Instructions
Instructionsand schemes of administration
For adults and children from 3 years of age are dispensed without a prescription.
Scheme of administration of tablets 12 mg in respiratory viral infections
Read carefully these instructions before you start using the drug, since they contain important information for you.
Keep the instructions: you may need them again.
This drug is available without a prescription. For optimal results, it should be used by strictly following all recommendations stated in the instructions.
The drug you are being treated with is intended for you personally: you should not give it to others, since it may cause harm to them even if they have the same symptoms as you.
Registration number: P N002935/04.
Trade name: Polyoxidonium®.
International nonproprietary name: Azoximer bromide (Аzoximeri bromidum).
Chemical name: copolymer of N-oxide of 1,4-ethylene piperazine and (N-carboxymethyl)-1,4-ethylene piperazine bromide.
Dosage form: tablets.
Composition per tablet: Active ingredient: azoximer bromide – 12 mg; Excipients: mannitol – 3.6 mg, povidone – 2.4 mg, lactose monohydrate – 185.0 mg, potato starch – 45.0 mg, stearic acid – 2.0 mg.
Description: Round flat cylindrical tablets of white or white with a yellowish tinge color, beveled, one side scored tablets and debossed on the other side with ‘PO’.
Pharmacotherapeutic group: immunomodulatory agent.
ATC Code: [L0З].
Azoximer bromide has a complex effect: immunomodulatory, detoxifying, antioxidant, and moderate anti-inflammatory.
The mechanism of Azoximer bromide immunomodulatory action is based on direct effect on phagocytic cells and natural killer cells, as well as stimulation of antibody formation and synthesis of interferon-alpha and interferon-gamma.
Detoxication 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 restores immunity in secondary immunodeficiency states caused by various infections, injuries, complications after surgery.
A characteristic feature of Azoximer bromide when applied topically (sublingually) is its ability to activate factors of early defense of the body against infection: the drug stimulates bactericidal properties of neutrophils, macrophages, enhances their ability to absorb bacteria, increases bactericidal properties of saliva and mucous secretion of the upper respiratory tract.
When administered orally, Azoximer bromide also activates lymphoid cells in the intestinal lymph nodes.
Azoximer bromide blocks soluble toxic substances and microparticles, has the ability to eliminate toxins, salts of heavy metals from the body, inhibits lipid peroxidation, both by intercepting free radicals and through elimination of catalytically active Fe2+ ions. Azoximer bromide reduces inflammatory response by normalizing the synthesis of pro- and anti-inflammatory cytokines.
Azoximer bromide is well tolerated, has no mitogenic or polyclonal activity, antigenic properties, does not have allergenic, mutagenic, embryotoxic, teratogenic, and carcinogenic effects.
Azoximer bromide is odorless and tasteless, has no local irritant effect when applied to the mucous membranes of the nose and oropharynx.
After oral administration, Azoximer bromide is rapidly absorbed from the gastrointestinal tract, bioavailability of the drug upon oral administration is more than 70%. Its maximum concentration in blood plasma is reached 3 hours after oral administration. Pharmacokinetics of Azoximer bromide is linear (its concentration in blood plasma is proportional to the dose taken).
Azoximer bromide is a hydrophilic compound. The apparent volume of distribution is approximately 0.5 L/kg, indicating that the drug is distributing mainly in the intercellular fluid. The half-absorption period is 35 minutes, and the elimination half-life is 18 hours.
Azoximer bromide is rapidly distributed throughout all organs and tissues of the body, penetrates through the blood-brain and blood-aqueous barriers. No cumulative effect. In the body, Azoximer bromide undergoes biodegradation to low molecular weight oligomers and is excreted mainly by the kidneys, via feces — not more than 3%.
It is used in adults and children from 3 years for the treatment and prevention of acute and chronic respiratory diseases in the stage of exacerbation and remission.
For treatment (in a complex therapy) of:
- Acute and exacerbation of chronic recurrent inflammatory infections of the oropharynx, paranasal sinuses, upper and lower respiratory tract, inner and middle ear;
- Allergic diseases (including pollinosis, bronchial asthma), complicated by recurrent bacterial, fungal, and viral infection.
