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

Active substanceGlutamyl-Cysteinyl-Glycine DisodiumGlutamyl-Cysteinyl-Glycine Disodium

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Glutoxim®

solution for injections

PHARMA VAM, CJSC Russia

Glutoxim®

powder

PHARMA VAM, CJSC Russia

Dosage form: & nbspinjection

Composition:

Active substance: Glutamyl-Cysteinyl-Glycine disodium 5 mg, 10 mg or 30 mg per ml.

ATExcipients: sodium acetate, acetic acid diluted, water for injection.

Description:

Transparent colorless or slightly colored liquid, odorless or with a faint smell of acetic acid.

Pharmacotherapeutic group:Immunostimulating agent

ATX: & nbsp

L.03.A.X Other immunostimulants

Pharmacodynamics:

Glutoxim ® renders immunomodulating, gemostimulating, detoxifying, hepatoprotective action, suppresses drug resistance of tumor cells to antibiotics of anthracycline series, alkylating agents; allows to overcome drug resistance Mycobacterium tuberculosis to isoniazid, associated with genes katG (the catalase peroxidase gene) and inhA (enol-APB-reductase gene).

Glutoxim ® potentiates the action of doxorubicin on tumor cells, chemotherapy agents (isoniazid, rifampicin, rifabutin, cycloserine, capreomycin, levofloxacin, cationic antimicrobial peptide of catalatezin) on Mycobacterium tuberculosis.

The immunomodulatory effect of Glutoxim® is due to a receptor-mediated effect on calcium dependent macrophage signaling pathways, which leads to an increase in:

- Survival and functional capacity of tissue macrophages;

- exocytosis of sub-membrane granules with intracellularly parasitic forms Mycobacterium tuberculosis;

- activity of lysosomal enzymes;

- formation of reactive oxygen species;

- absorption and death of microorganisms;

- secretion of cytokines: interleukin 1, interleukin 6, tumor necrosis factor, interferons, erythropoietin, interleukin 2; cationic antimicrobial peptides - Defensins, catalecidins.

The gemostimulating effect of Glutoxim® is due to the receptor-mediated enhancement of bone marrow hematopoiesis: the processes of erythropoiesis, lymphopoiesis and granulocytomonocytopoiesis. The effect on the progenitor cells of different lines of blood cells is mediated by the functioning of MAP and inositol kinase systems, leads to an increase in the stability of differentiating hematopoietic cells, restores their sensitivity to the action of endogenous factors of hemopoiesis.

Detoxification and hepatoprotective effects of the drug are due to the receptor-mediated enhancement of the expression of second-phase enzymes of xenobiotic detoxification, including glutathione reductase, glutathione peroxidase, glutathione-S-transferase, glucose-6-phosphate dehydrogenase, hemoxygenase-1, increased intracellular level of reduced glutathione, from the toxic effects of radicals.

Glutoxim® has a direct inhibitory effect on the activity of the multidrug resistance factor of tumor cells - the P-glycoprotein protein (Pgp), which determines the stability of tumor cells to the action of chemotherapy, including anthracycline antibiotics, preparations of alkylating action.

Glutoxim ® initiates the isoniazid transformation reaction - a prodrug, into a pharmacologically active form - isonicotinic acid, having a bacteriostatic effect on Mycobacterium tuberculosis, that allows to overcome drug resistance Mycobacterium tuberculosis, caused by negative transformation of genes katG (the catalase peroxidase gene) and inhA (enol-APB-reductase gene).

Glutoxim ® stimulates the processes of exocytosis of vesicles from macrophages with intracellularly parasitizing microorganisms, including Mycobacterium tuberculosis, ensuring their removal from the pharmacological shelter and making antibacterial drugs available for action, including isoniazid, rifampicin, rifabutin, cycloserine, capreomycin, levofloxacin.

Glutoxim ® enhances the secretion of cationic peptides - defensins and catalacidins by macrophages, stimulates their absorption by mycobacteria of tuberculosis, determining the mediated antibacterial action of the drug.

Pharmacokinetics:

Glutoxim ® belongs to the group of natural metabolites, which determines the features of its metabolism by existing cellular enzymatic systems. After intramuscular, intravenous or subcutaneous injection, bioavailability exceeds 90%. There is a linear relationship between the dose and concentration of the drug in the blood plasma. The maximum concentration of the drug in plasma with intravenous administration is observed within 2-5 minutes, with intramuscular injection within 7-10 minutes. As a natural product of a peptide nature, Glutoxim® is metabolized in the organs and tissues of the body with elimination through the kidneys.

