Active substanceMometasoneMometasone
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  • Dosage form: & nbspcream for external use
    Composition:

    100 g of cream contain:

    active substance: mometasone furoate OD g;

    Excipients: hexylene glycol 12.0 g, glyceryl monostearate 40-55-5.5 g, cetostearyl alcohol 5.5 g, macrogol cetostearate (macrogol 20 cetostearyl ether) 4.0 g, beeswax white 5.0 g, titanium dioxide 1.0 g, starch aluminum octenyl succinate 10.0 g, purified water 1.8 g, phosphoric acid diluted or orthophosphoric acid concentrated as a 10% solution 1.2 g, petrolatum up to 100 g.

    Description:The cream is white or almost white.
    Pharmacotherapeutic group:Glucocorticosteroid for topical application
    ATX: & nbsp

    R.01.A.D.09   Mometasone

    Pharmacodynamics:

    Mometasone is a synthetic glucocorticosteroid (GCS), which possesses an anti-inflammatory, antipruritic and antiexudative action. SCS induces the release of proteins that inhibit phospholipase A2 and are known under the general name lipocortins, which control the biosynthesis of inflammatory mediators such as prostaglandins and leukotrienes, by inhibiting the release of their common precursor, arachidonic acid.

    Pharmacokinetics:

    Absorption of Uniderm® cream is negligible. 8 hours after application to the intact skin (without occlusive dressing), about 0.4% of the drug is found in the systemic circulation.

    Indications:

    Inflammation and itching in dermatoses that respond to glucocorticosteroid therapy.

    Contraindications:

    - Hypersensitivity to any component of the drug or to glucocorticosteroid agents.

    - Pink acne, perioral dermatitis.

    - Bacterial, viral (Herpes simplex, chickenpox, Herpes zoster) or fungal infection of the skin.

    - Tuberculosis, syphilis.

    - Post-vaccination reactions.

    - Children up to 6 months.

    - Pregnancy (treatment of extensive skin areas, long-term treatment).

    - Lactation period (use in large doses and / and for a long time).

    Carefully:

    Applying to face and wrinkles, applying occlusive dressings, and also treating large areas of the skin and / or prolonged treatment (especially in children).

    Pregnancy and lactation:

    The safety of the use of Uniderm® cream during pregnancy and lactation has not been studied. Glucocorticosteroids penetrate the placental barrier.Long-term treatment and use of large doses during pregnancy should be avoided due to the threat of adverse effects on fetal development.

    Glucocorticosteroids are excreted in breast milk. In the event that the use of GCS is expected in large doses and / or for a long time, breastfeeding should be discontinued.

    Dosing and Administration:

    Outwardly.

    A thin layer of Uniderm® cream is applied to the affected areas of the skin once a day. The duration of the course of treatment is determined by its effectiveness, as well as the patient's tolerance, the presence and severity of side effects.

    Side effects:

    Rarely - irritation and dry skin, burning sensation, itching, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, signs of skin atrophy, striae, sweating. Less than 1% of cases - the formation of papules, pustules.

    When using Uniderm® cream for a long time and / or for treating large areas of the skin, or with the use of occlusive dressings, especially in children and adolescents, side effects may occur,characteristic of systemic corticosteroids, including adrenal insufficiency and Cushing's syndrome.

    Overdose:

    Symptoms: suppression of the hypothalamic-pituitary-adrenal system, including secondary adrenal insufficiency.

    Treatment: symptomatic, if necessary - correction of electrolyte imbalance, drug withdrawal (with prolonged therapy - gradual abolition).

    Special instructions:

    When applied to large areas of the skin for a long time, especially when using occlusive dressings may develop systemic corticosteroids. In view of this, patients should be observed for signs of suppressing function of the hypothalamic-pituitary-adrenal system and the development of Cushing's syndrome.

    Uniderm® cream should be avoided in the eyes.

    Propylene glycol, which is part of the preparation, may cause irritation at the site of application. In such cases, discontinue the use of Uniderm® cream and prescribe appropriate treatment.

    It should be borne in mind that the GCS is able to change the manifestations of certain skin diseases, which can make it difficult to diagnose. In addition, the use of GCS may be the cause of delayed wound healing.

    With prolonged therapy with SCS, sudden discontinuation of therapy can lead to the development of a rebound syndrome, manifested in the form of dermatitis with intense reddening of the skin and a burning sensation. Therefore, after a long course of treatment, the drug should be canceled gradually, for example, by switching to an intermittent treatment regimen before it is completely discontinued.

    Pediatric Use

    The safety and efficacy of Uniderm® cream in topical application in children for more than 6 weeks have not been studied.

    Due to the fact that the ratio of 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 Cushing's syndrome with any local GCS.

    Long-term treatment of children with SCS can lead to disruption of their growth and development.

    Children should receive a minimum dose of the drug sufficient to achieve the effect. In children from 6 months to 2 years old, the course of treatment should not exceed 5 days.

    Form release / dosage:Cream for external use 0,1%.
    Packaging:

    For 15 and 30 g in an aluminum tube.Each tube together with the instruction for use is placed in a pack of cardboard.

    Storage conditions:

    At a temperature of 15 to 25 ° C. Keep out of the reach of children.

    Shelf life:2 years. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Obsolete name of the trade product: & nbspUniderm®
    Date renamed: & nbsp14.04.2016
    Registration number:LSR-004198/08
    Date of registration:30.05.2008 / 14.04.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp13.06.2018
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