Crotamiton

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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.
- Dosing Information
- Massage gently into affected areas until medication is completely absorbed. Repeat as needed.
- LOTION: Shake well before using.
- 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.

### NonGuideline-Supported Use
- 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.

### NonGuideline-Supported Use
- There is limited information regarding Off-Label NonGuideline-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

## Package and Label Display Panel

# Patient Counseling Information
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

# 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
- A  B

# Drug Shortage Status

# Price