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The active ingredient of Exorolfinac - amorolfine - provides its fungistatic and fungicidal efficacy due to the destruction of the cytoplasmic fungal membrane through disruption of sterol biosynthesis, which reduces ergosterol levels and accumulates atypical stereoisomers - steric non-planar sterols. Due to the wide spectrum of action, amorolfine is highly active against not only the most common, but also rare fungal pathogens affecting the nail plate: dermatophytes: Microsporum spp., Trichophyton spp., Epidermophyton spp .; yeast mushrooms: Candida spp., Malassezia spp. (Pityrosporum spp.), Cryptococcus spp .; mold 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.
After applying the varnish on the nails, amorolfin penetrates the nail plate and further into the nail bed almost completely during the first 24 hours. The effective concentration of the substance is preserved in the lesions for 7 to 10 days even after the first application. Systemic absorption of the substance is slightly affected, its plasma concentration is below the sensitivity limit of the determination methods (<0.5 ng="" ml="" p="">
According to the instructions, Exorolfinlac is recommended for the local treatment of fungal lesions of the nail plates caused by yeast fungi, dermatophytes and mold fungi. The drug is also used for the prevention of fungal nail infections.
on 1 ml of varnish:
active ingredient: amorolfine - 50 mg (55.74 mg as amorolfine hydrochloride); 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.
Amorolfin is marketed under different brands and generic names, and comes in different dosage forms:
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Dosage and Administration
Ekzolfinlak is intended for external application to the affected nail plate of the fingers and / or toes. The procedure is performed 1–2 times a week, observing the following recommendations: Before using the drug, using the disposable nail file in the kit, if possible, remove the affected nail fragments, especially from its surface. The surface of the nail 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 immersed in a bottle of varnish, then it is carefully removed, without erasing the excess of the preparation on the neck of the bottle. The applicator on the entire surface of the affected nail plate evenly applied varnish, repeating the procedure for each of the affected nail. Stand a time of about 3 minutes to dry the varnish. The applicator is wiped with a napkin used for cleaning the nails, avoiding contact with it of the treated nails. The bottle is tightly closed immediately after the procedure. The used napkin is discarded. It is allowed to apply decorative nail polish on top of Exorolfinlac, but not earlier than 10 minutes after the procedure. Before reapplying the drug Exorolfine, the remaining decorative nail polish must be carefully removed, after which, using the attached nail files, treat the affected nail plates and remove the lacquer residues with cleansing wipes. Hands should be thoroughly washed after the end of each treatment procedure, but when applying the drug to the fingernails, you must first wait for the varnish to completely dry. After the varnish is completely dry, you can regularly wash your hands and feet with soap. The course of therapy for a long time, to stop the application of Ekzolfolfak should be after complete regeneration of the nail plate and cure affected nails. The average duration of a course for nails on hands 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. In the absence of such signs after 3 months, you should consult a doctor.
The use of the drug Eczolfine causes undesirable reactions in rare cases. Damage to the nails (damage to the nail plates, discoloration and brittleness of the nails) noted during the treatment process is most likely a result of a fungal infection. The frequency of undesirable reactions recorded when using Exorolphine in accordance with the accepted system-organ classification (in accordance with the scale: very often - more than 0.1; often - not more than 0.01, but less than 0.1; infrequently - not 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; unexplained frequency — it is impossible to quantify adverse reactions based on available data): skin and subcutaneous tissue: rarely - color change nail plate, nail damage, brittle nails tina (onycoclasia), fragility of the nail plate (onihorexis); extremely rarely - burning sensation of the skin; unexplained frequency - urticaria, pruritus, erythema, contact dermatitis, blisters; immune system: unexplained frequency - systemic hypersensitivity reactions. In case of aggravation of any of these side effects or the manifestation of other negative reactions that are not listed in the description, you should immediately consult a doctor.
- pregnancy and lactation period;
- children and adolescents under 18;
- hypersensitivity to amorolfine and other components of the drug.
Pregnancy and Lactation
Data on the use of amorolfine during pregnancy and during breastfeeding is limited, and therefore the use of Exorolfinlac is not recommended during these periods.
At therapy with Ekzolfinlak it is necessary: Do not use nail files used for treating the affected nails for the purpose of treating healthy nail plates. Wear impermeable gloves when working with organic solvents to protect coated nails. Avoid using artificial false nails. Do not apply the varnish too often or in violation of the requirements for the application, as this may cause irritation / dryness of the skin around the nail due to the presence of ethanol in the preparation. Take into account that the cleaning wipe contains a flammable substance. Avoid getting the drug in the ears, eyes, mucous membranes, and in case of unintentional contact immediately wash the affected surfaces with running water in large quantities. In case of systemic / local hypersensitivity reactions, the use of the drug is immediately stopped and the doctor is contacted, using the nail polish remover to remove the drug from the nails. In this case, you can not reapply Exorolfine. Conditions that predispose to the development of nail fungus diseases such as diabetes, impaired peripheral blood circulation, immunodeficiencies, as well as nail dystrophy or a destroyed nail plate, psoriasis, and other chronic skin diseases require treatment to 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 for the purpose of administering oral medications in order to carry out complex therapy.
The drug is used exclusively for the purpose of external use, in which the development of systemic signs of overdose is not expected. In case of accidental ingestion of Exorolfine, appropriate symptomatic treatment is required.
- Brand name: Ekzolfinlak
- Active ingredient: Amorolfin
- Dosage form: Nail polish: thickish colorless transparent liquid (2.5 ml in dark glass bottles, 30 napkins, 10 special spatulas and 30 disposable nail files for nails are included in the package; 1 box of cardboard packs).
- Manufacturer: Sandoz
- Effects of the newer antifungal agents (bifonazole, ICI 195, 739 and amorolfin) on in vitro phagocytic, lymphocytic and natural-killer cell responses
- Effect of Amorolfine (Ro 14–4767/002) on in vitro Phagocytosis and Intracellular Killing of Cartdida albicans by Human Neutrophils: Die Wirkung von Amorolfin Po 14–4767/002) in vitro auf Phagozytose und intrazellulare Abtotung von Candida albicans durch menschlische Neutrophile
- Single dose treatment of vaginal candidosis: Randomised comparison of amorolfine (50 mg and 100 mg) and clotrimazole (500 mg) in patients with vulvovaginal candidosis : Ein-Dosis-Behandlung der Vaginal-Candidose: Randomisierter Vergleich von Amorolfin (50 mg und 100 mg) und Clotrimazol (500 mg) bei Patientinnen mit Vaginal-Candidose
- Combination of amorolfine with various antifungal drugs in dermatophytosis : Kombination von Amorolfin mit verschiedenen Antimykotika bei Dermatophytose
- Kinetics of amorolfine in human nails : Die Amorolfin-Kinetik in Nageln des Menschen
- Further studies on the in vitro antifungal activity of amorolfine : Weitere Studien zur antifungalen Aktivitat von Amorolfin in vitro
- Bei Nagel- und Fußpilz wirkt Amorolfin fungistatisch und fungizid