Certificate of conformity (COC) Elidel cream 1%, 15g

Elidel cream 1%, 15g

$60.00

Active ingredient:	Pimecrolimus
Dosage form:	Cream
Indications for use:	Eczema, Neurodermatitis

Add to wishlist

Categories: Allergy, Medication

Indications

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).

How to take, course of use and dosage

Treatment should be started at the first signs of the disease to prevent a sharp development of its exacerbation.
1% Elidel cream 2 times a day is applied in a thin layer on the affected surface and gently rubbed until completely absorbed.
1% Elidel cream can be applied to the skin of any part of the body, including the head, face, neck, as well as on the area of diaper rash.
Elidel cream should be applied 2 times a day, until the symptoms of the disease completely disappear. 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 discontinuation of treatment, in order to avoid subsequent exacerbations, at the first signs of 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 drug applied, the area of the treated skin surface, or the duration of treatment.
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.

Contraindications

Hypersensitivity to pimecrolimus or any components of the drug.

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

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

With caution

There are no data on the safety of 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 damage (for example, with erythroderma).

Since the efficacy and safety of Elidel cream in immunocompromised patients 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 skin’s immune defense and the frequency 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 damage, the use of Elidel cream on the affected areas is possible only after the infection is cured.

Composition

Homogeneous cream from white to almost white in color.
1 g of cream contains 10 mg of pimecrolimus and auxiliary substances: sodium hydroxide 0.20 mg, citric acid anhydrous 0,50 mg, benzyl alcohol 10.00 mg, sodium cetostearyl 10.00 mg, mono-and diglycerides of 20.00 mg, cetyl alcohol 40,00 mg, stearyl alcohol 40,00 mg, propylene glycol 50,00 mg, railawy alcohol 100,00 mg medium chain triglycerides 150,00 mg, purified water 569,30 mg.

Composition

Homogeneous cream from white to almost white in color. 1 g of cream contains 10 mg of pimecrolimus and auxiliary substances: sodium hydroxide 0.20 mg, citric acid anhydrous 0,50 mg, benzyl alcohol 10.00 mg, sodium cetostearyl 10.00 mg, mono-and diglycerides of 20.00 mg, cetyl alcohol 40,00 mg, stearyl alcohol 40,00 mg, propylene glycol 50,00 mg, railawy alcohol 100,00 mg medium chain triglycerides 150,00 mg, purified water 569,30 mg.

Characteristics

By prescription.

Clinical pharmacology

Anti-inflammatory agent for topical application. Pharmacodynamics : Pimecrolimus is a macrolactam derivative of ascomycin and has an anti-inflammatory effect. 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 the calcium-dependent phosphatase calcineurin. Inhibition of calcineurin leads to suppression of T-lymphocyte proliferation and prevents transcription and production of early cytokines in type 1 and 2 T-helpers, such as interleukin-2, interferon-γ, interleukin-4, interleukin-5, interleukin – 10, tumor necrosis factor-α and granulocyte-macrophage colony stimulating factor. Pimecrolimus and tacrolimus equally inhibit the secondary immune response in isolated skin T helper cell colonies obtained from patients with atopic dermatitis. In vitro, pimecrolimus also prevents the 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 cells of the immune system and does not cause impaired 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 into T-effector cells under the action of Langerhans cells and dendritic cells, which is one of the main mechanisms of a specific immune response. Experimental models of skin inflammation demonstrated high anti-inflammatory activity of pimecrolimus after its topical and systemic use. When applied topically in experimental models of allergic contact dermatitis (AKD), pimecrolimus is comparable in effectiveness to highly active corticosteroids: clobetazol – 17 – propionate and fluticasone. It inhibits the inflammatory response in response to skin irritants, without causing changes in the consistency, compaction and atrophy of the skin. In addition, pimecrolimus effectively reduces skin inflammation, pruritus, and the severity of histopathological changes when applied topically and orally in experimental models of acute AKD. When applied topically, the degree of skin penetration of tacrolimus and pimecrolimus 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 unique mechanism of action of pimecrolimus consists 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, pimecrolimus effectively reduces itching and skin inflammation (erythema, infiltration, excoriation and lichenization). With prolonged use for 12 months, pimecrolimus effectively reduces the frequency of sudden exacerbations of ACD, without causing atrophy, irritation and hypersensitivity of the skin and without having a phototoxic or photosensitizing effect. Pharmacokinetics: Adults

The concentration of pimecrolimus in the blood was determined in 12 adult patients with atopic dermatitis (eczema) with a lesion 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 the body surface area after 1 year of treatment with Elidel, pimecrolimus concentrations in the blood remained at a low level and in most cases were below the minimum detectable concentration. The maximum concentration value 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. During the 3-week period of treatment with Elidel 2 times a day in 13 adult patients with dermatitis of the hands (when applying the cream on the palms and back of the hands and bandaging at night), the maximum recorded value of pimecrolimus concentration in the blood was 0.91 ng / ml. In 8 patients with pimecrolimus blood concentrations above the minimum detectable concentration, the AUC value ranged from 2.5-11.4 ng / ml.

