Elidel cream 1% 15g — Made in France — Free Delivery

Pharmacological properties

Pharmacodynamics. Pimecrolimus is a derivative of macrolactam ascomycin with anti-inflammatory action and a selective inhibitor of the formation and release of cytokine inflammatory mediators. pimecrolimus largely specifically binds to macrophyllin-12 and inhibits calcium-dependent phosphatase calcineurin. as a consequence, it suppresses the activation of t-lymphocytes by blocking the transcription of previously released cytokines.

Pimecrolimus combines high anti-inflammatory activity and negligible effect on systemic immune responses.

Pharmacokinetics. After external application of pimecrolimus to the skin, its blood level is very low, therefore, the metabolism of the preparation cannot be determined. In vitro plasma protein binding studies have shown that 99.6% of pimecrolimus is in a protein bound state. Most of the pimecrolimus in blood plasma is associated with various lipoproteins.

In the skin of people in vitro metabolism of the preparation was not observed.

Indications

Treatment of patients aged 2 years and older with mild to moderate atopic dermatitis, if treatment with topical corticosteroids is undesirable or impossible. this can be when:

• intolerance to local corticosteroids;
• insufficient effect of local corticosteroids;
• the need for use on the face and neck, where prolonged intermittent use of corticosteroids may be inappropriate.

Application

The duration of treatment is determined by the doctor depending on the stage and severity of the disease.

Elidel can be used for a short time to treat the signs and symptoms of atopic eczema and intermittently for a long time to prevent an exacerbation of the disease. Treatment should be started at the first signs and symptoms of atopic dermatitis.

Elidel should only be applied to areas affected by atopic dermatitis. Elidel must be used for the shortest possible time during an exacerbation of the disease. The patient or person caring for him should stop using Elidel when symptoms disappear. Treatment should be intermittent, short-term and short-term.

Elidel should be applied in a thin layer to the affected areas 2 times a day.

Research data confirm the periodic use of Elidel for a period of up to 12 months.

If no improvement is noted after 6 weeks or if the condition worsens, the use of Elidel should be discontinued. In this case, it is necessary to re-evaluate the diagnosis of atopic dermatitis and consider further therapeutic measures.

Adults. A thin layer of Elidel is applied to the affected skin 2 times a day and rubbed into the skin with light movements. Each of the affected areas should be treated with Elidel until the signs and symptoms of the disease disappear, after which the treatment should be discontinued.

Elidel can be used on all areas of the skin, including the head, face, neck and intertriginous area (the area of ​​the groin folds and genitals), except for the mucous membranes. Elidel should not be used in places under tight bandages.

With long-term therapy of atopic dermatitis (eczema), treatment with Elidel should be started at the first signs and symptoms of atopic dermatitis in order to prevent the spread and further exacerbation of the disease. Elidel should be used 2 times a day. Apply emollients immediately after using Elidel. For children, the dose and method of administration do not differ from the recommendations for adult patients.

Elderly patients. In patients over the age of 65, cases of atopic dermatitis (eczema) are rare. Elidel's clinical trials did not include enough patients in this age group to determine if their response to treatment was different from that of younger patients.

Contraindications

Hypersensitivity to pimecrolimus, other macrolactams or other components of the preparation.

Side effects

Infections: molluscum contagiosum.

From the immune system: anaphylactic reactions, including severe forms.

From the side of metabolism and nutrition: intolerance to alcohol (in most cases, flushing, rash, burning, itching or swelling that occurs immediately after drinking alcoholic beverages).

On the part of the skin and subcutaneous tissue: skin infections (folliculitis), furuncle, impetigo, herpes simplex, herpes zoster, herpes dermatitis (herpetic eczema), skin papilloma and worsening of the condition, allergic reactions, including rash, urticaria, angioedema, changes in skin color (hypopigmentation, hyperpigmentation).

General disorders and local reactions: burning at the site of application of the cream, reactions at the site of application (irritation, itching, erythema, rashes, pain, paresthesia, peeling, dryness, edema).

The period of post-marketing use of the preparation. In some cases, patients who used pimecrolimus cream reported malignant neoplasms, including cutaneous and other types of lymphomas, as well as skin cancer, although a causal relationship has not been established.

Cases of lymphadenopathy have been reported in post-marketing and clinical studies, but a causal relationship with treatment with Elidel has not been established.

Special instructions

Elidel is not recommended for use in patients with hereditary or acquired immunodeficiency or in patients receiving treatment with immunosuppressive preparations.

The long-term effect on the local immune response of the skin and on the incidence of malignant skin diseases is unknown. Elidel should not be applied to potentially malignant lesions or skin areas affected by precancerous diseases. Elidel should not be used on skin areas affected by acute viral infections (herpes simplex, chickenpox).

The efficacy and safety of Elidel has not been evaluated in the treatment of clinically infected atopic dermatitis. Before starting treatment with Elidel, the areas affected by the infection must be cured.

