Loceryl solution for external use of 5% 2,5 ml
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Active ingredients
Amorolfin
Release form
Solution
Composition
1.0 g of the drug contains: Active ingredient: amorolfine hydrochloride - 64.0 mg, which corresponds to amorolfine base - 57.4 mg. Auxiliary substances: methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate copolymer [1: 2: 0.2] - 143.0 mg, triacetin - 12.0 mg, butylacetate - 57.0 mg, ethyl acetate - 172.0 mg, absolute ethanol - 552, 0 mg.
Pharmacological effect
Antifungal drug for external use. It has a fungistatic and fungicidal effect due to damage to the cytoplasmic membrane of the fungus through disruption of the biosynthesis of sterols. The content of ergosterol decreases, the content of atypical steric non-planar sterols accumulates. It has a wide spectrum of action. Highly active against both 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.); Mold fungi: Alternaria spp., Scopulariopsis spp., Hendersonula spp. ; Fungi from the family Dematiaceae: Cladopsorium spp., Fonsecaea spp., Wangiella spp. ; Dimorphic fungi: Coccidioides spp., Histoplasma spp., Sporothrix spp.
Pharmacokinetics
When applied to the nails penetrates the nail plate and then into the nail bed (almost completely within the first 24 hours). Effect; a clear concentration remains in the affected nail plate for 7–10 days after the first application. Systemic absorption is negligible: the plasma concentration is below the detection limit of detection methods (less than 0.5 ng / ml).
Indications
treatment of fungal nail infections caused by dermatophytes, yeasts and molds; prevention of fungal infections of the nails.
Contraindications
Hypersensitivity to amorolfine or any of the components of the drug.
Use during pregnancy and lactation
Due to the limited data on the use of amorolfine in pregnant and lactating women, the use of the drug during pregnancy and during breastfeeding is not recommended.
Dosage and administration
Outwardly. Apply to the affected nails of the fingers or toes 1-2 times a week as follows: 1. Before using the preparation, remove, if possible, the affected areas of the nail (especially from its surface) using the attached nail file. ; 2. Then clean and degrease the surface of the nail with the supplied swab moistened with alcohol.Before each subsequent use of the drug, it is also necessary to treat the affected nails with a file and then remove the remaining lacquer layer with an alcohol swab. ; 3. Lower the applicator into the bottle with varnish and then carefully remove it without wiping off the excess varnish on the bottle neck. ;four. Using the applicator, apply the lacquer evenly on the entire surface of the affected nail. Repeat the above procedure for each affected nail. ;five. Let the varnish dry for 3 minutes. ; 6. Wipe the applicator with a tampon used to clean the nail, while avoiding the contact of the treated nails and the tampon. Tightly close the vial immediately after the procedure. Dispose of the used tampon. ; Applying decorative nail polish is possible no earlier than 10 minutes after applying Loceril nail polish. ; When you re-apply Loceril, you should carefully remove the remaining decorative varnish from the nails, then treat the affected nails with the help of the attached nail files and remove the remaining layer of varnish with alcohol tampons. ; At the end of the procedure, wash your hands thoroughly. If the varnish was applied to the nails on the hands, wait until it is completely dry. ; After the varnish has dried, regular washing of hands and feet with soap is allowed. ; Treatment should be continued until the nail regeneration and complete recovery of the affected area. ; The average duration of treatment is 6 months for fingernails and 9-12 months for toenails. ; Due to the slow growth of the nail plates, the first signs of improvement may become visible only after 2-3 months of the drug. In the absence of signs of improvement after 3 months, it is recommended to consult a doctor.
Side effects
When using the drug Lotseril adverse reactions are rarely observed. Nail damage such as discoloration, destruction of nail plates, brittle nails, can be the result of fungal nail infections. All adverse reactions noted with the use of the drug Loceryl, presented in the table below in accordance with the accepted classification systems; organs and frequency of occurrence: very often (≥ 1/10), often (≥ 1/100 - <1/10), infrequently (≥ 1/1000 - <1/100), rarely (≥ 1/10000 - <1/1000), very rarely (<1/10; 000),frequency unknown (cannot be estimated based on available data): Disorders of the skin and subcutaneous tissues; Rarely (≥ 1/10000 - <1/1000) Nail damage, discoloration, onychoclasia (fragility of the nail plate), onihorexis plates); Very rarely (<1/10000) Sensation of burning skin; Frequency unknown Erythema, pruritus, contact dermatitis, urticaria, blistering; If any of the side effects indicated in the instruction are aggravated, or any other side effects not mentioned should not Slowly inform your doctor.
Overdose
With external use of the drug, the development of systemic signs of overdose is not expected. In case of accidental ingestion of the drug, it is necessary to carry out appropriate symptomatic therapy.
Interaction with other drugs
Not installed.
special instructions
Files used to treat affected nails should not be used to process healthy nails; Organic solvents should wear impermeable gloves to protect varnished nails. ; during treatment should avoid using false artificial nails; ; the product contains ethanol, so too frequent or incorrect application can lead to irritation or dryness of the skin around the nail; The swab contains a flammable substance. ; Avoid getting varnish in the eyes, ears and mucous membranes. If varnish gets into your eyes, rinse immediately with water. Patients with conditions predisposing to the development of fungal nail infections (impaired peripheral blood circulation, diabetes, immunodeficiencies), as well as patients with nail dystrophy or destroyed nail plate, psoriasis or other chronic skin diseases should consult a doctor. ; If more than 2/3 of the nail plate is subject to destruction or fungal damage, you should also consult a doctor for the appointment of concomitant oral therapy.