Active substancePrednisolonePrednisolone
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  • Dosage form: & nbspointment for external use
    Composition:100 g of the preparation contain:

    active substance: prednisolone 0.5 g;

    Excipients: glycerin distilled (glycerol) 18.5 g, vaseline (paraffin soft) 14.0 g, stearic acid 5.0 g, emulsifier No. 1 (Lannette® SX) (5.0-7.0) g, nipagine (methylhydroxybenzoate) 0.08 g, nipase (propylhydroxybenzoate) 0.02 g, purified water to 100.0 g.

    Description:Ointment of white color.
    Pharmacotherapeutic group:glucocorticosteroid for topical application
    ATX: & nbsp

    H.02.A.B.06   Prednisolone

    Pharmacodynamics:

    With external application it has anti-inflammatory, anti-allergic, antipruritic and antiexudative action.

    Suppresses the formation of arachidonic acid, the formation and release of mediators of inflammation (histamine, prostaglandins, leukotrienes, lysosomal enzymes, etc.). Suppress cutaneous inflammatory reaction, reduce vasodilation and increased permeability of blood vessels in the inflammatory focus.

    Pharmacokinetics:

    Prednisolone after insignificant absorption from the surface of the skin binds to plasma proteins, undergoes a metabolism that occurs mainly in the liver. Isolated through the kidneys.

    Violation of the integrity of the skin or occlusive dressing can increase the percutaneous absorption of prednisolone.

    Indications:

    Prednisolon ointment is used in the complex therapy of inflammatory and allergic skin diseases of non-microbial etiology: eczema, allergic, seborrheic and contact dermatitis, neurodermatitis, psoriasis, lupus erythematosus, erythroderma.

    Contraindications:

    Hypersensitivity to Drug components, tuberculosis, syphilis, skin tumors, acne vulgaris, rosacea (possibly exacerbation of the disease), wound, ulcerative lesions, bacterial, viral and fungal skin diseases, pregnancy.

    Pregnancy and lactation:

    Glucocorticoids penetrate the placenta. Effects on the fetus can be particularly pronounced when applying the drug on large surfaces. The drug is not prescribed during pregnancy and lactation.

    Dosing and Administration:

    Outwardly. Ointment is applied a thin layer on the affected skin 1-3 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 1 year and older, the total duration of treatment should be limited and the measures leading to increased absorption of glucocorticosteroid absorption (warming, fixing and occlusive dressings) should be excluded.

    Side effects:

    When applying prednisolone ointment, especially in patients with individual intolerance,may occur hyperemia, swelling, itching within the area of ​​application of the drug, steroid acne, telangiectasia, burning sensation, irritation, dryness of skin.

    With its long-term use, it is also possible to develop secondary infectious skin lesions, atrophic changes in it, hypertrichosis.

    For the prevention of infectious skin lesions prednisolone ointment recommended to be administered in combination with antibacterial and antifungal agents.

    With prolonged use of ointment, especially on large areas of lesions may develop Cushing, as a manifestation of resorptive action of prednisolone. In these cases, the drug is canceled.

    Overdose:

    With prolonged use of the drug in large doses, symptoms of hypercorticism may appear.

    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.

    The duration of the drug should not exceed 14 days.

    Form release / dosage:

    Ointment for external use, 0,5%.

    Packaging:

    In tubes of aluminum for 10 g.

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

    Storage conditions:

    Keep out of the reach of children at a temperature of not more than + 25 ° C.

    Shelf life:

    2 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:P N001129 / 01
    Date of registration:07.08.2007
    The owner of the registration certificate:NIZHFARM, JSC NIZHFARM, JSC Russia
    Manufacturer: & nbsp
    Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia
    Information update date: & nbsp29.08.2015
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