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

    100 g of ointment contains:

    active substance: Clotrimazole in terms of 100% of the substance - 1 g;

    Excipients: propylene glycol 12.5 g, methyl parahydroxybenzoate (nipagin) 0.2 g, succinic acid 0.5 g, sodium benzoate 6 g, emulsion 3 g, castor oil 14 g, methylcellulose 3 g, distilled monoglycerides - 1.5 g, purified water - up to 100 g.

    Description:

    Ointment is white or almost white with a weak specific odor.

    Pharmacotherapeutic group:Antifungal agent
    ATX: & nbsp

    G.01.A.F.02   Clotrimazole

    Pharmacodynamics:

    An antifungal agent from the group of imidazole derivatives for external use reduces the synthesis of ergosterol, which is an integral part of the cell membrane of the microbial wall, and leads to a change in its structure and properties.

    In small concentrations, it acts fungistatically, and in large concentrations (more than 20 μg / ml) 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.

    Active against pathogenic dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis), yeast and mold fungi (Candida spp., Torulopsis glabrata, Rhodotorula spp., Pityrosporum orbiculare).
    Pharmacokinetics:Poorly absorbed through the skin and mucous membranes and practically does not have a systemic effect. It accumulates in the stratum corneum of the epidermis, penetrates into the keratin of the nails. The concentration in the deep layers of the epidermis is higher than the minimum suppressing concentration for dermatophytes.
    Indications:

    - Fungal skin diseases, including skin folds and feet caused by dermatophytes, yeast (Candida spp.), mold and other fungi and pathogens sensitive to clotrimazole: dermatomycosis, dermatophytosis, trichophytosis, epidermophytosis, microsporia, candidamycosis, interdigital fungal erosion, fungal paronychia;

    - mycoses complicated by secondary pyoderma, as part of complex therapy;

    - pityriasis lichen, multicolored lichen, erythrasma.

    Contraindications:Hypersensitivity to clotrimazole or excipients, pregnancy (I trimester), children under 2 years.
    Carefully:

    Lactation period, pregnancy (II and III trimester).

    Dosing and Administration:

    Outwardly.

    Adults, in the absence of other prescriptions, are recommended to apply the ointment 2-3 times a day with a thin layer on the previously cleaned and dry affected areas of the skin. A single dose for a palm-sized surface area is a 5 mm ointment column. For successful treatment it is important to regularly apply the ointment.

    The duration of therapy is individual and depends on the severity and localization of the disease. To achieve full recovery, do not stop treatment with ointment immediately after the disappearance of acute inflammation symptoms or subjective complaints.

    The duration of therapy should be about 4 weeks on average.

    Abnormal lichen is cured, mostly within 1-3 weeks, and erythrasma within 2-4 weeks.

    In fungal diseases of the skin of the legs, it is recommended to continue therapy for about 2 weeks after the relief of the symptoms of the disease.

    In children from 2 years, the drug is used in the above doses.
    Side effects:

    Local reactions: burning, swelling, irritation and peeling of the skin, paresthesia, erythematous rashes, the appearance of blisters.

    Allergic reactions: itching, hives.

    Overdose:Low systemic absorption of the active component of the drug with external application makes an overdose almost impossible.
    Interaction:Amphotericin B, nystatin, natamycin reduce the effectiveness of clotrimazole while simultaneously using them.
    Special instructions:

    It is necessary to avoid getting on the mucous membrane of the eyes.

    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.

    Children should avoid applying to large surfaces.

    Form release / dosage:

    Ointment for external use 1%.

    Packaging:For 20 g in an aluminum tube. Each tube together with the instruction for use is placed in a pack of cardboard.
    Storage conditions:

    In the dark place at a temperature of no higher than 15 ° 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 N001917 / 02
    Date of registration:21.11.2008 / 07.11.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia
    Manufacturer: & nbsp
    Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia
    Information update date: & nbsp30.01.2018
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