Azoximer bromide has a combined effect: immunomodulating, detoxifying, antioxidant and moderate anti-inflammatory.
The basis of the immunomodulating action of azoximer bromide is a direct effect on phagocytic cells and natural killers, as well as stimulation of antibody formation and synthesis of interferon-alpha and interferon-gamma.
The detoxification and antioxidant properties of azoximer bromide are largely determined by the structure and high-molecular nature of the drug. Azoximer bromide increases the body's resistance to local and generalized infections of bacterial, fungal and viral etiology. It also restores immunity in secondary immunodeficiency conditions, caused by various infections, injuries, complications after surgery, burns, autoimmune diseases, malignant neoplasms, the use of chemotherapeutic agents, cytostatics, steroid hormones.
A characteristic feature of azoximer bromide in local (nasal, sublingual) use is the ability to activate factors of the body's early defense against infection: the drug stimulates the bactericidal properties of neutrophils, macrophages, enhances their ability to absorb bacteria, increases the bactericidal properties of saliva and the secretion of the mucous membranes of the upper respiratory tract.
Azoximer bromide blocks soluble toxic substances and microparticles, has the ability to remove toxins, salts of heavy metals from the body, inhibits lipid peroxidation, both through the capture of free radicals and through the elimination of catalytically active Fe 2⁺ ions. Azoximer bromide reduces the inflammatory response by normalizing the synthesis of pro- and anti-inflammatory cytokines.
Azoximer bromide is well-tolerated, does not have mitogenic, polyclonal activity, antigenic properties, does not have allergenic, mutagenic, embryotoxic, teratogenic or carcinogenic effects. Azoximer bromide has no smell and taste, does not have a locally irritating effect when applied to the mucous membranes of the nose and oropharynx.

Azoximer bromide is characterized by rapid absorption and high speed of distribution in the body. Maximum concentration is achieved in blood during intramuscular administration in 40 minutes after the injection. The half-life for different ages ranges from 36 to 65 hours. The bioavailability of the drug is high: more than 90% during parenteral administration.
Azoximer bromide is rapidly distributed throughout all organs and tissues of the body, penetrates the blood-brain and blood-aqueous barrier. No cumulative effect observed for this medicine. In the body, azoximer bromide undergoes biodegradation to low-molecular weight oligomers, excreted mainly by the kidneys, with feces not more than 3%.

The drug is used in adults and children from 6 months old for the treatment and prevention of infectious and inflammatory diseases (of viral, bacterial or fungal etiology) in the stage of exacerbation and remission.

For adults treatment of the following conditions (as a component of combined therapy):

• chronic recurrent infectious and inflammatory diseases of various localization, bacterial, viral and fungal etiology in the acute stage;
• acute viral, bacterial infections of ENT-organs, upper and lower respiratory tract, gynecological and urological diseases;
• acute and chronic allergic diseases (including pollen fever, bronchial asthma, atopic dermatitis) complicated by bacterial, viral and fungal infections;
• malignant tumors during and after chemotherapy and radiation therapy to reduce the immunosuppressive, nephro- and hepatotoxic effects of drugs;
• generalized forms of surgical infections; to activate regenerative processes (fractures, burns, trophic ulcers);
• rheumatoid arthritis complicated by bacterial, viral and fungal infections associated with the prolonged use of immunosuppressants;
• lungs tuberculosis.

For the treatment of children over 6 months old (in combined therapy):

• acute and exacerbation of chronic inflammatory diseases of any localization (including ENT-organs: sinusitis — sinusitis, rhinitis, adenoiditis, hypertrophy of the pharyngeal tonsil, acute respiratory infection) caused by pathogens of bacterial, viral, fungal infections;
• acute allergic and toxic-allergic conditions complicated by bacterial, viral and fungal infections;
• bronchial asthma complicated by chronic respiratory tract infections;
• atopic dermatitis complicated by purulent infection;
• intestinal disbacteriosis (in combination with specific therapy).

For prophylaxis (monotherapy) in children over 6 months old and in adults:

• influenza and acute respiratory infections;
• post-surgery infectious complications.

• increased individual sensitivity;
• pregnancy, lactation;
• children aged below 6 months;
• acute renal failure.

• chronic renal failure (the drug is used no more than 2 times a week).

The use of the drug Polyoxidonium^® is contraindicated for pregnant women and women during breastfeeding (there is no clinical experience of its use in these conditions).
In an experimental study of the drug Polyoxidonium^® in animals, no effect on the generative function (fertility) of males and females, embryotoxic and teratogenic effects, effects on the development of the fetus were found, both when the drug was administered during pregnancy and during lactation.

Routes of administration of Polyoxidonium^®: parenteral, intranasal, sublingual.
The methods of administration, the dosage regimen, the necessity and frequency of the subsequent courses of therapy are chosen by the doctor depending on the severity of the disease and the age of the patient.

Preparation of solutions for parenteral administration (intramuscularly and intravenously):

• For intramuscular administration, Polyoxidonium^® 3 mg is dissolved in 1 mL (dose 6 mg in 2 mL) of water for injection or 0.9% sodium chloride solution. After adding the solvent, the drug is left for 2–3 minutes to swell, then mixed with rotary movements without shaking.
• For intravenous drop administration, Polyoxidonium^® is dissolved in 2 mL of sterile 0.9% sodium chloride solution. After adding the solvent, the drug is left for 2–3 minutes to swell, then mixed with rotary movements. The dose adjusted for the patient is sterilely transferred into the vial/bag with 0.9% sodium chloride solution.

The prepared solution for parenteral administration is not subjected to storage.

