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

    In 100 g of the drug contains:

    Active ingredient: Clotrimazole - 1.0 g;

    auxiliary components: cetyl alcohol 20.0 g; Vaseline - 22.0 g; glycerol - 12.0 g; polysorbate 80 (Tween 80) - 8.0 g; methylparahydroxybenzoate (nipagin) 0.1 g; distilled water - 36.9 g.

    Description:

    Homogeneous mass from white to white-yellowish color.

    Pharmacotherapeutic group:Antifungal agent
    ATX: & nbsp

    G.01.A.F.02   Clotrimazole

    Pharmacodynamics:

    Clotrimazole is a derivative of imidazole. Antifungal means of a wide spectrum of action. The effect of the drug is associated with a violation of the synthesis of ergosterol, which is part of the cell membrane of fungi, which causes a change in its structure and properties, and leads to lysis of the cell. At concentrations of 1 μg / ml in vitro and more than 6 μg / ml in vivo Clotrimazole acts fungistatically. At concentrations of more than 10 μg / ml has fungicidal effect on most species of fungi, not only on proliferating cells.In a relationship Candida has a fungicidal effect at concentrations of 2 μg / ml and above. 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.

    It is active against pathogenic dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis), yeast and mold fungi (Candida spp., Torulopsis glabrata, Rhodotorula, Pityrosporum orbiculare), as well as the causative agent Pityriasis versicolor (varicoloured varicella) and the causative agent of erythrasms .

    Has antimicrobial effect against Gram-positive (Staphylococcus, Streptococcus) and Gram-negative bacteria (Bacteroides, Gardnerella vaginalis), as well as against Trichomonas vaginalis, Malazessia furfur (causative agent Pityriasis versicolor) and Corynebacterium minussimum (causative agent of erythrasms).

    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 in the dermis and subcutaneous tissue, and exceeds the minimum inhibitory concentration for dermatophytes.

    Indications:

    - Fungal diseases of the skin, 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 other components of the drug, 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 on the previously cleaned (using soap with a neutral pH value) and dry affected areas of the skin and gently rubbed.

    A single dose for a palm-sized surface area is a 5 mm cream column.

    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 at least 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:

    In rare cases, local reactions are noted - 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.

    Special instructions:

    The drug is not intended for use in ophthalmic practice.

    Avoid contact with the eyes.

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

    After applying the cream, do not apply occlusive dressings.

    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.

    When signs of hypersensitivity or irritation appear, the treatment is stopped. If there is no effect within 3 days, you should confirm the diagnosis.

    In liver failure, liver function should be monitored periodically.

    In the case of an unintended method of administration (oral), the following symptoms are possible: anorexia, nausea, vomiting, abdominal pain, impaired liver function; rarely: drowsiness, hallucinations, frequent urination, skin allergic reactions. In these cases, it is necessary to take Activated carbon and see a doctor.

    Keep away from children!

    Form release / dosage:

    Cream for external use 1%.

    Packaging:

    For 20 grams in an aluminum tube, lacquered inside, with a screwed plastic lid. The neck of the tube must be sealed.

    1 tuba together with instructions for use in a cardboard bundle.

    Storage conditions:

    In dry, the dark place at a temperature 15-25 FROM.

    Do not freeze.

    Shelf life:3 years. Do not use after expiry date.
    Terms of leave from pharmacies:Without recipe
    Registration number:П N011890 / 01
    Date of registration:22.07.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:Hiperion S.A.Hiperion S.A. Romania
    Manufacturer: & nbsp
    Representation: & nbspРомфарма ОООРомфарма ООО
    Information update date: & nbsp29.01.2018
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