For prevention (monotherapy) of:
- Recurrent herpetic infection of the nasal and labial area;
- Exacerbations of chronic foci of infections of the oropharynx, paranasal sinuses, upper respiratory tract, inner and middle ear;
- Secondary immunodeficiency states arising due to aging or exposure to unfavorable factors.
- Increased individual sensitivity;
- Pregnancy, breastfeeding;
- Children under 3 years of age;
- Acute renal failure;
- Rare hereditary lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.
If you have any of the diseases mentioned in this section, consult your doctor before starting to take the drug:
- Chronic renal failure (use no more than 2 times a week).
The use of the Polyoxidonium® drug is contraindicated in pregnant women and women during breastfeeding (no clinical experience of use).
No embryotoxic and teratogenic effects, influence on fetal development were revealed during experimental use of the Polyoxidonium® drug in animals.
Before using the Polyoxidonium®drug, if you are pregnant or suppose that you could be pregnant, or planning pregnancy, you should consult your doctor.
During breastfeeding, you should consult your doctor before using the Polyoxidonium® drug.
Use the drug only according to the indications, method of administration, and dosage indicated in the instructions.
If after the treatment there is no improvement or your symptoms worsen or new symptoms appear, you should consult your doctor.
Orally and sublingually 20–30 minutes before meals daily 2 times a day: children over 10 years old and adults — 1 tablet, children from 3 to 10 years old — ½ tablet (6 mg).
If necessary, repeated courses of therapy in 3–4 months are possible. Upon repeated administration of the drug, its efficacy is not reduced.
Recommended treatment regimens:
Sublingually
For treatment in adults of:
- Influenza and acute respiratory infections — 1 tablet 2 times a day for 7 days;
- Inflammatory processes of the oropharynx — 1 tablet 2 times a day for 10 days;
- Exacerbations of chronic diseases of the upper respiratory tract, paranasal sinuses, chronic otitis — 1 tablet 2 times a day for 10 days;
- Allergic diseases (including pollinosis, bronchial asthma), complicated by recurrent bacterial, fungal, and viral infection — 1 tablet 2 times a day for 10 days.
For treatment in children from 3 to 10 years of:
- Influenza and acute respiratory infections — ½ tablet 2 times a day for 7 days;
- Inflammatory processes of the oropharynx — ½ tablet 2 times a day for 7 days;
- Allergic diseases (including pollinosis, bronchial asthma), complicated by recurrent bacterial, fungal, and viral infection — ½ tablet 2 times a day for 7 days.
For treatment in children over 10 years of:
- Influenza and acute respiratory infections — 1 tablet 2 times a day for 7 days;
- Inflammatory processes of the oropharynx — 1 tablet 2 times a day for 7 days;
- Exacerbations of chronic diseases of the upper respiratory tract, paranasal sinuses, chronic otitis — 1 tablet 2 times a day for 7 days;
- Allergic diseases (including pollinosis, bronchial asthma), complicated by recurrent bacterial, fungal, and viral infection — 1 tablet 2 times a day for 7 days.
For prevention in adults of:
- Influenza and acute respiratory infections during the pre-epidemic periods — 1 tablet daily for 10 days;
- Recurrent herpetic infection of the nasal and labial area — 1 tablet 2 times a day for 10 days;
- Exacerbations of chronic foci of infections of the oropharynx, paranasal sinuses, upper respiratory tract, inner and middle ear — 1 tablet daily for 10 days;
- Secondary immunodeficiency states arising due to aging or exposure to unfavorable factors — 1 tablet 1 time a day for 10 days
For prevention in children from 3 to 10 years of:
- Influenza and acute respiratory infections during the pre-epidemic periods — ½ tablet daily for 7 days;
- Recurrent herpetic infection of the nasal and labial area — ½ tablet 2 times a day for 7 days;
- Exacerbations of chronic foci of infections of the oropharynx, paranasal sinuses, upper respiratory tract, inner and middle ear — ½ tablet daily for 10 days.
For prevention in children over 10 years of:
- Influenza and acute respiratory infections during the pre-epidemic periods — 1 tablet daily for 7 days;
- Recurrent herpetic infection of the nasal and labial area — 1 tablet 2 times a day for 7 days;
- Exacerbations of chronic foci of infections of the oropharynx, paranasal sinuses, upper respiratory tract, inner and middle ear — 1 tablet daily for 10 days.
