Elidel, cream 1% 15 g

Eczema, Skin itching, Dry skin, Neurodermatitis 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).

Active ingredient

Pimecrolimus

Composition

1 g of the cream contains 10 mg of pimecrolimus,

and excipients:

• sodium hydroxide 0.20 mg,
• hydrous 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,
• triglycerides medium-chain 150.00 mg,
• cleared water 569.30 mg.

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How to take, the dosage

The treatment should be started at the first signs of the disease to prevent acute exacerbation.

1% Elidel cream is applied twice a day with a thin layer on the affected area and gently rubbed in until completely absorbed.

1% Elidel cream can be applied to the skin of any body parts including head, face and neck as well as to the diaper rash area.

Elidel cream should be used twice a day until the symptoms are completely gone. If the symptoms persist after 6 weeks of treatment it is necessary to repeat the examination in order to confirm the diagnosis of atopic dermatitis. After cessation of treatment, to avoid further exacerbations, at the first signs of relapse of atopic dermatitis the therapy must be resumed.
Softeners can be used immediately after application of Elidel 1% cream. However, after water procedures, emollients should be used before applying Elidel cream.

Given the very insignificant systemic absorption of pimecrolimus, there are no restrictions on the total daily dose of the drug to be applied, the area of the skin treated or the duration of treatment.
In case of contact of Elidel in the eyes, mucous membranes (oral or nasal cavity) you should immediately remove the cream and rinse the eyes and mucous membranes with running water.

Interaction

Potential interactions of 1% Elidel cream with other drugs have not been studied. Given that systemic absorption of pimecrolimus is very low, any interaction of Elidel cream with drugs for systemic use is unlikely.

When using Elidel cream in children aged 2 years and older the drug had no effect on the effectiveness of vaccination.

It is not recommended to apply the cream to the area of vaccine administration until the local manifestations of postvaccination reaction have completely disappeared.

Incompatibility. Since compatibility studies have not been conducted, it is not recommended to use the drug together with other topical agents.

Special Instructions

Treatment with topical calcineurin inhibitors, including Elidel, has rarely resulted in malignancies (e.g., skin tumors and lymphoma). The causal relation between these adverse events and the use of the drug has not been established.

In clinical trials on application of Elidel cream 0,9% of patients (14 out of 1544) developed lymphoadenopathy. Lymphadenopathy was generally caused by infectious diseases and disappeared after a course of appropriate antibiotic therapy. All patients either managed to identify the cause of lymphadenopathy or this undesirable phenomenon disappeared.

In patients treated with Elidel the etiology of lymphadenopathy should be determined and the patients should be monitored until the undesirable phenomenon disappears. If the etiology of lymphadenopathy is not established or if the patient has acute mononucleosis inflammation, the drug should be discontinued.

During the treatment with Elidel cream it is recommended to minimize natural or artificial insolation of the skin or to avoid ultraviolet irradiation. The possible effect of using the drug in skin lesions caused by ultraviolet radiation is unknown.

Influence on the ability to drive vehicles or operate machinery:
The effect of the use of Elidel cream on the ability to drive vehicles or operate machinery has not been established.

Contraindications

Caution

Side effects

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

The most frequent adverse events – reactions at the site of application were noted in 19% of patients treated with Elidel 1% cream, and in 16% of patients from the control group. These reactions mostly occurred in the early phase of treatment, were mild/moderate and of short duration. The adverse events listed below are listed by frequency, starting with the most frequent. The incidence of adverse reactions was rated 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” – < 1/10 000, including individual reports.

The adverse reactions presented below have been reported during post-marketing use of the drug (frequency estimate by the number of cases of NTs in an unspecified population).

Overdose

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

Pregnancy use