Amorolfine

What it is and how it works

Amorolfine inhibits two enzymes of fungal ergosterol biosynthesis (delta-14 reductase and delta-7,8 isomerase), depleting ergosterol and causing accumulation of abnormal sterols in the fungal cell membrane, with fungistatic and fungicidal activity against dermatophytes, yeasts and moulds.

Indications

Mild to moderate fungal nail infections (onychomycosis) without matrix involvement, caused by dermatophytes, yeasts or moulds.

Dosage and administration (summary)

5% nail lacquer applied to affected nails once or twice weekly after filing and cleansing, continued until the nail has regrown (usually 6 months for fingernails and 9–12 months for toenails).

Contraindications

Hypersensitivity to amorolfine or excipients.

Warnings and precautions

Avoid contact with eyes, ears and mucous membranes. Nail files used on infected nails should not be used on healthy nails. Artificial nails should be avoided during treatment; patients with diabetes, immunosuppression or extensive nail involvement may need systemic therapy.

Pregnancy

Avoid in pregnancy because experience is limited, although systemic absorption is negligible.

Storage and supply

Store below 30 °C; keep the bottle tightly closed, away from heat and flames (flammable).

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.