API

Amorolfine (0.25% w/w)

Drug classification

Amrolstar Cream is an antifungal agent, specifically a topical morpholine derivative.

Dosage form

Topical cream containing 0.25% w/w amorolfine.

API strength per dosage

Dose

Apply a thin layer of Amorolfine 0.25% cream once or twice daily to affected skin and surrounding area, as directed. Duration depends on infection site and severity. Safety and efficacy in children, or in patients with renal or hepatic impairment, are not established; use with caution. 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

Safety of topical amorolfine in pregnancy is not established; use only if potential benefit justifies potential risk to the fetus. Avoid unless clearly needed.

Precautions

Avoid contact with eyes, mucous membranes, and open wounds, use only on affected skin, discontinue if irritation or allergic reaction occurs, monitor for local side effects, not for use in children unless prescribed, avoid occlusive dressings, inform healthcare provider of persistent symptoms or worsening condition.

Contraindications

Hypersensitivity to amorolfine or any excipients, pregnancy, breastfeeding, children, use on mucous membranes, open wounds, or broken skin.