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

    in 1 g of cream:

    active substance: clotrimazole 10.0 mg;

    Excipients: propylene glycol, white soft paraffin, cetomacrogol 1000, benzyl alcohol, cetostearyl alcohol, liquid paraffin, sorbitan monostearate, purified water.

    Description:White homogeneous cream, free from foreign inclusions.
    Pharmacotherapeutic group:Antifungal agent
    ATX: & nbsp

    G.01.A.F.02   Clotrimazole

    Pharmacodynamics:

    Clotrimazole is a broad-spectrum antifungal agent for external use. The antimycotic effect of clotrimazole (an imidazole derivative) is associated with a disruption in the synthesis of ergosterol, which is part of the cell membrane of fungi, which changes permeability, membranes, 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 multi-colored lichen Pityriasis versicolor (Malassezia furfur).

    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 inhibitory concentration for dermatophytes.

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

    Indications:

    - Prevention and treatment of fungal skin diseases, including mycosis of skin folds, feet;

    - pityriasis (multicolored) deprive;

    - fungal lesions of the smooth skin of the body caused by dermatophytes, yeast (including the genus Candida), molds and other fungi, sensitive to clotrimazole;

    - mycoses complicated by secondary pyoderma as part of complex therapy.

    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. In adults and children, the ointment is applied a thin layer 2-3 times a day on the previously cleaned 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 deprivation is not less than 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: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 ability of clotrimazole to absorb is very low.

    Special instructions:

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

    Avoid application in the field of wound surfaces, ulcers, erosions and other violations of the integrity of the skin.

    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 see a doctor to confirm the diagnosis.

    Form release / dosage:Cream for external use 1%.
    Packaging:20 grams per aluminum tube.The tube is packed in a cardboard box with instructions for use.
    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use the product after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N015544 / 02
    Date of registration:30.09.2009
    Expiration Date:Unlimited
    The owner of the registration certificate:Micro Labs LimitedMicro Labs Limited India
    Manufacturer: & nbsp
    Representation: & nbspMICRO LABS LIMITED MICRO LABS LIMITED India
    Information update date: & nbsp21.11.2017
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