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

    100 g of the preparation contain:

    active substance: Clotrimazole-1.0 g;

    Excipients: wax emulsion 4.0 g, cetostearyl alcohol [cetyl alcohol 60%, stearic alcohol 40%] 2.0 g, monoglycerides 4.0 g, polysorbate 80 g 2.0 g, propylene glycol 2.0 g, glycerol 5.0 g, castor oil 7.0 g, methyl parahydroxy benzoate 0.15 g, propyl parahydroxybenzoate 0.05 g, purified water up to 100.0 g.

    Description:

    Ointment from white to white with a yellowish tint of color with a weak specific odor.

    Pharmacotherapeutic group:Antifungal agent.
    ATX: & nbsp

    G.01.A.F.02   Clotrimazole

    Pharmacodynamics:

    Clotrimazole is a representative of a group of imidazole antifungal drugs. The antimycotic effect of the active active agent clotrimazole (an imidazole derivative) is associated with a disruption in the synthesis of ergosterol included in the composition of the cell membrane of fungi, which changes the permeability of the membrane and causes subsequent lysis of the cell.In small concentrations, it acts fungistatically, and in large concentrations it is fungicidal, 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 Pityrosporum orbiculare (Malassezia furfur) and the causative agent of erythrasma.

    Pharmacokinetics:

    Clotrimazole is poorly absorbed through the skin 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 lesions, mycosis of skin folds, stop. Odruvidny deprchy, superficial candidiasis caused by dermatophytes, yeast (including genus Candida), molds and other fungi and pathogens sensitive to clotrimazole.

    Mycosis complicated by secondary pyoderma.

    Contraindications:

    Hypersensitivity to clotrimazole or excipients, the first trimester of pregnancy.

    Carefully:

    Lactation period.

    Pregnancy and lactation:

    Contraindicated in the first trimester of pregnancy.

    It is possible to use the drug in the II and III trimesters of pregnancy according to the doctor's prescription.

    With caution during lactation

    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.

    At the end of the course of therapy (with the disappearance of clinical manifestations) it is advisable to continue treatment for another 14 days, with fungal lesions of the skin of the legs for 2-3 weeks.

    Side effects:

    Itching, burning, tingling in the places of ointment application, the appearance of erythema, blisters, swelling, irritation and flaking of the skin, paresthesia. 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.

    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 3 days, you should confirm the diagnosis.

    Form release / dosage:

    Ointment for external use 1%.

    Packaging:Ointment for external use 1% in aluminum tubes of 15 g, 30 g. Each tube, together with instructions for medical use of the drug, is placed in a pack of cardboard.
    Storage conditions:

    In a dry place at a temperature of 5 to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years. Do not use the drug after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:PL-000775
    Date of registration:29.09.2011
    The owner of the registration certificate:MUROMSKY INSTRUMENT-MAKING PLANT, OJSC MUROMSKY INSTRUMENT-MAKING PLANT, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp29.09.2011
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