Elidel (pimecrolimus) cream 1% 15 g.

Description

Elidel Composition
active substance: pimecrolimus;

1 g of cream contains 10 mg of pimecrolimus;

Elidel excipients: sodium hydroxide, citric acid, benzyl alcohol, sodium cetostearyl sulfate, mono- and di-glycerides, cetyl alcohol, stearyl alcohol, propylene glycol, oleyl alcohol, medium chain triglycerides, purified water.

Elidel Dosage form
Cream for external use.

Basic physical and chemical properties: whitish homogeneous cream.

Pharmacotherapeutic group
Dermatological agents. Drugs used for atopic dermatitis, with the exception of corticosteroids.

ATX code D11A H02.

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 binds to a significant extent specifically with macrophilin-12 and inhibits calcium phosphatase – calcineurin. As a result, it suppresses the activation of T-lymphocytes, blocking the transcription of previously identified cytokines.

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

Pharmacokinetics
After topical application of pimecrolimus to the skin, its blood levels are very low, so the metabolism of pimecrolimus cannot be determined.

In vitro plasma protein binding studies have found that 99.6% of pimecrolimus is in a protein bound state. The largest fraction of pimecrolimus in plasma is associated with various lipoproteins.

In the skin of humans in vitro metabolism of the drug 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 from local corticosteroids;
the need for use on the face and neck, where prolonged intermittent use of corticosteroids may be inappropriate.

Contraindications
Hypersensitivity to pimecrolimus, other macrolactams, or other components of the drug.

Interaction with other medicinal products and other forms of interaction
Possible interactions of Elidel with other drugs have not been systematically evaluated. Pimecrolimus is metabolized exclusively by CYP 450 3A4. Given the minimal level of absorption, the interaction of Elidel with drugs that are used systemically is unlikely.

These data indicate that Elidel can be used simultaneously with antibiotics, antihistamines and GCS (oral, nasal or inhalation).

Given the minimal level of absorption, systemic interaction of Elidel during vaccination is unlikely. However, such studies have not been carried out. Therefore, patients with common or disseminated forms of the disease are recommended to vaccinate during periods when the drug is not used.

There is no data on the simultaneous use of immunosuppressive drugs that are prescribed for atopic eczema, such as ultraviolet B and A spectrum radiation, PUVA therapy (psoralen and ultraviolet A radiation), azathioprine and cyclosporine A.

Excessive exposure of the skin to ultraviolet rays (including the use of tanning beds, ultraviolet B and A radiation therapy and PUVA therapy) should be avoided when treating Elidel.

There have been rare cases of redness, rash, burning, itching, or swelling immediately after drinking alcohol in patients receiving pimecrolimus cream.