Expiration date: 05/2026
The composition and form of issue:
Tablets. 1 tablet contains:
Azoximer bromide 12 mg
Excipients: mannitol, povidone, beta-carotene from the mixture of 18 mg
excipients: lactose monohydrate — 185 mg potato starch — 45 mg stearic acid 2 mg
in a contour acheikova packing 10 PCs. in cardboard pack 1 or 2 packs.
Lyophilisate for preparation of solution for injections and local application. 1 vial contains:
Azoximer bromide 3mg or 6 mg
excipients: mannitol, povidone beta-carotene — 4.5 (dose 3 mg) or 9 (dose 6 mg) mg
in ampoules or vials colorless or dark neutral glass 4.5 (dose 3 mg) or 9 (dose 6 mg) mg the paper cartons of 5 ampoules or vials, or in a contour acheikova package 5 ampoules or vials in the paper cartons 1 package or in cartons of 5 ampoules or vials in the kit with a solvent in ampoules (5 ampoules water for injection or 5 vials of 0.9% sodium chloride solution isotonic).
Suppositories. 1 supp. contains:
Azoximer bromide 6 mg
Azoximer bromide 12 mg
excipients: mannitol, povidone beta-carotene — 9 (dose 6 mg) or 18 (for dose 12 mg) mg
base: cocoa butter beans — to obtain suppositories weighing 1.3 g
in a contour acheikova package 5 PCs in a pack 2 packs cardboard.
Description pharmaceutical form:
Tablets from white color with a yellowish tinge to yellow with an orange tint, ploskotsylindriceskie, with facet, scored on one side and the words "ON" on the other. Allowed subtle splashes of more intense color.
Lyophilisate for preparation of solution for injections and local application: porous mass of white color with a yellowish tinge to yellow. The drug is hygroscopic and photosensitive.
Suppositories: torpedo-shaped, light yellow color with a weak specific smell of cocoa butter.
Pharmacokinetics:
Pills: after intake of rapidly absorbed from the gastrointestinal tract, bioavailability of approximately 50%. Cmax in plasma achieved through 3 h after ingestion. The pharmacokinetics of the tablets is linear (concentration in plasma is proportional to the dose). Polyoxidonium is a hydrophilic compound. The apparent volume of distribution is approximately 0.5 l/kg, which suggests that the drug is distributed mainly in the intercellular fluid. The period of poluabsorbtion 35 min, T1/2 is 18 hours.
Lyophilisate for preparation of solution for injections and local application: it has high bioavailability (89%) the time to reach Cmax in blood after the/m introduction — 40 minutes rapidly distributed to all organs and tissues. The period of poluraspredelenia in the body with/in the introduction — 25 min, T1/2 (slow phase) and 25.4 h, with the/m introduction — 36,2 h
Suppositories: for rectal administration, has high bioavailability (at least 70%), reaching a Cmax in the blood at 1 h after injection. Poluraspredelenia period of about 0.5 h, the period of preliminaly — 36,2 h
The body is hydrolyzed to oligomers, which are excreted mainly by the kidneys. The cumulative effect is absent.
Description pharmacological action:
Polyoxidonium has immunomodulatory effects, increases the body's resistance against local and generalized infections. The basis of the mechanism of immunomodulating action of Polyoxidonium is a direct effect on phagocytic cells and natural killer cells, also stimulate the antibody productions.
Tablets (optional): Polyoxidonium activates the phagocytes in the peripheral blood and tissue macrophages, which promotes more rapid elimination of the pathogen from the body in the presence of a focus of infection. In addition, Polyoxidonium activates lymphoid cells in regional lymph nodes, namely b-cells that produce secretory IgA.
With sublingual application activates the lymphoid cells located in the nasal cavity, evstafievich tubes, the oropharynx, bronchi. In addition, activates the bactericidal properties of saliva.
Oral application also activates lymphoid cells in the lymph nodes of the intestine. The consequence of this is to increase resistance of respiratory tract, gastrointestinal tract and upper respiratory tract to infectious agents.
