Glutoxim | Glutoxim ampoules 1%, 2 ml, 5 pcs.

Latin name

GLUTOXIM

Release form

Injection, colorless or slightly colored, transparent, odorless or with a slight smell of acetic acid.

Packaging

2 ml (1%) - glass ampoules (5) - contour cell packaging (1) - packs of cardboard.

Pharmacological action of

Glutoxim® has an immunomodulatory, hemostimulating, detoxifying, hepatoprotective effect, inhibits the drug resistance of tumor cells to anthracycline antibiotics, alkylating agents allows to overcome the drug resistance of Mycobacterium antigens with tuberculosis (enol-APB reductase gene). Glutoxim® potentiates the effect of doxorubicin on tumor cells, chemotherapeutic agents (isoniazid, rifampicin, rifabutin, cycloserine, capreomycin, levofloxacin, the cationic antimicrobial peptide catalecidin) on Mycobacterium tuberculosis.

The immunomodulatory effect of the Glutoxim® preparation is due to a receptor-mediated effect on macrophage-dependent signaling pathways on calcium, which leads to an increase in the survival and functional viability of tissue macrophages

exocytosis of submembrane granules with intracellular parasitic activity of mycproblactid lysergicides activity lysergicides and death of microorganisms

secretion of cytokines: interleukin 1, interleukin 6, TNF, interferons, erythropoiet on,

interleukin 2-cationic antimicrobial peptides defensins, kataletsidinov.

The hemostatic effect of Glutoxim® is due to receptor-mediated enhancement of bone marrow hematopoiesis: the processes of erythropoiesis, lymphopoiesis and granulocyte-monocytopoiesis. The effect on the progenitor cells of different lines of blood cells is mediated by the functioning of the MAP and inositol kinase systems, leads to increased resistance of differentiating hematopoietic cells, restores their sensitivity to the action of endogenous factors of hematopoiesis.

The detoxifying and hepatoprotective effects of the drug are due to receptor-mediated increase in the expression of xenobiotic detoxification second-phase enzymes, including glutathione reductases, glutathione peroxidase, glutathione S-transferase, glucose-6-phosphate dehydrogenase, and hemo-oxygenase-lowering levels 1 toxic effects of radicals.

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

Glutoxim® initiates the transformation reaction of isoniazid - a prodrug, into a pharmacologically active form - isonicotinic acid, which has a bacteriostatic effect on Mycobacterium tuberculosis, which overcomes the drug resistance of Mycobacterium tuberculosis due to the negative transformation of the genes of katG (genase) catalase APB reductase).

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

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

Pharmacokinetics.

Absorption

Refers to a group of natural metabolites, which determines the characteristics of its metabolism by existing cellular enzymatic systems. After i / m, iv or s / c administration, bioavailability exceeds 90%. A linear relationship between the dose and the concentration of the drug in the blood plasma is noted. Cmax after iv administration is achieved within 2-5 minutes, after i / m administration - within 7-10 minutes.

Metabolism and excretion

As a natural peptide product, it is metabolized in the organs and tissues of the body. It is excreted in the urine.

Indications

prevention and treatment of secondary immunodeficiency conditions associated with radiation, chemical and infectious factors

restoration of suppressed immune reactions and the depressed state of bone marrow hematopoiesis

increase the body's resistance to various influences (infection, intoxication, radiation)

as a hepatoprotective agent for chronic viral hepatitis B and C

potentiation of therapeutic effects of antibiotic therapy

prevention of postoperative purulent complications

severe, common forms of tuberculosis and various localization (as part of complex therapy)

tuberculosis, drug-resistant

prophylaxis of exacerbations of chronic hepatitis in patients with tuberculosis as a result of anti-tuberculosis therapy

treatment of toxic complications of anti-tuberculosis therapy

as part of complex therapy of uncomplicated forms of psoriasis, including as a part of complex therapy of drop-shaped and exudative forms of psoriasis, with psoriatic erythroderma and arthropathic psoriasis, in patients with toxic or viral hepatitis, manifestations of non-specific syndrome of chronic diseases

as part of complex therapy of malignant neoplasms - for the prevention and treatment of toxic manifestations of chemo- and radiation therapy ( helps to reduce hemo-and hepatotoxic effects).

GlutoximВ® promotes the effective restoration of bone marrow hematopoiesis during antitumor therapy. GlutoximВ® eliminates or smoothes out the manifestations of the nonspecific syndrome of the disease (anemia, fatigue, decreased appetite, increased pain sensitivity).

Contraindications

pregnancy

lactation (breastfeeding)

hypersensitivity to the components of the drug.

Use during pregnancy and lactation

Clinical studies of the use of the drug GlutoximВ® during pregnancy and lactation (breastfeeding) have not been conducted.

Composition

1 ml1 amp.

glutamyl-cysteinyl-glycine disodium 10 mg20 mg

Dosage and administration of

For adults, the drug is administered iv, i / m and s / c at a dose of 5-40 mg daily, depending on the severity of the disease. The course dose is 50-300 mg.

For prophylactic purposes, the drug is used IM in a dose of 5-10 mg daily for 2 weeks.

With tuberculosis (as part of complex therapy), the drug is prescribed IM 60 mg 1 time / day daily in the first 10 days, the next 20 days, Glutoxim® is administered IM in a dose of 60 mg every other day. If necessary, conduct a second course of treatment after 1-6 months.

As part of the complex therapy of uncomplicated forms of psoriasis, Glutoxim® is used im daily in a daily dose of 10 mg for 15 days, then for another 5 weeks 2 times a week in a daily dose of 10 mg. Only 25 injections per treatment course.

As a means of accompanying chemotherapy in oncology, Glutoxim® is administered subcutaneously at a dose of 60 mg 1.5-2 hours before the use of antitumor agents. Next, between the courses of chemotherapy, the drug is administered sc in a dose of 60 mg every other day. In the next course of chemotherapy, the regimen of the drug is repeated.

As a means of accompanying radiation therapy, Glutoxim® is administered subcutaneously at a dose of 60 mg through 0. 5-1 hours after the next radiation session every other day throughout the entire course of radiation therapy.

Glutoxim® can be administered in the same syringe with water-soluble drugs.

Side effects

Possible: in some cases, an increase in body temperature (37.1-37.5 РC), pain at the injection site (to reduce pain, it is possible to administer the drug simultaneously with 1-2 ml of 0.5% novocaine solution).

Drug interaction

Glutoxime® when combined use potentiates the bacteriostatic effect of isoniazid, rifampicin, rifabutin, cycloserine, capreomycin, levofloxacin on Mycobacterium tuberculosis, anthracycline, anthracycline, antibacterial agent

Glutoxim® decreases therapeuticallyn effect of nifedipine and verapamil.

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

Isotonic sodium chloride solution or 5% glucose solution is used as a carrier solution for infusion administration.

Overdose

There have been no reports of overdose with Glutoxim® at this time.

Storage conditions

The drug should be stored in a dark place, out of the reach of children, at a temperature not exceeding 25 РC.

Expiration

3 years. Do not use after the expiry date stated on the packaging.



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dosage form

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Pharma VAM, Russia