Elidel - instructions for use, analogs, reviews and release forms (cream or ointment 1% non-hormonal) drugs for the treatment of atopic dermatitis (eczema) in adults, children (including infants) and pregnancy. Composition

In this article, you can read the instructions for using the drug Elidel. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Elidel in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Elidel in the presence of existing structural analogs. Use to treat atopic dermatitis (eczema) in adults, children (including infants), as well as during pregnancy and lactation. Composition of the preparation.

Elidel - preparation for external use. Pimecrolimus (active substance of the preparation Elidel) is a derivative of macromolactam ascomycin. Selectively inhibits the production and release of cytokines and mediators from T-lymphocytes and mast cells. Possesses anti-inflammatory properties.

Pimecrolimus specifically binds to cytosolic receptor macrophilin-12 and inhibits the calcium-dependent phosphatase - calcineurin. Inhibition of calcineurin leads to an inhibition of the proliferation of T-lymphocytes and preventing transcription and the production in T helper type 1 and 2 early cytokines such as interleukin-2, Interferon gamma, interleukin-4, interleukin-5, interleukin-10, of tumor necrosis factor alpha and granulocyte-macrophage colony-stimulating factor. Pimecrolimus and tacrolimus equally inhibit the secondary immune response in an isolated cell colonies of T-helper cells of the skin, derived from patients with atopic dermatitis.

Furthermore, after the interaction with the antigen / IgE pimecrolimus prevents antigen / IgE-mediated release of cytokines and inflammatory mediators from mast cells.Pimecrolimus does not affect the growth of keratinocytes, fibroblasts and endothelial cells and, in contrast to corticosteroids, has a selective effect on the cells of the immune system and does not cause disturbances in function, viability, differentiation processes, maturation of Langerhans cells in mice and dendritic cells of monocytic origin in humans. The drug does not affect the differentiation of "naive" T-lymphocytes in T-effector cells under the action of Langerhans cells and dendritic cells, which is one of the main mechanisms of a specific immune response.

On experimental models of cutaneous inflammation, the high anti-inflammatory activity of pimecrolimus was demonstrated after its local and systemic use. When applied locally in experimental models of allergic contact dermatitis (AKD), pimecrolimus is comparable in effectiveness to highly active corticosteroids: clobetasol-17-propionate and fluticasone, inhibits the inflammatory response in response to skin irritants without causing a change in the consistency and atrophy of the skin.

In addition, with local and oral administration of pimecrolimus on experimental models, AKD effectively reduces skin inflammation, itching, and severity of histopathological changes. With topical application, the degree of penetration into the skin of tacrolimus and pimecrolimus is equally good. However, the ability of pimecrolimus to penetrate the skin is less than that of tacrolimus and glucocorticosteroids (GCS). Thus, pimecrolimus has a selective effect on the skin.

The uniqueness of the mechanism of action of pimecrolimus is the combination of a selective anti-inflammatory effect on the skin with a slight effect on the systemic immune response.

When used for 6 weeks in children aged 3 months to 17 years, pimecrolimus effectively reduces itching and skin inflammation (erythema, infiltration, excoriation and lichenization). With prolonged use for 12 months, pimecrolimus effectively reduces the incidence of sudden exacerbation of AKD without causing atrophy, irritation and increased skin hypersensitivity and without phototoxic or photosensitizing effects.

Composition

Pimecrolimus + auxiliary substances (does not contain hormonal components).

Pharmacokinetics

Since the local application of pimecrolimus in the blood is very low, the determination of metabolic parameters is not possible.

Indications

• atopic dermatitis (eczema).

The drug is indicated for short-term and long-term use in adults, adolescents and children (aged 3 months).

Forms of release

Cream for external use 1% (sometimes mistakenly called ointment).

Instructions for use and how to use them

Treatment should be started at the first manifestations of the disease in order to prevent a sharp development of its exacerbation.

The cream is applied a thin layer on the affected surface 2 times a day and gently rubbed until completely absorbed.

The cream can be applied to the skin of any parts of the body, including the head, face, neck, and also on the area of ​​diaper rash.

The cream should be applied 2 times a day, until the symptoms disappear completely. If symptoms persist after 6 weeks of use, the patient should be re-examined to confirm the diagnosis of atopic dermatitis.After cessation of treatment, in order to avoid subsequent exacerbations, at the first signs of recurrence of atopic dermatitis therapy should be resumed.

Emollients can be used immediately after applying the cream. However, after water treatments, emollients should be used before applying Elidel cream.

Considering the very insignificant systemic absorption of pimecrolimus, the limitations of the total daily dose of the applied preparation, the area of ​​the skin surface to be treated, or the duration of treatment does not exist.

If Elidel gets into the eyes, on the mucous membranes (oral or nasal cavity), immediately remove the cream and rinse the eyes and mucous membranes with running water.

Side effect

• burning in place of application of cream
• local reactions (irritation, itching and redness of the skin)
• skin infections (folliculitis)
• suppuration
• deterioration of the disease
• herpes simplex
• Dermatitis due to herpes simplex virus (herpetic eczema)
• molluscum contagiosum
• local reactions such as rash, pain, paresthesia, peeling, dryness, puffiness
• cutaneous papillomas
• boils
• hives
• angioedema
• anaphylactic reactions
• alcohol intolerance (in most cases, immediately after drinking alcohol, reddening of the face, rash, burning, itching or swelling developed)
• skin color changes (hypopigmentation, hyperpigmentation)
• development of malignant tumors, including cutaneous and other types of lymphomas, skin cancer (a cause-and-effect relationship between these undesirable phenomena and the use of the drug has not been established).