Lyophilisate for preparation of solution for injections and local application and suppositories (optional): restores immune responses in secondary immunodeficiency, various infections, trauma, burns, autoimmune diseases, malignant neoplasms, complications after surgical operations, the use of chemotherapeutic agents, cytostatics, steroid hormones.
Along with immunomodulatory effects has a pronounced detoxification and antioxidant activity, has the ability to rid the body of toxins, salts of heavy metals, inhibit lipid peroxidation. These properties are determined by the structure and macromolecular nature of Polyoxidonium.
Increases the resistance of cell membranes to cytotoxic action of drugs and chemicals, reducing their toxicity.
Inclusion of Polyoxidonium in complex therapy of cancer patients reduces intoxication on the background of chemo - and radiotherapy, in most cases allows the treatment without change of the scheme of standard therapy in connection with the development of infectious complications and side effects (myelosuppression, vomiting, diarrhea, cystitis, colitis, etc.).
The use of Polyoxidonium on the background of secondary immunodeficiency States allows you to increase the efficiency and reduce the duration of treatment, significantly reduce the use of antibiotics, bronchodilators, corticosteroids, to lengthen the period of remission.
The drug is well tolerated, has mitogenic, polyclonal activity, antigenic properties, has no allergenic, mutagenic, embryotoxic, teratogenic and carcinogenic actions.
Dosage:
For patients receiving long-term immunosuppressive therapy, cancer having an acquired defect of the immune system - HIV. exposed, shows lasting from 2-3 months to 1 year, maintenance therapy with Polyoxidonium (adults 12 mg, children older than 6 years - 6 mg 1-2 times a week). Options recommended schemes application in the complex therapy
In chronic infektsionno-vospalennah diseases in the acute stage - according to the standard scheme, in remission - 1 suppository 1-2 days, total ku rcom 10-15 suppositories.
In acute infectious processes and to activate regenerering processes
(fractures, burns, trophic ulcers) - daily 1 suppository. The course of treatment is 10-15 suppositories
Tuberculosis - according to the standard scheme. The course of treatment - not less than 15 suppositories, then perhaps the use of maintenance therapy for 2 suppositories per week rate of up to 2-3 months
On the background
mio and radiation therapy of tumors - 1 suppository daily for 2-3 days before the start of therapy. Further, the frequency of administration of the suppositories is determined by the doctor depending on tolerability and duration of chemotherapy and Lou chevoy therapy: To rehabilitate often (more than 4-5 times per year) and chronically ill persons and in rheumatoid arthritis - 1 suppository a day. The course of treatment - 10-15 suppositories
For the correction of secondary immunodeficits, including those arising from aging - 1 suppository 12 mg 2 times a week. The course is not less than 10 suppositories 2-3 times per year as monotherapy:
For seasonal prophylaxis of exacerbations of chronic foci of infection, to prevent recurrent herpes infections - a day in adults 6-12 mg in children and 6 mg. year - 10 suppositories
For the correction of secondary immunodeficits, the prevention of influenza and acute respiratory infections -
the standard scheme
Gynecological diseases rectally and vaginally - the normal way.
Indications:
Tablets: adults and adolescents over 12 years for the treatment and prevention of infectious-inflammatory diseases (viral, bacterial and fungal etiology), not amenable to standard therapy in the acute stage and in remission.
In the complex therapy:
- acute and chronic recurrent infectious-inflammatory diseases of the oropharynx, paranasal sinuses, upper Airways, middle and inner ear
- allergic diseases, complicated by recurrent bacterial, fungal and viral infection (e.g. hay fever, asthma)
- for rehabilitation and often long-term (more than 4-5 times a year) sick.
As monotherapy:
- for the prevention of recurrent herpes infection
- for seasonal prophylaxis of exacerbations of chronic foci of infection of the oropharynx, paranasal sinuses, upper Airways, middle and inner ear
- in immunocompromised persons for the prevention of influenza and other acute respiratory infections in pre-epidemic period
- for the correction of secondary immunodeficiency resulting from aging or exposure to adverse factors.
