Treatment of patients from 2 years of age with mild to moderate atopic dermatitis when topical corticosteroids are not recommended or not, e.g. intolerance to topically applied corticosteroids, lack of response to topical corticosteroids, application to the face and neck, where prolonged discontinued corticosteroid therapy may not be appropriate.
Composition:
1 g of cream contains 10 mg of pimecrolimus.
Action:
Pimecrolimus is a lipophilic derivative of ascomycin macrolactam with anti-inflammatory and cell-selective inhibitor of cytokine synthesis and secretion. It has high affinity for macrophilin-12, binds to it and inhibits calcium-dependent calcineurin phosphatase, which leads to inhibition of cytokine synthesis in T lymphocytes.
Contraindications:
Hypersensitivity to pimecrolimus, other macrolactams or other ingredients of the preparation.
Precautions:
It should not be used in patients with congenital or acquired immunity, treated for immunosuppression (increased risk of developing lymphomas and malignant neoplasms of the skin) and on the surface of the skin infected with viruses (Herpes simplex, chickenpox) or at the site of potential cancer or pre-cancerous skin lesions. The efficacy and safety of the preparation in the treatment of atopic dermatitis with bacterial superinfection have not been evaluated. In the absence of a well-defined cause of generalized enlargement of the lymph nodes or acute infection with infectious mononucleosis, the use of the preparation should be discontinued. It is not recommended for patients with erythroderma or Netherton's syndrome. Due to the lack of tests, the preparation should not be used in children under 2 years of age.
Pregnancy and lactation:
The preparation should not be used during pregnancy. Caution should be exercised when using the preparation in lactating women. Nursing women should not use cream on the breast skin to prevent unintentional administration of the cream orally to newborns.
Side effects:
Very often: a burning sensation at the place where the cream is applied. Common: irritation, pruritus and erythema, and folliculitis. Uncommon: boil, impetigo, herpes simplex, shingles, dermatitis herpetiformis, infectious mucosa, skin papilloma, skin reactions at the application site (rash, pain, paresthesia, flaking of the epidermis, dry skin, swelling and exacerbation of atopic dermatitis). Rarely: alcohol intolerance (short-term after alcohol consumption, hot flushes, rash, burning sensation, itching, swelling), skin hypersensitivity reactions (including rash, urticaria, angioneurotic edema), skin color change. Very rare: anaphylactic reactions. In addition, there have been cases of malignant tumors, including cutaneous lymphoma, other types of lymphomas and skin cancer. Due to the content of cetyl alcohol, stearyl alcohol and propylene glycol, local skin irritation may occur.
Dosage:
Adults and children aged 2 years and above: a thin layer of cream should be applied twice a day to the affected skin (including the scalp, face, neck and skin surfaces covered by the process), then rub until the preparation is completely absorbed. The preparation can be used for a short time in the treatment of signs and symptoms of atopic eczema and for long periods with interruptions to prevent the recurrence of the disease. The product can only be used in areas with atopic dermatitis. Treatment should be started after the first symptoms of the disease, after the disappearance of symptoms should stop using the preparation. Treatment should be interrupted, short-lived and not continuous. The clinical trial data obtained data on the use of the preparation in cyclic treatment for no longer than 12 months. If there is no improvement after 6 weeks of treatment or if the disease worsens, discontinue the preparation and consider a different method of treatment.
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