Crotamiton

Pharmacologic Category

Dosing: Adult

Pruritus: Topical: Massage into affected areas until medication is completely absorbed; repeat as necessary

Scabies: Topical: Apply a thin layer and massage drug onto skin of the entire body from the neck to the toes (with special attention to skin folds, creases, and interdigital spaces). Repeat application in 24 hours. May re-treat if new lesions appear or itching persists more than 2 to 4 weeks after initial treatment (CDC 2010).

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in manufacturer's labeling.

Dosing: Pediatric

Scabies: Limited data available: Infants, Children, and Adolescents: Topical: Apply a thin layer onto skin of entire body from neck to toes; apply once daily for 3 days followed by a cleansing bath 48 hours after the last application; treatment may be repeated after 7 days if mites appear; not typically first-line therapy as other agents have shown greater efficacy (Hay 2012; Kliegman 2016; Red Book [AAP 2015] ); longer duration of treatment (5 days) has also been reported and was well tolerated (Cubela 1978; Glodust 2014; Konstantinov 1979).

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Use: Labeled Indications

Treatment of scabies (Sarcoptes scabiei) and symptomatic treatment of pruritus

* See Uses in AHFS Essentials for additional information.

Administration: Topical

For external use only; avoid eyes and mucous membranes. Shake lotion well before using. Take a bath or shower prior to application. Apply from neck down to toes. Trim fingernails and apply under nails (can use toothbrush, which should be disposed of after use). Take a cleansing bath 48 hours after the final application. Contaminated clothing and bed linens should be washed on hot cycle or dry-cleaned and all clothing and bedding should be changed the day after application.

Administration: Pediatric

Topical: For external use only; avoid eyes and mucous membranes. Shake lotion well before using. Wash thoroughly and scrub away loose scales, then towel dry; apply a thin layer and gently massage drug onto skin of the entire body from the neck to the toes (with special attention to skin folds, creases, and interdigital spaces); also apply cream or lotion under fingernails after trimming nails short; since scabies can affect the head, scalp, and neck in infants and young children, apply to scalp, neck, and body of this age group (Red Book [AAP 2015]); do not apply to the face, eyes, mouth, mucous membranes, or urethral meatus. Take a cleansing bath 48 hours after the final application. Contaminated clothing and bed linens should be washed on hot cycle or dry-cleaned and all clothing and bedding should be changed the day after application.

Storage/Stability

Store at room temperature.

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber severe skin irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues

Sound-alike/look-alike issues:

International issues:

Contraindications

Hypersensitivity to crotamiton or any component of the formulation; patients who manifest a primary irritation response to topical medications

Warnings/Precautions

Other warnings/precautions:

• Appropriate use: For external use only; avoid contact with face, eyes, mucous membranes, and urethral meatus. Do not apply to acutely inflamed, raw, or weeping skin. Discontinue use if severe irritation or sensitization occurs.

* See Cautions in AHFS Essentials for additional information.

Geriatric Considerations

If cure is not achieved after 2 applications, use alternative therapy.

Warnings: Additional Pediatric Considerations

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Pregnancy Risk Factor

Pregnancy Considerations

Animal reproduction studies have not been conducted; use during pregnancy only if clearly needed.

Breast-Feeding Considerations

It is not known if crotamiton is excreted in breast milk.

Adverse Reactions

Frequency not defined.

Central nervous system: Localized warm feeling

Dermatologic: Contact dermatitis, pruritus, skin rash

Hypersensitivity: Local hypersensitivity reaction

Local: Local irritation

* See Cautions in AHFS Essentials for additional information.

Allergy and Idiosyncratic Reactions

Crotamiton Allergy

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

There are no known significant interactions.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External:

Eurax: 10% (60 g [DSC])

Lotion, External:

Crotan: 10% (60 g, 227 g, 454 g) [contains benzyl alcohol, cetyl alcohol, propylene glycol]

Eurax: 10% (60 g [DSC], 454 g [DSC])

Generic Available (US)

Pricing: US

Lotion (Crotan External)

10% (per gram): $8.45

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Crotamiton has scabicidal activity against Sarcoptes scabiei; mechanism of action unknown. Antipruritic effects mediated by inhibition of histamine, serotonin, and PAR-2 (Sekine 2012).

