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Protopic ointment - anti-inflammatory drug for external use. Tacrolimus belongs to the group of calcineurin inhibitors. It binds to a specific cytoplasmic protein called immunophilin (FKBP 12), which is a cytosolic receptor for calcineurin (FK 506). As a result, a complex is formed including tacrolimus, FKBP 12, calcium, calmodulin and calcineurin, which leads to inhibition of the phosphatase activity of calcineurin. This makes it impossible to dephosphorylate and translocate the nuclear factor of activated T-cells (NFAT), which is necessary for the initiation of transcription of genes encoding the production of key cytokines (IL-2 and interferon-gamma) for the T-cell immune response.
In addition, tacrolimus inhibits transcription of genes encoding the production of such cytokines as IL-3, IL-4, IL-5, granulocyte-macrophage colony-stimulating factor (GMPCS) and tumor necrosis factor (TNF-α) that participate in the initial stages activation of T-lymphocytes.
In addition, under the influence of tacrolimus, the release of inflammatory mediators from mast cells, basophils and eosinophils, as well as a decrease in the expression of FcεRI (high affinity surface receptor for immunoglobulin E) on Langerhans cells, leads to a decrease in their activity and presentation of the antigen to T lymphocytes.
Ointment containing tacrolimus does not affect the synthesis of collagen and, thus, does not cause skin atrophy.
Treatment of atopic dermatitis (moderate severity and severe forms) in case of insufficient response of patients to traditional methods of treatment or contraindications to such.
Caution should be used Protopik in decompensated liver failure, with extensive skin lesions, especially long courses, as well as in children.
Adults and children over 2 years of ointment Protopic are applied a thin layer on the affected skin areas. The drug can be used on any part of the body, including the face and neck, in the area of skin folds. Do not apply the drug to the mucous membranes and under occlusive dressings.
For children and adolescents aged 2 to 16 years, treatment should begin with the application of 0.03% ointment Protopik. The duration of treatment under this scheme should not exceed 3 weeks. In the future, the frequency of application is reduced to 1, the treatment is continued until the foci of lesion are completely cleared.
In adults and adolescents 16 years of age and older, treatment should begin with the application of 0.1% Protopic ointment and continue until the lesions are completely cleared. As you improve, you can reduce the frequency of applying 0.1% of the ointment or switch to the use of 0.03% ointment Protopic. In case of recurrence of symptoms of the disease, treatment with 0.1% of ointment should be resumed. 2 If the clinical picture allows, an attempt should be made to reduce the frequency of application of the drug, or use 0.03% ointment.
Frequency of occurrence of undesirable reactions: very often (> 1/10), often (> 1/100, 1/1000, Local reactions: very often - burning and itching sensation, often - sensation of heat, redness, pain, irritation, rash in place As a rule, they are expressed moderately and pass within the first week after the start of treatment.
Infections: often - herpetic infection (herpes simplex of the face and lips, varicelliform hives of Kaposi).
Dermatological reactions: often - folliculitis, itching; rarely - acne.
From the side of the peripheral nervous system: often - paresthesia, hyperesthesia.
Other: often - alcohol intolerance (face hyperemia or symptoms of skin irritation after drinking).
During the entire period of observation of the drug, single cases of rosacea, malignization (cutaneous and other types of lymphomas, skin cancer) were recorded.
Protopic ointment can not be used in patients with congenital or acquired immunodeficiency or in patients who take immunosuppressants.
During the application of the Protopic ointment, sunlight, sunburn, UV-B or A therapy with psoralen (PUVA-therapy) should be avoided.
Protopik ointment should not be used to treat lesions that are considered to be potentially malignant or pre-malignant.
For 2 hours on the skin areas on which the ointment was applied, you can not use emollients.
The efficacy and safety of the use of Protopic ointment in the treatment of infected atopic dermatitis has not been evaluated. If signs of infection are present prior to the appointment of Protopik ointment, appropriate therapy is necessary. The use of Protopic ointment may be associated with an increased risk of developing a herpetic infection. In the presence of signs of herpetic infection, one should individually evaluate the relationship between the benefit and the risk of using Protopic.
In the presence of lymphadenopathy, the patient should be examined before starting therapy and observed during the period of application of the ointment. In the absence of an obvious cause of lymphadenopathy or in the presence of symptoms of acute infectious mononucleosis, it is necessary to stop using the Protopic ointment.
Avoid contact with ointment in the eyes and mucous membranes (in case of accidental ingestion, the ointment should be carefully removed and / or rinsed with water).
It is not recommended to apply Protopic ointment for occlusive dressings and wear tight, airtight clothing.
Just like using any other topical medication, patients should wash their hands after applying the ointment, except when the ointment is applied to the area of the hands for therapeutic purposes.
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Mastodynon 50ml drops