Elocom C® (Elocom S®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceMometasone + Salicylic acidMometasone + Salicylic acid
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  • Elocom C®
    ointment externally 
    MSD FARMASYUTIKALS, LLC     Russia
    • Dosage form: & nbspointment for external use
    Composition:

    In 1 g of ointment contains:

    Active substances: mometasone furoate 1.0 mg and salicylic acid 50.0 mg.

    Excipients: hexylene glycol - 120.0 mg; propylene glycol stearate - 20.0 mg; purified water - 30.0 mg; Vaseline - 729.0 mg; wax bee white - 50.0 mg.

    Description:

    Homogeneous ointment is white or almost white.

    Pharmacotherapeutic group:Glucocorticosteroid for topical use + keratolytic agent
    ATX: & nbsp

    D.07.X.C.03   Mometasone in combination with other drugs

    Pharmacodynamics:

    Mometasone is a glucocorticosteroid for topical and topical application. It has anti-inflammatory, antipruritic and vasoconstrictive properties. In general, the mechanism of anti-inflammatory action of glucocorticosteroids (GCS) of topical application is unclear. It is believed that GCS induce the release of proteins that inhibit phospholipase A2 and known under the general name of lipocortins. It is believed that these proteins control biosynthesis such potent mediators of inflammation as prostaglandins and leukotrienes, by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

    In the experiments in vitro it was shown that mometasone is a potent inhibitor of the synthesis of three cytokines involved in the development of the inflammatory process and its maintenance: interleukin-1 (IL-1), interleukin-6 (IL-6) and tumor necrosis factor alpha (TNFα).

    Salicylic acid causes exfoliation of the stratum corneum and does not lead to quantitative or qualitative changes in the structure of the viable epidermis. This mechanism of action is due to the dissolution of the intercellular binder.

    Pharmacokinetics:

    Suction. After a single external application of the ELOKOM-C® ointment without the use of an occlusive dressing for psoriatic skin lesions, approximately 1.5% of the applied dose is exposed to systemic absorption after 12 hours, the average concentration of salicylic acid in the blood plasma is 0.0908 mg / dL. Systemic toxic reactions to salicylic acid are usually associated with a higher plasma concentration (30-40 mg / dL).

    In the course of studies of the effect of a single-component preparation in the form of an ointment containing mometasone furoate as an active substance on the hypothalamic-pituitary-adrenal system (GGNS),it was shown that there was no effect on the administration of the drug to 15 g per day for 6 weeks or for repeated short treatment after the first course of therapy. It has also been shown that the combined use of mometasone and salicylic acid as a keratolytic agent does not affect the safety profile of mometasone in relation to the GHGN compared to the one-component preparation.

    After applying the Elocom-C® ointment twice daily for 3 weeks without the application of occlusive dressings, the concentration of salicylates in the blood plasma was <5 mg / dl, which is below the detection threshold and below the laboratory norm of salicylate concentration in the blood (15-30 mg / dL).

    Distribution. Due to the slight absorption of mometasone with external application, the distribution of the drug in the human body was studied by intravenous administration of a solution containing mometasone in a concentration of 1 mg / ml. The apparent volume of distribution was 917 liters, indicating a wide distribution of mometasone. 99% of mometasone in human blood plasma is in a bound state.

    Metabolism. After suction mometasone is subject to intensive metabolism with the formation of a variety of metabolites with stronger polar properties than mometasone.Due to the high polarity, the metabolites formed are not considered to have pharmacological activity. With the metabolism of mometasone, no basic metabolite is formed. After intravenous administration, the total rate of metabolic excretion from serum was 976 ml / min, which also confirms the intensive metabolism of mometasone.

    The main metabolites of salicylic acid, quantitatively determined in the blood plasma after external application of the Elocom-C® ointment were gentisic acid (CmOh= 0.00127 mg / dL after 24 hours) and salicyluric acid (CmOh= 0.0171 mg / dL after 3.3 hours).

    Excretion. Mometasone and salicylic acid, as well as their metabolites, are excreted by the kidneys and through the intestine. The half-life of salicylic acid is 2.8 hours.

    Indications:

    Ointment ELOKOM-C® is intended for the removal of inflammatory manifestations and hyperkeratosis in psoriasis, atopic dermatitis, seborrheic dermatitis.

    Contraindications:

    Children's age (up to 12 years).

    Hypersensitivity to mometasone, salicylic acid or to any component of the drug.

    Bacterial, viral (simple herpes, chicken pox,shingles) or fungal skin infections, rosacea or perioral dermatitis, post-vaccination reactions, tuberculosis, syphilis.

