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

    In 1 g of cream contains:

    active substance: mometasone furoate - 0.001 g;

    Excipients: paraffin liquid, paraffin soft white, propylene glycol, wax emulsion, sodium citrate, chlorocresol, cetomacrogol, water.

    Description:White homogeneous cream.
    Pharmacotherapeutic group:Glucocorticosteroid for topical application
    ATX: & nbsp

    R.01.A.D.09   Mometasone

    Pharmacodynamics:

    Mometasone is a synthetic glucocorticosteroid (GCS). Has anti-inflammatory, antipruritic and antiexudative action.

    SCS induces the release of proteins that inhibit phospholipase A2 and known collectively as lipocortins that control the biosynthesis of inflammatory mediators such as prostaglandins and leukotrienes, by inhibiting the release of their common precursor, arachidonic acid.

    It prevents the accumulation of neutrophils, which reduces inflammatory exudate and production of cytokines, inhibits the migration of macrophages, leads to a decrease in the processes of infiltration and granulation. Reduces inflammation due to decreased formation of chemotaxis substance (influence on "late" allergy reactions),inhibits the development of an "immediate" allergic reaction (due to inhibition of the production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells).

    With daily application of the cream to children over 2 years old with allergic dermatitis, the therapeutic effect is manifested in 3 weeks.

    Pharmacokinetics:Absorption of Gistan-H cream is low. After 8 hours after application to the intact skin (without occlusive dressing), about 0.4% of the dose is found in the systemic blood stream. With inflammation and damage to the skin, absorption increases.
    Indications:Inflammation and itching of the skin with dermatoses (including psoriasis, atopic dermatitis, seborrheic dermatitis), in which therapy is shown.
    Contraindications:

    - Hypersensitivity to any component of the drug or to other GCS.

    - Pink acne, perioral dermatitis.

    - Bacterial, viral (Herpes simplex, chicken pox, Herpes zoster) or fungal skin infection.

    - Tuberculosis, syphilis.

    Post vaccination reactions.

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

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

    - Children under 2 years old.

    Carefully:Applying to the face skin and intertriginoznuyu surface of the skin, the use of occlusive dressings, as well as the treatment of large areas of the skin and / or long-term treatment (especially in children).
    Pregnancy and lactation:

    The safety of the use of mometasone furoate during pregnancy and during lactation has not been studied.

    GCS penetrates 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.

    GCS is 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 the drug is applied to the affected areas of the skin once a day.

    Duration of treatment: 7-28 days, determined by the effectiveness of therapy, as well as patient tolerability, the presence and severity of side effects.

    Side effects:

    Local reactions: burning, itching, paresthesia, folliculitis, acne, skin atrophy, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, attachment of secondary infection, striae, sweating.

    The probability of occurrence of the listed undesirable phenomena increases at application of occlusive dressings.

    System Action: when external forms of SCS are used for a long time and / or for the treatment of large areas of the skin (the total area of ​​application is larger than the palm of the patient) or with the use of occlusive dressings, especially in children and adolescents, side effects typical for SCS of systemic action may occur, including adrenal insufficiency and Isenko-Cushing syndrome.

    Overdose:

    Symptoms: oppression of the hypothalamic-pituitary-adrenal system (including secondary adrenal insufficiency).

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

    Interaction:Not found.
    Special instructions:

    If there is no effect within 2 weeks of therapy, the diagnosis should be clarified.

    When applied to large areas of the skin for a long time, especially with the application of occlusive dressings, it is possible to develop a systemic action of GCS.

    Given this, it is necessary to monitor the function of the hypothalamic-pituitary-adrenal system.

    Avoid contact with the eyes.

    Propylene glycol included in the formulation may cause irritation at the site of application. In such cases, discontinue use of the drug and prescribe appropriate treatment.

    It should be borne in mind that SCS is able to change the manifestation of certain skin diseases, which can complicate the diagnosis. 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 treatment course, the drug should be abolished gradually, for example, by switching to an intermittent treatment regimen before it is completely discontinued.

    Pediatric Use

    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 the Itenko-Cushing syndrome with any local GCS.Long-term treatment of children with SCS can lead to disruption of their growth and development. The use of the drug in children for more than 3 weeks has not been studied.

    Children should receive a minimum dose of the drug sufficient to achieve the effect.

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

    For 5 g or 15 g of the drug in an aluminum tube.

    For 1 tube in a cardboard box together with instructions for use.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-008698/10
    Date of registration:25.08.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:Oxford Laboratories Pvt. Ltd.Oxford Laboratories Pvt. Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspOXFORD LABORATORY Pvt. Ltd. OXFORD LABORATORY Pvt. Ltd. India
    Information update date: & nbsp24.04.2017
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