Loceril® (Loceryl®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAmorolfinAmorolfin
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  • Loceril®
    solution locally externally 
    Galderma S.A.     Switzerland
  • Offomil Luck
    solution locally 
    Glenmark Pharmaceuticals Co., Ltd.     India
    • Dosage form: & nbspnail polish
    Composition:

    In 1.0 g of the drug contains:

    Active substance: amorolfine hydrochloride - 64.0 mg, which corresponds to amorolfine base - 57.4 mg.

    Excipients:

    methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate copolymer [1: 2: 0.2] - 143.0 mg,

    triacetin 12.0 mg,

    butyl acetate 57.0 mg,

    ethyl acetate - 172.0 mg,

    ethanol absolute - 552.0 mg.

    Description:transparent, colorless or almost colorless liquid.
    Pharmacotherapeutic group:antifungal agent.
    ATX: & nbsp

    D.01.A.E.16   Amorolfin

    Pharmacodynamics:

    Antifungal drug for external use. It has a fungistatic and fungicidal effect caused by damage to the cytoplasmic membrane of the fungus by disrupting the sterol biosynthesis. The content of ergosterol decreases, and the content of atypical steric non-planar sterols accumulates.

    Has a wide range of action. Highly active against both the most common and rare pathogens of fungal nail lesions:

    Dermatophytes: Trichovhvton svv., Microsporum spp., Epidermophyton spp.

    Yeast Mushrooms: Candida spp., Cryptococcus spp., Malassezia spp. (Pityrosporum spp.).

    Plesnevyh fungi: Alternaria spp., Scopulariopsis spp., Hendersonula spp.

    Mushrooms of family Dematiaceae: Cladopsorium spp., Fonsecaea spp., Wangiella spp.

    Dimorphous 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). Effective concentration is maintained in the affected nail plate for 7-10 days after the first application. Systemic absorption is negligible: the concentration in the plasma is below the sensitivity limit of the detection methods (less than 0.5 ng / ml).

    Indications:

    treatment of fungal nail lesions caused by dermatophytes, yeast and mold fungi;

    prevention of fungal nail lesions.

    Contraindications:

    Hypersensitivity to the drug.

    Pregnancy and lactation:

    It is not recommended to use the drug during pregnancy and lactation.

    Dosing and Administration:

    Outwardly. Apply on the injured nails of fingers or toes 1-2 times a week as follows:

    Before using the product, remove the affected areas of the nail (especially on its surface) with the help of the supplied nail file.

    Then clean the surface of the nail and degrease with the attached tampon moistened with alcohol.

    Nail treatment with a saw blade and a swab with alcohol should be performed before each use of the drug.

    Dip the spatula into the varnish.The scapula should be removed from the vial, without touching its neck, do not erase excess lacquer on the neck of the vial.

    Apply the varnish to the entire surface of the affected nail with a spatula.

    Repeat the above procedure for each affected nail.

    Close the vial tightly after use.

    Allow the varnish to dry for about 3 minutes.

    Treatment should continue until the regeneration of the nail and complete cure of the affected area.

    The average duration of treatment is 6 months for the nails on the hands and 9-12 months for the nails on the legs.

    Spatula wipe with used tampon. Avoid contact of processed nails and a tampon. Dispose of the used tampon.

    Side effects:

    Rarely (in 0.01% - 0.1% of cases) it is possible to damage the nail (discoloration, increased fragility of the nail plate), which may be a consequence of fungal nail injury. Very rarely (less than 0.01% of cases) - slight short-term burning in the nail area after application of the drug, contact dermatitis.

    Interaction:

    Not installed.

    Special instructions:

    - Files used for the treatment of damaged nails should not be used for the treatment of healthy nails;

    - persons working with organic solvents should wear impermeable gloves to protect nails covered with varnish;

    - During treatment, it is necessary to avoid the use of false artificial nails and do not use cosmetic nail varnish

    - the tampon contains a highly flammable substance.

    Avoid contact with eyes, ears and mucous membranes. Patients with conditions predisposing to the development of fungal nail lesions (violation of peripheral blood circulation, diabetes mellitus, immunodeficiencies), as well as patients with nail dystrophy or a destroyed nail plate should consult a doctor.


    Clinical data on the use of the drug in children are absent, so it should not be prescribed to children.

    Form release / dosage:

    Nail polish.

    Packaging:For 2.5 ml and 5 ml in a bottle of dark glass with a liner of polymer material, protecting the drug from drying. Each vial with instructions for use, 10 plastic spatulas laid in rows and fixed in a frame, 30 tampons moistened with isopropyl alcohol (in hermetically sealed envelopes from laminated aluminum foil) and 30 saws are placed in a cardboard box.
    Storage conditions:

    At a temperature of no higher than 30 ° C.

    Keep out of the reach of children!

    Shelf life:

    3 years. Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N012558 / 01
    Date of registration:28.04.2011
    The owner of the registration certificate: Galderma S.A. Galderma S.A. Switzerland
    Manufacturer: & nbsp
    Representation: & nbspGALDERMA, LLCGALDERMA, LLCRussia
    Information update date: & nbsp28.04.2011
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