Children

Pharmacokinetic studies of pimecrolimus were conducted 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. Pimecrolimus concentrations in the blood were at a consistently low level, regardless of the area of skin damage and the duration of therapy, and were in the same range of values as in adult patients treated with Elidel in the same doses. In 97% of cases, pimecrolimus concentrations in the blood were below 2 ng / ml, and in 60% – below 0.5 ng/ml (the minimum detectable concentration). The maximum 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 pimecrolimus concentration 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 treatment period, no increase in drug concentrations was observed in any of the patients. In 8 children aged 2 to 14 years with pimecrolimus content in the blood above the minimum detectable concentration, the AUC value ranged from 5.4-18.8 ng/ml when measured three times. AUC values in patients with a skin lesion area of less than 40% and more than 40% were comparable. In vitro studies, the binding of pimecrolimus to plasma proteins (mainly various lipoproteins) was 99.6%. Since the concentrations of pimecrolimus in the blood are very low when applied topically, it is not possible to determine the parameters of metabolism.

Use in elderly patients

Atopic dermatitis (eczema) is rarely seen in patients aged 65 years and older. The number of patients of this age in clinical trials of Elidel cream was insufficient to identify any differences in the effectiveness of treatment compared to younger patients.

Use in children

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

Indications

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).

Use during pregnancy and lactation

Pregnancy. There are no data on the use of 1% Elidel cream in pregnant women. In experimental studies, 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 offspring was not detected with topical application of the drug. Caution should be exercised when prescribing 1% Elidel cream to pregnant women. However, given the minimal degree of absorption of pimecrolimus when applied topically, the potential risk in humans is considered negligible.

Lactation. Isolation of the drug in breast milk after topical application in experimental models has not been studied. There are no data on the content of pimecrolimus in breast milk in nursing women. Since many medications are excreted in breast milk, caution should be exercised when prescribing 1% Elidel 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.

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

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

Contraindications

Hypersensitivity to pimecrolimus or any components of the drug.

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

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

With caution

Since the efficacy and safety of Elidel cream in immunocompromised patients 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.

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

Side effects

The use of 1% Elidel cream may cause minor transient reactions at the application site, such as a feeling of warmth and/or burning sensation. If these reactions are significant, patients should consult a doctor. The most frequent 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 at an early stage of treatment, were minor/moderate and short-lived. The following adverse events are listed by frequency, starting with the most frequent ones. The frequency of occurrence of adverse reactions was estimated as follows: occurring “very often” – ≥1/10, “often” – ≥1/100<1/10, “ sometimes” – ≥1/1000<1/100, “rarely” – ≥1/10 000<1/1000, “very rarely” –

Very common: burning sensation at the site of application of the cream. Common: 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, skin papillomas, boils.

The following adverse reactions were observed with post-marketing use of the drug (an estimate of the frequency based on the number of cases of AE in an unknown population).

Immune system disorders: very rare-anaphylactic reactions.

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

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

In most cases, redness of the face, rash, burning sensation, itching or swelling developed immediately after taking alcohol.

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

Interaction

Potential interactions of 1% Elidel cream with other drugs have not been studied. Given that the systemic absorption of pimecrolimus is very low, any interactions of Elidel cream with drugs for systemic use are 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 the cream on the areas of use of the vaccine until the local manifestations of the post-vaccination reaction completely disappear. Incompatibility. Since compatibility studies have not been conducted, it is not recommended to use the drug together with other local remedies.

How to take, course of use and dosage

Treatment should be started at the first signs of the disease to prevent a sharp development of its exacerbation. 1% Elidel cream 2 times a day is applied in a thin layer on the affected surface and gently rubbed until completely absorbed. 1% Elidel cream can be applied to the skin of any part of the body, including the head, face, neck, as well as on the area of diaper rash. Elidel cream should be applied 2 times a day, until the symptoms of the disease completely disappear. 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 discontinuation of treatment, in order to avoid subsequent exacerbations, at the first signs of 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 drug applied, the area of the treated skin surface, or the duration of treatment. 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.

Overdose

No cases of overdose or accidental ingestion of 1% Elidel cream have been observed.

Special instructions

When treated with topical calcineurin inhibitors, including Elidel, in rare cases, the development of malignant neoplasms (for example, skin tumors and lymphomas) has been noted. A causal relationship between these adverse events and the use of the drug has not been established. In clinical studies, when using Elidel cream,0.9% of patients (14 out of 1544) developed lymphadenopathy. Usually, lymphadenopathy was caused by infectious diseases and disappeared after a 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 ensure monitoring of patients until the complete disappearance of this undesirable phenomenon. If the etiology of lymphadenopathy is unknown or the patient has acute mononucleosis inflammation, the drug should be discontinued. When treating patients with Elidel cream, it is recommended to reduce artificial or natural sun exposure to the skin to a minimum or completely avoid ultraviolet radiation. The possible effect of using the drug in skin lesions caused by ultraviolet radiation is unknown. Influence on the ability to drive vehicles or work with mechanisms:The effect of Elidel cream on the ability to drive vehicles or work with mechanisms has not been established.

Form of production

Cream for external use 1% 15 g in an aluminum tube. 1 tube with instructions for use in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 ° C, do not freeze. The drug should be kept out of the reach of children.

Shelf

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

Active ingredient

Pimecrolimus

Conditions of release from pharmacies

By prescription

Dosage form

cream

Purpose

Pregnant women as prescribed by a doctor, Children as prescribed by a doctor, Adults as prescribed by a doctor, Children older than 3 months, Nursing mothers as prescribed by a doctor