API

Amorolfine (0.25% w/w)

Drug classification

Antifungal agent; specific subclass: Morpholine derivative.

Dosage form

Topical cream containing 0.25% w/w amorolfine.

API strength per dosage

Dose

Amorolfine 0.25% cream is typically applied once or twice daily to affected skin areas in adults. Safety and efficacy in children have not been established. No specific dose adjustments are recommended for renal or hepatic impairment. Use as directed by a healthcare professional; avoid contact with eyes and mucous membranes.

Mechanism of action

Amorolfine inhibits fungal sterol biosynthesis by noncompetitively inhibiting the enzymes Δ14-reductase and Δ7–Δ8-isomerase. This disrupts ergosterol production, leading to accumulation of abnormal sterols in the fungal cell membrane, increased membrane permeability, and ultimately fungal cell death.

Indications

Fungal nail infections

Side effects

Blisters on skin Nail disorder Skin irritation Skin rash Erythema skin redness

Pregnancy category

Limited human data; animal studies show no teratogenicity. Use during pregnancy only if potential benefit justifies potential risk to the fetus.

Precautions

Avoid contact with eyes and mucous membranes, use only on affected areas, not for oral or intravaginal use, monitor for local irritation or allergic reactions, discontinue if hypersensitivity occurs, avoid use on broken skin, inform healthcare provider of persistent symptoms, not recommended in pregnancy or lactation unless necessary.

Contraindications

Hypersensitivity to amorolfine or any excipients, pregnancy, lactation, children, open wounds or broken skin at application site.