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

    1 g of ointment contains:

    active substance: ketoconazole 20 mg;

    Excipients: propylene glycol, carmellose sodium, castor oil, distilled monoglycerides, emulsifying wax, nipagin (methyl parahydroxybenzoate), dibunol (butylhydroxytoluene), purified water.

    Description:

    Ointment from white to white with a creamy or pinkish hue of color, with a weak specific odor.

    Pharmacotherapeutic group:Antifungal agent
    ATX: & nbsp

    J.02.A.B.02   Ketoconazole

    D.01.A.C.08   Ketoconazole

    Pharmacodynamics:

    Ketoconazole is a synthetic derivative of imidazole diacsolane, which has a fungicidal or mycostatic effect. Active against dermatophytes: Trichophyton sp., Microsporum sp., Epidermophyton floccosum, fungi of the genus Candida, as well as with staphylococci and streptococci. Especially effective in relation to Pityrosporum sp.

    The mechanism of action consists in inhibiting the biosynthesis of ergosterol and changing the lipid composition of the fungal membrane.

    Symptomatic improvement is observed very quickly, even before the appearance of signs of recovery.

    With prolonged local application of ointment ketoconazole in the blood is not determined.

    Pharmacokinetics:With external application ketoconazole practically not absorbed into the systemic circulation.
    Indications:Local treatment of mycoses caused by drug-sensitive fungi: smooth skin dermatomycosis, inguinal epidermophytia, epidermophytia of brushes and feet, skin candidiasis, pityriasis, seborrheic dermatitis caused by Pityrosporum ovale.
    Contraindications:

    Mikozoral® should not be used in cases of hypersensitivity to ketoconazole, if the integrity of the skin is disturbed in places of presumed ointment application.

    Pregnancy and lactation:

    Given that ketoconazole is not practically absorbed into the systemic circulation during external application, it is possible to use it during pregnancy and lactation.

    However, before using Mikozoral® ointment in these cases, you should consult your doctor.

    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 1-2 times a day, depending on the severity of the lesion.

    Average duration of treatment is: for dermatomycosis smooth skin - 3-4 weeks, with inguinal epidermophytia - 2-4 weeks, with epidermophytosis stop - 4-6 weeks, with infections caused by yeast-like fungi - 2-3 weeks, withrubella - 2-3 weeks, with seborrheic dermatitis - 2-4 weeks. It should continue treatment for at least several days after the disappearance of the symptoms of the disease.

    If clinical improvement is not observed after 4 weeks of treatment, then the diagnosis should be clarified.

    Side effects:

    With topical application of Mikozoral® ointment, 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 special measures is not required.

    Interaction:The drug interaction of Mikozoral® with external application is not described.
    Special instructions:

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

    During treatment, general hygiene rules should be followed.

    Form release / dosage:

    Ointment for external use.

    Packaging:

    By 15, 20, 30, 40 or 50 g in an aluminum tube.

    Each tube together with the instruction for use is placed in a pack of cardboard.

    Storage conditions:

    At a temperature not higher than 15 ° ะก.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use the product after the date shown on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:P N000408 / 01
    Date of registration:08.12.2006 / 14.11.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia
    Manufacturer: & nbsp
    Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia
    Information update date: & nbsp06.06.2018
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