Orally
For treatment in adults of:
- Diseases of the upper and lower respiratory tract — 1 tablet 2 times a day for 10 days.
For treatment in children over 10 years of:
- Diseases of the upper and lower respiratory tract — 1 tablet 2 times a day for 10 days.
No side effects have been reported.
If you notice any side effect not specified in the instructions, inform your doctor about it.
No cases of overdose have been reported.
Azoximer bromide does not inhibit isoenzymes CYP1A2, CYP2С9, CYP2С19, CYP2D6, cytochrome Р-450, therefore the drug is compatible with antibiotics, antiviral, antifungal, and antihistamine drugs, glucocorticosteroids and cytostatic drugs.
If you take any of the above or other drugs (including OTC drugs), consult your doctor before you start taking Polyoxidonium.
In case of allergic reaction, you should stop taking the Polyoxidonium® drug and consult your doctor.
If it is necessary to stop taking the Polyoxidonium® drug, it can be discontinued immediately, without gradual dose reduction.
In case of missed administration of a drug dose, its subsequent administration shall be carried out according to the usual regimen, as indicated in the instructions or recommended by your doctor. A patient should not administer a double dose to compensate for missed doses.
Do not use the drug if there are any visual signs of its unsuitability for use (package defect, changed color of a tablet).
Administration of the Polyoxidonium® drug does not affect the ability to perform potentially dangerous activities requiring increased concentration and quickness of psychomotor reactions (including driving vehicles, working with moving mechanisms).
Tablets, 12 mg. 10 tablets in each blister made of polyvinylchloride film and aluminium foil. One or two blisters together with the instructions for use are placed in a cardboard pack.
3 years. Do not use after the expiration date.
Store at the temperature not exceeding 25 °С. Keep out of reach of children.
Over the counter.
NPO Petrovax Pharm, OOO
1, ul. Sosnovaya, s. Pokrov, Podolsk, Moscow Region, 142143, Russia
NPO Petrovax Pharm, OOO
1, ul. Sosnovaya, s. Pokrov, Podolsk, Moscow Region, 142143, Russia
tel.: 8 800 234-44-80
e-mail: adr@petrovax. ru
The drug is dispensed to adults without a prescription
Scheme of administration of suppositories 12 mg
Read carefully these instructions before you start using the drug, since they contain important information for you.
Keep the instructions: you may need them again.
This drug is available without a prescription. For optimal results, it should be used by strictly following all recommendations stated in the instructions.
The drug you are being treated with is intended for you personally: you should not give it to others, since it may cause harm to them even if they have the same symptoms as you.
Registration number: P N002935/03.
Trade name: Polyoxidonium®.
International nonproprietary name: Azoximer bromide (Аzoximeri bromidum).
Chemical name: copolymer of N-oxide of 1,4-ethylene piperazine and (N-carboxymethyl)-1,4-ethylene piperazine bromide.
Dosage form: vaginal and rectal suppositories.
Composition per tablet: Active ingredient: azoximer bromide – 6 mg or 12 mg; Excipients: mannitol – 1.8 mg, povidone – 1.2 mg, cocoa seed oil (cocoa oil) – 1,291.0 mg (for 6 mg dosage); mannitol – 3.6 mg, povidone – 2.4 mg, cocoa seed oil (cocoa oil) – 1,282.0 mg (for 12 mg dosage).
Description: torpedo-shaped suppositories of light yellow color with a faint specific smell of cocoa oil
Suppositories should be homogenous. Marbling of coloring and presence of air rod or funnel-shaped cavity on the cut is allowed.
Pharmacotherapeutic group: immunomodulatory agent.
ATC Code: [LO3].
Azoximer bromide has a complex effect: immunomodulatory, detoxifying, antioxidant, and moderate anti-inflammatory.
The mechanism of Azoximer bromide immunomodulatory action is based on direct effect on phagocytic cells and natural killer cells, as well as stimulation of antibody formation and synthesis of interferon-alpha and interferon-gamma.
Detoxication 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 restores immunity in secondary immunodeficiency states caused by various infections, injuries, complications after surgery.
A characteristic feature of Azoximer bromide when applied topically (sublingually) is its ability to activate factors of early defense of the body against infection: the drug stimulates bactericidal properties of neutrophils, macrophages, enhances their ability to absorb bacteria, increases bactericidal properties of saliva and mucous secretion of the upper respiratory tract.
