Tarolimus 0.03% ointment 15 g

Tradename:

Tarolimus

Tarolimus

Composition:

Each gram of ointment contains:

Tacrolimus 0.3 mg

Auxiliary components:

soft white paraffin; liquid paraffin; propylene carbonate; beeswax white; paraffin wax

Properties:

Tacrolimus binds to the cytosolic protein (FKBP12), which is responsible for the intracellular accumulation of the drug. The FKBP12-tacrolimus complex specifically and competitively interacts with calcineurin and inhibits it, which leads to calcium-dependent inhibition of T-cell signaling pathways of transduction 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, as as the formation of lymphokines (such as interleukins-2 and 3 and interferon gamma), the expression of the receptor for interleukin-2.

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.

Method of administration and dosage:

Outwardly. For adults and children over 2 years old, the ointment is applied in a thin layer to the affected skin. The drug can be used on any part of the body, including the face and neck, in the area of skin folds. The drug should not be applied to mucous membranes and under occlusive dressings.

Use in children (2 years of age and older) and adolescents under 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 frequenc use is reduced to 1 time per day, the treatm continues until the lesions are completely cleared.

Use in adults and adolescents 16 years of age and older:

Treatment should begin with the use 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 applying 0.1% ointment or switch to using 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 of 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%).

Precautions:

Tarolimus@ ointment should not be used in patients with congenital or acquired immunodeficiencies or in patients taking immunosuppressive drugs.

During the application of the ointment, it is necessary to avoid contact with the sun’s rays, visiting a solarium, therapy with UV B or A rays in combination with psoralen (PUVA therapy).

The ointment should not be used to treat lesions that are considered potentially malignant or precancerous.

For 2 hours, emollients should not be used the areas of the skin to 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, appropriate therapy is necessary before prescribing the ointment. The use of the ointment may be associated with an increased risk of developing herpes infection. In the presence of signs of herpes infection, the ratio of the benefits and risks of using 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 application.

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 habits: often alcohol intolerance (flushing of the face or symptoms of skin irritation after drinking alcohol).

Storage method:

At a temperature not higher than 30 degrees. In a dry place.

Packaging:

The cardboard box holds 15 gram tubes.