Active substanceClotrimazoleClotrimazole
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  • Clotrimazole-Teva
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  • Dosage form: & nbspcream for external use
    Composition:

    100 g of cream contain:

    active substance: clotrimazole 1.00 g;

    Excipients: benzyl alcohol 2.00 g, sorbitan stearate 2.00 g, polysorbate-60 1.50 g, cetyl palmitate 3.00 g, cetostearyl alcohol [cetyl alcohol 60%, stearyl alcohol 40%] 10.00 g, 2-octyldodecanol 13 , 50 g, purified water 67.00 g.

    Description:

    Homogeneous cream of white color.

    Pharmacotherapeutic group:Antifungal agent
    ATX: & nbsp

    G.01.A.F.02   Clotrimazole

    Pharmacodynamics:

    Clotrimazole-Teva is a broad-spectrum antifungal agent for external use. The antimycotic effect of the active active agent clotrimazole (imidazole derivative) is associated with impaired synthesis of ergosterol, which is part of the cell membrane of fungi, which changes the permeability of the membrane and causes subsequent lysis of the cell. In low 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 (Bactcroides, Gardnerella vaginalis), as well as in relation to Trichomonas vaginalis.

    In vitro in a concentration of 0.5-10 μg / ml clotrimazole suppresses the reproduction of the bacteria of the family Corynebacteria and Gram-positive cocci (with the exception of the utero-cocci) and has a trichomonaside action at a concentration of 100 μg / ml.

    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 the dermis and subcutaneous tissue.

    Indications:

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

    - pityriasis, erythrasma, superficial candidiasis caused by dermatophytes, yeast (including 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 cream is applied a thin layer 2-3 times a day for previously cleaned (using soap with a neutral value pH) and dry the affected skin areas and gently rub.

    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 cream, the appearance of erythema, blisters, swelling, irritation and flaking of the skin. Allergic reactions (itching, hives).

    Overdose:

    The use of the cream 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 applying the cream, 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:

    Cream for external use 1%.

    Packaging:

    For 30 g of the drug in an aluminum tube, tightened with aluminum foil to control the first opening, with a screw cap.

    1 tube together with the instruction for use is placed in a cardboard box.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C. Keep out of the reach of children!

    Shelf life:

    2 years.

    After opening the tube, the drug is suitable for use for 1 year.

    Do not use after the expiration date!

    Terms of leave from pharmacies:Without recipe
    Registration number:П N015523 / 03
    Date of registration:03.03.2009 / 21.01.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp30.01.2018
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