When administered orally, Azoximer bromide also activates lymphoid cells in the intestinal lymph nodes.
Azoximer bromide blocks soluble toxic substances and microparticles, has the ability to eliminate toxins, salts of heavy metals from the body, inhibits lipid peroxidation, both by intercepting free radicals and through elimination of catalytically active Fe2+ ions. Azoximer bromide reduces inflammatory response by normalizing the synthesis of pro- and anti-inflammatory cytokines.
Azoximer bromide is well tolerated, has no mitogenic or polyclonal activity, antigenic properties, does not have allergenic, mutagenic, embryotoxic, teratogenic, and carcinogenic effects.
Azoximer bromide in suppositories at rectal administration has high bioavailability (not less than 70%), reaching maximum concentration in blood 1 hour after administration. Its distribution half-life is about 0.5 hours, elimination half-life is 36.2 hours. In the body, it is hydrolyzed to oligomers, which are eliminated mainly by the kidneys. No cumulative effect.
Treatment and prevention of inflammatory infections (of viral, bacterial, and fungal etiology) in the stage of exacerbation and remission in adults and children over 1 year old.
For treatment in adults (in complex therapy) of:
- Acute and exacerbation of chronic recurrent inflammatory infections of various localizations, of bacterial, viral, and fungal etiology;
- Inflammatory diseases of the urogenital tract (urethritis, cystitis, pyelonephritis, prostatitis, salpingo-ophoritis, endometritis, colpitis, cervicitis, cervicosis, bacterial vaginosis);
- Various forms of pulmonary tuberculosis;
- Allergic diseases (including pollinosis, bronchial asthma, atopic dermatitis), complicated by recurrent bacterial, fungal, and viral infection;
- Rheumatoid arthritis complicated by recurrent bacterial, fungal, and viral infection, against the background of long-term administration of immunosuppressants;
- To activate regenerative processes (fractures, burns, trophic ulcers);
- In the complex therapy of cancer during chemotherapy and radiation therapy, to reduce the nephro- and hepatotoxic effects of drugs.
For prevention in adults (monotherapy) of:
- Recurrent and herpetic infection of the urogenital tract;
- Exacerbations of chronic foci of infections;
- Influenza and other acute respiratory infections during the pre-epidemic periods and epidemic periods in immunocompromised persons;
- Secondary immunodeficiency states arising due to aging or exposure to unfavorable factors.
For treatment in children from 6 to 18 years (in complex therapy) of:
- Acute and exacerbation of chronic recurrent inflammatory infections of various localizations, of bacterial, viral, and fungal etiology;
- Inflammatory diseases of the urogenital tract (urethritis, cystitis, pyelonephritis);
- Various forms of pulmonary tuberculosis;
- Allergic diseases (including pollinosis, bronchial asthma, atopic dermatitis), complicated by recurrent bacterial, fungal, and viral infection;
- To activate regenerative processes (fractures, burns, trophic ulcers);
- In the complex therapy of cancer during chemotherapy and radiation therapy, to reduce the nephro- and hepatotoxic effects of drugs.
For prevention in children from 6 to 18 years (monotherapy) of:
- Recurrent and herpetic infection of the urogenital tract;
- Exacerbations of chronic foci of infections;
- Influenza and other acute respiratory infections during the pre-epidemic periods and epidemic periods in immunocompromised persons.
For treatment in children from 1 to 6 years (in complex therapy) of:
- Acute and exacerbation of chronic recurrent inflammatory infections of various localizations, of bacterial, viral, and fungal etiology;
- Inflammatory diseases of the urogenital tract (urethritis, cystitis, pyelonephritis);
- Various forms of pulmonary tuberculosis;
- Allergic diseases (including pollinosis, bronchial asthma, atopic dermatitis), complicated by recurrent bacterial, fungal, and viral infection;
- To activate regenerative processes (fractures, burns, trophic ulcers).
For prevention in children from 1 to 6 years (monotherapy) of:
- Recurrent and herpetic infection of the urogenital tract;
- Exacerbations of chronic foci of infections;
- Influenza and other acute respiratory infections during the pre-epidemic periods and epidemic periods in immunocompromised persons.
