VA Class:AP900
ATC Class:D04AX
Crotamiton is a scabicide and antipruritic agent.115
Crotamiton is used for the topical treatment of scabies (mite infestation)103, 107, 115, 120 and the symptomatic management of pruritic skin.115 Crotamiton has been used for the topical treatment of pediculosis† (lice infestation), but safety and efficacy have not been established.103
Topical crotamiton is considered an alternative agent for the treatment of scabies.103, 107, 120
The American Academy of Pediatrics (AAP), the US Centers for Disease Control and Prevention (CDC), and other clinicians consider topical permethrin 5% to be the scabicide of choice because of its safety and efficacy profile relative to other available agents, particularly lindane;103, 104, 105, 107, 111, 116, 122 the CDC also recommends oral ivermectin as a scabicide of choice in adults.104 Recommendations for alternative therapy for the treatment of scabies differ among various clinicians.103, 104, 107 The AAP and some clinicians recommend topical crotamiton 10% or oral ivermectin as preferred alternatives;103, 107, 120 however, safety and efficacy of crotamiton have not been established in children†.115 Lindane (not recommended for pregnant or lactating women, children younger than 2 years of age, or individuals with extensive dermatitis) is considered a second-line agent and should be used for the treatment of scabies only in patients who have not responded to or who cannot tolerate other recommended therapies.103, 104, 114, 116 (See Uses: Scabies in Lindane 84:04.12.)
Crotamiton 10% generally is considered to be less effective than permethrin for the treatment of scabies.105, 118, 122 Crotamiton has been associated with frequent treatment failures,103, 109, 118 and some clinicians state that several applications of the drug may be required to cure scabies.105, 109 Although crotamiton previously was considered a scabicide of choice in infants†, 120 young children†, 120 and pregnant or lactating women†, the AAP, CDC, and other clinicians currently recommend use of permethrin 5% as the preferred scabicide in these individuals because of its low percutaneous absorption and relative topical safety.103, 104, 120
The CDC states that patients with human immunodeficiency virus (HIV) infection who have uncomplicated scabies should receive the same treatment as those without HIV infection.104 However, immunocompromised patients, including those with HIV infection, are at increased risk of developing Norwegian scabies and such patients should be managed in consultation with an expert.104 For further information on the management of scabies in patients with HIV infection, see Uses: Scabies in Permethrin 84:04.12.
Sexual contacts of patients receiving treatment for scabies and other individuals (household, family) who have had close personal contact with the patient within the previous month should be examined and treated with an effective scabicide.104 Scabicides, including crotamiton, are not effective in the prophylaxis of scabies.
The CDC recommends that scabies epidemics in institutional settings (e.g., nursing homes, hospitals, residential facilities and communities) be managed in consultation with an expert.104 Control of such epidemics requires treatment of the entire population at risk.102, 104, 112, 119
The most appropriate regimen for the treatment of Norwegian scabies (crusted scabies) is unclear.104 Norwegian scabies is a particularly severe and highly infectious form of scabies that usually occurs in immunocompromised, debilitated, or malnourished individuals and presents as crusted, hyperkeratotic, scaling plaques, which may be generalized or localized to the hands and feet.102, 103, 104, 109, 113 In this condition, the patient is infested with large numbers (thousands to millions) of Sarcoptes mites.102, 108, 109, 113 In less than 10% of patients with scabies, nodular scabies may develop, which is characterized by intensely pruritic nodules that persist for months after effective scabies therapy;103, 110 mites seldom are identified in these nodules.110 For further information on the management of Norwegian and nodular scabies, see Uses: Scabies in Permethrin 84:04.12.
In a comparative study evaluating topical crotamiton 10% cream and topical permethrin 5% cream administered once daily on 2 successive nights in children† and adults, 88% of those who received crotamiton were cured (no new lesions and healing of all original lesions) 4 weeks after treatment compared with 98% of patients who received permethrin.121
In a double-blind, randomized study in children with scabies who were 2 months to 5 years of age†, 60% of those who received crotamiton and 89% of those who received permethrin were cured (no new lesions and healing of all original lesions).118
Topical crotamiton has been used for the treatment of pediculosis capitis† (head lice infestation).103 Limited data indicate crotamiton 10% lotion may be effective for the treatment of head lice;103 however, safety and efficacy of the drug for this use have not been established.103
Topical crotamiton has been recommended as one option for the treatment of pediculosis corporis† (body lice infestation) in the adjunctive treatment of epidemic (louse-borne) typhus.103 The causative agent of epidemic typhus ( Rickettsia prowazekii ) is transmitted person-to-person by Pediculus humanus corporis , and adjunctive use of a topical cream or gel pediculicide (e.g., pyrethrins with piperonyl butoxide, crotamiton, lindane) may help prevent transmission of louse-borne typhus.103 Thorough delousing (especially among exposed contacts of individuals with typhus) is recommended in epidemic situations.103
Topical crotamitonis used for the symptomatic treatment of pruritus;115 however, efficacy of the drug for this use is based largely on uncontrolled studies.
