Instructions Exoderil medicated nail polish 5% bottle 2.5 ml
Composition
active ingredient: 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.
Dosage form
Medical nail polish.
Main physicochemical properties: clear colorless liquid.
Pharmacotherapeutic group
Antifungal preparations for dermatological use, other antifungal preparations for external use. ATX code D01A E16.
Pharmacological properties
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 action is based on changes in the fungal cell membrane, mainly due to its effect on the biosynthesis of sterols. The ergosterol content decreases and at the same time there is an accumulation of atypical steric non-planar sterols.
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; 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 and diffuses through the nail plate 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.
Indication
Treatment of onychomycosis without matrix involvement (mild and moderate) caused by dermatophytes, yeasts and molds.
Contraindication
Hypersensitivity to amorolfine or excipients included in the drug.
Special safety measures.
Avoid getting nail polish in your eyes, ears, and mucous membranes.
The use of nail polish and false nails should be avoided during treatment with the drug.
Interaction with other medicinal products and other types of interactions
There are no specific studies on concomitant treatment with other drugs for external use.
Application features
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.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Use during pregnancy or breastfeeding
In reproductive toxicity studies in laboratory animals, no signs of teratogenicity were found, but when the drug was 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 small. However, since there is no relevant experience, the use of Exoderil lacquer during pregnancy and breastfeeding should be avoided.
Method of administration and doses
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:
Before the first application of Amorolfine 5%, nail varnish, it is very important that the affected areas of the nail (especially the nail surface) are sanded as thoroughly as possible using the special nail file-scraper provided in the kit. The surface should then be cleaned and degreased with an alcohol wipe. Before re-applying Amorolfine 5%, the affected area of the nail should be sanded 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.
Apply the polish to the entire surface of the affected nail using one of the reusable applicators. Allow the 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 nail polish applicator against the neck of the bottle.
Warning: when working with organic solutions (solvents, white spirit), use waterproof gloves to keep the polish on your nails.
If you also have athlete's foot, you should be treated with an appropriate antifungal cream.
Children
The safety and efficacy of the drug in children (under 18 years of age) have not yet been established.
Overdose
No cases of overdose were observed.
In case of accidental ingestion of the drug, the stomach should be washed and an appropriate method of gastric emptying should be used.
Adverse reactions
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 (brittle nails), onychorrhexis (brittle nails); very rare (1/10,000): burning sensation of the skin.
Expiration date
36 months.
After opening the bottle – 6 months.
Storage conditions
No special storage conditions are required. Keep the bottle tightly closed. Keep out of the reach of children.
Packaging
2.5 ml per bottle. 1 bottle together with 10 spatulas, 30 cleaning swabs and 30 nail files in a cardboard box.
Vacation category
Without a prescription.
Producer
Lek Pharmaceutical Company Ltd.
Location of the manufacturer and its business address
Verovškova 57, Ljubljana 1526, Slovenia.
