Active substanceOmoconazoleOmoconazole
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  • Dosage form: & nbsp

    cream for external use

    Composition:

    In 1 tube (20 g):

    Active substance: Omoconazole micronized nitrate - 0.2 g.

    Excipients: paraffin ultra-liquid, polysorbate 40, carbomer 934 P, benzoic acid, sodium hydroxide (30% aqueous solution), macrogol and glycerides of palm oil esters (Labrafil M-2130-CS), Desalted water.

    Description:

    White homogeneous cream without a smell.

    Pharmacotherapeutic group:Antifungal agent
    ATX: & nbsp

    D.01.A.C.13   Omoconazole

    Pharmacodynamics:

    Active substance - nitrate of homoconazole is a derivative of imidazole, has antifungal and antibacterial properties.

    The mechanism of action is based on blocking the biosynthesis of ergosterol and changing the lipid composition of fungi.

    Acts fungistatically in relation to yeast fungi (Candida albicans, Candida glabrata and other species Candida), dermatophytes (Trichophyton spp., Ephidermophyton spp., Microsporum spp.), Pityrosporum orbiculare, Pityrosporum ovale, Aspergilus spp.

    According to research in vitro, Omoconazole has a bactericidal action against gram-positive bacteria.

    Pharmacokinetics:

    With external application is not absorbed, or absorbed to a very small extent.

    Indications:

    Local treatment of fungal diseases of the skin:

    - Candidiasis;

    - Diseases of the skin and hair caused by dermatophytes: dermatophytosis of brushes and feet, smooth skin, inguinal dermatophytosis, dermatophytosis of the scalp and region of the beard;

    - Pityriasis lichen; seborrheic dermatitis caused by Pityrospomum ovale.

    - Erythrasm.

    Contraindications:

    Hypersensitivity to the components of the drug.

    Carefully:In pregnancy and lactation.
    Pregnancy and lactation:

    Studies in animals have shown that in therapeutic doses homoconazole has no embryotoxic effect.

    The use of the drug Mikogal during pregnancy is possible only in cases where the potential benefit to the mother exceeds the possible risk to the fetus. If you need to use the drug during lactation, you should decide whether to stop breastfeeding.

    Dosing and Administration:

    Outwardly. The cream is applied to the affected area of ​​the skin 1-2 times a day with a thin layer and slightly rubbed. Depending on the nature of the fungal disease, the average course of treatment is 2-6 weeks. Treatment should continue for a further week after a complete cure (the disappearance of symptoms of inflammation,subjective complaints) in order to prevent recurrence of the disease.

    Side effects:

    The drug is well tolerated. In some cases, local burning or slight irritation of the skin can be felt. In most cases, these symptoms are temporary and do not require discontinuation of treatment.

    Special instructions:

    With caution should be used on large areas of damaged skin, in the treatment of children under the age of 5 years. It is not recommended for patients who are sensitive to benzoic acid.

    Do not apply to mucous membranes and skin in the eye area.

    To wash the body should use a neutral or slightly alkaline soap. During the treatment, underwear, towels and sponges for washing should be disinfected and changed daily.

    Form release / dosage:

    Cream for external use 1%.

    Packaging:20 grams of cream in an aluminum tube with a cap provided with a pin to pierce the head of the tube. One tube together with instructions for use in a cardboard box.
    Storage conditions:

    At a temperature of 15 ° C to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N012546 / 02
    Date of registration:13.12.2007
    Expiration Date:Unlimited
    The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
    Manufacturer: & nbsp
    Information update date: & nbsp23.04.2018
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