- Increased individual sensitivity;
- Pregnancy, breastfeeding;
- Children under 3 years of age;
- Acute renal failure;
- Rare hereditary lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.
If you have any of the diseases mentioned in this section, consult your doctor before starting to take the drug:
- ● Chronic renal failure (use no more than 2 times a week).
The use of the Polyoxidonium® drug is contraindicated in pregnant women and women during breastfeeding (no clinical experience of use).
No embryotoxic and teratogenic effects, influence on fetal development were revealed during experimental use of the Polyoxidonium® drug in animals.
Before using the Polyoxidonium®drug, if you are pregnant or suppose that you could be pregnant, or planning pregnancy, you should consult your doctor.
During breastfeeding, you should consult your doctor before using the Polyoxidonium® drug.
Use the drug only according to the indications, method of administration, and dosage indicated in the instructions.
If after the treatment there is no improvement or your symptoms worsen or new symptoms appear, you should consult your doctor.
If necessary, repeated courses of therapy are possible in 3–4 months.
Upon repeated administration of the drug, its efficacy is not reduced.
Recommended regimens for the use of the drug
Administration in adults
- Rectally 1 suppository 1 time a day after colon cleanse;
- Vaginally in gynecological diseases 1 suppository 1 time a day (for the night) is inserted into the vagina in the supine position.
For treatment in adults:
- In chronic inflammatory infections in the stage of exacerbation — suppositories 12 mg 1 time a day daily for 3 days, then every other day. Course of treatment — 10 suppositories;
- In acute infectious processes and to activate regenerative processes (fractures, burns, trophic ulcers) — suppositories 12 mg 1 time a day daily. Course of treatment — 10 suppositories;
- In gynecological diseases — suppositories 12 mg 1 time a day daily for 3 days, then every other day. Course of treatment — 10 suppositories;
- In exacerbation of urological diseases (urethritis, pyelonephritis, cystitis, prostatitis) — suppositories 12 mg 1 time a day daily. Course of treatment — 10 suppositories;
- In pulmonary tuberculosis — suppositories 12 mg 1 time a day daily for 3 days, then every other day. Course of treatment — 20 suppositories. After that, maintenance therapy is possible — suppositories 6 mg 2 times a week, a course of up to 2–3 months;
- In the complex therapy of cancer during chemotherapy and radiation therapy — suppositories 12 mg daily for 2–3 days before the beginning of the chemotherapy or radiation therapy course. Then 12 mg 2 times a week, a course of up to 20 suppositories;
- In allergic diseases complicated by infectious syndrome — suppositories 12 mg 1 time a day daily. Course of treatment — 10 suppositories;
- In rheumatoid arthritis — suppositories 12 mg every other day. Course of treatment — 10 suppositories.
For prevention (monotherapy) of:
- Exacerbations of chronic foci of infections, recurrent herpetic infection of the urogenital tract — suppositories 12 mg every other day. Course of treatment — 10 suppositories;
- Influenza and ARVI — suppositories 12 mg 1 time a day. Course of treatment — 10 suppositories;
- Secondary immunodeficiencies due to aging — suppositories 12 mg 2 times a week. Course of treatment — 10 suppositories, 2–3 times a year.
Administration in children
In children and adolescents from 1 to 18 years old suppositories are administered only rectally, 1 suppository 6 mg 1 time a day after colon cleanse.
For treatment in children and adolescents from 6 to 18 years:
- In chronic inflammatory infections in the stage of exacerbation — suppositories 6 mg 1 time a day daily for 3 days, then every other day. Course of treatment — 10 suppositories;
- In acute infectious processes and to activate regenerative processes (fractures, burns, trophic ulcers) — suppositories 6 mg 1 time a day daily. Course of treatment — 10 suppositories;
- In exacerbation of urological diseases (urethritis, pyelonephritis, cystitis) — suppositories 6 mg 1 time a day daily. Course of treatment — 10 suppositories;
- In pulmonary tuberculosis — suppositories 6 mg 1 time a day daily for 3 days, then every other day. Course of treatment — 20 suppositories. After that, maintenance therapy is possible — suppositories 6 mg 2 times a week, a course of up to 2–3 months;
- In the complex therapy of cancer during chemotherapy and radiation therapy — suppositories 6 mg daily for 2–3 days before the beginning of the chemotherapy or radiation therapy course. Then 6 mg 2 times a week, a course of up to 20 suppositories;
- In allergic diseases complicated by infectious syndrome — suppositories 6 mg 1 time a day daily. Course of treatment — 10 suppositories;
For prevention in children and adolescents from 6 to 18 years (monotherapy) of:
- Exacerbations of chronic foci of infections, recurrent herpetic infection of the urogenital tract — suppositories 6 mg every other day. Course of treatment — 10 suppositories;
- Influenza and ARVI — suppositories 6 mg 1 time a day. Course of treatment — 10 suppositories.