- Lyophilisate for preparation of solution for injections and local application
- Correction of immunity in adults and children from 6 months old.
Adults in the complex therapy:
- of chronic recurrent infectious-inflammatory diseases, not amenable to standard therapy in the acute stage and in remission
- acute and chronic viral and bacterial infections (including genital infectious and inflammatory diseases)
- tuberculosis
- acute and chronic allergic diseases (including pollinosis, bronchial asthma, atopic dermatitis), complicated by chronic recurrent bacterial and viral infection
- in Oncology during and after chemo - and radiotherapy of tumors to reduce immunosuppressive, nephrotoxicity and hepatotoxicity of drugs
- for activation of regeneration processes (fractures, burns, trophic ulcers)
- rheumatoid arthritis, long-term treated with immunosuppressants in complicated acute respiratory infections or influenza during rheumatoid arthritis
- for the prevention of postoperative infectious complications
- for the prevention of influenza and acute respiratory infections.
The children in the 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 tonsils, acute respiratory viral infections)
- acute allergic and toxic-allergic conditions
- bronchial asthma, complicated by chronic infections of the respiratory tract
- atopic dermatitis complicated by purulent infection
- intestinal dysbacteriosis (in combination with a specific therapy)
- for rehabilitation and often chronically ill
- for the prevention of influenza and acute respiratory infections.
Suppositories: adults and children over 6 years.
In the complex therapy for the correction of immune deficiency:
- of chronic recurrent infectious-inflammatory diseases, not amenable to standard therapy in the acute stage and in remission
- acute viral, bacterial and fungal infections
- inflammatory diseases of the urogenital tract, including urethritis, cystitis, pyelonephritis, prostatitis, oophoritis, endomyometritis, colpitis, cervicitis, servicesa, bacterial vaginitis (including viral pneumonias)
- various forms of tuberculosis
- allergic diseases, complicated by recurrent bacterial, fungal and viral infection (including pollinosis, bronchial asthma, atopic dermatitis)
- rheumatoid arthritis, long-term treated with immunosuppressants in complicated acute respiratory or influenza disease
- for activation of regeneration processes (fractures, burns, trophic ulcers)
- for rehabilitation and often long-term (more than 4-5 times a year) sick people
- during and after chemo - and radiotherapy of tumors
- to reduce the nephrotoxicity and hepatotoxicity of drugs.
As monotherapy:
- for the prevention of recurrent herpes infection
- for seasonal prophylaxis of exacerbations of chronic foci of infection, for the prevention of influenza and acute respiratory infections in pre-epidemic period
- for the correction of secondary immunodeficiency resulting from aging or exposure to adverse factors.
Contraindications:
Common to all dosage forms:
- increased individual sensitivity
- pregnancy (clinical experiences none)
- lactation.
For tablets (optional) — children up to age 12 years.
For suppository (optional) — children up to age 6 years.
With caution:
Common to all dosage forms — acute renal failure.
For tablets (optional) — lactose intolerance, lactase deficiency, malabsorption glucosegalactose.
To lyophilisate for preparation of solution for injections and local application (optional) — children up to age 6 months (clinical experience of the limited).
Application of pregnancy and breast-feeding:
Use in pregnancy and lactation is contraindicated (clinical experiences is missing). Excretion of Polyoxidonium in breast milk has not been studied.
Side effects:
The pill: side effects were reported.
Lyophilisate for preparation of solution for injections and local application: possible soreness at the injection site when the/m introduction.
Suppositories: not detected.
Drug interactions:
Tablets lyophilisate for preparation of solution for injections and local applications, suppositories: drug interactions is not established. Perhaps the use of Polyoxidonium with many drugs, including working with antibiotic, antiviral, antifungal and antihistamines, bronchodilators, corticosteroids, cytostatics and &beta-agonists.
Method of application and dose:
Pills. Oral and sublingual for 20-30 minutes before eating, daily 1, 2 or 3 times a day.
