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Pimecrolimus is a derivative of macrolactam ascomycin. Selectively inhibits the production and release of cytokines and mediators from T-lymphocytes and mast cells. It has anti-inflammatory properties.
Pimecrolimus binds specifically to macrophilin-12 and inhibits calcium-dependent phosphatase calcineurin. As a result, blocking the transcription of early cytokines, pimecrolimus inhibits the activation of T-lymphocytes. In particular, at nanomolar concentrations, pimecrolimus inhibits the synthesis of interleukin-2, interferon gamma (Th1 type), interleukin-4 and interleukin-10 (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. Pimecrolimus does not affect the growth of keratinocytes, fibroblasts and endothelial cells.
Pimecrolimus is effective in skin inflammation, but at the same time its effect on the systemic immune response is very small. In general, the uniqueness of the mechanism of action of pimecrolimus consists in the combination of anti-inflammatory activity, selective to the skin, with a low ability to induce systemic immune responses.
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).
1 g of cream contains pimecrolimus - 10 mg;
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, stearic 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.
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Dosage and Administration
Treatment should begin at the first manifestations of the disease to prevent the sharp development of its exacerbation.
1% cream Elidel 2 times a day, apply a thin layer on the affected surface and gently rub until completely absorbed.
Elidel 1% cream can be applied to the skin of any parts of the body, including the head, face, neck, as well as diaper areas.
Cream Elidel should be applied 2 times a day, until the complete disappearance of symptoms of the disease. If the severity of symptoms persists after 6 weeks of use of the drug, it is necessary to re-examine the patient to confirm the diagnosis of atopic dermatitis. After cessation of treatment, in order to avoid subsequent exacerbations, therapy should be resumed at the first sign of atopic dermatitis recurrence.
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 slight 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.
Applying 1% Elidel Cream can 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 common adverse events were reactions at the site of application of the drug 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.
The following adverse events are listed in frequency, starting with the most frequent. The frequency of occurrence of adverse reactions was assessed as follows: arising "very often" -> 1/10, "often" -> 1/100 <1/10, "sometimes" -> 1/1000 <1/100, "rarely" -> 1/10 000 <1/1000, "very rarely" - <1/10 000, 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 disease; herpes simplex; dermatitis due to herpes simplex virus (herpes eczema); molluscum contagiosum, local reactions such as rashes, pain, paresthesias, desquamation, dryness, swelling, skin papillomas, boils.
The undesirable reactions presented below were noted in the post-marketing use of the drug (assessment of the frequency by the number of cases of AE in an unspecified population).
On the part of the immune system: very rarely - anaphylactic reactions.
On the part of the metabolism (metabolic disorders): rarely - intolerance to alcohol.
From the skin and its appendages: rarely allergic reactions (rash, urticaria, angioedema); skin color changes (hypopigmentation, hyperpigmentation).
In most cases, immediately after ingestion of alcohol, a reddening of the face, rash, burning, itching or swelling developed.
With the use of Elidel cream, the development of malignant neoplasms, including cutaneous and other types of lymphomas, skin cancer was rarely observed. The causal relationship between these adverse events and the use of the drug has not been established.
Hypersensitivity to pimecrolimus or any component of the drug.
Children under 3 months old (since the safety and efficacy of the use of Elidel cream in children younger than 3 months have not been studied).
Elidel cream should not be applied to skin areas affected by acute viral, bacterial or fungal and infection.
There are no data on the safety of using Elidel cream in patients with Netherton syndrome and generalized erythroderma.Given the possible risk of increasing systemic absorption of the drug, Elidel cream is not recommended for use in patients with Netherton syndrome or in severe forms of inflammation or skin lesions (for example, erythroderma).
Since the efficacy and safety of using Elidel cream in immunocompromised patients has not been studied, the drug is not recommended for use in this category of patients.
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.
Potential interactions of 1% Elidel cream with other drugs have not been studied. Given that the systemic absorption of pimecrolimus is very small, any interaction of Elidel cream with drugs for systemic use is unlikely.
When applying 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 vaccine injection area until the local manifestations of the post-vaccination reaction completely disappear.
Since compatibility studies have not been conducted, it is not recommended to use the drug in conjunction with other local means.
Pregnancy and Lactation
Pregnancy. Data on the use of 1% Elidel cream in pregnant women do not. In experimental studies with local use of the drug 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 were not detected.