Crotamiton is applied topically to skin as a 10% cream or lotion.115
Crotamiton should not be applied to the face, eyes, or mouth.115 The drug is for topical use only and should not be administered orally or intravaginally.115
The lotion should be shaken well prior to administration.115
Before applying crotamiton for the treatment of scabies, the patient should bathe or shower with soap and water,115 taking care to scrub and remove scaling or crusted detritus, then towel dry. A thin layer of the 10% cream or lotion should be applied uniformly and massaged thoroughly into all skin surfaces below the chin (particularly to all creases and folds), including the entire trunk and extremities from the neck to the toes (including the soles of the feet).115 Fingernails should be trimmed short and the 10% cream or lotion applied underneath the fingernails, since sarcoptic mites frequently infest this area.115 A toothbrush may be used to apply the 10% cream or lotion under the trimmed fingernails; immediately after such use, the toothbrush should be wrapped in paper and properly discarded to prevent oral crotamiton exposure and potential toxicity.115
Measures to Avoid Reinfestation and Transmission
All clothing and bed linen that may have been contaminated by the infested individual during the 3 days prior to treatment should be removed from body contact for at least 72 hours or should be machine-washed in hot water and dried in a hot dryer or be dry-cleaned following treatment to avoid reinfestation or transmission of scabies.103, 104, 115
Items that cannot be laundered or dry-cleaned should be removed from body contact for ≥72 hours.103
Treatment of living areas with pesticides, including fumigation, is not necessary and is not recommended.103, 104
For the topical treatment of scabies, crotamiton 10% cream or lotion should be applied to the entire body (from the chin down).103, 107, 115 In adults, 30 g of the cream usually is sufficient for one application;115 a proportionately smaller amount is used in children†.
The manufacturer recommends a second application 24 hours after the first treatment.115 Because frequent treatment failures have been reported,103, 109 some clinicians suggest that several applications may be necessary to cure scabies.105, 109 At 48 hours after the last application, the patient should bathe or shower to remove the drug.103, 115
CDC recommends retreating patients who do not respond to crotamiton with an alternative regimen.104
Pruritus associated with scabies usually is not considered an indication for retreatment;103 such pruritus results from a hypersensitivity reaction of the host to the mite103, 104 and may persist for several weeks despite successful treatment.103 Oral antihistamines and topical corticosteroids may be used to help relieve symptoms.103 Topical or oral anti-infective therapy is indicated for secondary bacterial infections of the excoriated skin lesions.103
For the treatment of pediculosis capitis† (head lice infestation), crotamiton 10% has been applied to the scalp and left on for 24 hours before being washed off.103
When used for the symptomatic treatment of pruritus, crotamiton 10% cream or lotion should be massaged gently into affected areas until completely absorbed; application may be repeated as needed.115
When used in appropriate dosage, topical crotamiton appears to have a low order of toxicity.
Localized dermatologic effects, including primary irritation reactions (e.g., dermatitis, pruritus, rash) and allergic sensitivity reactions have been reported.115
Precautions and Contraindications
Crotamiton is contraindicated in patients with a history of sensitivity or allergy to the drug and in those who exhibit a primary irritation response to topically applied medications.115
If severe irritation or a sensitivity reaction occurs following topical application of crotamiton, the drug should be discontinued and appropriate therapy initiated.115
Crotamiton should not be applied in the eyes or mouth since irritation may occur.115 Contact with other mucous membranes, the vagina, and urethral meatus should be avoided.115
Crotamiton should not be applied to acutely inflamed, denuded, or weeping skin surfaces until acute inflammation has subsided.115
Safety and efficacy of crotamiton in children have not been established.115
Clinical studies of crotamiton 10% lotion or cream did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients.115 Although other clinical experience has not revealed age-related differences in response, greater sensitivity of some geriatric individuals cannot be ruled out.115
Long-term studies in animals to determine the carcinogenic potential of crotamiton have not been performed to date.115
Animal reproduction studies have not been performed with crotamiton.115 It is not known whether crotamiton can cause fetal harm when administered to pregnant women or affect reproductive capacity.115
Crotamiton should be used during pregnancy only when clearly needed.115
The oral LD50 of crotamiton is 2212 and 2011 mg/kg in rats and mice respectively.
Information is not available regarding overdosage following repeated topical application of crotamiton in humans.115 Oral ingestion of the drug may result in burning sensation of the mouth; irritation of the buccal, esophageal, and gastric mucosa; nausea; vomiting; and abdominal pain.115 There have been several reports of accidental ingestion of crotamiton in children resulting in acute toxicity. An 18-month- and a 2-year-old child ingested 2 g of cream and about 30 g of lotion, respectively, and death occurred in one child; however, a causal relationship to crotamiton has not been established.
There is no known specific antidote for orally ingested crotamiton. Overdosage of oral crotamiton should be treated with measures intended to eliminate the drug and reduce its absorption, in addition to symptomatic therapy. If accidental ingestion of the drug occurs, clinicians, patients, or their caregivers should contact a regional poison control center (800-222-1222).115
The mechanisms by which crotamiton exerts its scabicidal and antipruritic activity are not known.115
Crotamiton is toxic to the parasitic mite Sarcoptes scabiei (the causative organism of scabies). Resistance to crotamiton has not been conclusively demonstrated in Sarcoptes scabiei .
