Polyoxidonium lyophilic powder for injection 6mg №5

Mechanism of action

Azoximer bromide has a complex action: immunomodulatory, detoxifying, antioxidant, anti-inflammatory.

Azoximera bromide increases the body's resistance to local and generalized infections of bacterial, fungal and viral etiology. It restores immunity in secondary immunodeficiency states caused by various infections, injuries, complications after surgery, burns, autoimmune diseases, malignant tumors, the use of chemotherapeutic agents, cytostatics, steroid hormones.

The basis of the mechanism of immunomodulating action of azoxymere bromide is a direct effect on phagocytic cells and natural killers, as well as the stimulation of antibody production. Azoximer bromide is able to stimulate the synthesis of Interferon alfa and interferon gamma, which determines its antiviral efficacy and the possibility of administration for the prevention and treatment of influenza and ARVI.

A characteristic feature of azoxymere bromide in local (intranasal, sublingual) use is the ability to activate the body’s early defense factors against infection: the drug stimulates the bactericidal properties of neutrophils,macrophages, enhances their ability to absorb bacteria, increases the bactericidal properties of saliva and secretions of the mucous membrane of the upper respiratory tract. Local application of azoxymere bromide in the complex treatment of ENT-organ diseases significantly reduces the duration of acute rhinitis, sinusitis, reduces the risk of intracranial complications of ENT pathologies, as well as the frequency and duration of exacerbations of chronic diseases. Detoxification and antioxidant properties of azoxymere bromide are determined by the structure and high molecular nature of the drug and are not associated with activation of immune mechanisms. Azoxymere bromide blocks soluble toxic substances and microparticles, has the ability to excrete toxins, heavy metal salts from the body, inhibits lipid peroxidation. The combination of antioxidant, antiradical, membrane stabilizing and chelating properties makes azoxymere bromide a powerful anti-inflammatory agent.

Inclusion of the drug in complex therapy in oncological patients reduces intoxication on the background of Chemotherapy and radiation therapy, in most cases allows for standard therapy without changing the scheme due to the development of infectious complications and side effects (myelosuppression, vomiting, diarrhea, cystitis, colitis, and others).

The use of azoximer bromide on the background of secondary immunodeficiency states allows to increase the effectiveness and shorten the duration of treatment, significantly reduce the use of antibiotics, bronchodilators, GCS, lengthen the period of remission.

Azoximer bromide is well tolerated, does not possess mitogenic, polyclonal activity, antigenic properties, does not have allergenic, mutagenic, embryotoxic, teratogenic and carcinogenic effects.

Azoxymere bromide is odorless and tasteless; it does not have a local irritant effect when applied to the mucous membranes of the eye, nose, and oropharynx.

Pharmacokinetics

Suction and distribution

Azoxymere bromide is characterized by rapid absorption and a high rate of distribution in the body. C_max drug in the blood when the / m introduction is achieved after 40 minutes. The bioavailability of the drug is high: more than 90% - when administered parenterally.

Azoxymere bromide is rapidly distributed to all organs and tissues of the body, it penetrates the BBB and the hematophthalmic barrier. No cumulative effect.

Metabolism and excretion

In the body of azoxymere, bromide is biodegradable to low molecular weight oligomers, excreted mainly by the kidneys, with feces no more than 3%.

T_1/2 for different ages - from 36 hours to 65 hours

Indications

As part of complex therapy in adults

- in case of chronic recurrent infectious and inflammatory diseases of different localization of bacterial, viral and fungal etiology in the acute phase;

- in acute viral, bacterial infections of upper respiratory tract, upper and lower respiratory tract, gynecological and urological diseases;

- in acute and chronic allergic diseases (includingpollinosis, bronchial asthma, atopic dermatitis), complicated by bacterial, viral and fungal infections;

- for malignant tumors during and after chemotherapy and radiation therapy to reduce the immunosuppressive, nephrotoxic and hepatotoxic effects of drugs;

- with generalized forms of surgical infections;

- for the prevention of postoperative infectious complications;

- to activate regenerative processes (fractures, burns, trophic ulcers);

- with rheumatoid arthritis, complicated by bacterial, viral and fungal infections, against the background of long-term immunosuppressants;

- with pulmonary tuberculosis.

As part of complex therapy in children older than 6 months

- in acute and chronic inflammatory diseases of any localization (including ENT organs, sinusitis, rhinitis, adenoiditis, hypertrophy of the pharyngeal tonsil, SARS) caused by pathogens of bacterial, viral, fungal infections;

- in acute allergic and toxic-allergic conditions complicated by bacterial, viral and fungal infections;

- in case of bronchial asthma complicated by chronic infections of the respiratory tract;

- with atopic dermatitis, complicated by purulent infection;

- with intestinal dysbiosis (in combination with specific therapy).

In the form of monotherapy in adults and children from 6 months

- for the prevention of influenza and SARS;

- for the prevention of postoperative infectious complications.

Dosage and administration

Methods of use of the drug Polyoxidonium^®: parenteral, intranasal, sublingual.

The dosage regimen, route of administration, the need and frequency of subsequent courses of therapy are determined by the doctor depending on the diagnosis, the severity of the disease, the age of the patient.

Adults

V / m or in / in drip

Parenteral (intramuscular or intravenous drip) drug is prescribed to adults in doses of 6-12 mg 1 time / day, every other day, or 1-2 times a week, depending on the diagnosis and the severity of the disease.