Adults in doses of 12 or 24 mg, adolescents at a dose of 12 mg. Method and dosage regimen is determined by the doctor depending on diagnosis, acuity and severity of the process.
Sublingual:
- inflammation of the pharynx (bacterial, viral and fungal nature): 1 table. 2 times a day every 12 hours for 10-14 days. In severe forms of herpetic and fungal infections of oral cavity — 1 table. 3 times daily 8 hours for 15 days
- in chronic diseases of paranasal sinuses and chronic otitis: 1 table. 2 times a day every 12 hours for 5-10 days
- in chronic tonsillitis: 1 table. 3 times a day every 8 hours for 10-15 days
- in chronic diseases of the upper respiratory tract: adults — 2 tab. (24 mg), 2 times a day, teenagers — 1 table. (12 mg), 2 times a day, every 12 hours for 10-14 days
- for the prevention of influenza and acute respiratory infections: immunocompromised persons suffering from acute respiratory infections more than 4 times a year, in the pre-epidemic period adults — 2 tab. (24 mg) adolescents: 1 tab. (12 mg), 2 times a day every 12 h for 10-15 days.
Oral:
- in chronic diseases of the upper respiratory tract: adults — 2 tab. (24 mg), 2 times a day every 12 hours adolescents: 1 tab. (12 mg), 2 times a day, every 12 hours for 10-14 days.
Lyophilisate for preparation of solution for injections and local application.
Methods of application and doses for adults
Parenteral, intranasal. Applications are selected by the doctor depending on the severity of the disease and patient's age.
The/m or/in (drip): the drug is prescribed to adults in doses of 6-12 mg 1 time a day, every day, every other day, or 1-2 times a week depending on diagnosis and severity of the disease.
For the on/m introduction contents of the ampoule or vial is dissolved in 1.5–2 ml 0.9% sodium chloride solution or water for injection. For/in (drip) the introduction of the drug is dissolved in 2 ml of 0.9% sodium chloride solution, Gemodeza, Reopoliglyukina, or 5% dextrose solution, and then sterile transfer in a bottle with these solutions the volume of 200-400 ml.
The prepared solution for parenteral administration shall not be stored.
Intranasal: dose of 6 mg dissolved in 1 ml (20 drops) of distilled water, 0.9% sodium chloride solution or boiled water at room temperature.
Recommended regimens adults
Parenteral:
- acute inflammation: 6 mg daily for 3 days, then the day of the General course of 5-10 injections
- in chronic inflammatory disease: 6 mg every day 5 injections, then 2 times a week the course is at least 10 injections
- tuberculosis: 6-12 mg 2 times a week for the course of 10-20 injection
- patients with acute and chronic urogenital diseases: 6 mg every other day a course of 10 injections in combination with chemotherapy
- in case of chronic recurrent herpes: 6 mg every other day a course of 10 injections in combination with antiviral drugs, interferon and/or inducers of the synthesis of interferons
- for the treatment of complicated forms of allergic diseases: 6 mg, the course of 5 injections — 2 injections the first daily, then every other day. In acute allergic and toxic-allergic conditions to introduce/6-12 mg in combination with other anti-allergic drugs
- in rheumatoid arthritis: at 6 mg a day — 5 injections, then 2 times a week, at a rate not less than 10 injections.
In cancer patients:
before and during chemotherapy to reduce immunosuppressive, hepato - and nephrotoxic action of chemotherapeutic agents — 6-12 mg every other day a course of at least 10 injections, then frequency of administration is determined by the doctor depending on tolerability and duration of chemotherapy and radiation therapy
- for the prevention of the immunosuppressive effects of the tumor, for the correction of immunodeficiency after chemotherapy and radiotherapy, after surgical removal of the tumor shown long-term use of the drug Polyoxidonium (from 2-3 months up to 1 year) — 6-12 mg 1-2 times a week.
Patients with acute renal failure appoint not more than 2 times a week.