Care should be taken when prescribing 1% Elidel cream to pregnant women. However, given the minimum degree of absorption of pimecrolimus when applied topically, the potential risk in humans is considered negligible.
Lactation. 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 in nursing women is not. Since many drugs are excreted in breast milk, care should be taken 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 on the breast area.
In the treatment with topical calcineurin inhibitors, including Elidel, in rare cases, malignant neoplasms have been observed (for example, skin tumors and lymphomas). The causal relationship between these adverse events and the use of the drug has not been established.
In clinical studies with the use of Elidel cream, 0.9% of patients (14 out of 1544) developed lymphadenopathy. Typically, lymphadenopathy was due to infectious diseases and disappeared after a course of appropriate antibiotic therapy. In all patients, either it was possible to identify the cause of the development of lymphadenopathy or the disappearance of this adverse event was noted. In patients receiving treatment by Elidel with the development of lymphadenopathy, it is necessary to establish the etiology of the process and ensure that patients are monitored until this undesirable phenomenon completely disappears. If the etiology of lymphadenopathy is unknown or the patient has acute mononucleosis inflammation, the drug should be discontinued.
When treating with Elidel cream, patients are advised to minimize artificial or natural skin insolation or to completely avoid ultraviolet radiation. The possible effect of the use of the drug in skin lesions caused by ultraviolet irradiation is unknown.
Influence on ability to drive the car and work with mechanisms
The impact of the use of Elidel cream on the ability to drive vehicles or work with mechanisms has not been established.
Cases of overdose or accidental use of 1% Elidel cream orally were not observed.
- Brand name: Elidel
- Active ingredient: Pimecrolimus
- Dosage form: Cream for external use.
- Manufacturer: Meda Pharma GmbH & Co. KG
Studies and clinical trials of Pimecrolimus (Click to expand)
- Pimecrolimus and dual pimecrolimus-paclitaxel eluting stents decrease neointimal proliferation in a porcine model
- The GENESIS (Randomized, Multicenter Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent System in Patients with De Novo Lesions of the Native Coronary Arteries) Trial
- Feasibility, Safety, and Efficacy of a Novel Polymeric Pimecrolimus-Eluting Stent: Traditional Pre-Clinical Safety End Points Failed to Predict 6-Month Clinical Angiographic Results
- Do We Really Understand Pimecrolimus?
- Topical tacrolimus and pimecrolimus are not associated with skin atrophy
- Topical tacrolimus and pimecrolimus are not associated with skin atrophy: reply from author
- Pimecrolimus does not affect Langerhans cells in murine epidermis
- Evaluation of SDZ-ASM 981 [ELIDEL™ (pimecrolimus)] in a trial simulating clinical practice in managing childhood atopic dermatitis
- Pimecrolimus inhibits up-regulation of OX40 and synthesis of inflammatory cytokines upon secondary T cell activation by allogeneic dendritic cells
- Pimecrolimus inhibits up-regulation of OX40 and synthesis of inflammatory cytokines upon secondary T cell activation by allogenic dendritic cells
- Pimecrolimus does not affect the differentiation, maturation and function of human monocyte-derived dendritic cells, in contrast to corticosteroids
- Pimecrolimus: A review
- Pimecrolimus Identifies a Common Genomic Anti-inflammatory Profile, is Clinically Highly Effective in Psoriasis and is Well Tolerated
- Pimecrolimus Inhibits the Elicitation Phase but Does Not Suppress the Sensitization Phase in Murine Contact Hypersensitivity, in Contrast to Tacrolimus and Cyclosporine A1
- Pimecrolimus 1% cream for anogenital lichen sclerosus in childhood
- Pimecrolimus bij kinderen met atopische dermatitis
- Meta-analyse van pimecrolimus en tacrolimus bij atopische dermatitis
- Topical tacrolimus and pimecrolimus in the treatment of cutaneous lupus erythematosus: an evidence-based evaluation
- Time-kinetic study of repigmentation in vitiligo patients by tacrolimus or pimecrolimus
- Topical pimecrolimus does not prolong clear graft survival in a rat keratoplasty model
- Pimecrolimus (ELIDEL®) zur Behandlung des Lichen planus mucosae
- Topische Applikation von Pimecrolimus 1% bei erosivem oralen Lichen planus
- First chemoenzymatic synthesis of immunomodulating macrolactam pimecrolimus
- Treatment of oral lichen planus with topical pimecrolimus 1% cream