EXODERIL® LACQUER

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT EXODERIL® LACQUER (EXODERIL® LACQUER)

Composition:

Active substance: amorolfine;

1 ml of solution contains 55.74 mg of amorolfine hydrochloride, equivalent to 50 mg of amorolfine;

Excipients: ammonium methacrylate copolymer (type A), triacetin, butyl acetate, ethyl acetate, anhydrous ethanol.

Pharmaceutical form. Nail treatment lacquer.

Main physicochemical properties: clear, colorless liquid.

Pharmacotherapeutic group.

Antifungal agents for dermatological use, other antifungals for topical use. ATC code D01AE16.

Pharmacological Properties

Pharmacodynamics.

Exoderil® nail lacquer, 50 mg/mL, is an antifungal agent for topical use. Amorolfine belongs to a new class of chemical compounds; its fungicidal action is based on altering the fungal cell membrane, primarily through affecting sterol biosynthesis. The content of ergosterol decreases, while atypical non-planar sterols accumulate simultaneously.

Amorolfine is a broad-spectrum antifungal agent. It is highly active (MIC < 2 μg/mL) in vitro against:

dermatophytes Trichophyton, Microsporum, Epidermophyton;

yeasts Candida, Cryptococcus, Malassezia;

molds Hendersonula, Alternaria, Scopulariopsis, Scytalidium, Aspergillus;

dematiaceous fungi Cladosporium, Fonsecaea, Wangiella;

dimorphic fungi Coccidioides, Histoplasma, Sporothrix.

Bacteria, except for actinomycetes, are insensitive to amorolfine.

Pharmacokinetics.

Amorolfine contained in the nail lacquer penetrates into the nail plate and diffuses through it, thus being able to eradicate fungi located in the nail bed that are otherwise difficult to reach. Systemic absorption of the active ingredient following this type of application is very low; its plasma concentration remains below the detection limit even after one year of use.

Clinical characteristics.

Indications.

Treatment of onychomycosis without matrix involvement (mild to moderate degree) caused by dermatophytes, yeasts, and molds.

Contraindications.

Hypersensitivity to amorolfine or to any of the excipients contained in the product.

Interaction with other medicinal products and other forms of interactions.

Current data do not indicate the presence of clinically significant interactions.

Special precautions for use.

Exoderil® lacquer should not be applied to the skin around the nail. Avoid contact of the lacquer with eyes, ears, and mucous membranes.

Exoderil® lacquer should be used with caution in patients with conditions that predispose them to nail damage (peripheral circulation disorders, diabetes mellitus, and immunosuppression), as well as in patients with nail dystrophy and severely damaged nails (more than two-thirds of the nail plate destroyed). In such cases, systemic treatment should be considered.

Do not use artificial nails during treatment with Exoderil® lacquer.

When working with organic solvents, impermeable gloves should be worn to prevent dissolution of the lacquer. Cosmetic nail polish may be applied no sooner than 10 minutes after application of Exoderil® lacquer. Before reapplying Exoderil® lacquer, cosmetic nail polish must be carefully removed.

Systemic or local allergic reactions may occur after using this medicinal product. In such cases, application of the lacquer should be discontinued immediately and medical advice should be sought. The product should be thoroughly removed using a nail polish remover. The medicinal product must not be reused.

Use during pregnancy or breastfeeding.

There is limited data on the use of amorolfine during pregnancy and breastfeeding. Only a small number of pregnant women have been reported to use topical amorolfine since market entry, so the potential risk is unknown. Animal studies have shown reproductive toxicity when the drug was administered at high oral doses.

It is not known whether amorolfine is excreted in breast milk.

Exoderil® lacquer should not be used during pregnancy and breastfeeding, except when clearly necessary.

Ability to affect reaction speed when driving or operating machinery.

No effect.

Method of Administration and Dosage

Apply Exoderil® nail lacquer to the affected nails once or twice a week.

The lacquer should be applied carefully, strictly following these recommendations:

1. Before the first application of 5% amorolfine nail lacquer, it is very important to thoroughly file the affected nail areas (particularly the nail surface) using the special nail file-scraper provided in the package. Then, clean and degrease the surface with an alcohol wipe. Before each subsequent application of 5% amorolfine, the affected nail area should be filed again and then cleaned with an alcohol wipe.

Warning: Nail files-scrubbers used for infected nails must not be used for healthy nails.

2. Using one of the disposable applicators, apply the lacquer evenly over the entire surface of the affected nail. Allow the lacquer to dry for 3–5 minutes. After use, clean the applicator with the same alcohol wipe used for the nail. Keep the bottle tightly closed.

When applying the medication to each nail, dip the applicator into the lacquer bottle without wiping off the lacquer on the bottle neck.

Cosmetic nail polish may be applied no sooner than 10 minutes after Exoderil® nail lacquer application.

Warning: When working with organic solvents (e.g., solvents, white spirit), wear waterproof gloves to preserve the lacquer on the nails.

Treatment should be continued without interruption until the nail is fully restored and the affected areas have healed. The duration of treatment is generally 6 months for fingernails and 9 months for toenails (this primarily depends on the severity of the infection, its location, and the extent of nail involvement).

If athlete’s foot (tinea pedis) is also present, appropriate antifungal cream treatment should be used concurrently.

Children

Due to lack of data, Exoderil® nail lacquer is not recommended for patients under 18 years of age.

Overdose

Isolated cases of adverse reactions may occur. Possible nail disorders include nail discoloration and nail brittleness. Such reactions may also be associated with onychomycosis.

No systemic signs of overdose are expected following topical application of Exoderil® nail lacquer. In case of accidental oral ingestion, appropriate symptomatic treatment should be administered.

Adverse Reactions.

Unwanted reactions to the medicine occur rarely. Possible nail disorders (e.g. nail discoloration, brittleness, fragile nails). These reactions may also be caused by onychomycosis itself.

Skin and subcutaneous tissue disorders:
Rare (≥ 1/10000, < 1/1000): nail disorders, nail discoloration, onychoclasis (nail brittleness), onychorrhexis (fragile nails);
Very rare (< 1/10000): skin burning sensation;
Frequency not known (cannot be estimated based on available data): erythema, pruritus, contact dermatitis, urticaria, blisters.

Immune system disorders:
Hypersensitivity (systemic allergic reaction)*

*Adverse reactions reported since the medicine was marketed.

Shelf life. 36 months.

After opening the bottle – 6 months.

Storage conditions.

Keep the bottle tightly closed.

No special storage conditions required.

Packaging.

2.5 ml or 5 ml in a bottle. 1 bottle with 10 spatulas, 30 cleaning swabs, and 30 nail files in a cardboard box.

Supply category. Over-the-counter.

Manufacturer.

Lek Pharmaceuticals d.d.

Manufacturer's address and place of business.

Verovškova 57, 1526 Ljubljana, Slovenia.