Crotamiton is toxic to Pediculus humanus capitis (head lice) and Pediculus humanus corporis (body lice).103
Crotamiton is absorbed systemically following topical application to skin.117
In a study in healthy adults using radiolabeled crotamiton 10% lotion applied topically twice daily (229 mL applied on an area of the forearm 229 cm2), 4.8-8.8% of the dose (measured as radioactivity) was eliminated in urine.117 The absorption half-life was 2.7 hours and the rate of elimination was 30.9 hours.117
Crotamiton is a synthetic chloroformate salt. The drug occurs as a mixture of the cis- and trans-isomers.115 Crotamiton occurs as a colorless to slightly yellowish oil having a faint amine-like odor.115 The drug is miscible with alcohol and with methanol 115 and slightly soluble in water.
Crotamiton is commercially available as a cream or lotion containing 10% (w/w) of crotamiton.115 The cream or lotion base contains water, petrolatum, propylene glycol, steareth-2, cetyl alcohol, dimethicone, laureth-23, fragrance, magnesium aluminum silicate, carbomer-934, sodium hydroxide, diazolidinylurea, methylchloroisothiazolinone, methylisothiazolinone, and magnesium nitrate.115 In addition, the cream contains glyceryl stearate.115
Crotamiton 10% cream and lotion should be stored at room temperature.115
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Topical | Cream | 10% | Eurax® (with propylene glycol) | Bristol-Myers Squibb |
Lotion | 10% | Eurax® (with propylene glycol) | Bristol-Myers Squibb |
Only references cited for selected revisions after 1984 are available electronically.
102. Estes SA, Estes J. Therapy of scabies: nursing homes, hospitals, and the homeless. Semin Dermatol . 1993; 12:26-33. [PubMed 7682834]
103. American Academy of Pediatrics. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006.
104. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines 2006. MMWR Recomm Rep . 2006; 55(RR-11):1-94. [Fulltext MMWR]
105. Anon. Permethrin for scabies. Med Lett Drugs Ther . 1990; 32:21-2. [PubMed 2179695]
107. Anon. Drugs for parasitic infections. Med Lett Drugs Ther . Aug 2004. From the Medical Letter web site. [Web]
108. Rico MJ, Myers SA, Sanchez MR et al. Guidelines of care for dermatologic conditions in patients infected with HIV. J Am Acad Dermatol . 1997; 37:450-72. [PubMed 9308562]
109. Peterson CM, Eichenfield LF. Scabies. Ped Annals . 1996; 25:97-100.
110. Kerl H, Ackerman AB. Inflammatory diseases that simulate lymphomas: cutaneous pseudolymphomas. In: Fitzpatrick TB, Eisen AZ, Wolff K et al, eds. Dermatology in general medicine. 4th ed. New York: McGraw Hill Inc. 1993:1315-27.
111. Wilson DC, Leyva WH, King LE. Arthropod bites and stings. In: Fitzpatrick TB, Eisen AZ, Wolff K et al, eds. Dermatology in general medicine. 4th ed. New York: McGraw Hill Inc. 1993:2810-26.
112. Degelau J. Scabies in long-term care facilities. Infect Control Hosp Epidemiol . 1992; 13:421-5. [PubMed 1640101]
113. Kolar KA, Rapini RP. Crusted (Norwegian) scabies. Am Fam Physician . 1991; 44:1317-21. [PubMed 1718155]
114. Lindane Lotion USP, 1% prescribing information. From the FDA web site. Accessed 2003 Apr 4. [Web]
115. Westwood-Squibb Pharmaceuticals Inc. Eurax® (crotamiton) lotion/cream prescribing information. Princeton, NJ; 2005 Jan.
116. Food and Drug Administration. FDA public health advisory: safety of topical lindane products for the treatment of scabies and lice. 2003 Mar 28. From FDA website. Accessed March 29, 2007. [Web]
117. Dika E, Tosti A, Goldovsky M et al. Percutaneous absorption of crotamiton in man following single and multiple dosing. Cutan Ocul Toxicol . 2006; 25:211-6. [PubMed 16980246]
118. Taplin D, Meinking TL, Chen JA et al. Comparison of crotamiton 10% cream (Eurax) and permethrin 5% cream (Elimite) for the treatment of scabies in children. Ped Dermatol . 1990; 7:67-73.
119. Scheinfeld N. Controlling scabies in institutional settins. A review of medications, treatment models, and implementation. Am J Dermatol . 2004; 5:31-7.
120. Hengge UR, Currie BJ, Jager G et al. Scabies: a ubiquitous neglected skin disease. Lancet Infect Dis . 2006; 6:769-79. [PubMed 17123897]
121. Amer M, El-Gharib I. Permethrin versus crotamiton and lindane in the treatment of scabies. Int J Dermatol . 1992; 31:357-8. [PubMed 1375206]
122. Walker GJA, Johnstone PW. Interventions for treating scabies . Cochrane Database Syst Rev . 2000;(3):CD000320.