Atacute viral and bacterial infections of upper respiratory tract, upper and lower respiratory tract, gynecological and urological diseases: 6 mg daily for 3 days, then a day later in a course1 0 injection.

Atchronic recurrent infectious and inflammatory diseases of different localization, bacterial, viral and fungal etiology in the acute phase: on 6 mg every other day, spend 5 injections, then - 2 times a week with a course of 10 injections.

Atacute and chronic allergic diseases (including pollinosis, bronchial asthma, atopic dermatitis), complicated by bacterial, viral and fungal infections:6-12 mg, course - 5 injections.

Atrheumatoid arthritis, complicated by bacterial, viral and fungal infections, on the background of long-term immunosuppressants:6 mg every other day, 5 injections, then 2 times a week with a course of 10 injections.

Atgeneralized forms of surgical infections: 6 mg daily for 3 days, then - every other day with a course of 10 injections.

To activate regenerative processes (fractures, burns, trophic ulcers):on 6 mg within 3 days, further - in a day in a course of 10 injections.

For the prevention of postoperative infectious complications: 6 mg every other day - 5 injections.

Atpulmonary tuberculosis:6 mg 2 times a week with a course of 20 injections.

Havepatients with cancer:

- before and during chemotherapy to reduce the immunosuppressive, hepato-and nephrotoxic effects of chemotherapeutic agents appoint 6 mg every other day in a course of 10 injections; further, the frequency of administration is determined by the doctor depending on the tolerability and duration of chemotherapy and radiation therapy;

- for the prevention of the immunosuppressive effect of the tumor, for the correction of immunodeficiency after chemotherapy and radiation therapy, after surgical removal of the tumor shown long-term use of the drug Polyoxidonium^® (from 2-3 months to 1 year) at 6 mg 1-2 times a week. When prescribing a long course is not observed the effect of cumulation, manifestations of toxicity and addiction.

Intranasal administered at a dose of 6 mg / day - 3 drops in each nasal passage 3 times / day for 10 days:

- fortreatment of acute and exacerbations of chronic infections of the upper respiratory tract;

- forenhance regenerative processes of mucous membranes;

- for prevention of complications and recurrence of chronic diseases;

- for prevention of influenza and SARS.

Recommended treatment regimens in children

The drug is administered parenterally, intranasally, sublingually.The doctor determines the dose and route of administration, depending on the diagnosis, the severity of the disease, the age of the patient.

V / m or in / in drip

Parenteral (IM or IV drip) drug is prescribedchildren from 6 months at a dose of 100-150 mcg / kg daily, every other day or 2 times a week with a course of 5-10 injections.

Atacute and exacerbations of chronic inflammatory diseases of any localization (including ENT organs - sinusitis, rhinitis, adenoiditis, hypertrophy of the pharyngeal tonsil, ARVI) caused by pathogens of bacterial, viral, fungal infectionsthe drug is prescribed in 100 µg / kg for 3 days in a row, followed by a course of 10 injections.

Atacute allergic and toxic-allergic conditions (including bronchial asthma, atopic dermatitis) complicated by bacterial, viral and fungal infectionsthe drug is administered intravenously in a drip in a dose of 100 µg / kg for 3 days daily, then every other day with a course of 10 injections in combination with basic therapy.

Intranasal and sublingual

Apply daily in a daily dose of 150 mg / kg course up to 10 days. The drug is administered in 1-3 drops in one nasal passage or under the tongue with an interval of at least 1-2 hours, in 2-3 doses per day.

1 drop (0.05 ml) of the prepared solution contains 150 μg of the drug.

For intrazal and sublingual administration, the calculation of the daily dose forchildrenpresented in the table:

When a child’s body weight is more than 20 kg, the daily dose is calculated at the rate of 1 drop per 1 kg of body weight, but not more than 40 drops (6 mg of active ingredient).

Intranasal the drug is prescribed daily, 1-2 drops in each nasal passage 3 times / day course up to 10 days (see table):

- in acute and chronic rhinitis, rhinosinusitis, adenoiditis (treatment and prevention of exacerbations);

- for preoperative preparation of patients with surgical interventions for ENT pathology, as well as in the postoperative period in order to prevent infectious complications or relapse of the disease;

- for the treatment and prevention of influenza and other acute respiratory viral infections (within 1 month before the expected epidemic, at any time after the onset of the disease and in the period of convalescence).

Sublingual drug is prescribedchildren of early, preschool and primary school age daily in a daily dose of 150 mcg / kg in 2 divided doses for 10 days:

- with adenoiditis, tonsil hypertrophy (as a component of conservative therapy);

- for preoperative preparation and postoperative rehabilitation;

- for seasonal prophylaxis of exacerbations of chronic foci of infections of the oropharynx, upper respiratory tract, inner and middle ear;

- for the treatment of intestinal dysbiosis (in combination with basic therapy) for 10 days.

Rules for the preparation of solutions for parenteral (IM / IV) administration

For cookingsolution for the / m introduction The contents of the 3 mg vial are dissolved in 1 ml (the contents of the 6 mg vial in 1.5-2 ml) of water for injection or 0.9% sodium chloride solution. After making the solvent, the drug is left for 2-3 minutes for swelling, then stirred with rotational movements, without shaking.

For cookingsolution for in / in (drip) introduction The contents of the vial are dissolved in 2 ml of sterile 0.9% sodium chloride solution.After the solvent is added, the preparation is left for 2-3 minutes for swelling, then it is stirred by rotational movements