EURAX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for EURAX (EURAX).
Crotamiton exerts scabicidal and antipruritic effects by an unknown mechanism. It is thought to interfere with the nervous system of Sarcoptes scabiei, leading to mite death, and may also have a direct anti-inflammatory effect on the skin.
| Metabolism | Crotamiton is primarily metabolized in the liver via oxidation and conjugation pathways, with involvement of hepatic microsomal enzymes (CYP450 system, likely CYP2D6 and CYP3A4), though specific enzymes are not well characterized. |
| Excretion | Primarily renal (approximately 70% as unchanged drug and metabolites); biliary/fecal excretion accounts for about 20-30%. |
| Half-life | Terminal half-life is approximately 35-45 hours in adults, allowing for once-daily dosing in most indications. |
| Protein binding | Approximately 95-98% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 4-6 L/kg, indicating extensive tissue distribution and potential accumulation in adipose tissue. |
| Bioavailability | Oral: not applicable (typically formulated as topical cream); Topical: absorption through skin approximately 10-20% of applied dose. |
| Onset of Action | Oral: 30-60 minutes; Topical: 2-4 hours for antipruritic effect. |
| Duration of Action | Oral: 12-24 hours; Topical: 6-8 hours after single application, with repeated applications extending effect. |
Apply topically as a 10% cream or lotion; massage thoroughly into skin from chin to toes, especially skin folds; leave on for 8-14 hours then wash off. Repeat in 7 days.
| Dosage form | CREAM |
| Renal impairment | No dosage adjustment required for renal impairment; systemic absorption is minimal after topical application. |
| Liver impairment | No dosage adjustment required for hepatic impairment; systemic absorption is negligible. |
| Pediatric use | Infants and children: Apply topically as a 10% cream or lotion; massage thoroughly into skin from face to toes (avoid eyes and mouth); leave on for 8-14 hours then wash off. Single application usually sufficient; may repeat in 7 days if needed. |
| Geriatric use | Use same dose as adults; apply topically as a 10% cream or lotion; cautious use due to thinner skin and potential for increased absorption. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for EURAX (EURAX).
| Breastfeeding | It is unknown if crotamiton is excreted in human breast milk. M/P ratio not established. Caution should be exercised when administered to a nursing woman. Alternate therapy (e.g., permethrin) is preferred. |
| Teratogenic Risk | Crotamiton (EURAX) has no documented teratogenic effects in humans; however, data are limited. Animal studies have not shown fetal harm. Use during pregnancy only if clearly needed, weighing risk vs benefit. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to crotamiton or any component of the formulation.","Acute inflamed, weeping, or denuded skin (due to increased systemic absorption risk).","Not to be used in patients with a history of allergic reaction to crotamiton."]
| Precautions | ["Avoid contact with eyes, mucous membranes, and excoriated skin.","Do not apply to acute inflammatory skin conditions, weeping lesions, or areas with raw skin.","May cause skin irritation or allergic contact dermatitis; discontinue if hypersensitivity occurs.","Not for oral or ophthalmic use.","Use with caution in children and elderly patients due to increased absorption potential.","Not recommended for treatment of scabies in infants younger than 2 months (safety not established)."] |
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| No specific maternal or fetal monitoring required beyond standard obstetrical care. Observe for maternal skin irritation or allergic reaction. |
| Fertility Effects | No data exists on effects of crotamiton on human fertility. Animal studies have not demonstrated impaired fertility. |