EURAX Cream Ref.[27512] Active ingredients:

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Thornton & Ross Ltd., Linthwaite, Huddersfield, HD7 5QH, UK

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: other antipruritics (ATC code D04AX) and other ectoparasiticides, including scabicides (ATC code P03AX).

Crotamiton has a symptomatic action on pruritus and is an acaricide. As an acaricide agent, crotamiton is effective on the motor system of the mites by inducing irreversible cessation of spontaneous movements.

Eurax/Boots Dermacare Itch Relief Cream will provide relief from irritation for 6 to 10 hours after each application.

5.2. Pharmacokinetic properties

Eurax penetrates rapidly into human skin. Low but measurable concentrations of crotamiton are found in plasma, with a maximum level after 4-10 hours, declining rapidly thereafter.

5.3. Preclinical safety data

No preclinical studies were performed using Eurax Cream. Preclinical data do not show teratogenic nor genotoxic risk for crotamiton. Abnormalities of foetal development were observed following administration of corticosteroids to pregnant animals. Eurax Cream, a crotamiton containing cream, administered topically once daily for 3 months to rabbits was tolerated at doses of up to 200 mg/kg without signs of toxicity, apart from transient skin irritation. No sensitising or photo-sensitising potential has been observed in animal studies.

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