Tarolimus. 0.03% 15g
Tarolimus ointment is used for the treatment of atopic dermatitis (moderate and severe forms) in case of its resistance to other external therapy or the presence of contraindications to those.
Compound: Each gram of ointment contains:
Tacrolimus 0.3 mg
Auxiliary components: soft white paraffin; liquid paraffin; propylene carbonate; white beeswax; solid paraffin
Properties: Tacrolimus binds to a cytosolic protein (FKBP12) responsible for the intracellular accumulation of the drug. The FKBP12-tacrolimus complex, interacting specifically and competitively with calcineurin, inhibits it, which leads to calcium-dependent inhibition of T-cell signaling transduction pathways and prevention of transcription of a discrete group of lymphokine genes. Suppresses the formation of cytotoxic lymphocytes, which are mainly responsible for transplant rejection, reduces T-cell activation, T-helper-dependent B-cell proliferation, and the formation of lymphokines (such as interleukins-2 and 3 and interferon gamma), expression of the interleukin-2 receptor.
Indications: Tarolimus ointment is used at a dosage of 0.03 and 0.1% in adults and only 0.03% in children from 2 to 16 years old for the treatment of atopic dermatitis (moderate and severe forms) in case of its resistance to other external therapy or the presence of contraindications to those.
Dosage and administration: Outwardly. For adults and children over 2 years of age, the ointment is applied in a thin layer to the affected areas of the skin. 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.
Use in children (2 years and older) and adolescents up to 16 years of age: Treatment should begin with the application of 0.03% ointment 2 times a day. The duration of treatment according to this scheme should not exceed 3 weeks. In the future, the frequency of application is reduced to 1 time per day, treatment continues until the lesions are completely cleared.
Use in adults and adolescents 16 years of age and older: Treatment should begin with the application of 0.1% ointment 2 times a day and continue until the lesions are completely cleared. As you improve, you can reduce the frequency of application of 0.1% ointment or switch to the use of 0.03% ointment. In case of recurrence of symptoms of the disease, treatment with 0.1% ointment should be resumed twice a day. If the clinical picture allows, an attempt should be made to reduce the frequency of use of the drug or use a lower dosage – 0.03% ointment.
Contraindications: hypersensitivity to tacrolimus, excipients, macrolides; patients with genetic defects in the epidermal barrier, such as Netherton’s syndrome, as well as with generalized erythroderma due to the risk of a progressive increase in systemic absorption of tacrolimus; pregnancy; breast-feeding; children and adolescents under 16 years of age (at a dosage of 0.1%), children under 2 years of age (at a dosage of 0.03%).
Precautionary measures: Tarolimus ointment should not be used in patients with congenital or acquired immunodeficiencies or in patients who are taking immunosuppressive drugs. During the application of the ointment, it is necessary to avoid exposure to the skin of sunlight, visits to the solarium, therapy with UV rays B or A in combination with psoralen (PUVA therapy). The ointment should not be used to treat lesions that are considered potentially malignant or premalignant. For 2 hours, emollients should not be used on the skin areas on which the ointment was applied. The efficacy and safety of the ointment in the treatment of infected atopic dermatitis has not been evaluated. If there are signs of infection before the appointment of the ointment, appropriate therapy is necessary. The use of the ointment may be associated with an increased risk of developing a herpes infection. If there are signs of a herpes infection, the benefit-risk ratio of the ointment should be individually assessed.
Side effects: General disorders and local reactions: very often – burning and itching at the site of application; often – a feeling of warmth, redness, pain, irritation, rash in the area of \u200b\u200bapplication. Infections: often – herpes infection (herpes simplex of the face and lips, Kaposi’s varicelliform rash). Skin and subcutaneous tissue: often – folliculitis, itching; infrequently – acne. Nervous system: often – paresthesia, hyperesthesia. Metabolism and nutritional characteristics: often – alcohol intolerance (facial flushing or symptoms of skin irritation after drinking alcohol).
Storage method: At a temperature not higher than 30 degrees. In a dry place.