Crotamiton is a topical scabicide and antipruritic agent. It is used for the treatment and eradication of scabies and symptomatic treatment of pruritic skin. This drug was first employed in medical use in 1949; modern FDA approval was granted in 2007. The drug has been associated with scabies treatment failure.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
Cream/Ointment/Lotion Formulations
-The cream and lotion are for topical use only to the skin.
-Shake lotion well before use.
-Do not apply in the eyes or mouth. Do not apply to raw, weeping, or inflamed skin until acute inflammation has subsided.
Application for scabies:
-After taking a routine bath or shower, apply topically by massaging into the skin from the chin to the toes including folds and creases.
-Ensure application under fingernails (they should be trimmed short), as scabies are likely to remain under nails. A toothbrush may be used to apply crotamiton under fingernails. If a toothbrush is used to apply, wrap it in paper and discard immediately after use. Accidental use of the same toothbrush in the mouth could cause poisoning.
-A second application 24 hours later is recommended. NOTE: A 60 gram tube of cream or bottle of lotion will be sufficient for 2 applications for most patients.
-Clothing and bed linen should be changed the next morning. Contaminated clothing and bed linen may be washed in the hot cycle of the washing machine or dry-cleaned.
-A cleansing bath should be taken 48 hours after the last application.
Application for pruritus:
-For pruritus, massage cream or lotion into affected areas until the medication is absorbed; repeat as needed.
Primary skin irritation reactions including pruritus, rash (unspecified), atopic dermatitis, and allergic sensitivity reactions have rarely been reported with crotamiton. Some patients report a "cooling sensation" of the skin on application, and this may represent mild counter-irritant effect, and may contribute to antipruritic action.
Crotamiton is contraindicated in patients with hypersensitivity to crotamiton. If severe irritation or sensitivity develops, discontinue crotamiton therapy and initiate appropriate medical treatment.
Crotamiton is for external use only. Crotamiton should not be applied to raw, weeping, or acutely inflamed skin until the acute inflammation has resolved. Avoid accidental exposure systemically. Oral exposure or ingestion may cause poisoning and/or irritation; if swallowed, seek immediate medical advice from a Poison Control Center or doctor. Avoid oral and ocular exposure as this may cause ophthalmic irritation. In the event of ocular exposure, immediately flush the eye with fresh running water and seek medical advice.
The safety and efficacy of crotamiton has not been specifically established in adolescents, children, infants, or neonates. The medical literature does describe the use of crotamiton in infants >= 2 months of age for the treatment of scabies; however, other agents appear to be more effective, and crotamiton is considered a treatment alternative rather than a preferred treatment.
Crotamiton is classified in FDA pregnancy risk category C and should only be administered to a pregnant woman if clearly needed. Animal reproductive studies have not been conducted. It is unknown if crotamiton can cause fetal harm or adversely affect reproductive capacity. Crotamiton is generally not the preferred agent for scabies, but is considered an alternative agent. Permethrin cream (pregnancy risk category B) may be an appropriate scabicidal agent to consider if treatment is necessary (see Permethrin monograph).
Breast-feeding information is not available from the manufacturer at this time. Crotamiton is generally not the preferred agent for scabies, but is considered an alternative agent. Permethrin cream may be an appropriate scabicidal agent to consider if treatment is necessary. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
Per the manufacturer, this drug has been shown to be active against most strains of the following microorganisms either in vitro and/or in clinical infections: Sarcoptes scabiei
NOTE: The safety and effectiveness in treating clinical infections due to organisms with in vitro data only have not been established in adequate and well-controlled clinical trials.
For the treatment of scabies caused by Sarcoptes scabiei:
Topical dosage:
Adults: After routine bath, apply topically over the entire body from the chin to the toes. Repeat in 24 hours. Patient may take a cleansing bath 48 hours after second dose.
Infants*, Children*, and Adolescents*: The use of crotamiton has been described clinically, with the same directions as for adults, in infants and children as young as age 2 months, but treatment has been reported inferior to permethrin. However, due to treatment failures, other agents appear to be preferred; crotamiton is considered an alternative agent. There are no safety and efficacy data available from the manufacturer.
-for the treatment of pruritus:
Topical dosage:
Adults: Apply topically by massaging gently into affected area until medication is completely absorbed. Repeat if needed.
Maximum Dosage Limits:
-Adults
Per treatment course for scabies, 1 applications/day for 2 days, given 24 hours apart. For pruritis, usually 1 application/day, then as needed.
-Geriatric
Per treatment course for scabies, 1 applications/day for 2 days, given 24 hours apart. For pruritis, usually 1 application/day, then as needed.
-Adolescents
Safety and efficacy have not been established. Off-label per treatment course for scabies*, 1 application/day for 2 days, each application given 24 hours apart.
-Children
Safety and efficacy have not been established. Off-label per treatment course for scabies*, 1 application/day for 2 days, each application given 24 hours apart.
-Infants
>= 2 months: Safety and efficacy have not been established. Off-label per treatment course for scabies*, 1 application/day for 2 days, each application given 24 hours apart.
< 2 months: Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
No dosage adjustments are needed.
Patients with Renal Impairment Dosing
No dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Crotamiton products.
Crotamiton possess scabicidal and antipruritic properties. The mechanisms of these actions are not known, but the drug is toxic to the scabies mite; antipruritic effect may be due to counter-irritation mechanisms.
Crotamiton is administered topically to the skin. The pharmacokinetics and degree of systemic absorption of crotamiton after topical application have not been determined.