Amoderm Neo nail polish 50 mg/ml bottle 2.5 ml




Instructions for use Amoderm Neo nail polish 50 mg/ml bottle 2.5 ml
Composition
active ingredient: amorolfine;
1 ml contains: amorolfine hydrochloride equivalent to amorolfine 50 mg;
excipients: ammonium methacrylate copolymer (type A), triacetin, n-butyl acetate, ethyl acetate, anhydrous ethanol.
Dosage form
Medical nail polish.
Main physicochemical properties: transparent solution from colorless to light yellow.
Pharmacotherapeutic group
Antifungal preparations for dermatological use. Other antifungal preparations for topical use. ATX code D01A E16.
Pharmacological properties
Pharmacodynamics
Antifungal drug for topical use. It exhibits fungistatic and fungicidal action, which is due to changes in the cell membrane by disrupting the biosynthesis of sterols. Amorolfine inhibits two different enzymes involved in the biosynthesis of ergosterol delta14-reductase and delta7-delta8-isomerase.
Amorolfine has a broad spectrum of action. It is highly active against both the most common and rare pathogens of fungal nail infections:
dermatophytes: Trichophyton spp., Microsporum spp., Epidermophyton spp.; yeasts: 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 not sensitive to amorolfine. Propionibacterium acnes shows only weak sensitivity.
Pharmacokinetics
During the first 24 hours after application of the solution, amorolfine penetrates the nail plate and then into the nail bed. The effective concentration of amorolfine is maintained in the damaged nail plate for 7–10 days after the first application. Systemic absorption is insignificant: the concentration of amorolfine in the blood plasma is below the sensitivity limit of the detection methods (less than 0.5 ng/ml).
Indication
Fungal lesions caused by dermatomycetes, yeasts and molds, without involvement of the nail base. Treatment of uncomplicated distal and lateral onychomycoses caused by dermatomycetes, yeasts and molds, limited to two nails. Prevention of fungal nail lesions.
Contraindication
Hypersensitivity to amorolfine or excipients included in the composition of the drug.
Interaction with other medicinal products and other types of interactions
There are no specific studies regarding concomitant treatment with other topical medications.
Application features
Avoid getting nail polish in your eyes, ears, and mucous membranes.
You should also avoid using nail polish and false nails during treatment with the drug.
Patients with peripheral circulatory system diseases, diabetes mellitus and immunosuppression, with nail dystrophy and a destroyed nail plate should consult a doctor before use.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Use during pregnancy or breastfeeding
The safety of using 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 have been observed in breastfed infants. Since the concentration of amorolfine in breast milk is insignificant, amorolfine can be used during breastfeeding.
Before using the drug, a doctor's consultation is necessary.
Method of administration and doses
Nail polish should be applied to the affected area of the nail once a week. The patient should apply the polish as follows:
Equipment: 10 spatulas for applying varnish | Package contents: 10 spatulas for applying varnish, 30 cleaning wipes with isopropyl alcohol, 30 nail files in a cardboard box. |
1. Before the first application of the drug Amoderm Neo, it is very important that the affected areas of the nail (especially the surface of the nail) are polished as thoroughly as possible using a nail file. | 1. Before the first application of the drug Amoderm Neo, it is very important that the affected areas of the nail (especially the surface of the nail) are polished as thoroughly as possible using the nail file included in the kit. |
2. Then the nail surface should be cleaned and degreased with an alcohol solution. | 2. Then, clean and degrease the nail surface with the isopropyl alcohol cleaning wipe included in the kit. |
3. Using one of the spatulas included in the kit, apply the polish to the entire surface of the affected nail. | |
4. After application, you need to 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 the varnish. When removing the spatula, do not wipe it on the neck of the bottle. | |
6. Keep the bottle tightly closed. |