Cyclopoli® (Cyclopoli®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCyclopyroxCyclopyrox
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    • Dosage form: & nbspnail polish
    Composition:

    Composition - in 1 g of nail polish:

    Component name

    Amount (mg)

    Active substance:


    Cyclopyrox

    80.00 mg

    Excipients:


    Ethyl acetate

    40.00 mg

    Ethanol 96%

    730, 00 mg

    Cetostearyl alcohol

    10.00 mg

    Hydroxypropyl chitosan

    10.00 mg

    Purified water

    130.00 mg
    Description:Transparent, colorless or light yellow color, slightly viscous liquid.
    Pharmacotherapeutic group:antifungal agent
    ATX: & nbsp

    D.01.A.E   Other antifungal agents for external use

    D.01.A.E.14   Cyclopyrox

    Pharmacodynamics:

    Nail polish Cyclopoli® is an antifungal agent. The main active substance of the drug is cyclopyrox - a derivative of pyridone, which has a broad spectrum of antifungal activity, but also an antibacterial action against gram-positive and gram-negative microorganisms. Cyclopyrox Active against dermatophytes, yeast, molds. Depending on the concentration has a fungicidal or fungistatic effect. Minimum inhibitory concentration (MIC) for dermatophytes. yeast and yeast-like fungi from 0.9 to 3.9 μg / ml. No cases of resistance to the cyclopyrox have been recorded.

    Strains sensitive to cyclopyrox:

    Dermatophytes: Trichophyton mentagrophytes, Trichophyton rubrum, Trichophyton verrucosum, Trichophyton tonsurans, Trichophyton quinckearum, Trichophyton equinum, Trichophyton concentricum, Trichophyton gallinae, Trichophyton krajdenii, Trichophyton schoenleinii, Trichophyton soudanense, Trichophyton terrestre, Trichophyton violaceum, Microsporum canis, Microsporum gypseum, Microsporum audouini, Microsporum cookie . Microsporum nanum, Microsporum langeroni, Microsporum ferrugineum, Microsporum persicolor, Epidermophyton floccosum.

    Yeast mushrooms: Candida albicans, Candida tropicalis, Candida krusei, Candida parapsilosis, Candida pseudotropicalis, Candida glabrata, Candida brumptii, Candida guillermondii, Candida lipolytica, Candida utilis, Candida viswanthii, Malassezia furfur, Criptococcus neoformans, Saccharomyces cerevisiae.

    Pforestry mushrooms: Aspergillus flavus, Aspergillus fumigatus, Aspergillus niger, Penicillium spp., Neoscytalidium dimidiatum, Scytalidium hyalinum, Fusarium solani.

    Mechanism of action (antifungal effect) of the cyclopyrox is based on the inhibition of entry into the cell and inducing the removal from the cell of the components necessary for its vital activity.

    Pharmacokinetics:

    When applying nail polish on the affected nails cyclopyrox quickly penetrates into the nail plate and nail bed. Effective concentration is maintained in the affected nail plate for 24 hours.

    Numerous preclinical and clinical studies have shown that the effective concentration of cyclopyrox, when water-soluble 8% nail varnish is applied, is achieved through 7-10 minutes.After a single application and washing of the morsels with a soap solution after 6 hours, the concentration of the cyclopyrox in the platelet remains to 35% of the applied single dose.

    With repeated application of 8% of nail polish for 42 days, the concentration of cyclopyrox in the nail plate remained at the level of 20.45 μg / mg of the nail, which is more than 10 times higher than the MIC of the least sensitive to the cyclopyrox dermisthenfitov.

    System Absorption: Even with prolonged use - insignificant. The concentration of cyclopyrox in the plasma is below the limits of the methods of determination.

    As the film-forming agent of the dosage form, nail polish, a hydroalcoholic solution of hydroxypropyl chitosan (GPXH), which promotes rapid penetration of the active substance into the nail, and, performing barrier function, supports and protects the structure of the nails.

    Indications:

    Onychomycosis (fungal infections of the nails).

