Active substanceNaphthyfinNaphthyfin
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  • Dosage form: & nbspsolution for external use
    Composition:

    Per 1 ml:

    Active substance: naftifin hydrochloride 10.0 mg.

    Excipients: propylene glycol 50.0 mg, ethanol (ethyl alcohol 95%) 400.0 mg. purified water - up to 1 ml.

    Description:

    Transparent, colorless or slightly yellowish solution with the smell of ethanol.

    Pharmacotherapeutic group:Antifungal agent
    ATX: & nbsp

    D.01.A.E.22   Naphthyfin

    Pharmacodynamics:

    Mikoderil®, solution for external use, 1% - antifungal agent, For external use, referring to the class of allylamines. Its active ingredient is naphthyline. The mechanism of action is related to inhibition of squalene-2,3-epoxidase, which leads to a decrease in the formation of ergosterol, which is part of the cell wall of the fungus. Naphthyfin, affecting squalene epoxidase, does not affect the cytochrome P-450 system.

    Naphthyfin is active against dermatophytes, such as Trichophyton, Epidermophyton, Microsporum, yeast and yeast-like fungi (Candida spp., Pityrosporum), molds (Aspergillus) and other fungi (for example Sporothrix schenckii). For dermatophytes and aspergillas naphthyline is fungicidal. With regard to yeast fungi, the preparation shows fungicidal or fungistatic activity, depending on the strain of the microorganism. Naphthyfin has antibacterial activity against Gram-positive and Gram-negative microorganisms that cause secondary bacterial infections.

    Naphthyfine has an anti-inflammatory effect that contributes to the rapid disappearance of the symptoms of inflammation, especially itching.
    Pharmacokinetics:With external application naphthyline quickly penetrates the skin, creating stable antifungal concentrations in different layers, which makes it possible to use it once a day.
    Indications:

    - Fungal infections of smooth skin and skin folds (tinea corporis, tinea inquinalis);

    - interdigital mycoses (tinea manum, tinea pedum);

    - fungal infections of the nails (onychomycosis);

    - candidiasis of the skin;

    - pityriasis lichen;

    - inflammatory dermatomycosis (with or without itching).

    Contraindications:

    Hypersensitivity to naphthyfine or propylene glycol; pregnancy and lactation period (safety and efficacy of the drug in this category of patients has not been studied).

    Contraindicated application of the drug on the wound surface.

    Carefully:Children's age (clinical experience is limited).
    Pregnancy and lactation:

    The use of the drug during pregnancy and during lactation is not recommended (safety and effectiveness of the drug in this category of patients has not been studied).

    Dosing and Administration:

    Outwardly.

    With dermatomycosis and skin kalidoza.

    Mikoderil®, solution for external use, 1% applied once a day to the affected surface of the skin and adjacent areas after thorough cleaning and drying, capturing approximately 1 cm of healthy skin area but to the edges of the affected area. Duration of treatment: with dermatomycosis - 2-4 weeks (if necessary - up to 8 weeks), with candidiasis - 4 weeks.

    With lesions of the nails (onychomycosis).

    Before the first use of the drug, remove the affected part of the nail with scissors and a nail file.The drug is used 2 times a day, the duration of treatment with onychomycosis - up to 6 months. To prevent recurrence of infection, the drug should be continued for at least 2 weeks after the disappearance of clinical symptoms.

    Side effects:

    In some cases, local reactions can occur: dry skin, skin hyperemia and burning. Side effects are reversible and do not require withdrawal of treatment. If any of the side effects indicated in the manual are aggravated, or any other side effects not indicated in the instructions are noted, you should inform the doctor immediately.

    Overdose:No cases of overdose are reported.
    Interaction:

    No interaction with other drugs has been studied.

    Special instructions:

    Mikoderil®, solution for external use, 1% effective in the treatment of fungal infections affecting the skin area with hyperkeratosis, as well as in hair growth zones.

    Required course treatment.

    Avoid contact with the eyes and open wounds.

    Use in Pediatrics

    Caution should be used in children.

    Effect on the ability to drive transp. cf. and fur:Mikoderil®, solution for external use.1% does not adversely affect the ability to drive vehicles and perform other activities that require concentration of attention and speed of psychomotor reactions.
    Form release / dosage:

    Solution for external use. 1 %.

    Packaging:

    10 ml, 20 ml in bottles-droppers made of dark (amber) glass, sealed with polyethylene stoppers, droppers and polyethylene caps with the control of the first opening.

    Each vial-dropper along with the instruction for use is placed in a pack of cardboard.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.

    Shelf life:2 years. Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:LP-002895
    Date of registration:04.03.2015 / 28.09.2017
    Expiration Date:04.03.2020
    The owner of the registration certificate:OTISIFARM, OJSC OTISIFARM, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp23.04.2018
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