Timodepressin - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspSpray nasal dosed

Composition:

Composition:	dose
Active substance:	0.25 mg	0.5 mg
Gamma-Glutamyl-TryptophMr.(timodepressin) in terms of dry matter	2.5 grams	5.0 grams
Excipients:
Sodium chloride	9.0 g	9.0 g
Benzalkonium chloride	0.1 g	0.1 g
Sodium hydroxide 1 M	to pH 6.0-8.5
Water for injections	up to 1.0 liter

Description:

Colorless transparent liquid. A characteristic odor is allowed.

Pharmacotherapeutic group:Immunomodempressive agent

ATX: & nbsp

Selective immunosuppressants

Pharmacodynamics:

A synthetic peptide consisting of D-amino acids (glutamic acid and tryptophan) connected γpeptide bond. It has an immuno-depressant 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 cells - hematopoietic precursors into the S-phase.

Timodepressin® inhibits spontaneous production of tumor necrosis factor α (TNF) α), 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 when Timodepressin® is administered to the donor and recipient.

The drug promotes a faster and more cooperative release of healthy precursor 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:

With intranasal administration of Timodepressin®, its bioavailability is at least 90%. The maximum concentration (C_max) Timodepressin® in the systemic circulation is reached 5 minutes after its parenteral administration.

Suction: With intranasal application, absorption takes place through the nasal mucosa.

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 FROM_max exceeds that in blood by 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: 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 administered intranasally in adults and children from 2 years of age. The drug is used both in monotherapy, and in the complex treatment and prevention of relapses of various autoimmune diseases:

Chronic recurrent dermistozes:

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

Autoimmune pathology of the jointfabric:

Rheumatoid arthritis and other autoimmune diseases of connective tissue;

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.

Timodepressin® is also shown:

- with cytostatic chemotherapy and radiation therapy for the protection and preservation of stem cells and acceleration of the exit from granulocytopenia;

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

- in the prevention of graft rejection in the transplantation of organs and tissues.

Contraindications:Hypersensitivity to gamma-D-glutamyl-D-tryptophan and other(bacterial, fungal, parasitic, viral) diseases in the acute phase, uncontrolled arterial hypertension, pregnancy, the period of breastfeeding.

Dosing and Administration:

Chronic recurrent dermatoses

Psoriasis, pemphigus, atopic dermatitis, eczema, T-cell lymphomas of the skin

Intranasal Timodepressin® is used primarily as maintenance therapy and for the prevention of relapse, as well as in the treatment of children. The duration of courses and their number is determined by the clinical and morphological features of the disease.

Adults and children over 12 years of age the drug is administered in 1-2 doses (0.25 mg / dose or 0.5 mg / dose) in each nasal passage daily for 7-10 days, the course of treatment can be prolonged after a 2-day break.

Children aged 2 to 12 years the drug is administered in 1-2 doses (0.25 mg / dose or 0.5 mg / dose) in each nasal passage 1 time per day for 7-10 days. It is possible to hold up to 5 courses with breaks of 2 days.

Autoimmune pathology of connective tissue

Rheumatoid arthritis and other autoimmune diseases of connective tissue

Adults

The drug is used intranasally primarily as a maintenance therapy and for the prevention of relapse at 1-2 doses of 0.25 mg / dose or 0.5 mg / dose of a nasal spray in each nasal passage daily for 7-14 days. Then 2 times a week for 1-2 doses. The course of treatment is 16 weeks.

Hematological diseases

Autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, two- and three-rooted cytopenia, cytostatic chemo- and radiotherapy

Adults

To reduce the myelotoxic effect of cytostatic therapy, the drug is administered intranasally daily for 5-7 days to 1-2 doses (0.25 mg / dose or 0.5 mg / dose) in each nasal passage or in fractional 1 dose (0.25 mg / dose or 0.5 mg / dose) into one nasal passage 2-3 times a day. 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. Next, daily, once a day for 2-5 days, apply the spray depending on the duration of the course of chemotherapy. The main efficacy index is the number of leukocytes and granulocytes 3 days before the start of the next course of cytostatic therapy.

Timodepressin® is indicated for use before courses of polychemotherapy with a duration of no more than 2 weeks and interruptions of at least 2 weeks. With long, continuous regimens of cytostatic administration, its use is impractical.

With a recurrent course of primary and secondary autoimmune cytopenia Timodepressin® is recommended for injections of the first 2 courses, 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 used in combination with cytostatic immunosuppressants, whose dose is reduced by a factor of 2, and when the effect is achieved, cytostatic immunosuppressants are canceled.

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. Allergic reactions.

Overdose:

Cases of overdose when taking the drug are unknown.

Interaction:

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

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

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, it is necessary to apply the appropriate pathogenetic therapy.

If the side effect of the drug or unforeseen adverse reactions (chills, fever, exacerbation) associated with the use of the drug, it is necessary to stop taking the drug and consult a doctor.

Form release / dosage:Cnnasal dosed with 0.25 mg / dose, 0.5 mg / dose

Packaging:

3 ml, 5 ml or 10 ml in glass bottles.The vials are sealed with aluminum caps or plastic caps equipped with a dispensing pump with a plastic casing, an injector and a protective cap. Each label is labeled with writing paper or label paper, or a self-adhesive label. One bottle together with the instruction for use is placed in a pack of cardboard box.

Storage conditions:

Store in a dark place at a temperature of 2 to 25 ° 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:LSR-001836/08

Date of registration:17.03.2008 / 30.09.2014

The owner of the registration certificate:FARMA BIO LLC FARMA BIO LLC Russia

Manufacturer: & nbsp

MBNPK CITOMED, CJSC Russia

Information update date: & nbsp16.03.16

Illustrated instructions

Instructions

Timodepressin® (Thymodepressin)