Pharmacodynamics/Kinetics

Absorption: Amount of systemic absorption following topical use has not been determined

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

FDA Approval Date

June 26, 2003

References

American Academy of Pediatrics (AAP). In: Kimberlin DW, Brady MT, Jackson MA, Long SA, eds. Red Book: 2015 Report of the Committee on Infectious Diseases. 30th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2015.

American Academy of Pediatrics Committee on Drugs. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278.[PubMed 9024461]

Centers for Disease Control and Prevention (CDC). Parasites—Scabies. CDC website. http://www.cdc.gov/parasites/scabies/treatment.html. Published November 2, 2010. Accessed May 18, 2015.

Cubela V, Yawalkar SJ. Clinical experience with crotamiton cream and lotion in treatment of infants with scabies. Br J Clin Pract. 1978;32(8):229-231.[PubMed 728333]

Eichenfield LF, Honig PJ, “Blistering Disorders in Childhood,” Pediatr Clin North Am, 1991, 38(4):959-76.[PubMed 1651468]

Eurax (crotamiton) [prescribing information]. Jacksonville, FL: Ranbaxy; September 2012.

Goldust M, Rezaee E, Raghifar R. Comparison of oral ivermectin versus crotamiton 10% cream in the treatment of scabies. Cutan Ocul Toxicol. 2014;33(4):333-336.[PubMed 23431958]

Hay RJ, Steer AC, Engelman D, Walton S. Scabies in the developing world--its prevalence, complications, and management. Clin Microbiol Infect. 2012;18(4):313-323.[PubMed 22429456]

Hogan DJ, Schachner L, Tanglertsampan C, “Diagnosis and Treatment of Childhood Scabies and Pediculosis,” Pediatr Clin North Am, 1991, 38(4):941-57.[PubMed 1870912]

Kliegman RM, Stanton BMD, St. Geme J, Schor NF, eds. Nelson' s Textbook of Pediatrics. 20th ed. Philadelphia, PA: Saunders Elsevier; 2016.

Konstantinov D, Stanoeva L, Yawalkar SJ. Crotamiton cream and lotion in the treatment of infants and young children with scabies. J Int Med Res. 1979;7(5):443-448.[PubMed 499647]

Sekine R, Satoh T, Takaoka A, Saeki K, Yokozeki H. Anti pruritic effects of topical crotamiton, capsaicin, and a corticosteroid on pruritogen-induced scratching behavior. Exp Dermatol. 2012;21(3):201-204.[PubMed 22379965]

Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259.[PubMed 19188870]

World Health Organization (WHO). Guidelines on the Treatment of Skin and Oral HIV-Associated Condiyions in Children and Adults. 2014.[PubMed 19188870]

Brand Names: International

A-Bite (MY); Acomexol (CR, DO, GT, HN, MX, NI, PA, SV); Congen (PH); Crodex (BD); Cronix (BD); Crotam (BD); Crotamitex (DE, EG); Crotamiton (PL); Crotan (PK); Crotanol (VE); Crotaphil (JO, QA); Crotocort (MY); Crotorax (IN); Eurax (AE, AT, AU, BB, BF, BH, BJ, BM, BS, BZ, CH, CI, CL, CO, CY, EG, ET, FR, GB, GH, GM, GN, GR, GY, HK, HR, IE, IL, IN, IQ, IR, IT, JM, JO, KE, KW, LB, LR, LU, LY, MA, ML, MR, MT, MU, MW, MX, MY, NE, NG, NL, NO, NZ, OM, PE, PL, PT, QA, SA, SC, SD, SG, SI, SL, SN, SR, SY, TN, TT, TZ, UG, VN, YE, ZA, ZM, ZW); Eurax-Lotio (AT); Moz-Bite (ET, MY, SG, VN); Scabine (SY); Scabirax (EG); Ulex (TW); Uracin (KR); Youlifu (CN)

Last Updated 1/29/20

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