Offomil Luck (Oflomil Lak)

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 
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  • Offomil Luck
    solution locally 
    Glenmark Pharmaceuticals Co., Ltd.     India
    • Dosage form: & nbspnail polish
    Composition:

    1 ml of the preparation contains:

    Active substance:

    Amorolfin hydrochloride, converted to amorolfine 55.70 mg

    Excipients:

    Triacetin (glycerol triacetate) 50.00 mg

    Methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate copolymer [2: 0.2: 1] (ammonium methacrylate copolymer (Type A) (Eudragit RL 100)) 10.50 mg

    Ethyl acetate 125.0 mg

    Butyl acetate 150.0 mg

    Ethanol is anhydrous up to 1 ml.

    Description:transparent liquid from colorless to light yellow color.
    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. Reduces the content of ergosterol, accumulates the content of atypical steric non-flat sterols.

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

    Deermatophytes: Trichophyton spp., Microsporum spp., Epidermophyton spp.

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

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

    Mushrooms of family Dematiaceae: Cladosporium 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). 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 components of the drug.

    Pregnancy and lactation:

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

    Dosing and Administration:

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

    Before using the drug, remove the affected areas of the nail (especially on its surface) with the attached nail file.

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

    alcohol.

    The processing of nails with a nail file and a swab with alcohol must be carried out before each use of the preparation.

    Dip the spatula into the varnish. The spatula 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.

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

    Treatment should be continued continuously until the nail is regenerated and the wound is completely healed.

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

    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 seldom (less than 0.01% of cases) - slight short-term burning sensation in the nail area after application of the drug, contact dermatitis.

    Overdose:

    Offlomil Lak - a drug for external use with little systemic absorption and an overdose is unlikely.

    In case of accidental ingestion, the stomach must be cleaned and immediately consult a doctor.

    Interaction:Not installed.
    Special instructions:

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

    The nails used to treat the affected 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, the use of false artificial nails should be avoided and cosmetic nail varnish should not be used;

    The tampon contains a highly flammable substance;

    Avoid contact with the 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.


    Effect on the ability to drive transp. cf. and fur:

    Does not affect the ability to drive vehicles and mechanisms.

    Form release / dosage:

    Nail polish 5%.

    Packaging:For 2.5 ml in a bottle of dark glass with a plug of LDPE and screwed on the lid. A plastic pallet, instructions for use, a container of polypropylene containing 6 applicators equipped with polypropylene blades, 12 nail files wrapped in a plastic bag, 12 sachets with cleaning swabs and a bottle of the drug are placed in a carton pack.
    Storage conditions:

    Store in a dark place at a temperature of no higher than 25 ° C. Do not freeze. Keep out of the reach of children.

    Shelf life:

    2 years. Do not use the drug after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-002798
    Date of registration:29.12.2014
    The owner of the registration certificate:Glenmark Pharmaceuticals Co., Ltd.Glenmark Pharmaceuticals Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspGLENMARK PHARMACEUTICALS LTD. GLENMARK PHARMACEUTICALS LTD. India
    Information update date: & nbsp29.12.2014
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