GLUTOKSIM

Active material: glutamyl-cysteinyl-glycine disodium
When ATH: L03AX
CCF: Immunomodulator c system cytoprotective effect – tiopoetin
ICD-10 codes (testimony): A15, A18, B18.1, B18.2, J44, L40, T79.3, Z29.8, Z51.8
When CSF: 14.01.06
Manufacturer: PHARMA YOU ZAO (Russia)

Pharmaceutical form, composition and packaging

Solution for injection colorless or slightly colored, clear, odorless or with a faint odor of acetic acid.

Excipients: sodium acetate, acetic acid (diluted to pH 6.0), water d / and.

1 ml – glass ampoule (5) – packings Valium planimetric (1) – packs cardboard.

Solution for injection colorless or slightly colored, clear, odorless or with a faint odor of acetic acid.

Excipients: sodium acetate, acetic acid (diluted to pH 6.0), water d / and.

2 ml – glass ampoule (5) – packings Valium planimetric (1) – packs cardboard.

Solution for injection colorless or slightly colored, clear, odorless or with a faint odor of acetic acid.

Excipients: sodium acetate, acetic acid (diluted to pH 6.0), water d / and.

1 ml – glass ampoule (5) – packings Valium planimetric (1) – packs cardboard.

Solution for injection colorless or slightly colored, clear, odorless or with a faint odor of acetic acid.

Excipients: sodium acetate, acetic acid (diluted to pH 6.0), water d / and.

2 ml – glass ampoule (5) – packings Valium planimetric (1) – packs cardboard.

Pharmacological action

Glutoksim^® It plays an important role in the regulation of metabolic processes in cells and tissues. It has a selective effect on the sulfhydryl group of cell surface receptors, which leads to the restoration of sensitivity to regulatory peptide transport molecules, defines immunomodulatory, hemostimulating, toksikomodifitsiruyuschy tsitotropnye and other effects of the drug.

Glutoksim^® contributes to the actions of regulatory molecules peptide on normal and transformed cells. The main properties of the drug are immunofiziologicheskim: high tropism of the drug to the cells of the central immune system and lymphoid tissue; strengthening of bone marrow hematopoiesis: of erythropoiesis, lymphopoiesis and granulocyte-monocytopoiesis; Activation of phagocytosis (incl. in conditions of immunodeficiency states), recovery in peripheral blood neutrophil level, monotsitov, functional capacity of lymphocytes and tissue macrophages.

Among immunobiochemical effects of the drug should be made: stimulatory effect of the drug on the cascade mechanisms of phosphate modification of key proteins signalperedayuschih systems; initiation of action of cytokines, incl. IL 1, IL 6, Tumor Necrosis Factor, interferons, Erythropoietin, IL 2.

When used in oncology Glutoksim^® promote effective functional recovery of bone marrow hematopoiesis during anticancer therapy. Glutoksim^® removes or smoothes the nonspecific symptoms of illness syndrome (anemia, fatigue, decreased appetite, increased pain sensitivity).

Pharmacokinetics

Absorption

After the / m, w / w and s / c injection bioavailability exceeds 90%. It noted a linear relationship between dose and concentration of drug in blood plasma. C_max after / in the introduction is achieved within 2-5 m, After the / m – during 7-10 m.

Metabolism and excretion

It is metabolized in the organs and tissues of the body. Excreted in the urine.

Testimony

- Prevention and treatment of secondary immunodeficiency states, related to radiation, chemical and infectious factors;

- Restoration of the suppressed immune responses and oppressed status 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 the therapeutic effects of antibiotic treatment of chronic obstructive pulmonary disease;

- Prevention of postoperative septic complications;

- Heavy, common forms of tuberculosis of various localization (in the complex therapy);

- Tuberculosis, resistant to drug therapy;

- Prevention of exacerbations of chronic hepatitis B in patients with tuberculosis in the background of anti-tuberculosis therapy;

- Treatment of toxic complications of TB treatment;

- In the complex treatment of psoriasis, incl. moderate and severe forms of the presence of erythroderma, artropatii;

- In the complex treatment of malignant tumors – for the prevention and treatment of toxic effects of chemo- and radiation therapy (reduces hemo- and hepatotoxicity).

