Polyoxidonium solution

Composition for 1 ampoule or bottle:

Active substance: 

Polyoxidonium® (Azoximer bromide) - 6 mg

Excipients: 

mannitol, 

povidone, 

betacarotene - up to 9 mg.

Pharmacotherapeutic group:

immunomodulatory agent

ATX code: [L0З]

PHARMACHOLOGIC EFFECT

Polyoxidonium® has an immunomodulatory effect, increases the body's resistance to local and generalized infections. The basis of the mechanism of the immunomodulatory action of Polyoxidonium® is a direct effect on phagocytic cells and natural killer cells, as well as stimulation of antibody production.

Polyoxidonium® restores immunity in secondary immunodeficiency conditions caused by various infections, injuries, burns, autoimmune diseases, malignant neoplasms, complications after surgery, the use of chemotherapeutic agents, cytostatics, steroid hormones.

Along with the immunomodulatory effect, Polyoxidonium® has a pronounced detoxifying and antioxidant activity, has the ability to remove toxins, heavy metal salts from the body, and inhibits lipid peroxidation. These properties are determined by the structure and high-molecular nature of the Polyoxidonium® preparation. 

Its inclusion in the complex therapy of cancer patients reduces intoxication against the background of chemotherapy and radiation therapy, in most cases it allows standard therapy to be carried out without changing the scheme due to the development of infectious complications and side effects (myelosuppression, vomiting, diarrhea, cystitis, colitis, and others).

The use of Polyoxidonium® against the background of secondary immunodeficiency states allows to increase the effectiveness and shorten the duration of treatment, significantly reduce the use of antibiotics, bronchodilators, glucocorticosteroids, and lengthen the period of remission.

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

PHARMACOKINETICS

When administered intramuscularly, Polyoxidonium® has a high bioavailability (89%); the time to reach the maximum concentration in the blood - 40 minutes; quickly distributed to all organs and tissues. The half-life in the body (fast phase) is 0.44 hours, the half-life (slow phase) is 36.2 hours. In the body, the drug is hydrolyzed to oligomers, which are excreted mainly by the kidneys.

Correction of immunity in adults and children from 6 months.

In adults in complex therapy:

• chronic recurrent infectious and inflammatory diseases that do not respond to standard therapy in the stage of exacerbation and in remission;

• acute and chronic viral and bacterial infections (including urogenital infectious and inflammatory diseases);

• tuberculosis;

• acute and chronic allergic diseases (including pollinosis, bronchial asthma, atopic dermatitis), complicated by chronic recurrent bacterial and viral infections;

• in oncology during and after chemotherapy and radiation therapy to reduce the immunosuppressive, nephro - and hepatotoxic effects of drugs;

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

• rheumatoid arthritis, long-term treatment with immunosuppressants; with complicated acute respiratory infections during rheumatoid arthritis;

• for the prevention of postoperative infectious complications;

• for the prevention of influenza and acute respiratory infections

In children in complex therapy:

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

• acute allergic and toxic-allergic conditions;

• bronchial asthma complicated by chronic respiratory tract infections;

• atopic dermatitis complicated by purulent infection;

• intestinal dysbiosis (in combination with specific therapy);

• for the rehabilitation of often and long-term ill people;

• prevention of influenza and acute respiratory infections.

Polyoxidonium is contraindicated in pregnancy, lactation and children under 6 months of age (there is no clinical experience of use).

Increased individual sensitivity. Pregnancy, lactation (no clinical experience of use).

CAREFULLY

Acute renal failure, children up to 6 months of age (clinical experience of use is limited).

DOSAGE AND METHODS FOR ADULTS

Methods of using the drug Polyoxidonium®: parenteral, intranasal. The methods of application are chosen by the doctor depending on the severity of the disease and the age of the patient.

Intramuscularly or intravenously (drip): the drug is prescribed for adults in doses of 6-12 mg once a day, every other day, or 1-2 times a week, depending on the diagnosis and severity of the disease.

For intramuscular administration, the contents of the ampoule or vial are dissolved in 1.5-2 ml of 0.9% sodium chloride solution or water for injection. For intravenous (drip) administration, the drug is dissolved in 2 ml of 0.9% sodium chloride solution, Gemodeza-N,

Reopolyglyukin or 5% dextrose solution, then sterilely transferred into a vial with the indicated solutions with a volume of 200-400 ml.

The prepared solution for parenteral administration cannot be stored.

Intranasally: a dose of 6 mg is dissolved in 1 ml (20 drops) of distilled water, 0.9% sodium chloride solution or boiled water at room temperature.

