Index of drugs

Treatment of acute phase. Treatment of moderate and severe forms of atopic dermatitis in adults and adolescents ≥16 years of age in cases of insufficient response or lack of tolerance to conventional therapy, such as topical corticosteroid use - 0.03% and 0.1%. Treatment of moderate and severe forms of atopic dermatitis in children ≥ 2 years in cases where conventional treatment, such as topical corticosteroids, did not produce the desired result - 0.03% dose.Maintenance treatment. Maintenance therapy for moderate to severe atopic dermatitis to prevent relapse and prolong periods without recurrence in patients with a high incidence of exacerbation (i.e., 4 times a year or more) and who initially responded to treatment with tacrolimus Ointment 2 times daily for a maximum of 6 weeks (the changes have completely disappeared, almost disappeared or are mild) - a dose of 0.03% and 0.1%.

1 g ointment contains 0.3 mg or 1 mg of tacrolimus in the form of tacrolimus monohydrate.

The mechanism of action of tacrolimus in atopic dermatitis is not fully understood. By binding to specific cytoplasmic immunophilin (FKBP12), tacrolimus inhibits the calcium-dependent signal transduction cascade in T lymphocytes, thus preventing transcription and synthesis of IL-2, IL-3, IL-4, IL-5 and other cytokines, such as GM-CSF, TNF-α and IFN-γ. In researchin vitroin Langerhans cells isolated from healthy skin, it was shown that tacrolimus inhibits their activating effect on T lymphocytes. It also inhibits the release of inflammation mediators from mast cells of the skin, basophils and eosinophils. In patients with atopic dermatitis, healing of skin lesions during treatment with tacrolimus in ointment was associated with a decrease in Fc receptor expression on Langerhans cells and inhibition of their activating effect on T lymphocytes. Tacrolimus in the ointment did not influence the synthesis of collagen in humans. After repeated topical use of T_0,5 is 75 hours in adults and 65 hours in children.

Hypersensitivity to tacrolimus, macrolides or excipients.

It should not be used in patients with congenital or acquired immunodeficiency and on the affected skin surface if they are considered to be neoplastic or pre-cancerous lesions. Patients who used tacrolimus in ointment had cases of malignancies, including cutaneous lymphoma (eg T-cell lymphoma) and other types of lymphomas and skin cancers. If any new lesion develops on the skin, other than the existing eczema within the treated skin area, it should be evaluated by a doctor. Caution should be used in patients with hepatic insufficiency and in long-term use in patients with extensive skin lesions, especially in children. Do not use the preparation continuously for a long time. The efficacy and safety of the preparation in the treatment of atopic dermatitis with the accompanying infection has not been studied - the infection should be cured at the place of treatment before starting the treatment. Treatment with tacrolimus may be associated with increased inflammation of the hair follicle and virus infection of the skinHerpes simplex (herpetic eczema, herpes simplex, herpes labialis, Kaposi's lamellar sowing). If these infections occur, the benefit / risk ratio associated with the use of the preparation should be evaluated. Patients who develop lymphadenopathy should remain under control to ensure that lymph node changes completely disappear. Enlargement of lymph nodes occurring at the time of initiation of treatment should be examined and monitored. If the enlargement of the lymph nodes persists, its etiology should be clarified. If uncertainty about the aetiology of lymphadenopathy or acute infectious mononucleosis occurs, discontinuation of treatment with the preparation should be considered.Avoid contact of the preparation with eyes or mucous membranes. Occlusive dressings are not recommended. Due to the increased absorption of tacrolimus, the use of tacrolimus in patients with a skin barrier disorder such as Netherton's syndrome, lamellar hulls, generalized erythroderma or cutaneous graft-versus-host disease is not recommended. During treatment with ointment one should limit skin exposure to solar radiation and avoid ultraviolet radiation from tanning beds, UVB or UVA treatment in combination with psoralens (PUVA). Patients should be advised to minimize the time they spend in the sun, use sunscreen lotions and wear appropriate clothing. Patients, especially children and adolescents, should remain under constant control during treatment to assess response to treatment and follow-up. Do not use ointment in children under 2 years of age.

Do not use the preparation in pregnant women unless it is absolutely necessary. Animal studies have shown reproductive toxicity after general administration. Breast-feeding is not recommended during treatment. Following systemic administration, tacrolimus passes into breast milk.

Very common: burning and itching at the injection site. Common: local skin infection regardless of specific etiology including ia herpetic eczema, folliculitis, skin infection caused by virusHerpes simplex, other virus-induced infectionsherpes, Kaposi's poisoning, alcohol intolerance (baked or irritated skin after drinking alcoholic beverages), paresthesias and dyserosis (increased skin sensitivity, burning sensation), pruritus, local reactions (feeling of heat, erythema, pain, irritation, paresthesia, rash). Uncommon: acne. Not known: rosacea, swelling at the injection site, increased concentration of the drug. In addition, malignant tumors, including cutaneous lymphoma (eg T-cell lymphoma), other types of lymphomas and cases of skin cancer have been reported. In the maintenance therapy in patients with moderate and severe atopic dermatitis, adverse events were observed that occurred at a higher rate than in the control group: impetigo at the injection site (children) and infection at the injection site (children and adults).

Treatment should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis. The preparation can be used in the treatment of short-term or long-term intermittent treatment. Apply a thin layer of ointment to the affected or altered skin surface. The preparation can be used on any part of the body, including the face, neck and bends, except mucous membranes.Acute phase treatment. Ointment should be used until the changes completely disappear, almost completely disappear or become mild. It should be considered whether maintenance treatment is appropriate. If the first relapse of symptoms occurs, treatment should be resumed. Adults and adolescents ≥16 years: start with ointment 0.1% 2 times a day and continue to subside. If the symptoms return, ointment 0.1% 2 times a day should be re-applied. If the clinical condition permits, try to reduce the frequency of application of the ointment or apply an ointment of 0.03%. Improvement is observed within 1 week of starting treatment. If there are no signs of improvement after the second week of treatment, another treatment should be considered. Children ≥ 2 years: 0.03% ointment initially applied twice daily for 3 weeks, then reduce the frequency and use once a day until the lesion subsides.Maintenance treatment. In patients who used ointment twice a day and responded to treatment lasting up to 6 weeks (the lesions completely resolved, almost completely disappeared or are mild), the maintenance therapy is properly implemented. Adults and adolescents ≥16 years old: 0.1% ointment applied once daily for 2 days per week (eg on Monday and on Thursday) to the skin surface covered by atopic inflammation. 2-3 days of treatment should be observed. After 12 months, the doctor should assess the patient's condition and decide whether to continue maintenance treatment. If symptoms recur, you should return to treatment twice a day.Children ≥ 2 years: ointment 0.03% applied once a day for 2 days per week (eg on Monday and on Thursday) to the skin surface covered by atopic inflammation. 2-3 days of treatment should be observed. The assessment of the child's condition after 12 months of treatment should include discontinuation of treatment until the need to continue the treatment and to assess the course of the disease is considered.