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

    In 1 g of emulsion contains:

    Active substance: hydrocortisone 17-butyrate -1 mg,

    Excipients: paraffin soft white - 35,00 mg, paraffin hard - 50.0 mg, cetomacrogol 25-20.00 mg, cetostearyl alcohol 20.00 mg, borage oil 17.50 mg, propylene glycol- 50.0 mg, butylhydroxytoluene 0.20 mg, propyl parahydroxybenzoate 3.00 mg, butyl parahydroxybenzoate 1.50 mg, citric acid 6.00 mg, sodium citrate - mg, purified water - 790.80 mg.

    Description:

    White or almost white emulsion.

    Pharmacotherapeutic group:glucocorticosteroid for topical use.
    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 drug 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 Lokoid in the 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 level of cortisol in the blood plasma, it is usually not accompanied by a decrease in the reactivity of the pituitary-adrenal system, and the withdrawal of the drug leads to a rapid normalization of cortisol production.

    Pharmacokinetics:

    Suction

    After application, the active substance accumulates in the epidermis, mainly in the granular layer, 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 auxiliary 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 that special care be taken when prescribing the drug during lactation.

    Dosing and Administration:

    Outwardly.

    The Lockoid Crelo® is preferably used for acute inflammation, especially for wet areas, and this dosage form is also an optimal choice for lesions of skin areas with abundant hair (for example, the scalp).

    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.

    The drug can be applied with light massaging movements, if necessary, on the surface of the foci with wetness after applying Lokoid Krelo®, an occlusive dressing is applied. Remains of Lokoid Crelo® from the skin surface are removed with water. 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 use of occlusion, side effects characteristic of systemic glucocorticosteroids.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.

    With pronounced lichenification, dryness, hyperkeratosis, it is better to prefer Lokoid in the form of an ointment or Lipocream.

    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, while the difference between hydrocortisone 17-butyrate in this indicator from the usual hydrocortisone was not observed.

    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:

    By 30 grams of emulsion in bottles, from low density polyethylene with a dropper of low density polyethylene and screwed, lid of polypropylene. A label is attached to the vial.

    1 bottle with instructions for use in a cardboard box.
    Storage conditions:

    At a temperature of no higher than 25 ° C.

    In a place inaccessible to children.

    Shelf life:

    2 years. Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-000380
    Date of registration:25.02.2011
    The owner of the registration certificate:Astellas Farma Europe BVAstellas Farma Europe BV Netherlands
    Manufacturer: & nbsp
    Representation: & nbspASTELLAS PHARMA YUROP BV ASTELLAS PHARMA YUROP BV Netherlands
    Information update date: & nbsp04.12.2013
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