Recommended treatment regimens for adults

Parenteral:

In acute inflammatory diseases: 6 mg daily for 3 days, then every other day with a general course of 5-10 injections.

For chronic inflammatory diseases: 6 mg every other day, 5 injections, then 2 times a week with a course of at least 10 injections.

For tuberculosis: 6-12 mg 2 times a week with a course of 10-20 injections.

In patients with acute and chronic urogenital diseases: 6 mg every other day with a course of 10 injections in combination with chemotherapy.

For chronic recurrent herpes: 6 mg every other day with a course of 10 injections in combination with antiviral drugs, interferons and / or inducers of interferon synthesis.

For the treatment of complicated forms of allergic diseases: 6 mg each, a course of 5 injections: the first two injections daily, then every other day. In acute allergic and toxic-allergic conditions, administer intravenously 6-12 mg in combination with antiallergic drugs.

For rheumatoid arthritis: 6 mg every other day, 5 injections, then 2 times a week with a course of at least 10 injections.

In cancer patients:

- before and during chemotherapy to reduce the immunosuppressive, hepato- and nephrotoxic effects of chemotherapeutic agents, 6-12 mg every other day with a course of at least 10 injections; further, the frequency of administration is determined by the doctor depending on the tolerance 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, long-term use of the drug Polyoxidonium® (from 2-3 months to 1 year) is indicated, 6-12 mg 1-2 times a week.

In patients with acute renal failure, it is prescribed no more than 2 times a week. 

Intranasally prescribed 6 mg per day for the treatment of acute and chronic infections of the upper respiratory tract, to enhance the regenerative processes of the mucous membranes, to prevent complications and relapses of diseases, to prevent influenza and acute respiratory infections. 3 drops in each nasal passage after 2-3 hours (3 times a day) for 5-10 days.

METHODS OF APPLICATION AND DOSES FOR CHILDREN

Methods of using Polyoxidonium®: parenteral, intranasal, sublingual. The methods of application are chosen by the doctor depending on the diagnosis, the severity of the disease, the age and body weight of the patient.

Parenterally, the drug is prescribed to children from 6 months at a dose of 3 mg (intramuscularly or intravenously drip 0.1-0.15 mg / kg) daily, every other day or 2 times a week in a course of 5-10 injections (dose calculation is shown in the table).

For intramuscular administration, the drug is dissolved in 1 ml of water for injection or 0.9% sodium chloride solution.

For intravenous drip administration, the drug is dissolved in 1.5-2 ml of sterile 0.9% sodium chloride solution, Reopolyglyukin, Gemodez-N or 5% dextrose solution, sterile transferred into a bottle with the indicated solutions with a volume of 150-250 ml.

Intranasal and sublingual: daily at a daily dose of 0.15 mg / kg for 5-10 days. The drug is administered in 1-3 drops in one nasal passage or under the tongue after 2-3 hours.

To prepare a solution for intranasal and sublingual use, a dose of 3 mg is dissolved in 1 ml (20 drops), a dose of 6 mg - in 2 ml of distilled water, 0.9% sodium chloride solution or boiled water at room temperature. One drop of the prepared solution (50 μl) contains 0.15 mg of Polyoxidonium®, which is prescribed per 1 kg of the child's body weight.

Store the solution for sublingual and intranasal use in the refrigerator for no more than 7 days. Before use, the pipette with the solution must be warmed to room temperature (20-25 oС).

Recommended treatment regimens for children

• For acute inflammatory diseases: 0.1 mg / kg every other day with a course of 5-7 injections.

• For chronic inflammatory diseases: 0.15 mg / kg 2 times a week for up to 10 injections.

• In acute allergic and toxic-allergic conditions: intravenous drip at a dose of 0.15 mg / kg in combination with antiallergic drugs.

• For the treatment of complicated forms of allergic diseases in combination with basic therapy: intramuscularly, 0.1 mg / kg in a course of 5 injections with an interval of 1-2 days.

Intranasally, 1-3 drops are injected into one nasal passage after 2-3 hours (2-4 times a day). For intranasal and sublingual administration, the calculation of the daily dose for children is presented in the table.

5 kg - 5 drops 0.25 ml

10 kg - 10 drops 0.5 ml

15 kg - 15 drops 0.75 ml

20 kg - 20 drops 1.00 ml

Sublingual: for all indications - daily at a daily dose of 0.15 mg / kg for 10 days, for the treatment of intestinal dysbiosis for 10-20 days. 1-3 drops are dripped under the tongue after 2-3 hours.

Lyophilisate for solution for injection and topical use

In a dry place at a temperature of 2 to 8 ° C.

Keep out of the reach of children.