Active substanceKetoconazoleKetoconazole
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  • Dosage form: & nbspshampoo
    Composition:

    100 grams of shampoo contain:

    active substance: ketoconazole in terms of 100% substance 2 g;

    Excipients: propylene glycol 10 g, hypromellose 1.2 g, sodium laureth sulfate 23 g, sodium disulfite 0.2 g, macrogol glyceryl cocoate 2 g, imidourea 0.2 g, dye solar sunset yellow 0.04 g, hydrochloric acid diluted 8.3% to pH 6.0-8.0, water purified to 100 g.

    Description:

    Transparent viscous liquid from yellow or yellow-orange to orange 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, a synthetic derivative of imidazolidioxole, which has a strong antifungal effect against dermatophytes (Trichophyton sp., Epidermophyton sp., Microsporum sp.), yeast-like fungi (Candida sp., Malassezia furfur (Pityrosporum ovale), dimorphic fungi (Blastomyces dermatidis, Coccidioides immitis, Sporotrichum schenckii), as well as for staphylococci and streptococci.

    Mikozoral® shampoo quickly reduces peeling and itching of the scalp, which are usually associated with dandruff, seborrheic dermatitis and pityriasis.

    Pharmacokinetics:

    Absorption of ketoconazole through the skin with local application is negligible.

    With prolonged use ketoconazole in the blood is not determined.

    Indications:

    Treatment and prevention of dandruff, seborrheic dermatitis and pityriasis.

    Contraindications:

    Hypersensitivity to any of the components of the drug.

    Pregnancy and lactation:

    Because with topical application ketoconazole practically not absorbed, it is possible to use Mikozoral® shampoo during pregnancy and lactation.

    Dosing and Administration:

    Outwardly. Apply Mikozoral® shampoo to affected areas of the skin or scalp for 3-5 minutes, then rinse with water.

    Treatment:

    - various types of dandruff and seborrheic dermatitis of the scalp: 2 times a week for 3-4 weeks;

    - pityriasis lichen: daily for 5 days, and in the absence of effect, prolongation of the course to 7 days.

    Prevention:

    - various types of dandruff and seborrheic dermatitis of the scalp: weekly or 1 time in two weeks;

    - pityriasis lichen: daily for 3-5 days (one-time course) in the spring before the onset of summer.

    Side effects:

    Mycosoril® shampoo is usually well tolerated. Rarely local irritation and itching can occur. Hair can become greasy or dry.In some cases, mainly in patients with chemically damaged or gray hair, hair color changes can be noted.

    Overdose:

    With the use of shampoo Mikozoral ® development of an overdose is not expected, since the drug is intended for external use only. In case of accidental ingestion, symptomatic and supportive therapy should be prescribed. To prevent aspiration, do not induce vomiting or use gastric lavage.

    Special instructions:

    When using shampoo, avoid contact with eyes. If shampoo comes into the eyes, rinse with water.

    If local glucocorticosteroids were used for the treatment of seborrheic dermatitis for a long time, then it is recommended to continue local application of glucocorticosteroid preparations in combination with Mikozoral® shampoo with subsequent gradual abolition of glucocorticosteroids for 2-3 weeks to prevent withdrawal syndrome.

    Seborrheic dermatitis and dandruff are often accompanied by increased hair loss. In rare cases, increased hair loss can occur with the application of Mikozoral® shampoo.

    Effect on the ability to drive transp. cf. and fur:

    Mycosoril® shampoo does not affect the ability to drive and work with machinery.

    Form release / dosage:Shampoo 2%.
    Packaging:

    60 g per bottle of polyethylene, capped with a lid of polyethylene, or a tube of polyethylene, capped with a lid of polypropylene.

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

    Storage conditions:In the dark place at a temperature of 15 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:Without recipe
    Registration number:P N000408 / 02-2003
    Date of registration:08.12.2008 / 28.09.2009
    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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