Polyoxidonium, 6 mg/ml 1 ml 5 pcs

Pharmacotherapeutic group:

immunomodulatory agent.

ATX code: [L0Z]

Pharmacological properties

Pharmacodynamics

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

The basis of the mechanism of immunomodulatory action of Azoximer bromide is direct effect on phagocytic cells and natural killer cells as well as stimulation of antibody formation, synthesis of interferon-alpha and interferon-gamma.

The detoxifying and antioxidant properties of Azoximer bromide are largely determined by the structure and high molecular weight nature of the drug. Azoximera bromide increases the body’s resistance to local and generalized infections of bacterial, fungal and viral etiology. It restores immunity in conditions of secondary immunodeficiency caused by various infections, injuries, complications after surgical operations, burns, autoimmune diseases, malignant tumors, chemotherapeutic agents, cytostatics, steroid hormones.

A characteristic feature of Azoximer bromide when applied topically (intranasally, sublingually) is the ability to activate the body’s early defense factors against infection: the drug stimulates the bactericidal properties of neutrophils, macrophages and increases their ability to engulf bacteria, increases bactericidal properties of saliva and mucous secretions of the upper respiratory tract.

Azoximera bromide blocks soluble toxic substances and
micro particles, has the ability to remove toxins, salts of heavy metals from the body, inhibits lipid peroxidation through both interception of free radicals and through the elimination of catalytically active Fe2+ ions. Azoximer bromide reduces the inflammatory response by normalizing the synthesis of pro- and anti-inflammatory cytokines.

Azoximera bromide is well tolerated, has no mitogenic, polyclonal activity, antigenic properties, has no allergic, mutagenic, embryotoxic, teratogenic and carcinogenic action. Azoximer bromide
is odorless and tasteless, has no local irritant effect when applied
to the mucous membranes of the nose and oropharynx.

Pharmacokinetics

Azoximera bromide is characterized by rapid absorption and high rate of distribution in the body. Maximum concentration of the drug in blood when administered intramuscularly is reached after 40 minutes. The half-life for different ages is from 36 to 65 hours. Bioavailability of the drug is high: more than 90% when administered parenterally.

Azoximer bromide is quickly distributed to all organs and tissues of the body, penetrates through the blood-brain barrier and blood-ophthalmic barrier. There is no cumulative effect. In the body Azoximer bromide undergoes biodegradation to low-molecular oligomers, excreted mainly by the kidneys, with feces –
not more than 3%.

Indications

It is used in adults and children from 6 months of age for the treatment and prevention of infectious and inflammatory diseases (viral, bacterial and fungal etiology), in acute and remission stages.

To treat adults (in combination 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 tracts, gynecological and urological diseases
• acute and chronic allergic diseases (including pollinosis, bronchial asthma, atopic dermatitis), complicated by bacterial, viral and fungal infection;
• malignant tumors in the process of 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, against a background of long-term immunosuppressant therapy;
• tuberculosis of the lungs.

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

• acute and exacerbation of chronic inflammatory diseases of any localization (including.
• 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;
• gut disbacteriosis (combined with specific therapy).

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

• flu and acute respiratory infections;
• post-operative infectious complications.

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Active ingredient

Azoximera bromide

Composition

Active ingredient: azoximera bromide 3 mg or 6 mg;

Excipients: mannitol 0.9 mg, povidone K 17 0.6 mg (for 3 mg dosage); mannitol 1.8 mg, povidone K 17 1.2 mg (for 6 mg dosage).

How to take, the dosage

Methods of administration of Polioxidonium®: parenteral, intranasal, sublingual.

Methods of administration, dosing regimen, necessity and frequency of subsequent courses of therapy are chosen by a physician depending on the severity of the disease and age of the patient.

Preparing solutions for parenteral administration (intramuscular and intravenous):

For intramuscular administration, the drug Polyoxidonium® 3 mg is dissolved in 1 ml
(dose of 6 mg in 2 ml) of water for injection or 0.9% sodium chloride solution. After adding the solvent the drug is left to swell for 2-3 minutes, then stir it with rotary movements without shaking.

For intravenous drip administration Polioxidonium® is dissolved in 2 ml of sterile 0.9% sodium chloride solution. After the solvent is added, the drug is left to swell for 2-3 minutes, then it is stirred with rotating movements. The calculated dose for the patient is sterilely transferred into a vial/packet with 0.9% sodium chloride solution.

The prepared solution for parenteral administration must not be stored.

Preparing solution for intranasal and sublingual administration:

For children, the 3 mg dose is dissolved in 1.0 ml (20 drops), the 6 mg dose in 2.0 ml (40 drops)
(one drop (0.05 ml) of prepared solution contains 0.15 mg of the drug);

For adults, a dose of 6 mg is dissolved in 1.0 ml (20 drops) of distilled water,
0.9% sodium chloride solution or boiled water at room temperature.

