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Dosage form: & nbspSolution for intramuscular injection
Nasal drops
Composition:Solution for intramuscular injection:

Active substance:

γ-D-glutamyl-D-tryptophan disodium (Timodepressin) 1.0 g

Excipients:

Sodium chloride 9.0 g

Sodium hydroxide 1 M - to pH 6.0-8.5

Water for injection - up to 1.0 liter

Nasal drops

Active substance:

γ-D-glutamyl-D-tryptophan disodium (Timodepressin) 1.0 g

Excipients:

Sodium chloride 9.0 g

Sodium hydroxide 1 M - to pH 6.0-8.5

Water for injection - up to 1.0 liter

Description:

Colorless transparent liquid. A characteristic odor is allowed.

Pharmacotherapeutic group:Immunomodempressive agent
ATX: & nbsp
  • Selective immunosuppressants
  • Pharmacodynamics:Synthetic peptide consisting of D-amino acids (glutamic acid and tryptophan), connected by a γ-peptide bond. Has an immunosuppressive effect, inhibits the reaction of humoral and cellular immunity. Reversibly reduces the total number of lymphocytes in the peripheral blood, causing a proportional decrease in the level of both helpers and suppressors. Suppresses colony formation and the entry of stem progenitor cells into the S-phase.

    Timodepressin® reduces the number of activation markers on lymphocytes, inhibits the proliferation of T cells.

    The drug inhibits the spontaneous production of tumor necrosis factor α (TNFα), increases the production of interleukin 7 (IL-7), does not affect the production of interleukin 1 (IL-1).

    Timodepressin® reduces the acute "Graft-versus-host" reaction (GVHD), and 90% reduces chronic GVHD with the administration of Timodepressin® to the donor and recipient, promotes faster and more cooperative release of progenitor cells into the proliferative phase and the recovery of leukopoiesis.

    Timodepressin® is non-toxic, effective at low doses, and has a wide therapeutic dose range.

    Pharmacokinetics:

    When parenteral introduction, about 90% of the drug enters the systemic bloodstream, while intranasal administration of Timodepressin®, its bioavailability is also at least 90%. The maximum concentration (Cmax) Timodepressin® in the systemic circulation is reached 5 minutes after its parenteral administration.

    Suction: With intranasal application, absorption occurs from the mucous membranes of the nose. When parenteral application, absorption occurs at the injection site.

    Metabolism: The drug is metabolized by 70% in the liver.

    Distribution: Maximum Concentrations in organs and tissues are reached 15 minutes after the administration of the drug. In the bone marrow and liver Cmax exceeds that in blood in 9.5 and 3.45 times, respectively. In plasma, the concentration of Timodepressin® is 1.5 times higher, that is, the drug is predominantly stored in the plasma, rather than in the blood cells.

    Excretion: In parenteral and intranasal administration, excretion of Timodepressin® occurs in the urine (55-59%), as well as with feces (13-19%). The half-life is about 14 hours. The drug is completely excreted within 24 hours and does not accumulate in the body.

    Indications:

    Timodepressin® is used in adults and children from 2 years of age, is used both in monotherapy and in the complex treatment and prevention of relapses of various autoimmune diseases:

    - Chronic recurrent dermatoses:

    (psoriasis, pemphigus, atopic dermatitis, eczema, symptomatic treatment of T-cell lymphomas of the skin);

    - Autoimmune pathology of connective tissue:

    (rheumatoid arthritis and other autoimmune diseases of connective tissue, secondary rheumatoid syndrome in the background of lymphatic and other tumors);

    - Hematological diseases:

    - autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, two- and three-rooted cytopenia, including secondary on the background of lymphocytic lymphomas and chronic lymphocytic leukemia. Treatment scheme is selected individually.

    Timodepressin® is shown:

    - with cytostatic chemotherapy and radiation therapy to protect and preserve stem cells and accelerate the release of granulocytopenia;

    - for prevention of graft rejection during transplantation of organs and tissues.

    - with bone marrow transplantation to prevent rejection of the transplant.

    Contraindications:Contraindication to the use of the drug is pregnancy, lactation, uncontrolled arterial hypertension, infectious and viral diseases in the acute phase, individual intolerance of the drug.
    Dosing and Administration:

    Chronic recurrent dermatoses

    Psoriasis

    Timodepressin® is administered intramuscularly for 1-2 ml of the solution daily for 7-10 days, then 2 days for a break, and again a 7-10-day cycle of administration. Depending on the clinical situation, you can spend 3 to 5 cycles. Repeated cycles can be carried out up to 5 times.

    Intranasal Timodepressin® is prescribed primarily as maintenance therapy and for the prevention of relapse, as well as in the treatment of children. The drug is injected with 1-2 ml of nasal drops into each nasal passage for 10-14 days.

    In patients with generalized psoriatic erythroderma Timodepressin® is administered by intramuscular injection of 2 ml of the solution daily for 14 days, then 14 days intranasally with simultaneous addition of glucocorticosteroid hormones at medium doses (40-60 mg prednisolone).

    Atopic dermatitis

    Timodepressin® is administered intramuscularly by 1-2 ml of the solution daily for 7-14 days, the course of treatment can be prolonged after a 2-day break. The duration of the course and their number is determined by the clinical and morphological features of the disease.

    Intranasal preparation is prescribed primarily as maintenance therapy and for the prevention of relapse or in the treatment of children. Children are prescribed 1-2 ml of nasal drops in each nasal passage for 7 days, followed by a 2-day break and a repeated 7-day course.

