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antifungal drug for topical use. It has a fungistatic and fungicidal effect due to a change in the cell membrane by disrupting the biosynthesis of sterols. amorolfin inhibits two different enzymes involved in the biosynthesis of ergosterol-δ14-reductase and δ7-δ8-isomerase.
Amorolfin has a wide spectrum of action. Highly active relative to the most common and rare pathogens of fungal infections of the nails:
- dermatophytes: Trichophyton spp., Microsporum spp., Epidermophyton spp .;
- yeast fungi: Candida spp., Cryptococcus spp., Malassezia spp. (Pityrosporum spp.);
- molds: Alternaria spp., Scopulariopsis spp., Hendersonula spp., Aspergillus spp., Fusarium spp., Mucorales spp .;
- fungi of the genus Dematiaceae: Cladopsorium spp., Fonsecaea spp., Wangiella spp .;
- dimorphic fungi: Coccidioides spp., Histoplasma spp., Sporothrix spp.
Bacteria, with the exception of Actinomyces, are insensitive to amorolfine. Propionibacterium acnes is only mild.
Pharmacokinetics During the first 24 hours after applying the solution, amorolfine penetrates the nail plate and then into the nail bed. An effective concentration of amorolfin is maintained in the damaged nail plate for 7–10 days after the first application. Systemic absorption is negligible: the concentration of amorolfin in blood plasma is below the sensitivity limit of determination methods (0.5 ng / ml).
Fungal lesions caused by dermatomycete, yeast and mold, without damage to the nail base.
Treatment of uncomplicated distal and lateral onychomycoses caused by dermatomycetes, yeast and mold, limited to two nails.
Prevention of fungal infections of the nails.
Nail polish must be applied to the affected area of the nail 1 time per week. the patient should apply the varnish as follows:
1. Before the first application of the drug Amoderm Neo, it is very important that the affected areas of the nail (in particular the surface of the nail) be sanded as thoroughly as possible with a nail file.
2. Then the surface of the nail should be cleaned and degreased with an alcohol solution.
Before re-applying the drug Amoderm Neo, the affected area of the nail should be sanded again, after which the nail should be cleaned with an alcohol solution.
Warning: nail files used for affected nails should not be used for healthy nails.
3. One of the spatulas included in the kit must be applied to the entire surface of the affected nail.
4. After application, let the varnish dry for 3-5 minutes.
5. When applying the product to each affected area of the nail, it is necessary to lower the spatula into the bottle with varnish. When removing the spatula, do not wipe it on the neck of the bottle.
6. Keep the bottle tightly closed.
Warning: when working with organic solutions (solvents, white spirit, etc.) it is necessary to use waterproof gloves to preserve the varnish on the nails.
Treatment should be continued without interruption until the nail is restored and the affected areas heal. The frequency and duration of treatment depends mainly on the intensity and location of the infection. Usually, treatment lasts 6 months (for nails on the fingers) and 9-12 months (for nails on the toes). Repeat treatment is recommended at intervals of approximately 3 months.
If there is also foot dermophytosis, it is necessary to be treated with an appropriate antifungal cream.
Hypersensitivity to amorolfine or excipients that make up the drug.
There may be isolated cases of adverse reactions. nail lesions (such as discoloration of the nails, brittle nails) may occur. such reactions may also be associated with onychomycosis.
On the part of the skin: rarely (≥1 / 10,000, 1/1000) - nail damage, discoloration of the nails; very rarely (1/10 000) - a burning sensation of the skin.
Avoid contact with eyes, ears and mucous membranes.
You should also avoid using decorative nail polish and false nails during treatment with the drug.
Patients with diseases of the peripheral circulatory system, diabetes mellitus and immunosuppression, with dystrophy of the nail and a damaged nail plate should consult a doctor before use.
Use during pregnancy and lactation. The safety of the drug Amoderm Neo during pregnancy has not been established, therefore, it is not recommended to use the drug during this period.
No side effects were found in breast-fed infants.
Since the concentration of amorolfin in breast milk is not significant, amorolfin can be used during lactation.
Before using the drug, you need to consult a doctor.
Children. The effectiveness and safety of the drug in children have not been established, and therefore it is not prescribed for this age group of patients.
The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Does not affect.
There are no special studies regarding the simultaneous treatment of other drugs for external use.
Overdose cases were not noted, since the drug is used topically.
In case of accidental ingestion, it is necessary to rinse the stomach.
At a temperature not exceeding 30 ° C. Keep the bottle tightly closed.