Elidel cream 1%, 15 g

Atopic dermatitis (eczema).

The drug is indicated for short-term and long-term treatment of atopic dermatitis in adults, adolescents and children (from 3 months).

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

1% cream Elidel 2 times a day is applied in a thin layer to the affected surface and gently rubbed until completely absorbed.

Elidel 1% cream can be applied to the skin of any part of the body, including the head, face, neck, and also on the diaper rash area.

Elidel cream should be applied 2 times a day, until the symptoms of the disease disappear completely. If the severity of symptoms persists after 6 weeks of using the drug, it is necessary to re-examine the patient to confirm the diagnosis of atopic dermatitis. After stopping treatment, in order to avoid subsequent exacerbations, at the first signs of a relapse of atopic dermatitis, therapy should be resumed.

Emollients can be applied immediately after applying 1% Elidel cream. However, after water treatments, emollients should be applied before applying Elidel cream.

Given the very low systemic absorption of pimecrolimus, there are no restrictions on the total daily dose of the applied drug, the area of ??the treated skin surface or the duration of treatment.

In case of contact with Elidel in the eyes, on the mucous membranes (oral or nasal cavity), the cream should be immediately removed and the eyes and mucous membranes should be rinsed with running water.

1 g of cream contains

10 mg of pimecrolimus, as well as excipients: sodium hydroxide 0.20 mg, anhydrous citric acid 0.50 mg, benzyl alcohol 10.00 mg, sodium cetostearyl sulfate 10.00 mg, mono and diglycerides 20.00 mg, cetyl alcohol 40, 00 mg, stearyl alcohol 40.00 mg, propylene glycol 50.00 mg, oleyl alcohol 100.00 mg, medium-chain triglycerides 150.00 mg, purified water 569.30 mg.

Contraindications:

Hypersensitivity to pimecrolimus or any of the components of the drug.

Children up to 3 months of age (since the safety and efficacy of using Elidel cream in children under 3 months has not been studied).

Elidel cream should not be applied to areas of the skin affected by an acute viral, bacterial or fungal infection.

Carefully

There are no data on the safety of using Elidel cream in patients with Netherton's syndrome and generalized erythroderma. Given the possible risk of increased systemic absorption of the drug, Elidel cream is not recommended for use in patients with Netherton's syndrome or in severe forms of inflammation or skin lesions (for example, with erythroderma).

Since the efficacy and safety of using Elidel cream in patients with weakened immunity have not been studied, the drug is not recommended for use in this category of patients.

There are no data on the safety of long-term use of Elidel cream.

Since the effect of long-term use of the drug on the immune protection of the skin and the incidence 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 the affected areas is possible only after the infection has been cured.

Application during pregnancy and lactation

Latin name: Elidel

Russian name: Elidel

Active substance: pimecrolimus

Description

homogeneous cream from white to almost white.

Detailed description:

Pharmacotherapeutic group: topical anti-inflammatory agent

ATX code: D11AX15

Pharmacological properties

Pharmacodynamics

Pimecrolimus is a derivative of the macrolactam ascomycin and has anti-inflammatory effects. Pimecrolimus selectively inhibits the production and release of cytokines and inflammatory mediators from T-lymphocytes and mast cells. Pimecrolimus specifically binds to the cytosolic receptor macrophilin-12 and inhibits calcium-dependent phosphatase - calcineurin. Inhibition of calcineurin leads to suppression of the proliferation of T-lymphocytes and prevents the transcription and production of early cytokines in T-helpers 1 and 2, such as interleukin-2, interferon-?, interleukin-4, interleukin-5, interleukin-10, tumor necrosis factor -? and granulocyte-macrophage colony-stimulating factor. Pimecrolimus and tacrolimus equally suppress the secondary immune response in isolated cell colonies of T-helper cells of the skin,obtained in patients with atopic dermatitis. In vitro, pimecrolimus also 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, unlike corticosteroids, has a selective effect on the cells of the immune system and does not cause dysfunction, viability, differentiation processes, maturation of Langerhans cells in mice and dendritic cells of monocytic origin in humans. The drug has no effect on the differentiation of 'naive' T-lymphocytes into T-effector cells under the influence of Langerhans cells and dendritic cells, which is one of the main mechanisms of a specific immune response.In vitro, pimecrolimus also 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, unlike corticosteroids, has a selective effect on the cells of the immune system and does not cause dysfunction, viability, differentiation processes, maturation of Langerhans cells in mice and dendritic cells of monocytic origin in humans. The drug has no effect on the differentiation of 'naive' T-lymphocytes into T-effector cells under the influence of Langerhans cells and dendritic cells, which is one of the main mechanisms of a specific immune response.In vitro, pimecrolimus also 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, unlike corticosteroids, has a selective effect on the cells of the immune system and does not cause dysfunction, viability, differentiation processes, maturation of Langerhans cells in mice and dendritic cells of monocytic origin in humans. The drug has no effect on the differentiation of 'naive' T-lymphocytes into T-effector cells under the influence of Langerhans cells and dendritic cells, which is one of the main mechanisms of a specific immune response.has a selective effect on the cells of the immune system and does not cause dysfunctions, viability, differentiation processes, maturation of Langerhans cells in mice and dendritic cells of monocytic origin in humans. The drug has no effect on the differentiation of 'naive' T-lymphocytes into T-effector cells under the influence of Langerhans cells and dendritic cells, which is one of the main mechanisms of a specific immune response.has a selective effect on the cells of the immune system and does not cause dysfunctions, viability, differentiation processes, maturation of Langerhans cells in mice and dendritic cells of monocytic origin in humans. The drug has no effect on the differentiation of 'naive' T-lymphocytes into T-effector cells under the influence of Langerhans cells and dendritic cells, which is one of the main mechanisms of a specific immune response.which is one of the main mechanisms of a specific immune response.which is one of the main mechanisms of a specific immune response.

