Mikogal (Mikogal)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceOmoconazoleOmoconazole
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  • Mikogal
    suppositories the vagina. 
    Teva Pharmaceutical Enterprises Co., Ltd.     Israel
  • Mikogal
    cream externally 
    Teva Pharmaceutical Enterprises Co., Ltd.     Israel
  • Ulcozol®
    capsuleslyophilizate
    Laboratorios Bago S.A.     Argentina
    • Dosage form: & nbsp

    Vaginal suppositories

    Composition:

    Active substance: Omoconazole nitrate micronized 150 mg, 300 mg, 900 mg.

    Excipient: solid fat (Witepsol W 25) - 2500 mg.

    Description:

    White or almost white homogeneous suppositories of cylindrical shape.

    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. It exhibits fungistatic activity against the main pathogenic fungi, such as yeast fungi (Candida albicans, Candida glabrata and other types Candida), dermatophytes (Trichophyton, Epludermophyton, Microsporam), Pityrosporum orbiculare, Pityrosporum ovale and species Aspergilus. According to research in vitro the drug is effective against certain gram-positive bacteria.

    The mechanism of action is based on the blocking of biosynthetic processes.
    Pharmacokinetics:

    When using a 150 mg vaginal suppository once a day (6 days course), the plasma concentration measurement after the first, third and sixth day of treatment did not reach the detection level of the drug (25 ng / ml),which corresponds to approximately 2-3% of the drug. When using higher doses homoconazole can accumulate. The degree of absorption with inflammation of the mucosa can increase. Studies on both animals and humans have shown that the ingested homoconazole quickly and largely metabolized. Most metabolites are conjugated to glucuronide or sulfate.

    Indications:

    It is recommended for treatment of vulvovaginitis caused by fungi Candida (acute, chronic and recurrent), as well as with candidiasis during pregnancy.

    Contraindications:

    Hypersensitivity to the components of the drug.

    Carefully:In pregnancy and lactation.
    Pregnancy and lactation:

    The use of vaginal suppositories during the first trimester of pregnancy and during lactation is possible only after a careful individual evaluation of the benefit / risk ratio by the physician.

    Studies in animals have shown that applied in therapeutic doses homoconazole does not have an embryotoxic effect, nor does it harm postnatal development.

    Controlled clinical studies with pregnant and lactating mothers were not conducted.Until now, there is no evidence that would indicate that Omoconazole is in breast milk.

    Dosing and Administration:

    Vaginal Candles 150 mg: for 6 consecutive days in the evening, before going to bed, insert 1 candle deep into the vagina.

    Vaginal Candles 300 mg: for 3 consecutive days in the evening, before going to bed, insert 1 candle deep into the vagina.

    Vaginal Candles 900 mg: before going to bed, insert 1 candle deep into the vagina.

    Side effects:

    The drug is usually well tolerated. In some cases, localized burning or itching can be felt during treatment. In most cases, these symptoms are temporary and do not require discontinuation of treatment.

    Special instructions:

    It is necessary to strictly observe the duration of the course of treatment.

    Do not use the drug during menstruation. It is advisable to begin treatment after menstruation.

    Fatty components of vaginal suppositories change the quality of condoms, so avoid their simultaneous use and think about replacing contraception. During the course of treatment and within a week after it, the hygienic procedures of the vagina should be avoided. 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.

    In case of fungal infection of the labia and adjacent areas, it is recommended to use an antifungal cream additionally.

    Form release / dosage:

    Vaginal suppositories 150 mg, 300 mg, 900 mg:

    Packaging:

    Suppositories of 150 mg - 6 suppositories in a cellulose-free container (strip) made of aluminum foil coated with polyethylene.

    Suppositories of 300 mg - 3 suppositories in a cellulose-free contour pack (strip) made of aluminum foil coated with polyethylene.

    Suppositories of 900 mg - 1 suppository in a cellulose-free contour pack (strip) made of aluminum foil coated with polyethylene.

    One strip with instructions for use in a cardboard bundle.

    Storage conditions:

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

    Keep out of the reach of children.

    Shelf life:

    2 years. Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N012546 / 01
    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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