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

    For 100 g of ointment:

    Active substance: hydrocortisone acetate - 1.0 g.

    Excipients: Vaseline medical, lanolin (lanolin anhydrous), pentaerythritol dioleate (pentol), stearic acid, methyl parahydroxybenzoate (nipagine or methylparaben), propyl parahydroxybenzoate (nipazole or propylparaben), purified water.

    Description:Ointment is white with a yellowish tint or light yellow color.
    Pharmacotherapeutic group:Glucocorticosteroid for topical application
    ATX: & nbsp

    S.01.B.A.02   Hydrocortisone

    H.02.A.B.09   Hydrocortisone

    D.07.A.A.02   Hydrocortisone

    Pharmacodynamics:

    Hydrocortisone is a synthetic glucocorticosteroid drug for external use. Has anti-inflammatory, anti-edematous, antipruritic effect. It inhibits the release of cytokines (interleukins and interferon) from lymphocytes and macrophages, inhibits the release of eosinophils mediators of inflammation, disrupts the metabolism of arachidonic acid and the synthesis of prostaglandins. Stimulating glucosteroid receptors induces the formation of lipocortin.Reduces inflammatory cell infiltrates, reduces the migration of leukocytes, incl. lymphocytes into the area of ​​inflammation. When administered at recommended doses does not cause systemic side effects.

    Pharmacokinetics:

    After application, it accumulates in the epidermis (mainly in the granular layer). Metabolized directly in the epidermis, and later in the liver. Excreted by the kidneys and intestines.

    Indications:Inflammatory and allergic skin diseases of non-microbial etiology (including those accompanied by itching): eczema, allergic and contact dermatitis, neurodermatitis, psoriasis, erythroderma, pruritus, insect bites, seborrhea.
    Contraindications:

    Hypersensitivity to hydrocortisone or other components of the drug, wound, ulcerative skin lesions, bacterial, viral and fungal skin diseases, skin tuberculosis and syphilitic skin lesions. Rosacea, vulgar acne, perioral dermatitis, skin tumors, children under 2 years. Pregnancy.

    Carefully:Lactation period, diabetes, tuberculosis (systemic lesion).
    Pregnancy and lactation:
    Dosing and Administration:Outwardly.Ointment is applied a thin layer on the affected skin 2-3 times a day. The duration of treatment depends on the nature of the disease and the effectiveness of therapy, usually 6-14 days; when the disease persists, it can be prolonged to 20 days. On limited foci, occlusal dressings can be used to enhance the effect. When using ointment in children from 2 years of age and older, the total duration of treatment should be limited to a period of not more than two weeks and the measures leading to increased absorption of the steroid (warming, fixing and occlusive dressings) should be excluded.
    Side effects:Hyperemia, swelling and itching in the places of ointment application. With prolonged use, it is also possible to develop secondary infectious skin lesions, atrophic changes in it, hypertrichosis. With prolonged use of the ointment or the use of an occlusive dressing, especially in large areas of the lesion, it is possible to develop symptoms of hypercorticism (hyperglycemia, glucosuria, reversible suppression of adrenal cortex function, manifestation of Cushing's syndrome) as a manifestation of the resorptive action of hydrocortisone.
    Overdose:
    Acute overdose is unlikely, however, with excessive or prolonged use of the drug, a chronic overdose is possible, accompanied by signs of Cushing: hyperglycemia, glycosuria, reversible inhibition of the function of the adrenal cortex, the manifestation of Cushing's syndrome.

    Treatment. The corresponding symptomatic treatment was shown. In the case of chronic toxic effects, a gradual withdrawal of the drug is recommended.

    Interaction:
    Special instructions:

    In cases of use of the drug in children, on the face or under occlusive dressings, the duration of treatment should be reduced to two weeks. In childhood, suppression of the function of the adrenal cortex can develop faster. In addition, there may be a decrease in the secretion of growth hormone. When using the drug for a long time, it is necessary to observe body mass, growth, concentration of plasma cortisol. Children under 12 years of age appoint only under medical supervision.

    Avoid contact with eyes and mucous membranes.

    If after 7 days of application there is no improvement or impairment is observed, the drug should be discontinued and consult a doctor.In case of resumption of symptoms a few days after discontinuation of the drug should consult a doctor.

    With long-term treatment and / or application to large surfaces, it is recommended to prescribe a diet with sodium restriction and high potassium content; to introduce into the body a sufficient amount of protein.

    It is necessary to control blood pressure, blood glucose, blood coagulability, diuresis, body weight of the patient, plasma cortisol level.

    To prevent infectious skin lesions, the drug is recommended to be prescribed in combination with antibacterial and antifungal agents.
    Effect on the ability to drive transp. cf. and fur:
    Form release / dosage:

    Ointment for external use 1%.

    Packaging:

    For 5 g, 10 g, 15 g, 20 g, 30 g in tubes aluminium or laminate.

    Each tube with instructions for usein a pack of cardboard.

    Storage conditions:

    At a temperature of 8 to 15 ° C.

    Keep out of the reach of children.

    Shelf life:

    5 years. Do not apply at the end of the period shelf life.

    Terms of leave from pharmacies:Without recipe
    Registration number:P N001666 / 01
    Date of registration:22.07.2008 / 05.08.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp05.04.2017
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