    Contraindications:

    Hypersensitivity to the active substance or other components of the drug, pregnancy, the period of breastfeeding, children under 10 years.

    Dosing and Administration:

    The drug is intended for external use. Nail polish should be applied daily a thin layer on the affected nails of the fingers or toes. The drug is applied to the entire surface of the affected nail, grasping the skin around the nail and the receding edge of the nail. It takes 30 seconds to dry the varnish. Within 6 hours after applying the nail polish, do not wash them. Therefore, it is recommended to apply the drug in the evening before bedtime after hygiene procedures. As a rule, complete cure of the nails on the hands occurs after 6 months of treatment, on the legs after 9-12 months.

    Any other recommendations on the method of administration, dosage regimen, treatment course for elderly patients, adolescents are not required.

    Side effects:

    Perhaps a brief burning sensation, itching, skin irritation, flushing, discoloration of the nail, allergic reactions, contact dermatitis, peeling of the skin near the affected nail.

    If any of the side effects mentioned in the manual are aggravated, or other side effects not indicated in the instructions are noted, the doctor should be informed immediately.

    Overdose:

    Due to low absorption of the drug, an overdose is unlikely.In case of swallowing the drug, it is necessary to clean the stomach and perform symptomatic treatment.

    Interaction:

    Not studied.

    Special instructions:

    - To remove varnish from nails, it is sufficient to rinse them with water, acetone, solvents, and nail files are not required. If the nail files are still used for the treatment of injured nails, do not use them to handle healthy nails.

    - During treatment, do not apply false artificial nails and do not use cosmetic nail polishes.

    - At the beginning of treatment with Cyclopoli® varnish, a white matte layer can appear on the nail surface. To remove it, wash the nails thoroughly with water with neutral soap, use a brush or a hard nail sponge if necessary.

    - It is recommended to trim the overgrown nails regularly.

    - For 4 weeks after the end of treatment, after a healthy nail is grown, it is necessary to perform a control mycological examination.

    - Avoid contact with eyes, mucous membranes.

    - Persons working with organic solvents should wear impermeable gloves to protect nails covered with medical varnish.

    - With prolonged use of the drug, sensitization may occur.

    - Patients with a condition predisposing to the development of fungal nail lesions (violation of peripheral blood circulation, diabetes, immunodeficiency), as well as patients with nail dystrophy before using the drug is recommended to see a doctor.

    - To prevent varnish drying, close the lid tightly after use. To prevent the lid from adhering, avoid varnish getting on the thread.

    - It is recommended to store the drug (nail polish) in a box to protect it from sunlight.

    - The drug should be stored at room temperature, at a temperature below 15 °, the varnish may become gel-like, the formation of flakes and sediment may occur. To restore the nail polish, shake the bottle vigorously for 1 minute.

    - Before applying the nail polish, make sure there is no sediment or flakes in the vial.

    - If you missed the application of the varnish, do not apply it excess in several layers, it is enough to continue the treatment according to the instructions for use.

    - Do not dispose of the remaining product in drains or household waste.

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

    The drug does not affect the ability to drive vehicles or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:Nail polish 8%.
    Packaging:

    Nail polish 8% 3.3 ml or 6.6 ml of the preparation in glass (type III), colorless transparent bottles, equipped with a screw cap with a brush for applying varnish.

    1 bottle is placed in a cardboard box together with instructions for use.

    Storage conditions:

    In the dark place at a temperature of 15 to 30 ° C.

    In a place inaccessible to children.

    Shelf life:

    Shelf life: 3 years, do not use after the expiration date indicated on the package.

    Use the medication within 6 months from the time the vial is opened.
    Terms of leave from pharmacies:Without recipe
    Registration number:LP-003223
    Date of registration:29.09.2015
    Expiration Date:29.09.2020
    The owner of the registration certificate:Polikhem S.A.Polikhem S.A. Luxembourg
    Manufacturer: & nbsp
    Information update date: & nbsp01.12.2016
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