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

    In 100 g of the drug contains:

    active substance: prednisolone 0.5 g,

    Excipients: Vaseline 14.0 g, glycerol 18.5 g, stearic acid 5.0 g, emulsifier No. 1 7.0 g, methyl parahydroxybenzoate 0.08 g, propyl parahydroxybenzoate 0.02 g, purified water 54.9 g.

    Description:

    Homogeneous ointment from white to light yellow color.

    Pharmacotherapeutic group:glucocorticosteroid for topical application
    ATX: & nbsp

    H.02.A.B.06   Prednisolone

    Pharmacodynamics:

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

    Suppresses the release 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.

    Suppresses the effect of macrophages, target cells, cytokines, which are involved in the development of the reaction in the form of allergic contact dermatitis. Prevents the access of sensitized T-lymphocytes and macrophages to target cells.

    Pharmacokinetics:

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

    Excreted by the kidneys.

    Indications:

    In complex therapy: urticaria, atopic dermatitis, simple chronic lichen (limited neurodermatitis), eczema, seborrheic dermatitis, discoid lupus erythematosus, simple and allergic dermatitis, toxicermy, erythroderma, psoriasis, alopecia; epicondylitis, tendovaginitis, bursitis, humeroscapular periarthritis, keloid scars, sciatica, Dupuytren's contracture.

    Contraindications:

    Hypersensitivity to the drug components, bacterial, viral and fungal skin lesions, tuberculosis, syphilis, skin tumors, acne vulgaris, rosacea, skin post-vaccination reactions, open wounds, trophic ulcers, children's age (under 1 year), pregnancy.

    Pregnancy and lactation:

    Glucocorticosteroids are excreted in breast milk. Precautions should be observed when using Prednisolone in nursing mothers, in particular, the drug should not be applied to the skin of the breast before feeding. If you need to use the drug in large doses and / or for a long time, you should stop breastfeeding.

    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 applying ointment in children from 1 year old and older, the total duration of treatment should be limited. It should be borne in mind that in young children, skin folds, diapers and diapers can have an effect similar to the effect of an occlusive dressing, and increase the systemic resorption of the active substance of the drug.Due to the fact that the ratio of the surface area and body weight is greater in children than in adults, children are at greater risk of suppressing the function of the hypothalamic-pituitary-adrenal system and the development of the Itenko-Cushing syndrome with any local glucocorticosteroids. Long-term treatment with a glucocorticosteroid can lead to disruption in the growth and development of the child. Therefore, children should receive the minimum effective dose of the drug as short as possible to achieve the effect and the drug should be administered under the supervision of a doctor.

    For the prevention of recurrence in the treatment of chronic diseases Therapy should continue for some time after the disappearance of all symptoms.

    On areas with denser skin (for example, elbows, palms and feet), as well as places from which the drug is easily washed, ointment can be applied more often. To enhance the effect, occlusive dressings can be used.

    Side effects:

    "Steroid" acne, purpura, telangiectasia, burning and itching of the skin, irritation and dry skin. With prolonged use and / or when applied to large surfaces, hypercorticism may develop,As a manifestation of the resorptive effect of prednisolone. In these cases, the drug should be discontinued and consult a doctor.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:

    Symptoms: suppression of the hypothalamic-pituitary-adrenal axis, hyperglycemia, glycosuria, Cushing's syndrome. Symptoms disappear after discontinuation of the drug.

    Treatment: gradual withdrawal of the drug, symptomatic treatment, if necessary, correction of electrolyte imbalance.

    Interaction:

    No data available.

    Special instructions:

    The duration of the drug should not exceed 14 days.

    Like other glucocorticosteroids for external use, the drug Prednisolone can not be applied to the skin in the eye region (because of the possible development of glaucoma and cataracts) and also on the surface of the wound.

    If the course of the disease is complicated by the development of a secondary bacterial or fungal infection, to drug therapy Prednisolone it is necessary to add a specific antibacterial or antifungal agent.

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

    Data on the effects of prednisolone on the ability to control vehicles and mechanisms are not available.

    Form release / dosage:Ointment for external use, 0,5%.
    Packaging:

    For 10 g and 15 g in aluminum tubes.

    Each tube together with the instruction for use 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:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N002435 / 01-2003
    Date of registration:16.05.2008
    The owner of the registration certificate:MUROMSKY INSTRUMENT-MAKING PLANT, OJSC MUROMSKY INSTRUMENT-MAKING PLANT, OJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspMUROMSKY INSTRUMENT-MAKING PLANT, OJSCMUROMSKY INSTRUMENT-MAKING PLANT, OJSC
    Information update date: & nbsp29.08.2015
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