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

    In 1 g of ointment contains:

    Active substance: hydrocortisone 17-butyrate-1 mg,

    Excipients: polyethylene ointment base (oil vaseline 95%, polyethylene 5%) - q.s. up to 1.0 g.

    Description:

    Translucent, from light gray to almost white color, smooth, oily ointment.

    Pharmacotherapeutic group:Glucocorticosteroid for topical application
    ATX: & nbsp

    S.01.B.A.02   Hydrocortisone

    H.02.A.B.09   Hydrocortisone

    D.07.A.A.02   Hydrocortisone

    Pharmacodynamics:

    Lokoid® is a synthetic, non-halogenated glucocorticosteroid for external use. The esterification of the hydrocortisone molecule with the residue of butyric acid (butyrate) made it possible to radically increase the activity of the preparation as compared to native hydrocortisone. Lokoid® has a rapidly advancing anti-inflammatory, anti-edematous, antipruritic effect.

    The use of Lokovda in recommended doses does not cause suppression of the hypothalamic-pituitary-adrenal system.Although the use of large doses of the drug for a long time, especially with the use of occlusive dressings, can lead to an increase in the cortisol content in the blood plasma, this is usually not is accompanied by a decrease in the reactivity of the pituitary-adrenal system, and the abolition of the drug leads to a rapid normalization of cortisol production.

    Pharmacokinetics:

    Suction

    After the application, the active substance accumulates in the epidermis, mainly in the granular layer, the systemic absorption is negligible. A small amount of hydrocortisone 17-butyrate is absorbed into the systemic blood stream unchanged.

    Metabolism

    Most hydrocortisone 17-butyrate is metabolized to hydrocortisone and other metabolites directly in the epidermis and subsequently in the liver.

    Excretion

    Metabolites and a small part of unchanged hydrocortisone 17-butyrate is excreted by the kidneys and through the intestine.

    Indications:

    Superficial, uninfected, sensitive to local glucocorticosteroids skin diseases:

    - dermatitis, including atopic, contact, seborrhoeic;

    - eczema;

    - psoriasis.

    Contraindications:

    - Hypersensitivity to hydrocortisone or ancillary components of the drug.

    - bacterial skin infections (strepto- and staphyloderma, gram-negative folliculitis, etc.);

    - viral skin infections (herpes simplex, chicken pox, shingles, etc.)

    - fungal skin infections;

    - tuberculosis and syphilitic skin lesions;

    - parasitic skin infections;

    - Neoplastic skin changes (benign and malignant tumors);

    - acne, rosacea, perioral dermatitis;

    - postvaccination period;

    - violation of the integrity of the skin (wounds, ulcers).

    Carefully:Pregnancy, lactation.
    Pregnancy and lactation:Glucocorticosteroids penetrate the placenta. Effects on the fetus can be particularly pronounced when applying the drug on large surfaces. There is no data on the amount of hydrocortisone excreted in breast milk; it is recommended to observe special caution when prescribing the drug during lactation.
    Dosing and Administration:

    Outwardly.

    A lokoid in the form of an ointment is used in subacute and chronic processes, especially in the presence of lichenification, infiltration, dryness.

    The drug is applied to the affected areas of the skin with a thin layer 1-3 times a day. When there is a positive dynamics, the frequency of application of the drug can be reduced to 2-3 times a week. To improve penetration, the drug is applied by massaging movements. In cases of refractory disease, for example, in the localization of dense psoriatic plaques on the elbows, the knees, the drug can be used under occlusive dressings. The dose of the drug used during the week should not exceed 30-60 g.

    Side effects:

    Local Reactions: Skin irritation, in rare cases - other local reactions, characteristic of external steroid therapy.

    Systemic reactions:

    With long-term use, application to large surfaces and / or the use of occlusion, side effects characteristic of systemic glucocorticosteroids can be observed. The risk of local and systemic side effects when using Lokoid is lower than using fluorinated steroids.

    Overdose:

    There are no data on Lokoid overdose. With prolonged use of the drug in high doses, it is possible to enhance the side effects described above.When symptoms of hypercortisy appear, the drug should be discarded.

    Interaction:

    There are no data on drug interactions of Lokoid.

    Special instructions:

    Do not apply Lokoid® to the periorbital area due to the risk of developing glaucoma. With systematic exposure to conjunctiva, there is a risk of increased intraocular pressure.

    Any glucocorticosteroids for external use in the form of an ointment is not advisable to use on the scalp, as well as with acute inflammation (especially exudative). For the treatment of steroid-sensitive skin lesions localized in the face, folds, genitalia, as well as on skin areas with abundant hair, it is preferable to use other medicinal forms of Lokoid (cream, crelo).

    The drug is not desirable to use in the presence of atrophic skin changes.

    The risk of local and systemic side effects increases when applied to extensive areas of damage, prolonged use, the use of occlusion and in childhood.

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

    As with any glucocorticosteroid drug, it is desirable to limit the duration of application and the course dose is minimal enough to stop the skin process.

    Pediatric Use

    Possible use in children from 6 months of age. In cases of use of the drug in children, on the face area or under occlusive dressings, the duration of the course of treatment should be reduced.

    When used in children, the skin surface area on which the drug is applied should not exceed 20% of the total.

    In childhood, suppression of the function of the adrenal cortex can develop faster. In addition, there may be a decrease in the excretion of growth hormone When using the drug for a long time, it is necessary to observe the body weight, growth, plasma cortisol level. In a study in children who received 30-60 g of Lokoid per week for 4 weeks compared to 1% hydrocortisone ointment, no child showed any adrenocortical dysfunction, with differences Hydrocortisone 17-butyrate was not observed in this indicator from conventional hydrocortisone.

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

    Data on the influence of Lokoid on the ability to drive vehicles and work with mechanisms there.

    Form release / dosage:Ointment for external use 0,1%.
    Packaging:For 30 g of ointment is placed in an aluminum tube with an aluminum membrane and a screw cap made of high-density polyethylene. 1 tuba together with instructions for use in a cardboard bundle.
    Storage conditions:

    At a temperature of no higher than 25 ° C.

    In a place inaccessible to children.

    Shelf life:

    5 years. Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N013840 / 01
    Date of registration:06.03.2009 / 01.06.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:Temmler Italia Sr.L.Temmler Italia Sr.L. Italy
    Manufacturer: & nbsp
    Representation: & nbspLEO Pharmaceutical Products Ltd.LEO Pharmaceutical Products Ltd.
    Information update date: & nbsp03.04.2018
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