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 18.5 g, vaseline 14.0 g, stearic acid 5.0 g, macrogol cetostearate (Cremophor A6) 4.76 g, macrogol cetostearate (Cremophor A25) 2.24 g, methyl parahydroxybenzoate 0.08 g, propyl parahydroxybenzoate 0 , 02 g, purified water 54.9 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.).

    It suppresses skin inflammatory reaction, reduces vasodilatation and increased vascular permeability in the inflammatory focus.

    Pharmacokinetics:

    Prednisolone after absorption from the surface of the skin binds to proteins plasma, is exposed to the metabolism that occurs, mainly in the liver. It is excreted 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).

    If you have any of these diseases, consult a doctor before taking the drug.

    Carefully:

    Pregnancy, lactation.

    Pregnancy and lactation:

    External use of prednisolone in pregnant women is allowed in cases where, according to the attending physician, the potential benefit for pregnant women 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.

    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 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.

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

    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 the effect of an occlusive dressing and increase the systemic resorption of the active substance of the drug.

    Due to the fact that in children the ratio of the area and body weight is larger than that of adults, children are at greater risk of suppressing the function of the hypothalamic-pituitary-adrenal system and the development of Cushing's syndrome with the application of any topical glucocorticosteroids. Long-term treatment with a glucocorticosteroid can lead to disruption in the growth and development of the child.Therefore, children should crawl the minimum dose of the drug to achieve the effect and the drug should be administered under the supervision of a doctor.

    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, it is possible to develop hypercorticism as a manifestation of the resorptive effect of prednisolone. In these cases, the drug should be discontinued and consult a doctor.

    If any adverse side reaction occurs, consult a doctor as soon as possible.

    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: oppression of hypothalamic-pituitary-adrenal function systems; hyperglycemia, glucosuria, Itenko-Cushing syndrome.

    Symptoms disappear after stopping the drug.

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

    Interaction:

    No data available.

    Special instructions:

    The duration of the drug should not exceed 14 days.

    Like other local glucocorticosteroids, the drug Prednisolone can not apply to the skin in the eye area (due to the possible development of glaucoma and cataracts), as well as on the 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.

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

    Data on the impact on the ability to drive vehicles and mechanisms are missing.

    Form release / dosage:

    Ointment for external use, 0,5%.

    Packaging:

    For 10 or 15 grams in tubes of aluminum.

    Each tube together with instructions for medical use in a pack of cardboard.

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:PL-000679
    Date of registration:28.09.2011
    The owner of the registration certificate:BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC Republic of Belarus
    Manufacturer: & nbsp
    Representation: & nbspBORISOVSKIY FACTORY OF MEDPREPARATES, OJSCBORISOVSKIY FACTORY OF MEDPREPARATES, OJSC
    Information update date: & nbsp28.08.2015
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