Clinical and pharmacological group: & nbsp

Antifungal means

Included in the formulation
  • Batrafen®
    cream externally 
  • Batrafen®
    solution externally 
  • Daphnejin
    cream the vagina. 
    Polikem Sr.L.     Italy
  • Daphnejin
    suppositories the vagina. 
    Polikem Sr.L.     Italy
  • Fonzial®
    solution locally 
  • Cyclopoli®
    solution locally externally 
    Polikhem S.A.     Luxembourg
  • АТХ:

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

    D.01.A.E.14   Cyclopyrox

    Pharmacodynamics:

    Pharmacological action - antifungal, fungicidal.

    Is active against the main pathogens of onychomycosis, including Trichophyton rubrum, Epidermophyton floccosum, Candida albicans, Scopulariopsis brevicaulis, Microsporum canis, Malassezia furfur, separate strains of bacteria (both gram-positive and gram-negative). The most effective (local application) in the early stages of onychomycosis caused by dermatophytes, yeast-like and mold fungi, with distal nail damage (no more than half or one-third of the nail), without involving the matrix, with white superficial onychomycosis caused by T. mentagrophytes (damage only to the surface of the nail plate), and after the treatment of onychomycosis after systemic therapy to prevent relapses.

    With multi-colored lichen, clinical and mycological improvement is observed after 2 weeks of treatment (not earlier).

    In the form of nail polish quickly (during the first hours from the application) and penetrates deep into the nail and is long deposited at the site of infection; Lacquer forms a physical barrier that prevents reinfection.

    Pharmacokinetics:

    Rapidly penetrates the skin and mucous membranes, creating levels of concentrations significantly exceeding the minimum inhibitory concentration and persisting for 1-2 weeks after discontinuation of treatment.

    Cream for external use. When applying cream on large surfaces (750 cm2) and for a long time (6 hours or more) can be detected in the blood (1.3% of the dose), while 94-97% binds to plasma proteins, the half-life is 1.7 hours, is excreted by the kidneys.

    Nail polish. Values ​​of fungicidal concentrations with a one-day application of nail polish exceed the maximum plasma concentration 20-30 times (plasma maximum concentration for dermatophytes, fungi of the genus Candida, mold and yeast-like fungi - 0.98-3.9 μg / ml, for mycoplasma and Trichomonas vaginalis - 7.8-31.3 μg / ml).

    Penetrates into hair, hair follicles, sebaceous glands and skin, creating fungicidal concentrations. The connection with plasma proteins is 94-97%.Biotransformation in the liver (glucuronation). Half-life is 1.7 hours (1% solution). Elimination mainly by the kidneys.

    Indications:

    Onychomycosis, fungal lesions of the skin and mucous membranes (especially vaginal candidiasis).

    I.B35-B49.B49   Mycosis, unspecified

    I.B35-B49.B49   Mycosis, unspecified

    I.B35-B49.B35.1   Mycosis of nails

    I.B35-B49.B35   Dermatophytosis

    I.B35-B49.B37.2   Candidiasis of skin and nails

    XIV.N70-N77.N76   Other inflammatory diseases of the vagina and vulva

    Contraindications:

    Hypersensitivity, pregnancy, breast-feeding, children's age (up to 10 years).

    Carefully:

    The use of cyclopyrox in young children is possible only on strict indications.

    Pregnancy and lactation:

    Action category for the fetus by FDA-B. During pregnancy and lactation, the use of the drug is only possible if the intended benefit to the mother exceeds the possible risk to the fetus or the baby.

    During pregnancy, the use of the drug is possible according to the indications and under the supervision of a doctor. During the lactation period, the issue of stopping breastfeeding should be addressed.

    Dosing and Administration:

    Outwardly.

    Lacquer apply to the affected nail a thin layer with a special brush on the lid of the bottle for the first month every other day, for the second month - 2 times a week, the third - 1 time a week.In order to increase the efficiency before the treatment, it is recommended to remove as much of the affected nail as possible and to treat the remainder with a nail file to create an uneven surface. Once a week, all the varnish is removed with a conventional solvent, or after a warm bath scraped off its surface layer.

    Cream or solution Apply on the skin 2 times a day and rub (at least 2 weeks). After the disappearance of clinical manifestations, the drug is used for another 1-2 weeks to prevent relapse.

    Vaginal cream with the help of the applicator is inserted deep into the vagina once a day for 6 days; cream can be treated with perivaginal and perianal areas.

    Powder: pour in sufficient quantity in socks or shoes (for prevention).

    Candles for vaginal: 1 candle once a day for 3-6 days.

    Side effects:

    Local reactions: itching, burning sensation, redness and flaking of the skin near the aching nail; allergic phenomena.

    Overdose:

    Not described. Treatment is symptomatic.

    Interaction:

    The effect is increased by systemic antimycotic agents.

    During treatment with a cyclopyrox in the form of nail polish, it is not recommended to use cosmetic nail polish.

    Special instructions:

    Duration of use should not exceed 6 months (vaginal cream - 2 weeks). The lack of effect in the treatment of dermatomycosis or onychomycosis after 4 weeks requires clarification of the diagnosis.

    The use of drugs that improve blood circulation, vitamins, immunity stimulants and local therapy (massage of the fingers and toes, warm baths) can shorten treatment time.

    The therapeutic effect with onychomycosis depends on the regular disinfection of footwear (gloves) before the growth of healthy nails.

    When used in gynecological practice (vulvovaginitis), an obligatory cure condition is simultaneous therapy of the sexual partner.

    Avoid contact with eyes.

    Instructions
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