Amorolfine Hydrochloride (cream)

Amorolfine Hydrochloride is indicated for the treatment of

• Tinea pedis (athlete's foot),
• Tinea cruris, Tinea inguinalis,
• Tinea corporis,
• Tinea manuum &
• Pityriasis versicolor.

Amorolfine is a broad spectrum topical antimycotic. It is a morpholine antifungal drug that inhibits the fungal enzymes D14 reductase and D7-D8 isomerase. This inhibition affects fungal sterol synthesis pathways & depletes ergosterol .

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 localization 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 or as directed by the physicians.

Use in Children and Adolescents: Owing to the lack of clinical experience, the use of this cream in children is not recommended.

There are no specific studies involving concomitant treatment with other topical medicines.

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

Adverse drug reactions like Skin and subcutaneous tissue disorders are rare and mostly mild in nature.

Amorolfine Hydrochloride cream should not be used during pregnancy and lactation unless clearly necessary. Breast feeding women must not use the cream in the breast area.

Avoid contact of Amorolfine Hydrochloride cream with eyes, ears and mucous membranes. A systemic or local allergic reaction could possibly occur after use of this cream. If this happens, the cream should be stopped immediately and medical advice should be sought. Remove the cream carefully by cleaning the skin. The cream should not be reapplied.

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

Topical Antifungal preparations

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.