Polyoxidonium, lyophilizate 6 mg 5 pcs

Pharmacotherapeutic group:

immunomodulatory agent

ATC code: [L0Z]

Pharmacological ACTION

Polioxidonium® has an immunomodulatory effect and increases the body’s resistance to local and generalized infections. The basis of the mechanism of immunomodulatory action of Polioxidonium® is a direct effect on phagocytic cells and natural killers and stimulation of antibody formation.

Polioxidonium® restores immunity in cases of secondary immunodeficiency conditions caused by various infections, injuries, burns, autoimmune diseases, malignant tumors, complications of surgery, chemotherapeutic agents, cytostatics, steroid hormones.

In addition to its immunomodulating action, Polioxidonium® has strong detoxifying and antioxidant activity, detoxifying the body to remove toxins and salts of heavy metals, and inhibits lipid peroxidation. These properties are determined by the structure and the high-molecular nature of Polioxidonium®.

Inclusion of this medicine in the treatment of cancer patients reduces intoxication because of chemotherapy and radiation therapy and in most cases allows to perform standard therapy without changing the regimen due to the development of infectious complications and side effects (myelosuppression, vomiting, diarrhea, cystitis, colitis etc.).

The use of Polioxidonium® against the background of secondary immunodeficiency states can improve the effectiveness and shorten the duration of treatment, significantly reduce the use of antibiotics, bronchodilators, glucocorticosteroids and extend the period of remission.

The drug is well tolerated, has no mitogenic, polyclonal activity, antigenic properties and has no allergic, mutagenic, embryotoxic, teratogenic and carcinogenic action.

Pharmacokinetics

Polioxidonium® by intramuscular administration has high bioavailability (89 %); time of maximum concentration in blood – 40 minutes; fast distribution in all organs and tissues. Period of half-distribution in an organism (fast phase) – 0.44 hours, period of half-excretion (slow phase) – 36.2 hours. In the body the drug is hydrolyzed to oligomers, which are excreted mainly by the kidneys.

Indications

Immunity correction in adults and children from 6 months.

In adults in the complex therapy:

– chronic recurrent infectious-inflammatory diseases that do not respond to standard therapy in the acute stage and in remission;

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

– tuberculosis;

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

p> – in oncology in and after chemo- and radiation therapy to decrease the immunosuppressive, nephro- and hepatotoxic effects of medicines;

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

– Rheumatoid arthritis with prolonged treatment with immunosuppressants; in complicated course of rheumatoid arthritis;

– for the prevention of postoperative infectious complications;

– for the prevention of flu and SARS

In children as a complex therapy:

– acute and chronic inflammatory diseases caused by causative agents of bacterial, viral, fungal infections (including.ч.

– acute allergic and toxic-allergic conditions;

– bronchial asthma complicated by chronic respiratory tract infections;

– atopic dermatitis complicated by purulent infection;

– intestinal disbacteriosis (in combination with specific therapy);

– for the rehabilitation of the often and long-term ill;

– prevention of influenza and acute respiratory infections.

Active ingredient

Composition

Composition per 1 ampoule or vial:

Polioxidonium® (Azoximer bromide) – 6 mg

Associates:

mannitol,

povidone,

betacarotene – up to 9 mg.

How to take, the dosage

Ways of administration and doses for adults

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

Intramuscularly or intravenously (drops): The drug is given to adults in doses of 6-12 mg once a day, every other day, or once or twice 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, Hemodez-N,

Reopolyglucin or 5% dextrose solution, then sterilely transferred into a bottle with the above solutions of 200-400 ml volume.

The prepared solution for parenteral administration should not 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 regimen for adults

Parenterally:

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

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

In case of tuberculosis: 6-12 mg 2 times a week for a course of 10-20 injections.

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

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

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

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

In cancer patients:

– before and against the background of chemotherapy to reduce the immunosuppressive, hepato- and nephrotoxic effects of chemotherapeutic agents: 6-12 mg every other day for a course of at least 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 administration of Polioxidonium® (from 2-3 months to 1 year) 6-12 mg weekly, 1-2 times.

In patients with acute renal failure, it is prescribed not more than 2 times a week.

Inntranasally 6 mg daily is administered for treatment of acute and chronic ENT-organ infections; for strengthening of regenerative processes of mucous membranes, for prevention of disease complications and relapses and for prevention of flu and acute respiratory diseases. 3 drops in each nostril every 2-3 hours (3 times a day) for 5-10 days.

Ways of administration and doses for children

Ways of administration of Polioxidonium®: parenterally, intranasally, sublingually. The method of administration is chosen by the doctor depending on the diagnosis, severity of the disease, age and body weight of the patient.

Parenterally the drug is prescribed to children from 6 months old in a dose of 3 mg (intramuscularly or intravenously in a 0.1-0.15 mg/kg drop) daily, every other day or twice a week for a course of 5-10 injections (the table shows the dose calculation).

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

For intravenous drops the drug is dissolved in 1.5-2 ml of sterile 0.9% solution of sodium chloride, Reopolyglucin, Hemodez-N or 5% solution of dextrose; the drug is sterile transferred into a bottle with the above solutions of 150-250 ml volume.

Intranasally and sublingually: daily in 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.

Interaction

Special Instructions

Contraindications

Individual hypersensitivity. Pregnancy, lactation (no clinical experience of use).

WARNING

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

Side effects

Pregnancy use

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