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

    Active substance:

    Hydrocortisone acetate -1.0 g

    Excipients:

    methylparahydroxybenzoate (nipagine) - 0.08 g

    propyl parahydroxybenzoate (nipazole) - 0.02 g

    petrolatum -45.0 g

    stearic acid - 3.0 g

    anhydrous lanolin -10.0 g

    pentaerythritol dioleate (pentol) - 5.0 g

    purified water - up to 100 g of ointment

    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 by inflammatory mediators, disrupts the metabolism of arachidonic acid and synthesizes prostaglandins. Stimulating glucocorticosteroid receptors induces the formation of lipocortin.Reduces inflammatory cell infiltrates, reduces the migration of leukocytes, including 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. It is 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, erythroderia, prurigo, 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, acne vulgaris, perioral dermatitis, skin tumors, pregnancy, the period of breastfeeding, children under 2 years.

    Carefully:

    Diabetes mellitus, tuberculosis (systemic damage).

    Pregnancy and lactation:

    The drug during pregnancy and breastfeeding is 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. In applying the ointment in children aged 2 years and older should limit the total duration of the treatment period of not more than two weeks and to exclude events that lead to increased absorption of hydrocortisone (warming, fixing and occlusive dressings).

    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 use of occlusive dressings, especially on large areas of lesions, may develop symptoms of Cushing (hyperglycemia, glucosuria, reversible inhibition of the function of the adrenal cortex, the manifestation of the syndrome Cushing's), as a manifestation of rezrbtivnogo 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 hypercorticism: hyperglycemia, glucosuria, reversible suppression of adrenal cortex function, manifestation of Itenko-Cushing syndrome.

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

    Interaction:

    Barbiturates, antiepileptic and antihistamines reduce effectiveness.

    Paracetamol promotes the development of hepatotoxicity.

    Reduces the activity of salicylates, hypoglycemic agents, increases - anticoagulants.

    Cardiac glycosides and non-potassium-sparing diuretics increase hypokalemia, anabolic steroids increase the hydrophilicity of tissues.

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

    In cases of application of the drug in children, the duration of treatment should be reduced to two weeks for the area of ​​the face under occlusive dressings.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 somatropin. Children from 2 to 12 years of age should take the drug only after consulting a doctor and then 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. If symptoms return after a few days after discontinuation of the drug, consult a physician.

    With long-term treatment and / or application to large surfaces, it is recommended to prescribe a diet with sodium restriction and high potassium content; Enter into the body A sufficient amount of protein. It is necessary to control blood pressure, blood glucose, blood clotting, diuresis, body weight of the patient, plasma cortisol concentration.

    To prevent infection, the drug is recommended to be prescribed in combination with antibacterial and antifungal agents.

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

    During the period of drug treatment, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Ointment for external use 1 %.

    Packaging:

    10 grams in tubes of aluminum.

    Each tube together with instructions for medical use of the drug is placed in a cardboard box.

    Storage conditions:

    At a temperature not higher than 15 ° С.

    Keep out of the reach of children.

    Shelf life:

    3 years. Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:P N002694 / 01-2003
    Date of registration:28.04.2008 / 18.11.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp05.04.2017
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