For treatment in children from 1 to 6 years:
- In chronic inflammatory infections in the stage of exacerbation — suppositories 6 mg 1 time a day, the first three doses every other day, then the interval between doses can be increased up to 3 days. Course of treatment — 5 suppositories;
- In acute infectious processes and to activate regenerative processes (fractures, burns, trophic ulcers) — suppositories 6 mg 1 time a day every other day. Course of treatment — 5 suppositories;
- In exacerbation of urological diseases (urethritis, pyelonephritis, cystitis) — suppositories 6 mg 1 time a day every other day. Course of treatment — 5 suppositories;
- In pulmonary tuberculosis — suppositories 6 mg 1 time a day, the first three doses every other day, then the interval between doses can be increased up to 3 days. Course of treatment — 10 suppositories;
- In allergic diseases complicated by infectious syndrome — suppositories 6 mg 1 time a day every other day. Course of treatment — 5 suppositories.
For prevention in children from 1 to 6 years (monotherapy) of:
- Exacerbations of chronic foci of infections, recurrent herpetic infection of the urogenital tract — suppositories 6 mg 1 time a day, with the interval between doses of 3 days. Course of treatment —5 suppositories;
- Influenza and ARVI — suppositories 6 mg 1 time a day every other day. Course of treatment — 5 suppositories
Long-term (from 2–3 months up to 1 year) maintenance therapy with the Polyoxidonium® drug (in adults — 12 mg, in children over 6 years — 6 mg 1–2 times a week) is indicated for patients receiving long-term immunosuppressive therapy, oncological, irradiated patients or patients with acquired immune system defect — HIV
Very rare: local reactions in the form of redness, swelling, itching of the perianal area, vaginal itching due to individual sensitivity to components of the drug.
If you notice any side effect not specified in the instructions, inform your doctor about it.
No cases of overdose have been reported.
Azoximer bromide does not inhibit isoenzymes CYP1A2, CYP2С9, CYP2С19, CYP2D6, cytochrome Р-450, therefore the drug is compatible with antibiotics, antiviral, antifungal, and antihistamine drugs, glucocorticosteroids and cytostatic drugs.
If you take any of the above or other drugs (including OTC drugs), consult your doctor before you start taking Polyoxidonium.
In case of allergic reaction, you should stop taking the Polyoxidonium® drug and consult your doctor.
If it is necessary to stop taking the Polyoxidonium® drug, it can be discontinued immediately, without gradual dose reduction.
In case of missed administration of a drug dose, its subsequent administration shall be carried out according to the usual regimen, as indicated in the instructions or recommended by your doctor. A patient should not administer a double dose to compensate for missed doses.
Do not use the drug if there are any visual signs of its unsuitability for use (package defect, changed color of a tablet).
Administration of the Polyoxidonium® drug does not affect the ability to perform potentially dangerous activities requiring increased concentration and quickness of psychomotor reactions (including driving vehicles, working with moving mechanisms).
Vaginal and rectal suppositories, 6 mg, 12 mg.
5 suppositories in each blister made of polyvinylchloride film. Two blisters together with the instructions for use are placed in a cardboard pack.
2 years. Do not use the drug after the expiration date.
Store at the temperature not exceeding 15 °С.
Do not freeze. Keep out of reach of children.
Over the counter.
NPO Petrovax Pharm, OOO
1, ul. Sosnovaya, s. Pokrov, Podolsk, Moscow Region, 142143, Russia
tel: +7 (495) 926-21-07,
e-mail: info@petrovax.ru;
NPO Petrovax Pharm, OOO
1, ul. Sosnovaya, s. Pokrov, Podolsk, Moscow Region, 142143, Russia
tel: +7 (495) 926-21-07,
e-mail: info@petrovax.ru;
For children over 1 year of age are available without a prescription
Scheme of administration of suppositories 6 mg
Read carefully these instructions before you start using the drug, since they contain important information for you.
