Active substanceKetoconazoleKetoconazole
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  • Dosage form: & nbspointment for external use
    Composition:

    In 100 g of ointment contains:

    active substance: ketoconazole 2.0 g;

    Excipients: macroola 400, macrogol 4000.

    Description:

    Homogeneous ointment of white color.

    Pharmacotherapeutic group:antifungal agent
    ATX: & nbsp

    J.02.A.B.02   Ketoconazole

    D.01.A.C.08   Ketoconazole

    Pharmacodynamics:

    Ketoconazole, an imidazole-dioxalane derivative, has an antifungal effect against dermatophytes, such as Trichophyton sp., Epidermophyton sp., Microsporum sp., yeast-like fungi, such as Candida sp., dimorphic fungi, eumycetes and Malassezia furfur (Pityrosporum ovale). The mechanism of action is the inhibition of the synthesis of ergosterol and membrane lipids (TG and phospholipids), necessary for the synthesis of the cell wall of fungi (fungi lose the ability to form filaments and colonies), and impair the permeability of the cell wall. Inhibits the transformation of blastospore Candida albicans in invasive forms. Ketoconazole exhibits antifungal activity against Pityrosporum ovale and Pityrosporum orbiculare, causing excessive skin peeling.

    Also active against staphylococci and streptococci.

    Pharmacokinetics:

    Absorption of the active substance through the skin with local application is negligible. With prolonged use, the content of ketoconazole in the blood is not determined.

    Indications:Local treatment of mycoses caused by drug-sensitive fungi: inguinal epidermophytia, epidermophytia of hands and feet, skin candidiasis, pityriasis, seborrheic dermatitis caused by Pityrosporum ovale.
    Contraindications:

    Ointment PERSHOTAL should not be used with hypersensitivity to ketoconazole, with violation of the integrity of the skin in places of supposed ointment application, in women during lactation.

    Carefully:

    As a result of clinical studies ketoconazole in plasma it is not found out, nevertheless, women during pregnancy should take the drug with caution.

    Dosing and Administration:

    With smooth skin dermatomycosis (inguinal epidermophyte, epidermophytia of hands and feet, skin candidiasis and pityriasis), the ointment is applied to the affected area immediately adjacent to it 1 time per day.

    With seborrheic dermatitis ointment is applied to the affected area 2 times a day.

    The average duration of treatment is:

    - with smooth skin dermatomycosis - 3-4 weeks;

    - with inguinal epidermophytia - 2-4 weeks;

    - with epidermophytia stop - 4-6 weeks;

    - for infections caused by yeast-like fungi - 2-3 weeks;

    - with pityriasis, 2-3 weeks;

    - with seborrheic dermatitis - 2-4 weeks.
    Side effects:

    With topical application of ointment PERHOTAL, local allergic reactions in the form of burning, hives and skin rashes are possible. In rare cases contact dermatitis occurs.

    Overdose:

    Since the drug is intended for external use only and is not practically absorbed into the systemic bloodstream, the development of overdose symptoms is unlikely. If you accidentally take ointment inside, you should wash the stomach and perform symptomatic treatment.

    Interaction:

    Drug interaction of the drug PERHOTAL with external application is not described.

    Special instructions:

    The drug is intended for external use only, and is not used in ophthalmic practice. Avoid contact with ointment in the eyes.

    When combined long-term use with topical forms of glucocorticosteroids (GCS) to prevent the development of the syndrome of "withdrawal" is recommended to use GCS in the morning,and ointment PERHOTAL - in the evening, followed by a gradual cancellation of GCS for 2-3 weeks.

    During treatment, general hygiene rules should be followed.

    Information about the presence of any adverse effects in children is absent, their effectiveness and safety have not been established.
    Form release / dosage:Ointment for external use 2%.
    Packaging:

    For 15 mg in plastic tubes with a screwed plastic cover.

    1 tube with instructions for use in cardboard pack.
    Storage conditions:

    At a temperature of no higher than 30 ° C.

    In a place inaccessible to children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N014668 / 02
    Date of registration:20.07.2009
    The owner of the registration certificate:Jepak InternationalJepak International India
    Manufacturer: & nbsp
    Representation: & nbspJEPAK INTERNATIONALJEPAK INTERNATIONALRussia
    Information update date: & nbsp20.07.2009
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