Glutoksim^® It promotes effective functional recovery of bone marrow hematopoiesis during anticancer therapy. Glutoksim^® removes or smoothes the nonspecific symptoms of illness syndrome (anemia, fatigue, decreased appetite, increased pain sensitivity).

Dosage regimen

Adults the drug is administered in /, i / m and s / c in a dose of 5-40 mg daily depending on the severity of the disease. Kursovaya dose – 50-300 mg.

FROM prophylactically drug use / m dose 5-10 mg daily for 2 weeks.

At tuberculosis (in the complex therapy) the drug is prescribed in / m 60 mg 1 time / day daily for the first 10 days, subsequent 20 Glutoxim days^® injected i / m in a dose of 60 mg a day. If necessary, a second course of treatment by 1-6 Months.

At psoriaze (in the complex therapy) the drug is prescribed in the / m daily in a daily dose 10 mg for 15 days, then for a further 5 weeks 2 twice a week in a daily dose of 10 mg. A course of treatment - 25 injection.

As maintenance chemotherapy agents in oncology Glutoksim^® injected s / c in a dose of 60 mg for 1.5-2 h before the application of anticancer agents. Further, between courses of chemotherapy drug is administered s / c at a dose 60 mg a day. The next course of chemotherapy Regimen repeated.

As means accompanying radiotherapy Glutoksim^® injected s / c in a dose of 60 mg after 0.5-1 h after irradiation of the next session a day during the entire course of radiation therapy.

Glutoksim^® may be administered in the same syringe with a water-soluble drug.

Side effect

Maybe: in some cases – fever (37.1-37.5° C), soreness at the injection site (to reduce pain, the introduction of the drug at the same time 1-2 ml 0.5% procaine solution / Novocaine /).

Contraindications

- Pregnancy;

- Lactation (breast-feeding);

- Hypersensitivity to the drug.

Pregnancy and lactation

Clinical trials of the drug Glutoxim^® Pregnancy and lactation (breast-feeding) not carried out.

Cautions

In clinical studies demonstrated an increase in the frequency of positive responses to radical radiation therapy for locally advanced cervical cancer. The frequency of complete remission was 77% (in the control group - 38%). Observed faster recovery of peripheral blood and improve the general condition of patients on the background radiation therapy.

Using glutoxim^® in the treatment of non-small cell lung cancer chemotherapy allowed to carry out in full, reduce the need for colony stimulating factor, Erythropoietin, transfusions of blood and blood components.

According to the results of clinical trials, the appointment glutoxim^® in patients with psoriasis experienced a faster and complete regression of lesions (the infiltration, peeling, puffiness), decreased itching, improves quality of life. When Arthropathic form reduces the intensity of arthralgia and shorten hospital stay. With concomitant liver disease psoriasis Glutoxim^® demonstrated hepatoprotective effect. A more rapid regression of the symptoms of psoriasis also shows the children, receiving Glutoxim^® in the complex therapy.

Demonstrated a significant increase in terms of remission of psoriasis: through 6 months after treatment aggravation arose in 19% patients (in the control group - in 29%), through 12 months - in 34% (in the control group - in 46%).

When tuberculosis is shown shortening bacterial, reducing the frequency and severity of toxic reactions in the combined use of anti-TB drugs (ALT increase, IS, bilirubin), reduction in the incidence of toxic hepatitis. Application glutoxim^® It prevents development of dyspepsia, caused by the use of rifampicin and isoniazid in high doses (gravity / pain in the right upper quadrant, nausea, loss of appetite). The normalization of the menstrual cycle and increase potency, which caused a decrease adverse events of chemotherapy.

Glutoksim^® It allows you to quickly prepare patients for surgery and reduce the frequency of specific postoperative complications in patients with drug-resistant fibro-cavernous pulmonary tuberculosis.

In the combined therapy of infections, sexually transmitted, Glutoksim^®, facilitating exocytosis intracellularly located parasites, It increases the efficiency of the use of antimicrobials. In the treatment of chronic recurrent STIs showed an increase in terms of remission and relapse in the absence of a significant number of patients.

Overdose

Currently, cases of drug overdose Glutoxim^® not reported.

Drug Interactions

Not found clinically significant drug interactions Glutoxim^® with other drugs.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored in the dark, inaccessible to children at temperature not exceeding 25 ° C. Shelf life – 3 year. Do not use after expiry date, on the package.