor. It is miscible with alcohol and with methanol. Crotamiton is a mixture of the cis and trans isomers. Its molecular weight is 203.28.


|PK=*The pharmacokinetics of crotamiton and its degree of systemic absorption following topical application have not been determined.
|PK=*The pharmacokinetics of crotamiton and its degree of systemic absorption following topical application have not been determined.
Line 109: Line 109:


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


<!--How Supplied-->
<!--How Supplied-->
|howSupplied=Eurax® (crotamiton USP)
|howSupplied='''Eurax® (crotamiton USP)'''


Cream: 60 g tubes NDC 10631-091-60 (NSN 6505-00-116-0200)
*Cream: 60 g tubes NDC 10631-091-60 (NSN 6505-00-116-0200)


Lotion: 60 g (2 oz.) bottles NDC 10631-092-60 (NSN 6505-01-153-4423)
*Lotion: 60 g (2 oz.) bottles NDC 10631-092-60 (NSN 6505-01-153-4423)


454 g (16 oz.) bottles NDC 10631-092-16
*454 g (16 oz.) bottles NDC 10631-092-16


SHAKE WELL before using.
*SHAKE WELL before using.
|storage=Store at room temperature.
|storage=*Store at room temperature.


Keep out of reach of children.
*Keep out of reach of children.
|packLabel=[[File:Crotamiton pdp.png|600px|thumbnail|left]]
|packLabel=[[File:Crotamiton pdp.png|600px|thumbnail|left]]
{{clear}}
{{clear}}
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[[File:Crotamiton label.png|600px|thumbnail|left]]
[[File:Crotamiton label.png|600px|thumbnail|left]]
{{clear}}
{{clear}}
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
|fdaPatientInfo=*There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


<!--Precautions with Alcohol-->
<!--Precautions with Alcohol-->

Revision as of 21:14, 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

  • There is no specific information on the effect of overtreatment with repeated topical applications in humans. A death was reported but cause was not confirmed.
  • Accidental oral ingestion may be accompanied by burning sensation in the mouth, irritation of the buccal, esophageal and gastric mucosa, nausea, vomiting, abdominal pain.
  • If accidental ingestion occurs, call your Poison Control Center.

Pharmacology

Mechanism of Action

  • Eurax has scabicidal and antipruritic actions. The mechanisms of these actions are not known.

Structure

  • Eurax (crotamiton USP) is a scabicidal and antipruritic agent available as a cream or lotion for topical use only. Eurax provides 10% (w/w) of the synthetic, crotamiton USP, in a vanishing-cream or emollient-lotion base containing: carbomer-934, cetyl alcohol, diazolidinylurea, dimethicone, fragrance, laureth-23, magnesium aluminum silicate, magnesium nitrate, methylchloroisothiazolinone, methylisothiazolinone, petrolatum, propylene glycol, sodium hydroxide, steareth-2, and water. In addition, the cream contains glyceryl stearate.
  • Crotamiton is N-ethyl-N-(o-methylphenyl)-2-butenamide and its structural formula is:
  • Crotamiton USP is a colorless to slightly yellowish oil, having a faint amine-like odor. It is miscible with alcohol and with methanol. Crotamiton is a mixture of the cis and trans isomers. Its molecular weight is 203.28.

Pharmacodynamics

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

Pharmacokinetics

  • The pharmacokinetics of crotamiton and its degree of systemic absorption following topical application have not been determined.

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

Eurax® (crotamiton USP)

  • Cream: 60 g tubes NDC 10631-091-60 (NSN 6505-00-116-0200)
  • Lotion: 60 g (2 oz.) bottles NDC 10631-092-60 (NSN 6505-01-153-4423)
  • 454 g (16 oz.) bottles NDC 10631-092-16
  • SHAKE WELL before using.

Storage

  • Store at room temperature.
  • Keep out of reach of children.

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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