Keep the instructions: you may need them again.
This drug is available without a prescription. For optimal results, it should be used by strictly following all recommendations stated in the instructions.
The drug you are being treated with is intended for you personally: you should not give it to others, since it may cause harm to them even if they have the same symptoms as you.
Registration number: P N002935/03.
Trade name: Polyoxidonium®.
International nonproprietary name: Azoximer bromide (Аzoximeri bromidum).
Chemical name: copolymer of N-oxide of 1,4-ethylene piperazine and (N-carboxymethyl)-1,4-ethylene piperazine bromide.
Dosage form: vaginal and rectal suppositories.
Composition per tablet: Active ingredient: azoximer bromide – 6 mg or 12 mg; Excipients: mannitol – 1.8 mg, povidone – 1.2 mg, cocoa seed oil (cocoa oil) – 1,291.0 mg (for 6 mg dosage); mannitol – 3.6 mg, povidone – 2.4 mg, cocoa seed oil (cocoa oil) – 1,282.0 mg (for 12 mg dosage).
Description: torpedo-shaped suppositories of light yellow color with a faint specific smell of cocoa oil
Suppositories should be homogenous. Marbling of coloring and presence of air rod or funnel-shaped cavity on the cut is allowed.
Pharmacotherapeutic group: immunomodulatory agent.
ATC Code: [LO3].
Azoximer bromide has a complex effect: immunomodulatory, detoxifying, antioxidant, and moderate anti-inflammatory.
The mechanism of Azoximer bromide immunomodulatory action is based on direct effect on phagocytic cells and natural killer cells, as well as stimulation of antibody formation and synthesis of interferon-alpha and interferon-gamma.
Detoxication 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 restores immunity in secondary immunodeficiency states caused by various infections, injuries, complications after surgery.
A characteristic feature of Azoximer bromide when applied topically (sublingually) is its ability to activate factors of early defense of the body against infection: the drug stimulates bactericidal properties of neutrophils, macrophages, enhances their ability to absorb bacteria, increases bactericidal properties of saliva and mucous secretion of the upper respiratory tract.
When administered orally, Azoximer bromide also activates lymphoid cells in the intestinal lymph nodes.
Azoximer bromide blocks soluble toxic substances and microparticles, has the ability to eliminate toxins, salts of heavy metals from the body, inhibits lipid peroxidation, both by intercepting free radicals and through elimination of catalytically active Fe2+ ions. Azoximer bromide reduces inflammatory response by normalizing the synthesis of pro- and anti-inflammatory cytokines.
Azoximer bromide is well tolerated, has no mitogenic or polyclonal activity, antigenic properties, does not have allergenic, mutagenic, embryotoxic, teratogenic, and carcinogenic effects.
Azoximer bromide in suppositories at rectal administration has high bioavailability (not less than 70%), reaching maximum concentration in blood 1 hour after administration. Its distribution half-life is about 0.5 hours, elimination half-life is 36.2 hours. In the body, it is hydrolyzed to oligomers, which are eliminated mainly by the kidneys. No cumulative effect.
Treatment and prevention of inflammatory infections (of viral, bacterial, and fungal etiology) in the stage of exacerbation and remission in adults and children over 1 year old.
For treatment in adults (in complex therapy) of:
- Acute and exacerbation of chronic recurrent inflammatory infections of various localizations, of bacterial, viral, and fungal etiology;
- Inflammatory diseases of the urogenital tract (urethritis, cystitis, pyelonephritis, prostatitis, salpingo-ophoritis, endometritis, colpitis, cervicitis, cervicosis, bacterial vaginosis);
- Various forms of pulmonary tuberculosis;
- Allergic diseases (including pollinosis, bronchial asthma, atopic dermatitis), complicated by recurrent bacterial, fungal, and viral infection;
- Rheumatoid arthritis complicated by recurrent bacterial, fungal, and viral infection, against the background of long-term administration of immunosuppressants;
- To activate regenerative processes (fractures, burns, trophic ulcers);
- In the complex therapy of cancer during chemotherapy and radiation therapy, to reduce the nephro- and hepatotoxic effects of drugs.
