Active substanceClotrimazoleClotrimazole
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  • Dosage form: & nbspointment for external use
    Composition:

    100 g of ointment contains:

    active substance: clotrimazole 1.0 g;

    Excipients: polypropylene glycol, polyethylene oxide 400, polyethylene oxide 1500, methyl parahydroxybenzoate (nipagin).

    Description:Homogeneous ointment is white or almost white.
    Pharmacotherapeutic group:Antifungal agent.
    ATX: & nbsp

    G.01.A.F.02   Clotrimazole

    Pharmacodynamics:

    Clotrimazole is a broad-spectrum antifungal agent for topical application. The antimycotic effect of the active active agent clotrimazole (imidazole derivative) is associated with a disruption in the synthesis of ergosterol, which is part of the cell membrane of fungi, which changes the permeability of the membrane and causes subsequent cell lysis. In small concentrations, it acts fungistatically, and in large concentrations it acts fungicidal, and not only on proliferating cells.In fungicidal concentrations, it interacts with mitochondrial and peroxidase enzymes, resulting in an increase in the concentration of hydrogen peroxide to a toxic level, which also contributes to the destruction of fungal cells.

    Effective against dermatophytes, yeast-like and mold fungi, as well as the causative agent of a multicolored lichen Pityriasis versicolor (Malazessia furfur) and the causative agent of erythrasma. Has antimicrobial effect against gram-positive (staphylococcus, streptococcus) and gram-negative bacteria (Bacteroides, Gardnerella vaginalis), as well as Trichomonas vaginalis.
    Pharmacokinetics:

    Clotrimazole is poorly absorbed through the skin and mucous membranes and has virtually no systemic effect. The concentration in the deep layers of the epidermis is higher than the minimum suppressing concentration for dermatophytes.

    With external application, the concentration of clotrimazole in the epidermis is higher than in dermis and subcutaneous tissue.

    Indications:

    - Fungal skin diseases, mycosis of skin folds, feet;

    - pityriasis, erythrasma, superficial candidiasis caused by dermatophytes, yeast (including the genus Candida), molds and other fungi and pathogens sensitive to clotrimazole;

    - Mycoses complicated by secondary pyoderma.

    Contraindications:

    Hypersensitivity to clotrimazole or excipients, I trimester of pregnancy.

    Carefully:

    Lactation period.

    Pregnancy and lactation:

    In clinical and experimental studies, it has not been established that the use of the drug during pregnancy or during lactation has a negative effect on the health of a woman or fetus (child). However, the question of the appropriateness of prescribing the drug should be decided individually after consulting a doctor.

    The application of the drug directly to the lactating breast is contraindicated.

    Dosing and Administration:

    Outwardly. The ointment is applied a thin layer 2-3 times a day to the previously cleaned (using soap with a neutral pH value) and dry affected areas of the skin and gently rubbed.

    The duration of treatment depends on the severity of the disease, the localization of pathological changes and the effectiveness of therapy.

    Treatment of dermatomycosis is not less than 4 weeks, pityriasis lichen - 1-3 weeks.

    In fungal diseases of the foot skin, therapy is recommended to continue for at least 2 weeks after the symptoms of the disease have been eliminated.

    Side effects:

    Itching, burning, tingling in the places of application of the ointment, the appearance of erythema, blisters, swelling, irritation and flaking of the skin. Allergic reactions (itching, hives).

    Overdose:

    The use of ointment in elevated doses does not cause any reactions and conditions that are life-threatening.

    Interaction:

    Amphotericin B, nystatin, natamycin reduce the effectiveness of clotrimazole when used simultaneously.

    When using ointment, negative interactions with other agents are not known and should not be expected, because the resorption capacity of clotrimazole is very low.

    Special instructions:

    It is not recommended to apply the drug on the skin in the eye area.

    When treating onychomycosis, care should be taken to ensure that the processed nail plates are short-cut or have a rough surface for better penetration of the active substance. In these cases, preference should be given to the solution because of the best, penetrating properties.

    Patients with hepatic insufficiency should periodically monitor the functional state of the liver.

    When signs of hypersensitivity or irritation appear, the treatment is stopped.

    If there is no effect within 4 weeks, you should confirm the diagnosis.

    Form release / dosage:

    Ointment for external use 1%.

    Packaging:

    For 20 or 40 g of the drug in a tube or bank of dark glass.

    1 Tube or bank together with instructions for use in a cardboard bundle.

    Storage conditions:

    In a dry place, protected from light and out of reach of children, at a temperature not exceeding 20 ° C.

    Shelf life:2 years. Do not use after expiry date indicated on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:LS-001053
    Date of registration:23.08.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:VERTEKS, AO VERTEKS, AO Russia
    Manufacturer: & nbsp
    Representation: & nbspVERTEKS CJSC VERTEKS CJSC Russia
    Information update date: & nbsp29.01.2018
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