Indications:

Glutoxim ® is used in adults: as a means of preventing and treating secondary immunodeficient conditions associated with radiation, chemical and infectious factors, to restore suppressed immune responses and the depressed state of bone marrow hematopoiesis; to increase the resistance of the organism to various pathological influences - infectious agents, chemical and / or physical factors (intoxication, radiation, etc.); as a hepatoprotective agent for chronic viral hepatitis B and C; for potentiating the therapeutic effects of antibacterial therapy of chronic obstructive pulmonary diseases; for the prevention of postoperative purulent complications.

Solution for injection 10 and 30 mg / ml is used as a part of complex anti-tuberculosis therapy of severe widespread forms of tuberculosis of all localizations, in the presence of drug resistance of mycobacterium tuberculosis, for the prevention of exacerbations of chronic hepatitis in patients with tuberculosis against the background of antituberculous therapy, for the treatment of toxic complications of antituberculous therapy.

The solution for injections is used as part of complex therapy of psoriasis, including moderate and severe forms with the presence of erythroderma, arthropathy.

Glutoxim ® is used in the complex therapy of malignant neoplasms. Glutoxim ® is used in oncology for the prevention and treatment of toxic manifestations of chemo- and radiotherapy (contributes to the reduction of hemo- and hepatotoxic effects). Glutoxim ® promotes the effective recovery of bone marrow hematopoiesis during antitumor therapy.

Glutoxim ® eliminates or alleviates the manifestations of nonspecific disease syndrome (anemia, fatigue, decreased appetite, increased pain sensitivity).

Contraindications:

The use of the drug is contraindicated in cases of individual intolerance, during pregnancy, during lactation.

Dosing and Administration:

The drug Glutoxim® is administered intravenously, intramuscularly, subcutaneously. Assign daily 5-40 mg (for 1 course - 50-300 mg), depending on the nature of the disease.

With the preventive purpose, the drug is administered intramuscularly daily for 5-10 mg for 2 weeks.

In the complex therapy of tuberculosis Glutoxim ® 60 mg is administered once a day for the first 10 days daily intramuscularly, the next 20 days Glutoxim ® 60 mg is administered intramuscularly every other day, one injection per day.

If necessary, repeat the course of treatment after 1-6 months.

In the complex therapy of psoriasis, Glutoxim® is administered intramuscularly daily at a daily dose of 10 mg for 15 days, then for 5 weeks 2 times a week at a daily dose of 10 mg. A total of 25 injections per course of treatment.

As a means of accompanying chemotherapy in oncology, Glutoxim® 60 mg is administered subcutaneously 1.5-2 hours before antitumor agents are used. Further between courses of chemotherapy Glutoxim® 60 mg is administered subcutaneously every other day. In the next course of chemotherapy, the pattern of application of the drug is repeated.

As a means of accompanying radiotherapy, Glutoxim® 60 mg is injected subcutaneously 0.5-1 hour after a regular irradiation session every other day throughout the course of radiotherapy.

Glutoxim® can be administered in a single syringe with water-soluble drugs.

Side effects:

In some patients, there may be a slight increase in temperature (up to 37.1 ° C - 37.5 ° C), soreness at the injection site of the drug.In case of poor subjective tolerability of morbidity, Glutoxim® is administered together with 1-2 ml of a 0.5% solution of novocaine.

Overdose:

No cases of drug overdose have been reported.

Interaction:

Glutoxim®, when combined, potentiates the bacteriostatic effect of isoniazid, rifampicin, rifabutin, cycloserine, capreomycin, levofloxacin on Mycobacterium tuberculosis, anthracycline antibiotic doxorubicin, an alkylating agent - etoposide on tumor cells.

Glutoxim ® reduces the therapeutic effect of nifedipine and verapamil.

Inhibitors of the cyclooxygenase pathway of oxidation of arachidonic acid - indomethacin, meloxicam - reduce or completely suppress the pharmacological action of Glutoxim®.

Special instructions:

As the carrier solution for infusion introduction isotonic sodium chloride solution or 5% glucose solution is used.

Form release / dosage:

Solution for injection, 5, 10 and 30 mg / ml.

Packaging:

1 or 2 ml into neutral glass ampoules.

For 5 or 10 ampoules (containing 1 ml or 2 ml) in a contoured cell pack of a polyvinyl chloride film and foil of aluminum printed varnished or paper with a single-layer polyvinylidene chloride coating.

For 5 or 10 ampoules (containing 1 ml or 2 ml) in a contiguous cell pack of a polyvinyl chloride film without foil or coating.

For 1, 2, 5 or 10 (containing 5 or 10 ampoules) contour packs together with a knife ampoule or scarifier together with instructions for use in a pack of cardboard.

When packing ampoules with incisions, rings and break points, scarifiers or ampoule knives do not.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N002010 / 01

Date of registration:29.09.2008 / 14.03.2016

Expiration Date:Unlimited

The owner of the registration certificate:PHARMA VAM, CJSC PHARMA VAM, CJSC Russia