Bifosin® (Bifosine®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceBifonazoleBifonazole
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    • Dosage form: & nbsppowder for external use
    Composition:

    active substances: bifonazole 1.0 g;

    Excipients: Zinc oxide, corn starch, talc up to 100 g.

    Description:

    White or light cream with a grayish hue of color powder. The drug must completely pass through silk screen No. 46.

    Pharmacotherapeutic group:Antifungal agent
    ATX: & nbsp

    D.01.A.C.10   Bifonazole

    Pharmacodynamics:

    Bifonazole, the active substance of the preparation Bifosin®, is an imidazole derivative and has a broad antifungal activity spectrum.

    It acts fungicidally against dermatophytes (trichophyton, microsporum, epidermophyton); fungistatic - yeast-like, mold fungi (Aspergillus ferrus, Scopulariopsis brevicautus), Malassezia fufur, is active against Corynebacterium minutissimum (the minimum inhibitory concentration (MIC) ranges from 0.5 to 2 μg / ml) and in relation to Gram-positive cocci, with the exception of enterococci (MIC of 4-16 μg / ml).

    The target of the drug is ergosterol - the most important component of the fungal membrane. Bifosin® suppresses the synthesis of ergosterol at two stages of its formation, which leads to structural and functional damage to the cytoplasmic membrane of fungi. The minimum effective concentration is 5 ng / ml for a duration of exposure of at least 6 hours; at a concentration of 3 ng / ml inhibited the growth of rapidly proliferating mycelium Trichophyton mentagrophytes. On yeast-like fungi of the genus Candida renders fugistaticheskoe, and in concentration of 20 ng / ml - fungicidal action.

    Pharmacokinetics:

    It penetrates well into the affected layers of the skin. Absorption - 0,6-0,8%, concentration in the blood plasma is not determined. After 6 hours after application, the concentration in the skin reaches or many times exceeds the minimum effective concentration for the main fungi that cause dermatomycosis: 1 mg / cm2 in the upper layer of the epidermis (Stratum comeum), 5 mg / cm2 at Stratum papillare. The half-life of the skin is 19-32 h (depending on its density).

    Indications:

    Treatment of skin lesions caused by dermatophytes, yeast-like, mold fungi, and Malassezia fufur and Corynebacterium minutissimum: foot and hand mycoses, smooth skin dermatomycosis, dermatomycosis of the scalp, pityrious lichen, superficial candidiasis of the skin, erythrasma.

    Contraindications:

    Hypersensitivity to bifonazole or any other component of the drug.

    Carefully:

    Breast age, pregnancy (I trimester).

    Pregnancy and lactation:

    The research data show that the drug does not have any negative effect on the mother and fetus. However, the use of the drug in the first trimester of pregnancy is possible only on strict indications.

    Dosing and Administration:

    The drug should be used once a day in the evening before bedtime. The drug is applied a thin layer on the affected area of ​​the skin and carefully rubbed.

    To achieve a satisfactory result, treatment should be continuous and continued for the following recommended periods:

    - mycosis stop and interdigital stop intervals 3-4 weeks.

    - dermatomycosis of the scalp 4 weeks.

    - smooth skin dermatomycosis 2-3 weeks.

    - pityriasis lichen, erythrasma 2 weeks.

    - superficial candidiasis of skin 2-4 weeks.

    After the elimination of clinical manifestations of mycosis, treatment should be continued for 2 weeks, applying the drug once a day to prevent relapse.

    Side effects:

    Hyperemia and skin irritation, burning sensation, eczema, skin itching, vesicular rash; local reactions in the form of maceration, peeling, hyperemia.

    It is very rare to develop allergic dermatitis.

    These side effects are reversible and disappear after discontinuation of therapy.

    Interaction:

    The drug can be used concomitantly with other drugs, since no drug interactions have been identified.

    Special instructions:

    In the absence or inadequate efficacy, the patient should be additionally examined (state of immunity, blood, endocrine system, microcirculation of the affected area) and adjust the treatment in accordance with the results of the survey.

    Use in infants is possible only under the supervision of a doctor.

    Avoid contact with eyes.

    Form release / dosage:Powder for external use, 1%.
    Packaging:

    For 30 grams in a can of polyethylene with instructions for use in a pack of cardboard.

    Storage conditions:

    In a dry, dark place at a temperature of 15 to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:P N002487 / 03
    Date of registration:19.12.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspSYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products SYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products Russia
    Information update date: & nbsp16.02.2017
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