Exorolfinlak nail polish 5%, 2.5ml

Composition

per 1 ml of varnish:

active ingredient:

Amorolfine-50 mg (in the form of Amorolfine hydrochloride-55.74 mg);

auxiliary ingredients:

ethyl acetate-150 mg;

triacetin-10.5 mg;

eudragit RL PO (methacrylic acid copolymer) – 125 mg;

butyl acetate-50 mg;

ethanol-480 mg

Pharmacological action

Pharmacodynamics

The active component of Exorolfinlak-Amorolfine-provides its fungistatic and fungicidal effectiveness due to the destruction of the cytoplasmic fungal membrane by disrupting the biosynthesis of sterols, which reduces the level of ergosterol and accumulates atypical stereoisomers – steric non-planar sterols.

Due to the wide range of actions Amorolfinee is highly active against not only the common but also rare fungal pathogens affecting the nail plate: dermatophytes: Microsporum spp. Trichophyton spp. Epidermophyton spp. ; yeast: Candida spp. Malassezia spp. (Pityrosporum spp. ), Cryptococcus spp. ; fungi: Scopulariopsis spp. Alternaria spp. Hendersonula spp. ; mushrooms of the family Dematiaceae: Fonsecaea spp. Cladosporium spp. Wangiella spp. ; dimorphic fungi: Histoplasma spp., Coccidioides spp. Sporothrix spp.

Pharmacokinetics

After applying nail polish to the nails, Amorolfine penetrates almost completely into the nail plate and then into the nail bed during the first 24 hours. The effective concentration of the substance remains in the affected areas from 7 to 10 days, even after the first application. Systemic absorption of the substance is insignificant, its plasma concentration is below the sensitivity limit of the methods of determination (

Indications

According to the instructions, Exorolfinlak is recommended for topical treatment of fungal lesions of the nail plates caused by yeast, dermatophytes and mold fungi. The drug is also used for the prevention of fungal nail lesions.

Use during pregnancy and lactation

Data on the use of Amorolfine during pregnancy and lactation are limited, and therefore the use of Exorolfinlak during these periods is not recommended.

Recommendations for use

Exorolfinlak is intended for external application on the affected nail plates of the fingers and / or toes. The procedure is performed 1-2 times a week, following the following recommendations: Before using the drug, using a disposable nail file included in the kit, if possible, remove the affected fragments of the nail, especially from its surface. The nail surface is cleaned and degreased with a special cleaning cloth from the kit (for each subsequent application, repeat the procedure for treating the affected nails with a nail file, after which the remaining layer of varnish is removed with a cleaning cloth). The applicator is dipped in a bottle of varnish, then it is carefully removed, without erasing the excess drug on the neck of the bottle. An applicator is applied to the entire surface of the affected nail plate in an even layer of varnish, repeating the procedure for each affected nail. Maintain a time of about 3 minutes for the varnish to dry. The applicator is wiped with a cloth used for cleaning the nails, avoiding contact with the treated nails. The bottle is tightly closed immediately after the end of the procedure. The used napkin is discarded. It is allowed to apply decorative nail polish on top of Exorolfinlak, but not earlier than 10 minutes after the procedure. Before repeated use of Exorolfinlak, the remaining decorative nail polish must be carefully removed, then use the attached nail files to treat the affected nail plates and remove the remaining varnish with cleaning cloths. You should thoroughly wash your hands after the end of each treatment procedure, but when applying the drug to your fingernails, you must first wait for the varnish to dry completely. After the varnish is completely dry, you can regularly wash your hands and feet using soap. The course of therapy is long, the use of Exorolfinlak should be discontinued after complete regeneration of the nail plate and healing of the affected nails. The average duration of the course for fingernails is 6 months, for toenails-9-12 months. Since the nail plates grow slowly, the first signs of improvement are noticeable only after 2-3 months of systematic use of the drug. If there are no such signs after 3 months, you should consult a doctor.

Contraindications

• pregnancy and lactation;
• children and adolescents under 18 years of age;
• hypersensitivity to Amorolfine and other components of the drug.

Side effects

The use of Exorolfinlak causes undesirable reactions in rare cases. The nail damage observed during treatment (destruction of the nail plates, discoloration and fragility of the nails) is most likely the result of fungal damage. The frequency of adverse reactions recorded when using Exorolfinlak in accordance with the accepted organ-system classification (according to the scale: very often-more than 0.1; often-no more than 0.01, but less than 0.1; infrequently-no more than 0.001, but less than 0.01; rarely-no more than 0.0001, but less than 0.001; extremely rarely-less than 0.0001; unclear frequency-it is impossible to quantify adverse reactions based on available data): skin and subcutaneous tissues: rarely – discoloration of the nail plate, nail damage, fragility of the nail plate (onychoclasia), fragility of the nail plate (onychorexis); extremely rarely – burning sensation of the skin; unclear frequency – urticaria, pruritus, erythema, contact dermatitis, blisters; immune system: unclear frequency – systemic hypersensitivity reactions. If any of these side effects worsen or other negative reactions occur that are not listed in the description, you should immediately consult a doctor.

Overdose

The drug is used exclusively for external use, which is not expected to develop systemic signs of overdose. In case of accidental ingestion of Exorolfinlak, appropriate symptomatic treatment is required.

Special instructions

When treating Exorolfinlak, it is necessary: Do not use the nail files used for the treatment of affected nails for the purpose of treating healthy nail plates. When working with organic solvents, wear impermeable gloves to protect the nails covered with the product. Avoid using artificial false nails. Do not apply the nail polish too often or in violation of the application requirements, as this may lead to irritation/dryness of the skin around the nail due to the presence of ethanol in the preparation. Note that the cleaning cloth contains a highly flammable substance. Avoid contact with the drug in the ears, eyes, and mucous membranes, and in case of unintentional contact, immediately flush the affected surfaces with running water in large quantities. In case of systemic / local hypersensitivity reactions, the drug should be stopped immediately and a doctor should be consulted, after removing the drug from the nails with nail polish remover. In this case, you can not apply Exorolfinlak again. Conditions predisposing to the development of fungal nail diseases, such as diabetes mellitus, peripheral circulatory disorders, immunodeficiency, as well as nail dystrophy or a destroyed nail plate, psoriasis, and other chronic skin diseases, require contacting a specialist. When more than 2/3 of the nail plate is destroyed or affected by the fungus, it is also necessary to consult a doctor to prescribe oral medications for the purpose of complex therapy.

Form of production

Nail polish: thickish colorless transparent liquid (2.5 ml each in dark glass bottles, the set includes 30 napkins,10 special spatulas and 30 disposable nail files; in a pack of cardboard,1 set each).

Storage conditions

Store in a place protected from light, out of reach of children, at temperatures up to 25 °C.

Expiration date

After opening, the bottle should be used for 6 months.

Active ingredient

Amorolfine

Dosage form

Tablets