    Eczema

    Timodepressin® is injected intramuscularly with 1-2 ml of the solution daily for 10 days, then 2-5 days for a break, and again a 10-day cycle of administration is repeated. Intranasal preparation is prescribed mainly as a supportive therapy and for the prevention of relapse or in the treatment of children. Children are prescribed 1-2 ml of nasal drops in each nasal passage for 10 days, followed by a 2-5 day break and a repeated 10-day course.

    T-cell lymphoma of the skin

    With this disease, the drug is administered intramuscularly 2 ml of solution daily by three 7-day courses with 5-day intervals against the background of moderate doses of glucocorticosteroids (30-40 mg of prednisolone).

    Pemphigus

    The drug is used for various types of pemphigus in complex treatment with glucocorticosteroids. Timodepressin® is prescribed intramuscularly for 1 ml of solution daily for 2 weeks in a complex therapy with prednisolone (60-80 mg / day). After 7-10 days after the start of treatment, the daily dose of prednisolone is reduced by 1/3, followed by a gradual decrease in the dose of prednisolone (by 5 mg every 4-5 days). If necessary, maintain a maintenance dose of prednisolone - 5 mg per day.

    Rheumatoid arthritis

    Timodepressin® is administered intramuscularly to 1-3 ml of the solution daily for 7-14 days, then 2 times a week. The course of treatment is 16 weeks.

    Intranasal Timodepressin® is prescribed primarily as maintenance therapy and for the prevention of recurrences of 1-2 ml of nasal drops to each nasal passage for 5-10 days, then 2 times a week.

    Application after cytostatic therapy

    To reduce the myelotoxic effect of cytostatic therapy, Timodepressin® is administered intramuscularly daily for 5-7 days to 1-2 ml of the solution. The administration of the drug begins 24-48 hours before the first course of cytostatic chemotherapy (1st and 2nd injection). The third administration is performed 12 hours before the start of polychemotherapy. Depending on the duration of the chemotherapy course, the drug continues to be injected daily with 1-2 ml of the solution once a day. The main efficacy index is the number of leukocytes and granulocytes 3 days before the start of the next course of cytostatic therapy. The drug can also be administered intranasally by 1-2 ml of nasal drops into each nasal passage, or fractional by 0.5 ml in each nasal passage 2-3 times a day, starting 24-48 hours before the first course of chemotherapy. Timodepressin® is indicated for use before courses of polychemotherapy with a duration of no more than 2 weeks and breaks not less than 2 weeks. With long, continuous regimens of cytostatic administration, its use is impractical.

    With a recurring course of primary and secondary autoimmune cytopenias, Timedepressin® is recommended to use the first 2 courses as injections, then, with a positive effect, it is possible to switch to a course application of the drug intranasally for several months to stabilize the process.

    With insufficient effect from the first courses of drug use, it is recommended to increase the daily dose by 2-3 times and to shorten the break between courses up to 7 days. After achieving the effect, it is necessary to carry out supportive course treatment, during which the dose of the drug can be reduced, and the break between the courses to increase.

    In severe recurrent course, Timodepressin® is prescribed in combination with cytostatic immunosuppressants, the dose of which decreases by a factor of 2, and when the effect is achieved, cytostatic immunosuppressants are canceled.

    Dosing regimen in children's practice:

    For children from 2 to 12 years, Timodepressin® is prescribed intramuscularly for 0.5-1 ml of a solution for intramuscular injection or intranasal for 0.5-1 ml of nasal drops per each nasal passage 1 time per day for 7-10 days, then break 2 days and, if necessary, repeat the course.It is possible to hold 1 to 5 courses.

    Children over 12 years of age Timedepryn® are prescribed intramuscularly for 1-2 ml of a solution for injection or intranasal for 1-2 ml of nasal drops in each nasal passage 1 time per day for 7-10 days, then break for 2 days, then 1-2 course for 7-10 days.

    Side effects:

    After the second course of treatment with Timodepressin®, a transient decrease in the number of white blood cells is possible, with the preservation of the leukocyte formula of peripheral blood.

    Overdose:

    Cases of overdose when using the drug are unknown.

    Interaction:

    It is not recommended to appoint simultaneously with drugs that have an immunostimulating effect.

    When combined with cytostatics, Timodepressin® does not reduce their antitumor effect.

    Special instructions:

    The use of Timodepressin®, like other immunosuppressants, predisposes to exacerbation of latent bacterial, fungal, parasitic and viral infections. At the first clinical manifestations of the infectious process, the appropriate pathogenetic therapy. If you have an unforeseen effect of the drug, you should consult a doctor.

    Form release / dosage:Solution for intramuscular injection 1 mg / ml
    Nasal drops 0,1%
    Packaging:

    1 ml per ampoule of neutral glass. 5 ampoules per contour pack of PVC film. One or two contour packs together with the instructions for use and the ampoule ampoule or scarifier are placed in a pack of cardboard. When packaging ampoules with a ring or break point, the ampoule or ampoule ampoule knives are not inserted.

    5 ml in bottles of neutral glass. The vials are sealed with rubber stoppers and rolled with aluminum caps. 1 bottle complete with a cork-pipette or lid-dropper and instructions for use are placed in a pack of cardboard box.

    Storage conditions:

    Store in a dark place at a temperature of 2 to 15 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:Р N000022 / 03
    Date of registration:14.03.2008 / 25.02.2016
    The owner of the registration certificate:FARMA BIO LLC FARMA BIO LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp20.03.16
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