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

    On 1 g

    Active substance: hydrocortisone acetate 10.0 mg.

    Excipients: Vaseline 450.0 mg, lanolin 100.0 mg, pentaerythritol dioleate (pentol) 50.0 mg, stearic acid 95 30.0 mg, methyl parahydroxybenzoate 0.8 mg, propyl parahydroxybenzoate 0.2 mg, water, up to 1 g.

    Description:Ointment from white with a yellowish tinge to 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 topical application, 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, reduces the metabolism of arachidonic acid and the synthesis of prostaglandins. Stimulating steroid receptors induces the formation of lipocortin.Reduces inflammatory cell infiltrates, reduces the migration of leukocytes and lymphocytes to the area of ​​inflammation. Local application of the drug at recommended doses does not cause side effects of systemic effects.

    Pharmacokinetics:

    After application, it accumulates in the epidermis (mainly in the granular layer). Metabolized directly in the epidermis, and later in the liver. It is excreted by the kidneys and with bile.

    Indications:

    Inflammatory and allergic skin diseases of non-microbial etiology: eczema, allergic and contact dermatitis, neurodermatitis, psoriasis.

    Contraindications:Hypersensitivity to hydrocortisone and any of the excipients of the drug; wound, ulcerative skin lesions, bacterial, viral and fungal skin infections, tubercular and syphilitic skin lesions: rosacea, acne vulgaris, perioral dermatitis; skin tumors; pregnancy, the period of breastfeeding (due to the lack of clinical data on safety of use); children under 2 years.
    Carefully:Diabetes mellitus, tuberculosis (systemic lesion).
    Pregnancy and lactation:Contraindicated.
    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 ointment is used in children from 2 years and older, the total duration of treatment should be limited and the measures leading to increased resorption of steroid absorption (warming, fixative 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 ointment or the use of an occlusive dressing, especially in large areas of damage, it is possible to develop hypercorticism, as a manifestation of the resorptive action of hydrocortisone acetate.

    Overdose:

    Symptoms. Acute overdose is unlikely. With prolonged use of the drug in large doses, the appearance of symptoms of hypercorticism (hyperglycemia, glucosuria, reversible inhibition of the adrenal cortex function, Isenko-Cushing syndrome) is possible.

    Treatment is symptomatic; gradual withdrawal of the drug is recommended.

    Interaction:

    With prolonged use, due to possible resorption to the systemic circulation, hydrocortisone can reduce the effectiveness of insulin, oral hypoglycemic, antihypertensive drugs, anticoagulants, the concentration of salicylates and praziquantel in blood plasma.

    The risk of side effects of hydrocortisone is increased: androgens, estrogens, oral contraceptives, anabolic steroids (hirsutism, acne); antipsychotic drugs, carbutamide, azathioprine (cataract);

    holinoblokatory, antihistamine medicines, tricyclic antidepressants, nitrates (glaucoma); diuretics (hypokalemia); non-steroidal anti-inflammatory drugs (increased risk of ulceration in the gastrointestinal tract);

    paracetamol (hepatotoxicity).

    When used with cardiac glycosides, it is possible to develop digitalis intoxication. Simultaneous use of lead and silver leads to mutual inactivation.

    When combined with amphotericin B, it is possible to develop dilated myocardial damage and heart failure.

    Barbiturates, antiepileptic and antihistamines reduce the effectiveness of hydrocortisone.

    Special instructions:

    In cases of use of the drug in children, on the face area or under occlusive dressings, the duration of the course of treatment should be reduced.

    In childhood, suppression of the function of the adrenal cortex can develop faster. In addition, there may be a decrease in the excretion of growth hormone. When using the drug for a long time, it is necessary to observe the body weight, growth, plasma cortisol level. Children up to 12 years of age, the drug is prescribed only under medical supervision. Avoid contact with ointment in the eyes.

    If after 7 days of application there is no improvement or a worsening of the condition occurs, as well as if the symptoms resume after a few days after the drug has been discontinued, the drug should be discontinued and consulted with the doctor.

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

    It is necessary to control blood pressure, blood glucose, blood coagulation, 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:Not described.
    Form release / dosage:

    Ointment for external use 1%.

    Packaging:10 grams per tube of aluminum. Each tube together with instructions for medical use of the drug is placed in a pack of cardboard.
    Storage conditions:

    At a temperature not exceeding 20 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use the product after the expiration date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:P N001130 / 01
    Date of registration:10.05.2007 / 18.06.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:NIZHFARM, JSC NIZHFARM, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp05.04.2017
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