    Pregnancy and lactation (treatment of large areas of the skin and / and for a long time), since there have been no controlled studies.

    Do not apply on the face or in the groin and armpits.

    Carefully:

    As for all GCS, ELOKOM-C® ointment should be used with caution when applied to large areas of the body and / or for prolonged use. It is not recommended to use in natural skin folds. SCS can mask the development of skin infections. When developing a concomitant skin infection, antifungal, antibacterial or antiviral agents should be used.

    Pregnancy and lactation:

    The information that the external application of GCS or salicylic acid can lead to systemic action and the detection of the drug in breast milk is not available. Since many GCS penetrate the placental barrier, prolonged treatment and the use of large doses during pregnancy should be avoided due to the threat of adverse effects on fetal development.

    SCS is excreted in breast milk, therefore, in the case where 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 ELOKOM-C® ointment should be applied to the affected areas of the skin twice a day, in the morning and in the evening; the maximum daily dose is 15 g. The duration of the course of treatment is determined by the attending physician.

    Side effects:

    Weak or moderate burning sensation at the site of ointment application, itching, skin atrophy, peeling, irritation, skin maceration, dry skin, folliculitis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, atrophic skin bands, sweat, secondary infections, hypertrichosis. In children, in addition, it is possible to suppress the function of the hypothalamic-pituitary-adrenal system, including the development of the Itenko-Cushing syndrome.

    Overdose:

    Long-term treatment with GCS when administered topically in excessive amounts can lead to suppression of the hypothalamic-pituitary-adrenal system and secondary adrenal insufficiency.If suppression of the hypothalamic-pituitary-adrenal system is observed, then the use of the ointment should be stopped or the frequency of application should be reduced. The frequency of application is determined by the attending physician.

    In the case of toxicity caused by salicylic acid, the use of the ELOKOM-C® ointment should be discontinued. The introduction of liquid helps to remove salicylates from the body with urine. As necessary, oral or intravenous sodium bicarbonate and potassium salts can be administered.

    Interaction:

    No interaction of the Elocom-C® ointment with other drugs has been recorded. Theoretically, there is a probability of the displacement of salicylic acid from the connection with the proteins tolbutamide, methotrexate, heparin, pyrazinamide, drugs that promote the excretion of uric acid, and indirect anticoagulants. Although no communication was reported about the interaction of the ELOKOM-C® ointment with these substances, this information should be borne in mind when it is assigned together with these compounds.

    Special instructions:

    When applied to large areas of the skin for a long time, it is possible to develop a systemic effect of GCS.

    Given this, patients should be observed in terms of signs of suppression of the hypothalamic-pituitary-adrenal system and the development of the Itenko-Cushing syndrome. This is especially important in pediatrics. Due to the fact that the ratio of skin surface and body weight in children is higher than in adults, children more than adults are predisposed to suppression of the hypothalamic-pituitary-adrenal system and development of the Itenko-Cushing syndrome in response to SCS therapy. Children should receive the minimum amount of GCS required to achieve the effect.

    Long-term therapy with the use of GCS may have an undesirable effect on growth and development of children.

    Avoid contact with Elocom-C® ointment in the eyes. Elokom-C® ointment is not to be used in ophthalmology.

    SCS can cause a change in the appearance of affected areas of the skin, which makes it difficult to establish the correct diagnosis.

    In case of irritation, including excessive dryness of the skin, Elokom-C® ointment should be discontinued and appropriate treatment should be prescribed.

    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.

    Any of the side effects described in the systemic use of glucocorticosteroids, including suppression of the adrenal glands, may occur with local application, especially in children.

    If a concomitant skin infection develops, the necessary antifungal, antiviral or antibacterial agent should be used. If the positive response to treatment is not achieved quickly, the Elocom-C® ointment should be discontinued until the infection is properly eliminated.

    Elocom-C® ointment is not recommended for use with occlusive dressings, including diapers and plastic panties.

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

    The effect of the ELOKOM-C® ointment on the ability to drive and work with machinery has not been noted.

    Form release / dosage:Ointment for external use.
    Packaging:

    For 15 g or 45 g of ointment in aluminum tubes with a neck covered with white high-density polyethylene (HDPE), closed with a membrane and a screw-on plastic lid made of HDPE.One tube together with the instruction for use is placed in a cardboard box.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    In a place inaccessible to children.

    Shelf life:

    2 years. Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N015104 / 01
    Date of registration:10.09.2008 / 29.07.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:MSD FARMASYUTIKALS, LLC MSD FARMASYUTIKALS, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp09.08.2016
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