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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.
Ointment Protopic applied at a dosage of 0.1% in adults for the treatment of atopic dermatitis (moderate severity and severe forms) in case of its resistance to other external therapy 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.
In adults and children over the age of 2 years, the Protopic ointment is applied a thin layer on the affected areas of the skin. The drug can be applied to any part of the body, including the face, neck and flexion surfaces; Do not apply the drug to the mucous membranes and apply under occlusive dressings.
Treatment of affected areas of the skin is carried out until the disappearance of atopic dermatitis. Typically, improvement is noted during the first week of treatment. If signs of improvement are not noticed within 2 weeks after the beginning of the application of the ointment, alternative options for further treatment should be considered. Ointment Protopik can be used for a short time or for a long time in the form of periodically repeated courses of therapy. Treatment should be resumed with the appearance of the first signs of exacerbation of atopic dermatitis.
Use in children older than 2 years. Treatment should be started by applying 0.03% ointment Protopik 2 times a day for 3 weeks. In the future, the frequency of application is reduced to 1 time per day, the duration of treatment - until the complete cleansing of lesions.
Use in the elderly (over 65 years). Correction of the dosing regimen is not necessary.
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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