Amorolfine is a topical antimycotic. Amorolfine belongs to a new chemical class, and its fungicidal action is based on an alteration of the fungal cell membrane targeted primarily on sterol biosynthesis. The ergosterol content is reduced, and at the same time unusual sterically nonplanar sterols accumulate.

Amorolfine Hydrochloride is indicated in Dermatomycoses caused by dermatophytes: tinea pedis (athlete's foot), tinea cruris, tinea inguinalis, tinea corporis, tinea manuum. Pityriasis versicolor.

Adult: To be applied to affected skin areas once daily following cleansing (in the evening). The treatment should be continued without interruption until clinical cure, and for 3-5 days thereafter. The required duration of treatment depends on the species of fungi and on the localisation of the infection. In general, treatment should be continued for at least two to three weeks. With foot mycoses, up to six weeks of therapy may be necessary.

Elderly: There are no specific dosage recommendations for use in elderly patients.

Children: There are no specific dosage recommendations for children owing to the lack of clinical experience available to date.

Amorolfine cream must not be reused by patients who have shown hypersensitivity to the active substance or to any of the excipients.

Side effects are Skin Irritation, erythema, pruritus, skin burning sensation, Hypersensitivity (systemic allergic reaction).

Overdose Effects

Amorolfine is for topical use. In the event of accidental oral ingestion, an appropriate method of gastric emptying may be used.

Pregnancy & Lactation

No experience exists of use during pregnancy and nursing, therefore, the use of Amorolfine should be avoided during pregnancy and lactation. Reproductive toxicology studies showed no evidence of teratogenicity in laboratory animals but embryotoxicity was observed at high oral doses. The systemic absorption of amorolfine during and after topical administration is very low and therefore the risk to the human foetus appears to be negligible. Amorolfine Cream should not be used during pregnancy and/or lactation unless clearly necessary. Breast-feeding women must not use the cream in the breast area.

Precautions & Warnings

Avoid contact of Amorolfine cream with eyes, ears and mucous membranes. This medicinal product contains stearyl alcohol which may cause local skin reaction (e.g. contact dermatitis) Owing to the lack of clinical experience available to date, the use of Amorolfine 0.25% cream in children is not recommended. A systemic or local allergic reaction could possibly occur after use of this product. If this happens, the product should be stopped immediately and medical advice should be sought. Remove the product carefully by cleaning the skin. The product should not be reapplied.