Clinical and pharmacological group: & nbsp

Antifungal means

Included in the formulation
  • Mikogal
    suppositories the vagina. 
  • Mikogal
    cream externally 
  • Ulcozol®
    capsuleslyophilizate
    Laboratorios Bago S.A.     Argentina
  • АТХ:

    D.01.A.C.13   Omoconazole

    Pharmacodynamics:

    The imidazole derivative exhibits an antifungal effect by blocking the biosynthesis of the ergosterol of the fungal cell membrane. "Target" for the action of the drug - enzyme 14-α-demethylase.

    14-α-demethylase is part of a group of enzymes known collectively as "cytochrome P450". All enzymes of the cytochrome P450 group contain a hematinic iron-containing pigment. Omoconazole binds to the iron atom of the hematinic group and inactivates 14-α-demethylase, which leads to a disruption in the synthesis of ergosterol and the accumulation of lanosterol and other sterols. Their incorporation into the membrane instead of ergosterol significantly disrupts the structure and function of the fungal cell membrane.

    The decrease in the synthesis of ergosterol, as well as the accumulation of 14α-methylsterols, destroys the densely packed acyl chains of the phospholipids of the fungal membranes. Destabilization of the fungal membrane leads to dysfunction of membrane enzymes, including those involved in the electron transport chain, and ultimately to cell death.

    The drug shows fungistatic activity in relation to yeast-like fungi of the genus Candida, dermatophytes (Trichophyton, Epidermophyton, Microsporum), Pityrosporum ovale, Pityrosporum orbiculare and species Aspergillus. In experiments in vitro the bactericidal action of the drug against gram-positive bacteria was detected.

    Pharmacokinetics:

    With external use, the drug is not practically absorbed, with intravaginal application for 6 days at a dose of 150 mg absorbs approximately 2-3% of the drug. The use of high doses of the drug can lead to cumulation.

    Indications:

    Outwardly:

    - candidiasis;

    - pityriasis lichen;

    - erythrasma;

    - fungal 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;

    - seborrheic dermatitis caused by Pityrosporum ovale.

    Locally:

    - Candidiasis during pregnancy;

    - treatment of acute, chronic and recurrent vulvovaginitis caused by fungi of the genus Candida.

    I.B35-B49.B35.0   Mycosis of the beard and head

    I.B35-B49.B35.2   Mycosis brushes

    I.B35-B49.B35.3   Mycosis of the feet

    I.B35-B49.B35.4   Mycosis of the trunk

    I.B35-B49.B35.6   Epidermophytosis inguinal

    I.B35-B49.B36.0   Multicolored lichen

    I.B35-B49.B37.3   Candidiasis of the vulva and vagina (N77.1 *)

    XII.L00-L08.L08.1   Erythrasm

    XII.L20-L30.L21   Seborrheic dermatitis

    XV.O20-O29.O23   Urinary tract infection in pregnancy

    Contraindications:

    Hypersensitivity.

    Carefully:

    Pregnancy and lactation. Caution should be applied to the cream on large areas of the affected skin, in the treatment of infants and children under 5 years of age.

    Pregnancy and lactation:

    Adequate and detailed studies have not been conducted. Use with caution.

    If intravaginal application is necessary in the first trimester of pregnancy and during lactation, the expected benefit of therapy for the mother and the potential risk to the fetus or infant should be assessed.

    Dosing and Administration:

    Outer: 1-2 times a day to apply to the affected area, the course of treatment is from 2 to 6 weeks.

    Intravaginal: once a day, the duration of the course of treatment depends on the dosage and is determined by the attending physician.

    Side effects:

    Burning, itching and irritation in the place of application.

    Overdose:

    Not described.

    Interaction:

    Not described.

    Special instructions:

    Do not use during menstruation.

    It is advisable to begin treatment after menstruation. Avoid contact with eyes. It is not recommended for patients who are sensitive to benzoic acid.

    Avoid contact of suppositories with latex products (contraceptive diaphragms, condoms),since the fatty components of vaginal suppositories change the quality of condoms. During therapy and for 1 weeks after it is finished, you can not wash the vagina. In the case of infection of the labia and adjacent areas, it is recommended to use an antifungal cream additionally.

    Daily change of underwear, towels is obligatory; Sponge for washing should be disinfected and use only neutral or slightly alkaline soap.

    Impact on the ability to drive vehicles and manage mechanisms

    Not found.

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