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Black Box Warning
Title
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Overview
Crotamiton is a pesticide that is FDA approved for the treatment of scabies (sarcoptes scabiei) and for symptomatic treatment of pruritic skin. There is a Black Box Warning for this drug as shown here. 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)
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)
Contraindications
Condition1
Warnings
Title
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Crotamiton 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
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Crotamiton in the drug label.
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
There is no FDA guidance on the use of Crotamiton with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Crotamiton with respect to geriatric patients.
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.
