Exoderil for nails medicinal solution 50 mg/ml bottle 2.5 ml with 10 spatulas, 30 cleaning swabs and 30 nail files

Pharmacodynamics. Exoderil® varnish, nail varnish 50 mg/ml – is an antifungal agent for topical use. Amorolfine belongs to a new class of chemical compounds, its fungicidal effect is to change the membrane of the fungal cell, mainly due to the effect on the biosynthesis of sterols. The content of ergosterol decreases and at the same time there is an accumulation of atypical steric non-planar sterols.

Amorolfine is a broad-spectrum antifungal agent. It has high activity (MIC 2 μg/ml) in vitro against:

• dermatophytes Trichophyton, Microsporum, Epidermophyton;
• yeasts Candida, Cryptococcus, Malassezia;
• mold fungi Hendersonula, Alternaria, Scopulariopsis, Scytalidium, Aspergillus;
• fungi of the Dematiacea family: Cladosporium, Fonsecaea, Wangiella;
• dimorphic fungi Coccidioides, Histoplasma, Sporothrix.

Bacteria, with the exception of actinomycetes, are insensitive to the action of amorolfine.

Pharmacokinetics. Amorolfine from nail polish penetrates the nail plate and diffuses through it and is therefore able to eradicate fungi located in the nail bed and which are difficult to reach. Systemic absorption of the active substance with this application is very low.

There is no evidence of accumulation of the drug in the body after prolonged use of Exoderil varnish, nail varnish 50 mg/ml.

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

Nail polish should be applied to the affected area of ​​the finger or nail once a week.

The patient should apply the varnish as follows:

1. Before the first application of Amorolfine 5%, nail varnish, it is very important that the affected areas of the nail (in particular the nail surface) are filed as thoroughly as possible using the special nail file-scraper provided. The surface should then be cleaned and degreased with an alcohol wipe. Before re-application of Amorolfine 5%, the affected area of ​​the nail should be filed again, after which the nail should be cleaned with an alcohol wipe.

Warning: Nail file scrapers that have been used on affected nails should not be used on healthy nails.

2. Apply the nail polish to the entire surface of the affected nail using one of the reusable applicators. Allow the nail polish to dry for 3-5 minutes. After use, clean the applicator with the same alcohol wipe as the nail. Keep the bottle tightly closed.

When applying the product to each nail, dip the applicator into the nail polish bottle without wiping the applicator with the nail polish on the neck of the bottle.

Warning: when working with organic solutions (solvents, white spirit, etc.), you should use waterproof gloves to keep the polish on your nails.

Treatment should be continued without interruption until the nail has grown back and the affected areas have healed. The required frequency and duration of treatment depend mainly on the intensity and location of the infection. This usually lasts 6 months (for fingernails) and 9-12 months (for toenails). It is recommended to repeat the treatment at intervals of approximately 3 months.

If you also have tinea pedis, you must use an appropriate antifungal cream.

Hypersensitivity to amorolfine or excipients included in the drug.

Adverse drug reactions are rare. Nail lesions are possible (e.g., nail discoloration, brittleness, nail fragility). These reactions may also be due to onychomycosis itself.

Skin and subcutaneous tissue disorders: rare (≥1/10,000, 1/1000): nail disorders, nail discoloration, onychoclasia (fragility of nails), onychorexis (fragility of nails); very rare (1/10,000): burning sensation of the skin.

The use of nail polish and false nails should be avoided during treatment with the drug.

Avoid getting nail polish in your eyes, ears, and mucous membranes.

Patients with underlying medical conditions that make them susceptible to fungal nail infections (peripheral circulatory disorders, diabetes, and immunosuppression) should consult a doctor.

Patients with nail dystrophy and a destroyed nail plate should consult a doctor.

Use during pregnancy and breastfeeding. Studies of reproductive toxicity in laboratory animals have not revealed signs of teratogenicity, but when the drug is administered orally in high doses, embryotoxic effects were noted. Systemic absorption of amorolfine during and after topical application is very low, so the risk to the human fetus is very low. However, since there is no relevant experience with use, the use of Exoderil varnish during pregnancy and breastfeeding should be avoided.

Children: The safety and efficacy of the drug in children (under 18 years of age) have not been established.

The ability to influence the reaction speed when driving vehicles or working with other mechanisms. Does not affect.

There are no specific studies on concomitant treatment with other drugs for external use.

No cases of overdose have been reported.

In case of accidental ingestion, the stomach should be washed and an appropriate method of gastric emptying should be used.

No special storage conditions are required. Keep the bottle tightly closed. Keep out of the reach of children.