Since patients with atopic dermatitis have a tendency to superficial skin infections, including herpetic eczema (Kaposi's herpetiformis), treatment with Elidel may increase the risk of infection with the herpes simplex virus or the occurrence of herpetic eczema, in which case treatment with Elidel should be discontinued until the viral infection disappears.

Patients with acute atopic dermatitis have an increased risk of bacterial skin infections (impetigo) when treated with Elidel.

The use of Elidel can cause minor transient reactions at the site of application, such as a feeling of warmth and / or burning. Patients should inform the doctor about this if reactions at the site of application of the preparation are significantly pronounced.

It is not recommended to use the preparation under an occlusive dressing.

Avoid contact of the preparation with the eyes and mucous membranes. If the preparation accidentally gets on these areas, it should be thoroughly wiped off or washed off with water.

The physician should advise the patient on appropriate sun protection measures, such as limiting sun exposure, using protective equipment, and covering the skin with clothing.

Elidel contains cetyl and stearyl alcohol, which can cause local skin reactions. Elidel also contains propylene glycol, which can irritate the skin.

Elidel contains the active ingredient pimecrolimus, a calcineurin inhibitor. In patients after transplantation and long-term systemic use of immunosuppressants, systemic use of calcineurin inhibitors is associated with an increased risk of lymphomas and malignant skin diseases.

Cases of malignant diseases, including cutaneous and other forms of lymphomas and malignant skin tumors, have also been reported in patients using pimecrolimus cream. However, patients with atopic dermatitis treated with Elidel did not show significant systemic levels of pimecrolimus.

During clinical studies of Elidel 10 mg / g, the development of lymphadenopathy was noted in 0.9% of cases. They were usually associated with infections and disappeared with appropriate antibiotic therapy, but most of them had an understandable etiology or disappeared on their own. Therefore, when lymphadenopathy appears in patients who used Elidel at a dose of 10 mg / g, the etiology of this process should be clarified. In the absence of an obvious etiology of lymphadenopathy or with the appearance of acute infectious mononucleosis, treatment with this preparation should be discontinued. Monitoring of patients with developed lymphadenopathy is necessary to confirm its disappearance.

Patient groups with a potentially high risk of systemic influence. Studies of the use of Elidel have not been carried out in patients with Netherton's syndrome. Due to the possibility of a higher systemic absorption of pimecrolimus, the use of Elidel in patients with Netherton's syndrome is not recommended.

Since the safety of using Elidel for patients with erythroderma has not been evaluated, the preparation is not recommended for this group of patients.

In patients with acute inflammatory processes of the skin or its damage, the systemic concentration may be higher.

During pregnancy and breastfeeding. There is no sufficient data regarding the use of Elidel in pregnant women. Animal studies with external use have not revealed a direct or indirect negative effect on embryonic / intrauterine development of the fetus. Oral animal studies have shown reproductive toxicity.

Due to the minimal level of absorption of pimecrolimus after topical application of Elidel, the possible risk to humans is considered limited. However, Elidel should not be used during pregnancy.

Elidel should be used with caution in women who are breastfeeding.

Women who are breastfeeding can use Elidel, but should not apply it to the breast area in order to avoid inadvertent ingestion of the preparation into the oral cavity of babies.

Children. The use of Elidel in children under 2 years of age is not recommended.

The ability to influence the reaction rate when driving or working with other mechanisms. The influence of Elidel on the ability to drive vehicles and work with mechanisms has not been established.

Interactions

Possible interactions of Elidel with other preparations have not been systematically evaluated. pimecrolimus is metabolized exclusively by cyp 3a4. given the minimal level of absorption, interaction of Elidel with preparations that are used systemically is unlikely.

These data indicate that Elidel can be used concomitantly with antibiotics, antihistamines and glucocorticoids (oral, nasal or inhaled).

Given the minimal level of absorption, systemic interaction of Elidel during vaccination is unlikely. However, no such studies have been carried out. Therefore, patients with common or disseminated forms of the disease are recommended to vaccinate during periods when the preparation is not used.

There are no data on the concomitant use of immunosuppressive preparations that are prescribed for atopic eczema, such as ultraviolet B and A spectrum radiation, PUVA therapy (psoralen and ultraviolet A radiation), azathioprine and cyclosporine. Excessive exposure of the skin to ultraviolet rays (including the use of tanning beds, ultraviolet B and A spectrum therapy and PUVA therapy) should be avoided when treating with Elidel.

There have been rare cases of redness, rashes, burning sensation, itching or swelling immediately after drinking alcohol in patients who used pimecrolimus cream.

Overdose

There are no reports of cases of elidel overdose.

Storage conditions

At a temperature not exceeding 25 ° C, do not freeze. after opening the tube, use the preparation within 12 months.