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: & nbspspray for external use
    Composition:

    Per 100 ml:

    active substance: bifonazole 1.0 g;

    Excipients: propylene glycol 30.0 ml, isopropanol (isopropyl alcohol) 40.0 ml, macrogol-400 to 100 ml.

    Description:

    Transparent, colorless or slightly colored liquid.

    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.

    Effective fungicidal for dermatophytes (Trichophyton, Microsporum, Epidermophyton); fungistatic - yeast-like, mold fungi (Aspergillus ferrus, Scopulariopsis brevicautus), Malassezia furfur, 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. Bifonazole 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%, the 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). The duration of the skin is 36-48 hours.

    Indications:

    Treatment of skin lesions caused by dermatophytes, yeast-like, mold fungi, and Malassezia furfur 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, lactation period.
    Carefully:

    Thoracic age (up to 1 year), pregnancy (I trimester).

    Pregnancy and lactation:

    The research data show that the drug does not have any negative effect on the mother and fetus. The use of the drug in the first trimester of pregnancy is possible only on strict indications. In the II and III trimesters of pregnancy Bifosin® can be used in accordance with the indications, since the drug is applied externally and does not have systemic effects.

    During lactation it is necessary to stop breastfeeding.

    Dosing and Administration:

    The drug should be used once a day in the evening before bedtime. The drug is sprayed on the affected areas in an amount sufficient to thoroughly moisturize them and, in addition, applied to adjacent areas of intact skin.

    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.

    - mycosis of the scalp 4 weeks.

    - smooth skin dermatomycosis 2-3 weeks.

    - pityriasis lichen, erythrasma 2 weeks.

    - superficial candidiasis of skin 2-4 weeks.

    The drug dosage form is convenient for treating mycosis of the scalp.

    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, allergic reactions, 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.

    Overdose:

    Extremely low systemic absorption of the drug with external application makes an overdose almost impossible.

    Interaction:

    No reactions of drug interaction were detected.

    Special instructions:

    In the absence or inadequate efficacy, the patient should additionally be 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 (under 1 year of age) is possible only under the supervision of a doctor.

    Avoid contact with eyes.
    Effect on the ability to drive transp. cf. and fur:

    The drug has no effect on the ability to drive vehicles, mechanisms and engage in other hazardous activities requiring special attention and quick reactions.

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

    For 20 ml in plastic bottles with a nozzle-sprayer.

    Each vial with instructions for use is placed in a pack of cardboard.

    Storage conditions:

    In the dark place at a temperature of no higher than 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:LS-002576
    Date of registration:21.12.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:SYNTHESIS, JSC Joint-stock Kurgan Society of Medical Preparations and Products SYNTHESIS, JSC Joint-stock Kurgan Society of Medical Preparations and Products 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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