Why do I need this medicine?

Amorolfine is used to treat fungal infections of the fingernails and toenails.

This medicine may also be used to treat certain fungal skin infections such as athlete's foot.

How do I use this medicine?

Apply Amorolfine exactly as directed by your doctor or according to the instructions on the label. Do not apply more or less than instructed by your doctor.

Your doctor will also discuss the use of this medicine as different preparations of Amorolfine may only be used for a specific condition.

Do not use this medicine for any conditions other than what is prescribed by your doctor.

Amorolfine is available as a skin cream or medicated nail lacquer.

If you are using the skin cream to treat fungal skin infections, follow these steps:

Clean and dry the affected area before application.

Rub the cream gently on the skin until it disappears, preferably during the evening.

Wash your hands after using.

Replace the cap of the tube.

If you are using the medicated lacquer to treat

Indications and Dosage

Topical/Cutaneous

Dermatomycoses

Adult: For cases caused by dermatophytes: As 0.25% cream: Apply onto the affected area(s) once daily, preferably in the evening. Continue treatment for 3-5 days after clinical cure is achieved. Treatment duration: 2-3 weeks (up to 6 weeks for foot mycoses).

Topical/Cutaneous

Onychomycosis

Adult: For cases caused by dermatophytes, yeasts, and moulds: As 5% medicated nail lacquer: Apply evenly onto the entire surface of the affected nail(s) once or twice weekly after filing and cleansing with the provided nail file and cleansing pads. Continue treatment until the nail has regenerated and the affected areas are cured. Therapy evaluation is recommended every 3 months. Treatment duration: Approx 6 months (fingernails); 9-12 months (toenails).

Contraindications

Hypersensitivity.

Special Precautions

Pregnancy and lactation.

Adverse Reactions

Significant: Systemic or local hypersensitivity reaction, including contact dermatitis.

Skin and subcutaneous tissue disorders: Erythema, pruritus, urticaria, blister. Rarely, skin irritation; nail disorder or discolouration, onychoclasis, onychorrhexis, burning senation of skin around the nail.

Patient Counseling Information

Avoid contact with the eyes, ears, and mucous membranes. Medicated nail lacquer: Avoid contact with the surrounding skin around the nails. Nail files used for affected nails should not be used for healthy nails. Avoid use of artificial nails during treatment. Wear impermeable gloves when working with organic solvents (e.g. thinners, white spirits).

Action

Description: Amorolfine is a broad spectrum morpholine derivative topical antimycotic agent. It alters the fungal cell membrane by interfering with sterol biosynthesis, resulting in the reduction of ergosterol and the accumulation of unusual sterically nonplanar sterols.

Pharmacokinetics:

Absorption: Minimal systemic absorption.

Distribution: Penetrates and diffuses through the nail plate.