Manual administration and dosages in adults

Parenterally (intramuscularly or intravenously): The drug is given to adults in dosages of 6-12 mg 1 time daily, every other day or 1 or 2 times a week depending on the diagnosis and disease severity.

In acute viral and bacterial infections of ENT organs, upper and lower respiratory tracts, gynecologic and urologic diseases: 6 mg daily for 3 days and then 10 injections once a day.

In chronic recurrent infectious-inflammatory diseases of various localizations, bacterial, viral and fungal etiology, in the acute stage: 6 mg every 5 injections daily, 2 times a week with 10 injections.

In case of acute and chronic allergic diseases (including pollen allergy, bronchial asthma, atopic dermatitis) complicated by bacterial, viral and fungal infection: 6-12 mg, 5 injections.

In rheumatoid arthritis complicated by bacterial, viral and fungal infection, against the background of long-term immunosuppressant therapy: 6 mg every other day
5 injections, then 2 times a week for a course of 10 injections.

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

For activation of the regenerative processes (fractures, burns, trophic ulcers): 6 mg for 3 days, then every other day for 10 injections.

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

In case of pulmonary tuberculosis: 6 mg 2 times a week for a course of 20 injections.

In cancer patients:

– before and against the background of chemotherapy to reduce the immunosuppressive, hepato- and nephrotoxic effects of chemotherapeutic agents: 6 mg every other day for a course of
10 injections; further the frequency of administration is determined by the doctor depending on tolerance and duration of chemotherapy and radiation therapy;

In order to prevent immunosuppressive effects of the tumor, to correct immunodeficiency after chemotherapy and radiation therapy, after surgical removal of a tumor, long-term use of Polioxidonium® (from 2-3 months to 1 year) 6 mg 1-2 times a week is indicated. No cumulation effect, toxicity or habituation are observed when prescribing a long course.

Intranasally, 6 mg daily (3 drops in each nostril 3 times a day – for 10 days):

– for the treatment of acute and exacerbations of chronic infections of the ENT organs;

– to enhance the regenerative processes of mucous membranes;

– for the prevention of complications and relapses of chronic diseases;

– for the prevention of flu and acute respiratory infections.

Methods of administration and doses in children

Methods of administration of Polioxidonium®: parenteral, intranasal and sublingual. Methods of administration are chosen by a doctor, depending on the severity of the disease and the age of the patient.

Parenteral (intramuscular or intravenous): should be administered in children from 6 months old at the dose of 0.1-0.15 mg/kg daily, every other day or twice a week for the course of 5-10 injections.

Intranasally and sublingually: daily in a daily dose of 0.15 mg/kg for up to 10 days.

The drug is administered in 1-3 drops in one nasal passage or under the tongue at intervals 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.

The calculation of the daily dose for intranasal and sublingual administration is shown in Table 1.

Table 1. Calculation of daily dose of Polioxidonium® for intranasal or sublingual administration in children.

The prepared solution for intranasal and sublingual use can be stored at room temperature in the manufacturer’s package for up to 48 hours.

Recommended treatment regimens in children:

Parenterally:

In acute and exacerbations of chronic inflammatory diseases of any localization (including. In acute and chronic inflammatory diseases of any localization (including ENT – sinusitis, rhinitis, adenoiditis, tonsillar hypertrophy, acute respiratory viral infections) caused by bacterial, viral and fungal pathogens: 0.1 mg/kg for 3 consecutive days, then 10 injections every other day.

In acute allergic and toxic-allergic states (including bronchial asthma, atopic dermatitis) complicated by bacterial, viral and fungal infections: intravenously with a dose of 0.1 mg/kg, 3 days daily and then daily, 10 injections in combination with basic therapy.

Intranasally: 1-2 drops daily in each nasal passage 3 times a day for a course of up to
10 days (see Table 1 for calculation of daily doses of the drug for intranasal and sublingual administration):

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

For preoperative preparation of patients during surgical interventions for ENT diseases as well as in postoperative period to prevent infectious complications or recurrence of the disease;

The treatment and prevention of influenza and other acute respiratory infections (within 1 month before the expected epidemic), at any time after the onset of the disease and in the period of recuperation);

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

In adenoiditis, tonsil hypertrophy: (as a component of conservative treatment);

For preoperative preparation and postoperative rehabilitation;

For seasonal prevention of exacerbations of chronic infections of the oropharynx, upper respiratory tract, inner and middle ear;

To treat intestinal dysbacteriosis (in combination with basic therapy) for
10 days.