Intranasally administered 6 mg/day for treatment of acute and chronic infections of ENT-organs, to enhance the regenerative processes of the mucous membranes, prevention of complications and recurrences of diseases, for the prevention of influenza and acute respiratory infections. 3 drops in each nostril 2-3 hours (3 times daily) for 5-10 days.
Methods of application and dosages for children
Parenteral, intranasal, sublingual. Applications are selected by the doctor depending on diagnosis, severity of disease, age and body weight of the patient.
Parenteral drug is administered to children from 6 months to a dose of 3 mg (/m or/in the drip of 0.1–0.15 mg/kg) daily, every other day or 2 times a week a course of 5-10 injections (calculation of doses specified in the table).
For the on/m introduction the drug is dissolved in 1 ml of water for injections or 0.9% solution of sodium chloride.
For in/drip in the introduction of the drug is dissolved in 1.5–2 ml sterile 0.9% solution of sodium chloride Reopoliglyukina, Gemodez-N, or 5% dextrose solution, sterile transferred into vials with these solutions the volume of 150-250 ml.
Granatello and sublingually daily in a daily dose of 0.15 mg/kg for 5-10 days. The drug is administered 1 to 3 drops in one nostril or under the tongue 2-3 h. For preparation of solution for intranasal and sublingual applications of a dose of 3 mg dissolved in 1 ml (20 drops) at a dose of 6 mg in 2 ml of distilled water, 0.9% sodium chloride solution or boiled water at room temperature. In one drop of the prepared solution (50 µl) contains 0.15 mg of the drug Polyoxidonium, which is prescribed per 1 kg of body weight of the child.
Solution for sublingual and intranazalnoe application store in the refrigerator for 7 days. Before use, the pipette solution should be heated to room temperature (20-25 °C).
Recommended regimens children:
- acute inflammation: 0.1 mg/kg every other day a course 5-7 injection
- in chronic inflammatory diseases: 0.15 mg/kg 2 times a week rate to 10 injections
- in acute allergic and toxic-allergic conditions: in/drip in the dose of 0.15 mg/kg in combination with other anti-allergic drugs
- for the treatment of complicated forms of allergic diseases in combination with basic therapy: in/m to 0.1 mg/kg at a rate of 5 injections with an interval of 1-2 days.
Intranasally administered 1 to 3 drops in one nostril 2-3 hours (2-4 times a day). For intranasal and sublingual administration based on the daily doses for children are shown in the table.
| The child's weight, kg | The number of drops per day | The volume of injected solution, ml |
| 5 | 5 | 0,25 |
| 10 | 10 | 0,5 |
| 15 | 15 | 0,75 |
| 20 | 20 | 1,0 |
- in chronic infectious and inflammatory diseases in the acute stage — according to the standard scheme, in remission — 1 supp. after 1-2 days, the General course is 10-15 supp.
- when acute infectious processes and for activation of regeneration processes (fractures, burns, trophic ulcers): daily 1 supp., the course of treatment — 10-15 supp.
- tuberculosis: according to the standard scheme, course of treatment — not less than 15 supp., further, it is possible to use maintenance therapy — 2 supp. a week a course of 2-3 months
- on the background of chemotherapy and radiation therapy of tumors: 1 supp. daily for 2-3 days before the start of therapy, then the frequency of administration of the suppositories is determined by the doctor depending on tolerability and duration of chemotherapy and radiation therapy
- rehabilitation often (more than 4-5 times per year) and chronically ill persons and in rheumatoid arthritis: 1 supp. through the day, course of treatment — 10-15 supp.
- for correction of secondary immunodeficiencies, including arising as a result of aging: 1 supp. (12 mg), 2 times per week, the course is not less than 10 supp. 2-3 times a year.
- for seasonal prophylaxis of exacerbations of chronic foci of infection, prevention of recurrent herpetic infections: adults in a day — 6-12 mg for children — 6 mg. year — 10 supp.
- for correction of secondary immunodeficiencies, the prevention of influenza and acute respiratory infections: according to the standard scheme.
- gynecological diseases (rectal or vaginal): the standard scheme.