In experimental models of skin inflammation, a high anti-inflammatory activity of pimecrolimus has been demonstrated after its local and systemic use. When applied topically in experimental models of allergic contact dermatitis (ACD), 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 changes in texture, thickening and skin atrophy.

In addition, pimecrolimus effectively reduces skin inflammation, itching, and the severity of histopathological changes when applied topically and orally in experimental models of acute ACD. When applied topically, the penetration of tacrolimus and pimecrolimus into the skin is equally good. However, the ability of pimecrolimus to penetrate the skin is less than that of tacrolimus and glucocorticosteroids. Thus, pimecrolimus has a selective effect on the skin.

The uniqueness of the mechanism of action of pimecrolimus lies in 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 from 3 months to 17 years old, pimecrolimus effectively reduces itching and skin inflammation (erythema, infiltration, excoriation and lichenification). With long-term use for 12 months, pimecrolimus effectively reduces the incidence of sudden exacerbations of AKD, without causing atrophy, irritation and increased skin hypersensitivity and without phototoxic or photosensitizing effects.

Pharmacokinetics

Adults

The concentration of pimecrolimus in the blood was determined in 12 adult patients with atopic dermatitis (eczema) with lesions of 15-59% of the body surface area, treated with 1% Elidel cream 2 times a day for 3 weeks. In 77.5% of cases, the concentration of pimecrolimus in the blood was below 0.5 ng / ml (the minimum detectable concentration), and in 99.8% - below 1 ng / ml. The maximum blood concentration of pimecrolimus recorded in one patient was 1.4 ng / ml.

In 98% of 40 adult patients with an initial lesion of 14-62% of body surface area after 1 year of treatment with Elidel, the concentration of pimecrolimus in the blood remained at a low level and in most cases was below the minimum detectable concentration. The maximum concentration of 0.8 ng / ml was recorded after 6 weeks of treatment in only two patients. None of the patients showed an increase in concentration during 12 months of treatment. For a 3-week period of treatment with Elidel 2 times a day in 13 adult patients with dermatitis of the hands (when applying the cream to the palms and the back of the hands and bandaging at night), the maximum recorded value of the concentration of pimecrolimus in the blood was 0.91 ng / ml.

In 8 patients with blood levels of pimecrolimus above the minimum detectable concentration, the AUC value ranged from 2.5-11.4 ng / ml.

Children

Pharmacokinetic studies of pimecrolimus were carried out in 58 children aged 3 to 14 years with atopic dermatitis (eczema) affecting 10-92% of the body surface area, treated with 1% Elidel cream 2 times a day for 3 weeks. Five children received treatment for 1 year as needed.

The concentration of pimecrolimus in the blood was at a consistently low level, regardless of the area of ??skin lesions and the duration of therapy, and were in the same range of values ??as in adult patients receiving therapy with Elidel at the same doses. In 97% of cases, the concentration of pimecrolimus in the blood was below 2 ng / ml, and in 60% - below 0.5 ng / ml (the minimum detectable concentration). The maximum value of the concentration of pimecrolimus, recorded in two patients aged 8 months and 14 years, was 2.0 ng / ml.

Among the youngest children (from 3 to 23 months), the maximum concentration of pimecrolimus recorded in one patient was 2.6 ng / ml.

In five children treated with Elidel for 1 year, pimecrolimus concentrations were consistently low. The maximum value recorded in one child was 1.94 ng / ml. During the entire period of treatment, an increase in drug concentrations was not observed in any of the patients.

In 8 children aged 2 to 14 years with a blood level of pimecrolimus above the minimum detectable concentration when measured three times, the AUC value ranged from 5.4-18.8 ng / ml. AUC values ??in patients with skin lesions less than 40% and more than 40% were comparable.

