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

    100 g of ointment contains:

    active substance: prednisolone 0.5 g;

    Excipients: glycerol (glycerin distilled), vaseline medical, stearic acid, emulsifier №1, methylparahydroxybenzoate (nipagin), propyl parahydroxybenzoate (nipazole), purified water.

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

    Isolated through the kidneys.

    Indications:

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

    Carefully:Pregnancy, lactation.
    Pregnancy and lactation:

    Pregnancy

    External use of prednisolone in pregnant women is allowed in cases where, according to the attending physician, the potential benefit for a pregnant woman prevails over the possible risk to the fetus. In these cases, the application should be short and limited to small areas of the skin. Data on the teratogenic effect are absent.

    Breast-feeding

    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. During the period of aftercare, it is possible to use the drug once a day.To prevent relapses in the treatment of chronic diseases, therapy should continue for some time after the disappearance of all symptoms.

    On sites with more dense skin (for example, elbows, palms and feet), and also places from which the preparation is easily erased, the ointment can be applied more often.

    For limited areas of the skin, occlusal dressings can be used to enhance the effect.

    Side effects:

    Steroid acne, purpura, telangiectasia, burning and itching of the skin, irritation and dry skin.

    With long-term 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.

    Overdose:

    Symptoms: oppression of hypothalamic-pituitary-adrenal function system, hyperglycemia, glucosuria, Itenko-Cushing 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 local glucocorticosteroids, the drug Prednisolone Do not apply to the skin in the eye area (because of the possible development of glaucoma and cataracts), as well as on wound surfaces.

    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 antimycotic agent.

    Pediatric Use

    When ointments are used in children, 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 that of an occlusive dressing, and increase the systemic resorption of the active substance of the drug. In connection with the fact that in children the ratio of surface area and body weight is greater than that of y. adults, children are at greater risk of suppressing the function of the hypothalamic-pituitary. adrenal system and the development of Cushing's syndrome in the application of any local glucocorticosteroids. Long-term treatment with glucocorticosteroid can lead to disruption in the growth and development of the child.Therefore, children should receive the minimum dose of the drug to achieve the effect and the drug should be administered under the supervision of a doctor.

    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 5 g, 10 g, 15 g in tubes aluminum or laminate.

    Each tube with instruction for use is placed in a pack of cardboard.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N001616 / 01
    Date of registration:16.06.2008
    The owner of the registration certificate:SYNTHESIS, JSC Joint-stock Kurgan Society of Medical Preparations and Products SYNTHESIS, JSC Joint-stock Kurgan Society of Medical Preparations and Products Russia
    Manufacturer: & nbsp
    Representation: & nbspSYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products SYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products Russia
    Information update date: & nbsp29.08.2015
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