Contraindications

• Children under 3 months of age (because safety and effectiveness of Elidel cream in children under 3 months of age have not been studied);
• application of Elidel cream on skin areas affected by acute viral, bacterial or fungal infection;
• hypersensitivity to pimecrolimus or any components of the drug.

Application in pregnancy and lactation

There are no data on the use of the drug in pregnant women. When pregnancy, the drug should be administered with caution. However, given the minimum degree of absorption of pimecrolimus in topical application, the potential risk in humans is considered negligible.

In experimental studies with topical application of the drug direct or mediated damaging effects of Elidel on the coursepregnancy, development of the embryo / fetus, the course of labor and postnatal development of the offspring was not revealed. Isolation of the drug with breast milk after topical application on experimental models has not been studied.

It is not known whether pimecrolimus is excreted in human breast milk. Since many drugs are excreted in breast milk, caution should be exercised when administering Elidel cream to lactating women. However, given the minimal degree of systemic absorption of pimecrolimus in topical application, the potential risk to humans is considered negligible.

Nursing women should not apply Elidel cream to the area of ​​the mammary glands.

The effect of Elidel cream on fertility in men and women is not established.

Application in elderly patients

Atopic dermatitis (eczema) is rarely observed in patients aged 65 years and older. The number of patients of this age in clinical studies of Elidel cream was insufficient to detect any difference in treatment effectiveness compared to young patients.

Use in children

Contraindicated in children under 3 months (since.safety and efficacy of using Elidel cream in children under 3 months of age have not been studied).

Recommendations for dosing for infants or infants (3-23 months), children (2-11 years) and adolescents (12-17 years) do not differ from the recommendations for adult patients.

special instructions

Data on the safety of prolonged use of Elidel cream are not available.

Since the effect of prolonged use of the drug on the immune defense of the skin and the frequency of development of malignant neoplasms has not been studied, Elidel cream should not be applied to damaged areas of the skin with possible malignancy or dysplastic changes.

In the case of bacterial or fungal skin lesions, the use of Elidel cream on affected areas is possible only after curing the infection.

In the treatment of calcineurin inhibitors for topical use, including Elidel, malignant neoplasms (for example, skin tumors and lymphomas) have been observed rarely. Causal relationship between these adverse events and the use of the drug is not established.

In clinical studies with the use of Elidel cream, 0.9% of patients (14 of 1544) had development of lymphadenopathy.Usually, lymphadenopathy was caused by infectious diseases and disappeared after the course of appropriate antibiotic therapy. All patients either managed to identify the cause of lymphadenopathy or noted the disappearance of this undesirable phenomenon. In patients receiving treatment with Elidel, with the development of lymphadenopathy, it is necessary to establish the etiology of the process and to ensure that patients are monitored until this undesirable phenomenon disappears completely. If the etiology of lymphadenopathy is unidentified or if the patient has acute mononucleosis, the drug should be discontinued.

When treating with Elidel cream, patients are advised to minimize artificial or natural skin insolation to a minimum or completely avoid ultraviolet irradiation. The possible effect of the drug on skin lesions caused by ultraviolet radiation is unknown.

Impact on the ability to drive vehicles and manage mechanisms

The effect of using Elidel cream on the ability to drive vehicles or work with mechanisms is not established.

Drug Interactions

Potential interaction of Elidel cream with other drugs has not been studied.Given that the systemic absorption of pimecrolimus is very low, any interaction of the Elidel cream with drugs for systemic use is unlikely.

When using Elidel cream in children aged 2 years and older, the drug did not affect the effectiveness of vaccination.

It is not recommended to apply cream on the area of ​​administration of the vaccine to the complete disappearance of local manifestations of postvaccinal reaction

Because compatibility studies have not been conducted, it is not recommended to use the drug in conjunction with other topical agents.

Analogues of the drug Elidel

Elidel does not have a structural analogue for the active substance.

Analogues on pharmacological action (agents for the treatment of atopic dermatitis):

• Advantan
• Akortin
• Acriderm
• Apulein
• Asmawal 10
• Berlikort
• Betaderm
• Bronal
• Videestim
• Wobenzym
• Galium Hel
• Hydrocortisone
• Histaglobin
• Histafen
• Dexazone
• Dexamethasone
• Depantol
• Deperzolone
• Derinath
• Dermatop
• Dermozolone
• Dimephosphon
• Diprosalik
• Diprospan
• Zaditen
• Zirtek
• Kenalog
• Ketof
• Claritin
• Clemastine
• Laennec
• Lokoid
• Lorinden
• Lorinden C
• Oxycourt
• Parlazin
• Pyridoxine
• Polyoxidonium
• Prednisolone
• Radevit
• Sinaflan
• The Synoderm
• Skin Cap
• Sopolkort H
• Suprastin
• Suprastinex
• Tavegil
• Tranexam
• Triamcinolone
• Fenistil
• Flucture
• Flucinar
• Fortecortin
• Frenasma
• Friederm
• Fluorocort
• Fucicorte
• Chlorprotixen
• Celestoderm B
• Celestoderm B with Garamycin
• Celeston
• Cetrin
• Cyclosporin
• Zinocap
• Ezacinone
• Exalb
• Elokom
• Enterosan
• Erolin.

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