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

    Each gram of the drug contains:

    Active substance: clotrimazole 10.0 mg

    Excipients: propylene glycol 50.0 mg, petrolatum white 120.0 mg, paraffin liquid 60.0 mg, wax emulsion cetomacrogol 135.0 mg, gasoline alcohol 10.0 mg, methyl parahydroxybenzoate 1.5 mg, propyl parahydroxybenzoate 0.5 mg, butyl hydroxy toluene 1, 0 mg, sodium dihydrogen phosphate dihydrate 0.8 mg, sodium hydrogen phosphate 0.6 mg, water purified to 1000 mg.

    Description:A homogeneous cream of white color.
    Pharmacotherapeutic group:Antifungal agent
    ATX: & nbsp

    G.01.A.F.02   Clotrimazole

    Pharmacodynamics:

    Pharmacological action - an antifungal agent of a wide spectrum of action for topical application, antibacterial, antiprotozoal, trihomonatsidnoe. 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 cobecoming a cell membrane of fungi, what changes membrane permeability and causes subsequent lysis of the cell. In fungicidal concentrations, it interacts with mitochondrial and peroxidase enzymes, resulting in an increase in the neHydrogen to the toxic level, which also contributes to the destruction of fungal cells.

    It shows fungicidal and fungistatic activity against dermatomycetes (Trichophyton rubrum. Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis), yeast-like and mold fungi (Candida spp., including Candida albicans, Torulopsis glabrata, kind Rhodotorula, Pityrosporum orbiculare). Active in relation to the pathogen of a multi-colored lichen - Pityrosporum orbiculare (Malassezia furfur). Effective against Gram-positive bacteria - the causative agent of erythrasma Corynebacterium minutissimum, and Staphylococcus spp., Streptococcus spp., gram-negative bacteria - Bacteroides, Gardnerella vaginalis. In high concentrations, it is active in relation to 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 use, the concentration of clotrimazole in the epidermis is higher than in the dermis and subcutaneous tissue.

    Indications:

    - Fungal skin diseases, mycosis skin scalesadok, stop;

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

    - Mycosis complicated by secondary pyodeaRmie.

    Contraindications:

    - Hypersensitivity to clotrimazole or other components of the drug

    - 1 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 whether to prescribe the drug in the II or III trimester should be addressed individually after consultation with the doctor. When prescribing the drug during the II or III trimesters of pregnancy, it is necessary to take into account the ratio of the prospective benefit from the appointment of the drug to the mother and the possible risk to the fetus. The application of the drug directly to the lactating mammary gland is contraindicated.

    Dosing and Administration:

    Outwardly.The cream is applied a thin layer 2-3 times a day on the previously cleaned (using soap with a neutral pH value) and dried affected skin areas 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 depriving -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:

    Allergic reactions in the form of itching, hives, burning, tingling in the places of application of the cream. Perhaps the appearance of erythema, blisters, swelling, irritation and flaking of the skin.

    Overdose:

    The use of a 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.

    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.

    Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive vehicles and mechanisms.
    Form release / dosage:

    Cream for external use 1%.

    Packaging:By 20 g of the preparation in an aluminum tube with a screwed plastic cover provided with a point for piercing the protective membrane. One tube together with instructions for use in a cardboard box.
    Storage conditions:

    In a dry, dark place at a temperature of 2 ° C to 25 ° C. Keep out of the reach of children.

    Shelf life:

    4 years. Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:P N008874 / 02
    Date of registration:12.09.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:Glenmark Pharmaceuticals Co., Ltd.Glenmark Pharmaceuticals Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspGLENMARK PHARMACEUTICALS LTD. GLENMARK PHARMACEUTICALS LTD. India
    Information update date: & nbsp21.11.2017
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