ELIDEL CREAM 1% 15G

Dosage form

Cream for external use

1 g contains pimecrolimus 10 mg

Packaging

Tuba 15

Mechanism of action

Derived macrolactam ascomycin. Selectively blocks the formation and release of cytokines and mediators from T-lymphocytes and mast cells. The peculiarity of pimecrolimus is the combination of anti-inflammatory activity (skin-selective) with a low ability to induce systemic immune responses. It binds specifically to macrophilin-12 and inhibits calcineurin-derived Ca2 + phosphatase. As a result, blocking the transcription of early cytokines, inhibits the activation of T-lymphocytes. At nanomolar concentrations, inhibits the synthesis of interleukin2, Interferon gamma (Th1 type), interleukin4 and interleukin10 (Th2 type) in human T-lymphocytes. In addition, in vitro, after interaction with the antigen / IgE complex, pimecrolimus prevents antigen / IgE-mediated release of cytokines and inflammatory mediators from mast cells. Does not affect the growth of keratinocytes, fibroblasts and endothelial cells. It shows high anti-inflammatory activity after topical use. It is effective in the same way as high-level GCS for external use, but unlike them it does not cause skin atrophy. Suppresses the inflammatory response in response to exposure to skin irritants in contact dermatitis. Reduces skin inflammation and itching and normalizes histopathological changes in case of widespread neurodermatitis (atopic dermatitis) of an acute course. The degree of penetration of pimecrolimus through the skin is 10 times less than tacrolimus.

Indications and usage

Common atopic dermatitis (atopic dermatitis).

Contraindications

• hypersensitivity to thimecrolimus or any component of the drug;
• children up to 3 months (the safety and efficacy of using Elidel cream in children under 3 months have not been studied);
• the presence of acute viral, bacterial or fungal infections of the skin.

Carefully:

• patients with Netherton syndrome (data on the safety of use is not) - the risk of increased systemic absorption of the drug is possible;
• severe forms of inflammation or skin lesions, incl. generalized erythroderma (no safety data is available) - the risk of increased systemic absorption of the drug is possible;
• weakened immunity - because efficacy and safety have not been studied.
• Safety data for long-term use of Elidel cream are not available.
• Since the effect of long-term use of the drug on the immune protection of the skin and the incidence of malignant tumors has not been studied, Elidel Cream should not be applied to the 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.

Data on the use of the drug in pregnant women do not. In experimental studies with the local application of the drug directly or indirectly, the damaging effect of Elidel cream on the course of pregnancy, the development of the embryo / fetus, the course of childbirth and the postnatal development of the offspring has not been identified. Care should be taken when appointing pregnant women. However, given the minimum degree of absorption of pimecrolimus when applied topically, the potential risk in humans is considered negligible.

The excretion of the drug with breast milk after topical application in experimental models has not been studied. Data on the content of pimecrolimus in breast milk of lactating women is not.

Since many drugs are excreted in breast milk, caution should be exercised when prescribing 1% Elidel cream to lactating women. However, given the minimum degree of systemic absorption of pimecrolimus when applied topically, the potential risk to humans is considered negligible.

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

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

Dosage and administration

Outwardly. The cream is applied with a thin layer on the affected surface and gently rubbed until completely absorbed 2 times a day until the symptoms disappear. Given the very insignificant systemic absorption of pimecrolimus, there are no limitations to the total daily dose of the applied preparation, the area of ​​the treated skin surface or the duration of treatment.

Adverse reactions

The use of Elidel Cream may cause minor transient reactions at the site of application, such as a feeling of warmth and / or burning. At considerable severity of these reactions, patients should consult a doctor.

The most frequent reactions at the site of use of the drug were observed in 19% of patients receiving treatment with Elidel cream, and in 16% of patients in the control group. These reactions mainly occurred at an early stage of treatment, were minor / moderate and short.

Determination of the frequency of adverse reactions: very often (≥1 / 10); often (≥1 / 100, <1/10); sometimes (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000), including individual messages.

Very often - a 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 (herpes eczema), molluscum contagiosum; local reactions such as rash, pain, paresthesia, peeling, dryness, swelling, skin papillomas, boils.

The adverse reactions listed below were observed with post-marketing use of the drug (estimated frequency by the number of cases of adverse events in an unidentified population).

Immune system: very rarely - Anaphylactic reactions.

Metabolism (metabolic disorders): rarely intolerance to alcohol.

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

In most cases, immediately after ingestion of alcohol, a reddening of the face, rash, burning, itching or swelling developed.

The use of Elidel Cream has rarely shown the development of malignant neoplasms, including skin and other types of lymphomas, and skin cancer. The causal relationship between these adverse events and the use of the drug has not been established.

Cautions

Treatment should begin at the first manifestations of the disease to prevent the sharp development of its exacerbation. It can be applied to the skin of any parts of the body, including the head, face, neck, as well as on the area of ​​diaper rash. After cessation of treatment, in order to avoid subsequent exacerbations, therapy should be resumed at the first signs of recurrence of common neurodermatitis. Softening drugs can be applied immediately after applying the cream, but after water treatments they should be applied before applying the cream. It is not recommended to apply the cream on the vaccine injection area until local manifestations of the post-vaccination reaction disappear completely.

Drug Interactions

Given that systemic absorption of pimecrolimus is very small, any interactions of the cream with drugs for systemic use are unlikely. It is not recommended to use the drug in conjunction with others.DOS for external use.

Storage conditions

At a temperature not higher than 25 ° C (do not freeze).