In in vitro studies, the binding of pimecrolimus to plasma proteins (mainly various lipoproteins) was 99.6%.

Since the concentration of pimecrolimus in the blood is very low when applied topically, the determination of metabolic parameters is not possible.

Elderly patients

Atopic dermatitis (eczema) is rarely seen in patients aged 65 and over. The number of patients of this age in clinical studies of Elidel cream was insufficient to reveal any differences in the effectiveness of treatment compared with young patients.

Application in children

Dosing recommendations for infants (3-23 months), children (2-11 years old) and adolescents (12-17 years old) do not differ from those for adult patients.

Indications for use:

Atopic dermatitis (eczema).

The drug is indicated for short-term and long-term treatment of atopic dermatitis in adults, adolescents and children (from 3 months).

Mode of application:

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

1% cream Elidel 2 times a day is applied in a thin layer to the affected surface and gently rubbed until completely absorbed.

Elidel 1% cream can be applied to the skin of any part of the body, including the head, face, neck, and also on the diaper rash area.

Elidel cream should be applied 2 times a day, until the symptoms of the disease disappear completely. If the severity of symptoms persists after 6 weeks of using the drug, it is necessary to re-examine the patient to confirm the diagnosis of atopic dermatitis. After stopping treatment, in order to avoid subsequent exacerbations, at the first signs of a relapse of atopic dermatitis, therapy should be resumed.

Emollients can be applied immediately after applying 1% Elidel cream. However, after water treatments, emollients should be applied before applying Elidel cream.

Given the very low systemic absorption of pimecrolimus, there are no restrictions on the total daily dose of the applied drug, the area of ??the treated skin surface or the duration of treatment.

In case of contact with Elidel in the eyes, on the mucous membranes (oral or nasal cavity), the cream should be immediately removed and the eyes and mucous membranes should be rinsed with running water.

Ingredients: 1 g of cream contains

10 mg of pimecrolimus, as well as excipients: sodium hydroxide 0.20 mg, anhydrous citric acid 0.50 mg, benzyl alcohol 10.00 mg, sodium cetostearyl sulfate 10.00 mg, mono and diglycerides 20.00 mg, cetyl alcohol 40, 00 mg, stearyl alcohol 40.00 mg, propylene glycol 50.00 mg, oleyl alcohol 100.00 mg, medium-chain triglycerides 150.00 mg, purified water 569.30 mg.

Contraindications:

Hypersensitivity to pimecrolimus or any of the components of the drug.

Children up to 3 months of age (since the safety and efficacy of using Elidel cream in children under 3 months has not been studied).

Elidel cream should not be applied to areas of the skin affected by an acute viral, bacterial or fungal infection.

Carefully

There are no data on the safety of using Elidel cream in patients with Netherton's syndrome and generalized erythroderma. Given the possible risk of increased systemic absorption of the drug, Elidel cream is not recommended for use in patients with Netherton's syndrome or in severe forms of inflammation or skin lesions (for example, with erythroderma).

Since the efficacy and safety of using Elidel cream in patients with weakened immunity have not been studied, the drug is not recommended for use in this category of patients.

There are no data on the safety of long-term use of Elidel cream.

Since the effect of long-term use of the drug on the immune protection of the skin and the incidence 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 the affected areas is possible only after the infection has been cured.

Application during pregnancy and lactation

Pregnancy .

There are no data on the use of 1% Elidel cream in pregnant women. In experimental studies with the local application of the drug, the direct or indirect damaging effect of Elidel on the course of pregnancy, the development of the embryo / fetus, the course of labor and the postnatal development of the offspring was not revealed. Care should be taken when prescribing Elidel 1% cream to pregnant women. However, given the minimal absorption of pimecrolimus when applied topically, the potential risk in humans is considered negligible.

Lactation. The excretion of the drug in breast milk after topical application has not been studied in experimental models. There are no data on the content of pimecrolimus in breast milk in lactating women. Since many drugs are excreted in breast milk, caution should be exercised when prescribing Elidel 1% cream to nursing women. However, given the minimal degree of systemic absorption of pimecrolimus when applied topically, the potential risk to humans is considered negligible.

Breastfeeding women should not apply Elidel 1% cream to the breast area.

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

Side effects

The use of 1% Elidel cream may cause minor transient reactions at the site of application, such as a feeling of warmth and / or burning. If these reactions are significant, patients should consult a doctor.

The most common adverse events - reactions at the site of application of the drug were observed in 19% of patients treated with 1% Elidel cream, and in 16% of patients from the control group. These reactions mainly occurred early in the treatment, were minor / moderate and of short duration.

The adverse events below are listed by frequency, starting with the most common. The frequency of occurrence of undesirable reactions was assessed as follows: emerging Уvery oftenФ -? 1/10, УoftenФ -? 1/100 <1/10, УsometimesФ -? 1/1000 <1/100, УrarelyФ -? 1/10 000 <1/1000, Уvery rareФ - <1/10 000, including individual messages.

