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.

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;

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.