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Eurax

Generic Name: Crotamiton
Class: Scabicides and Pediculicides
VA Class: AP900
Chemical Name: N-ethyl-N-(o-methylphenyl)-2-butenamide
CAS Number: 483-63-6

Introduction

Scabicide and antipruritic agent.115

Uses for Eurax

Scabies

Alternative for topical treatment of scabies in adults.103 107 115 120 AAP, CDC, and others usually recommend topical permethrin 5% as scabicide of choice;103 104 105 107 111 116 120 122 oral ivermectin also recommended by CDC as a drug of choice.104

May be less effective than topical permethrin.105 118 121 122 Treatment failures have occurred;103 109 118 several applications of the drug may be necessary.105 109

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Other scabicides usually recommended for treatment of severe or crusted (Norwegian) scabies.102 103 104 109 113 Aggressive treatment with a multiple-dose oral ivermectin regimen or concomitant use of oral ivermectin and a topical scabicide may be necessary.103 104 HIV-infected and other immunocompromised patients are at increased risk of developing Norwegian scabies; CDC recommends that such patients be managed in consultation with an expert.104

HIV-infected individuals with uncomplicated scabies should receive the same treatment regimens as those without HIV infection.104

Pediculosis

Has been used for treatment of pediculosis capitis (head lice infestation).103 Safety and efficacy not established.103

Treatment of pediculosis corporis (body lice infestation).103 One of several options recommended for treatment of pediculosis corporis 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 thorough delousing (especially among exposed contacts of individuals with typhus) is recommended in epidemic situations.103

Pruritus

Symptomatic treatment of pruritus.115

Eurax Dosage and Administration

General

Measures to Avoid Reinfestation and Transmission

  • To avoid reinfestation or transmission of scabies, clothing and bed linen that may have been contaminated by the infested individual during the 3 days prior to treatment should be decontaminated (machine-washed in hot water and dried in a hot dryer or dry-cleaned).103 104

  • Items that cannot be laundered or dry-cleaned should be removed from body contact for ≥72 hours.103

  • Fumigation of living areas is not necessary and is not recommended.103 104

Administration

Topical Administration

Apply topically to skin as 10% cream or lotion.115

Do not apply to face, eyes, mouth,115 urethral meatus, or mucous membranes.a For external use only; do not administer orally or intravaginally.115

Shake lotion before using.115

Scabies

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

Apply thin layer of the cream or lotion uniformly and massage thoroughly into all skin surfaces below the chin (particularly all creases and folds) including the entire trunk and extremities from the neck to the toes (including the soles of the feet).115 Trim fingernails short and apply the cream or lotion underneath the fingernails with a toothbrush; wrap the toothbrush in paper and properly discard to prevent potential oral crotamiton exposure and toxicity.115

Remove the cream or lotion 48 hours after the last application by bathing.103 115

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.104

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 The entire population at risk should be treated during institutional outbreaks.104 119

Pruritus does not indicate treatment failure and is not usually 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/or topical corticosteroids may be used to help relieve pruritus.103 Topical or oral anti-infectives are indicated for treatment of secondary bacterial infections of excoriated skin lesions.103

Dosage

Pediatric Patients

Scabies
Topical

Cream or lotion: Apply a thin, uniform layer and massage 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 and underneath the fingernails).115 A proportionately smaller amount is applied in children compared to the amount applied in adults (30 g usually is sufficient in adults).a Wash off by bathing 48 hours after the last application.115

The manufacturer recommends a second application 24 hours after the first treatment.115 Frequent treatment failures reported;103 109 some clinicians suggest several applications are necessary to cure scabies.105 109 CDC recommends that patients who do not respond to crotamiton should be retreated with an alternative regimen.104

Pediculosis
Pediculosis Capitis (Head Lice Infestation)
Topical

Lotion has been applied to the scalp and left on for 24 hours before being washed off.103

Adults

Scabies
Topical

Cream or lotion: Apply a thin, uniform layer and massage 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 and underneath the fingernails).115 Usually, 30 g of the cream is sufficient for one application.115 Wash off by bathing 48 hours after the last application.115

The manufacturer recommends a second application 24 hours after the first treatment.115 Frequent treatment failures reported;103 109 some clinicians suggest several applications are necessary to cure scabies.105 109 CDC recommends retreating patients who do not respond to crotamiton with an alternative regimen.104

Pediculosis
Pediculosis Capitis (Head Lice Infestation)
Topical

Lotion has been applied to the scalp and left on for 24 hours before being washed off.103

Pruritus
Topical

Cream or lotion: Massage gently into affected areas until completely absorbed; repeat application as needed.115

Cautions for Eurax

Contraindications

  • Known sensitivity or allergy to crotamiton or known primary irritation response to other topical medications.115

Warnings/Precautions

Sensitivity Reactions

Dermatologic and Sensitivity Reactions

If severe irritation or a sensitivity reaction occurs following topical application, discontinue and initiate appropriate therapy.115

General Precautions

Administration Precautions

Avoid contact with the eyes or mouth since irritation may occur.115

Avoid contact with mucous membranes, the vagina, and urethral meatus.a 115

Do not apply to acutely inflamed skin or denuded or weeping skin surfaces until acute inflammation has resolved.115

Specific Populations

Pregnancy

Category C.115

Lactation

Information regarding distribution into milk not available.115

Pediatric Use

Safety and efficacy not established in children.115

Geriatric Use

Insufficient experience in controlled clinical studies in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.115 Other clinical experience has not revealed age-related differences in response; however, greater sensitivity of some geriatric individuals cannot be ruled out.115

Common Adverse Effects

Primary irritation reactions (e.g., dermatitis, pruritus, rash), allergic sensitivity reactions.115

Eurax Pharmacokinetics

Absorption

Bioavailability

Absorbed systemically following topical application to skin.117

Elimination

Elimination Route

In a study in healthy adults using radiolabeled crotamiton 10% lotion applied topically twice daily (0.229 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

Half-life

Following topical application to skin, absorption half-life is 2.7 hours and rate of elimination is 30.9 hours.117

Stability

Storage

Topical

Cream or Lotion

Room temperature.115

Actions and Spectrum

  • The mechanisms of crotamiton’s scabicidal,115 pediculicidal,103 and antipruritic effects 115 not known.

  • Active against Sarcoptes scabiei (mite that causes scabies),103 104 115 Pediculus humanus var. capitis (head louse),103 and Pediculus humanus var. corporis (body louse).103

  • Resistance to crotamiton has not been conclusively demonstrated in S. scabiei.a

Advice to Patients

  • Importance of using only as directed.115

  • Advise patients regarding personal protective measures to avoid reinfestation or transmission of scabies.103 104 115

  • Importance of taking a routine bath or shower prior to application, applying the cream or lotion as directed, and removing the drug by bathing 48 hours after the last application.115

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription or OTC drugs, dietary supplements, herbal supplements, or any other skin product.115

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.115

  • Importance of informing patients of other important precautionary information.115 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Crotamiton

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

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions September 1, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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.

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 ()

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. [IDIS 392270] [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.

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.

a. AHFS Drug Information 2007. McEvoy GK, ed. Crotamiton. Bethesda, MD: American Society of Health-System Pharmacists; 2007:3498-99.

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.

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