Preparation of the solution for intranasal and sublingual administration:

• for children 3 mg dose is dissolved in 1.0 mL (20 drops), 6 mg dose in 2.0 mL (40 drops) (one drop (0.05 mL) of the prepared solution contains 0.15 mg of the drug);
• for adults 6 mg dose is dissolved in 1.0 mL (20 drops) of distilled water, 0.9% sodium chloride solution or boiled water at room temperature.

The medicinal product is administered parenterally (intramuscularly or intravenously): at doses 6–12 mg once daily, or every other day, or 1–2 times a week depending on diagnosis and disease severity.
During acute viral, bacterial infections of ENT-organs, upper and lower respiratory tract, gynecological and urological diseases: 6 mg daily for 3 days, then every other day by total course of 10 injections.
During chronic recurrent infectious and inflammatory diseases of various localization, bacterial, viral and fungal etiology in the acute stage: 6 mg every other day, 5 injections, then 2 times a week by the course of 10 injections.
Acute and chronic allergic diseases (including pollen fever, bronchial asthma, atopic dermatitis) complicated by bacterial, viral and fungal infections: 6–12 mg, course of 5 injections.
Rheumatoid arthritis complicated by bacterial, viral and fungal infections associated with the prolonged use of immunosuppressants: 6 mg every other day, 5 injections, then 2 times a week by the course of 10 injections.
Generalized surgical infections: 6 mg daily for 3 days, then every other day by total course of 10 injections.
For activation of regeneration processes (fractures, burns, trophic ulcers): 6 mg for 3 days, then every other day by total course of 10 injections.
Prevention of post-surgery infectious complications: 6 mg every other day, course of 5 injections.
Lungs tuberculosis: 6 mg 2 times a week by the course of 20 injections.

In oncological patients:

• before and during chemotherapy to decrease immunosuppressive, hepato- and nephrotoxic action of chemotherapeutic agents 6 mg every other day by course of 10 injections; further the frequency of injection is defined by a doctor depending on tolerance and duration of chemo- and radiation therapy;
• for the prevention of immunosuppressive effect of tumor, for correction of immunodeficiency after chemo- and radiation therapy, after surgical tumor removal long-term using of Polyoxidonium^® (from 2–3 months to 1 year) 6 mg 1–2 times a week is indicated. When prescribing a long-term course, there is no accumulation effect, manifestations of toxicity and addiction.

For intranasal administration administer 6 mg per day (3 drops in each nasal lumen 3 times a day for 10 days):

• for the treatment of acute and exacerbations of chronic ENT-organs infections;
• to enhance the regenerative processes of the mucous membranes;
• to prevent chronic diseases' complications and relapses;
• for prophylaxis of influenza and ARVI.

Routes of administration of Polyoxidonium^®: parenteral, intranasal, sublingual. The methods of administration are chosen by a physician depending on disease severity and age of the patient.
Parenteral (intramuscular or intravenous): administered to children from 6 months at a dose of 0.1–0.15 mg/kg daily, every other day or 2 times a week with a course of 5–10 injections.
Intranasal and sublingual: daily at a dose of 0.15 mg/kg for the period up to 10 days.
The drug is administered in 1–3 drops in one intranasal passage or under the tongue with an interval of at least 1–2 hours, in 2–3 doses per day.
One drop (0.05 mL) of the prepared solution contains 0.15 mg of the drug.
Calculation of the daily dose for intranasal and sublingual administration is provided in Table 1.
Table 1. Calculation of Polyoxidonium^® daily dose for intranasal and sublingual administration in children

Weight of a child	Number of drops a day
5 kg	5 drops
10 kg	10 drops
15 kg	15 drops
20 kg	20 drops

If 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 the active substance).
The prepared solution for intranasal and sublingual administration can be stored at room temperature in the manufacturer's packaging up to 48 hours.

The recommended therapeutic regimen for children

Parenterally:

• During acute and exacerbation of chronic inflammatory diseases of any localization (including ENT-organs: sinusitis, rhinitis, adenoiditis, hypertrophy of the pharyngeal tonsil, acute respiratory infection) caused by pathogens of bacterial, viral, fungal infections: 0.1 mg/kg for 3 consecutive days, then every other day by total course of 10 injections.
• During acute allergic and toxico-allergic diseases (including bronchial asthma, atopic dermatitis) complicated by bacterial, viral and fungal infections: intravenous drop infusion at a dose of 0.1 mg/kg, for 3 consecutive days, then every other day, a course of 10 injections in combination with basic therapy.

Intranasally: daily 1–2 drops in each intranasal lumen 3 times a day up to 10 days (see the calculation of the daily dose for intranasal and sublingual administration in Table 1):

• during acute and chronic rhinitis, rhinosinusitis, adenoiditis (treatment and prevention of exacerbations);
• for pre-operative preparation of patients during ENT pathology surgical interventions, as well as in the post-operative period in order to prevent infectious complications or relapses of the disease;
• for the treatment and prevention of influenza and other acute respiratory viral infections (within 1 month before the alleged epidemic, at any time after the onset of the disease and during the period of recovery).

Sublingually for children of early, preschool and primary school age: daily at a dose of 0.15 mg/kg in 2 doses for 10 days:

• during adenoiditis, tonsil hypertrophy (as a component of conservative treatment);
• for pre-surgery preparation and post-surgery rehabilitation;
• for seasonal prevention of exacerbations of chronic infections of the oropharynx, upper respiratory tract, inner and middle ear;
• for the treatment of intestinal disbacteriosis (in combination with basic therapy) for 10 days.

While using Polyoxidonium^®, the following general and local reactions were observed:

• during parenteral administration: rare (≥1/1 000 to <1/100) — tenderness, redness and thickening of the skin at the site of administration;
• during parenteral administration and topical application: very rare (≥1/10 000) — increased body temperature, slight anxiety, chills, hypersensitivity to the components of the drug (allergic reactions).