Very often: burning sensation at the site of application of the cream. Often: local reactions (irritation, itching and redness of the skin), skin infections (folliculitis). Sometimes: suppuration; worsening of the disease; herpes simplex; dermatitis caused by the herpes simplex virus (herpetic eczema); molluscum contagiosum, local reactions such as rash, pain, paresthesia, peeling, dryness, swelling, cutaneous papillomas, boils.

The following adverse reactions were observed during post-marketing use of the drug (frequency assessment by the number of cases of AE in an unknown population).

From the immune system: very rarely - anaphylactic reactions.

From the side of metabolism (metabolic disorders): rarely - alcohol intolerance.

From the side of the skin and its appendages: rarely - allergic reactions (rash, urticaria, angioedema); changes in skin color (hypopigmentation, hyperpigmentation).

In most cases, facial flushing, rash, burning, itching, or swelling developed immediately after drinking alcohol.

With the use of Elidel cream, in rare cases, the development of malignant neoplasms, including cutaneous and other types of lymphomas, and skin cancer, was noted. A causal relationship between these adverse events and the use of the drug has not been established.

Overdose

Cases of overdose or accidental use of 1% Elidel cream inside were not observed.

Interactions with other medicinal products and other types of interactions .

ѕотенциальные взаимодействи¤ 1% крема Ёлидел с другими препаратами не изучались. ”читыва¤, что системна¤ абсорбци¤ пимекролимуса очень незначительна, какие-либо взаимодействи¤ крема Ёлидел с препаратами дл¤ системного применени¤ маловеро¤тны.

ѕри применении крема Ёлидел у детей в возрасте 2-х лет и старше препарат не оказывал вли¤ни¤ на эффективность вакцинации.

Ќе рекомендуетс¤ нанесение крема на области введени¤ вакцины до полного исчезновени¤ местных про¤влений поствакцинальной реакции.

Ќесовместимость

ѕоскольку исследовани¤ совместимости не проводились, не рекомендуетс¤ примен¤ть препарат совместно с другими местными средствами.

ќсобые указани¤

ѕри лечении ингибиторами кальциневрина местного применени¤, включа¤ Ёлидел, в редких случа¤х отмечалось развитие злокачественных новообразований (например, кожных опухолей и лимфом). ѕричинно-следственна¤ св¤зь между данными нежелательными ¤влени¤ми и применением препарата не установлена.

¬ клинических исследовани¤х при применении крема Ёлидел у 0,9% пациентов (14 из 1544) отмечалось развитие лимфоаденопатии. ќбычно лимфоаденопати¤ была обусловлена инфекционными заболевани¤ми и исчезала после проведени¤ курса соответствующей антибиотикотерапии. ” всех пациентов или удавалось вы¤вить причину развити¤ лимфоаденопатии или отмечалось исчезновение данного нежелательного ¤влени¤. ” больных, получающих лечение Ёлиделом, при развитии лимфоаденопатии необходимо установить этиологию процесса и обеспечить наблюдение за пациентами до полного исчезновени¤ данного нежелательного ¤влени¤. ѕри неустановленной этиологии лимфоаденопатии или наличии у пациента острого мононуклеозного воспалени¤ препарат следует отменить.

ѕри лечении кремом Ёлидел пациентам рекомендуетс¤ уменьшить до минимума искусственную или естественную инсол¤цию кожи или полностью избегать ультрафиолетового облучени¤. ¬озможное вли¤ние применени¤ препарата при поражени¤х кожи, вызванных ультрафиолетовым облучением, неизвестно.

¬ли¤ние на способность управл¤ть автотранспортом или работать с механизмами

¬ли¤ние применени¤ крема Ёлидел на способность управл¤ть автотранспортом или работать с механизмами не установлено.

‘орма выпуска:  рем дл¤ наружного применени¤ 1% 15 г, 30 г и 100 г в алюминиевой тубе. 1 туба с инструкцией по применению в картонной пачке.

”слови¤ хранени¤: ’ранить при температуре не выше 25?—, не замораживать. ѕрепарат следует хранить в недоступном дл¤ детей месте.

Shelf life is 2 years. The drug should not be used after the expiration date. After the first opening, use within 1 year.

Terms of dispensing By prescription.

Producer: MEDA Pharma GmbH & Co.KG, Germany

Produced by:

MEDA Manufacturing,

33700 J.F. Kennedy Avenue Merignac, France

Organization authorized to accept claims from consumers in the Russian Federation:

LLC 'Maylan Pharma'

109028, Moscow, Serebryanicheskaya nab., 29, floor 9;

Tel. +7 (495) 660-5303

Fax +7 (495) 660-5306