For prevention in adults (monotherapy) of:
- Recurrent and herpetic infection of the urogenital tract;
- Exacerbations of chronic foci of infections;
- Influenza and other acute respiratory infections during the pre-epidemic periods and epidemic periods in immunocompromised persons;
- Secondary immunodeficiency states arising due to aging or exposure to unfavorable factors.
For treatment in children from 6 to 18 years (in complex therapy) of:
- Acute and exacerbation of chronic recurrent inflammatory infections of various localizations, of bacterial, viral, and fungal etiology;
- Inflammatory diseases of the urogenital tract (urethritis, cystitis, pyelonephritis);
- Various forms of pulmonary tuberculosis;
- Allergic diseases (including pollinosis, bronchial asthma, atopic dermatitis), complicated by recurrent bacterial, fungal, and viral infection;
- To activate regenerative processes (fractures, burns, trophic ulcers);
- In the complex therapy of cancer during chemotherapy and radiation therapy, to reduce the nephro- and hepatotoxic effects of drugs.
For prevention in children from 6 to 18 years (monotherapy) of:
- Recurrent and herpetic infection of the urogenital tract;
- Exacerbations of chronic foci of infections;
- Influenza and other acute respiratory infections during the pre-epidemic periods and epidemic periods in immunocompromised persons.
For treatment in children from 1 to 6 years (in complex therapy) of:
- Acute and exacerbation of chronic recurrent inflammatory infections of various localizations, of bacterial, viral, and fungal etiology;
- Inflammatory diseases of the urogenital tract (urethritis, cystitis, pyelonephritis);
- Various forms of pulmonary tuberculosis;
- Allergic diseases (including pollinosis, bronchial asthma, atopic dermatitis), complicated by recurrent bacterial, fungal, and viral infection;
- To activate regenerative processes (fractures, burns, trophic ulcers).
For prevention in children from 1 to 6 years (monotherapy) of:
- Recurrent and herpetic infection of the urogenital tract;
- Exacerbations of chronic foci of infections;
- Influenza and other acute respiratory infections during the pre-epidemic periods and epidemic periods in immunocompromised persons.
- Increased individual sensitivity;
- Pregnancy, breastfeeding;
- Children under 3 years of age;
- Acute renal failure;
- Rare hereditary lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.
If you have any of the diseases mentioned in this section, consult your doctor before starting to take the drug:
- ● Chronic renal failure (use no more than 2 times a week).
The use of the Polyoxidonium® drug is contraindicated in pregnant women and women during breastfeeding (no clinical experience of use).
No embryotoxic and teratogenic effects, influence on fetal development were revealed during experimental use of the Polyoxidonium® drug in animals.
Before using the Polyoxidonium®drug, if you are pregnant or suppose that you could be pregnant, or planning pregnancy, you should consult your doctor.
During breastfeeding, you should consult your doctor before using the Polyoxidonium® drug.
Use the drug only according to the indications, method of administration, and dosage indicated in the instructions.
If after the treatment there is no improvement or your symptoms worsen or new symptoms appear, you should consult your doctor.
If necessary, repeated courses of therapy are possible in 3–4 months.
Upon repeated administration of the drug, its efficacy is not reduced.
Recommended regimens for the use of the drug
Administration in adults
- Rectally 1 suppository 1 time a day after colon cleanse;
- Vaginally in gynecological diseases 1 suppository 1 time a day (for the night) is inserted into the vagina in the supine position.
For treatment in adults:
- In chronic inflammatory infections in the stage of exacerbation — suppositories 12 mg 1 time a day daily for 3 days, then every other day. Course of treatment — 10 suppositories;
- In acute infectious processes and to activate regenerative processes (fractures, burns, trophic ulcers) — suppositories 12 mg 1 time a day daily. Course of treatment — 10 suppositories;
- In gynecological diseases — suppositories 12 mg 1 time a day daily for 3 days, then every other day. Course of treatment — 10 suppositories;
- In exacerbation of urological diseases (urethritis, pyelonephritis, cystitis, prostatitis) — suppositories 12 mg 1 time a day daily. Course of treatment — 10 suppositories;
- In pulmonary tuberculosis — suppositories 12 mg 1 time a day daily for 3 days, then every other day. Course of treatment — 20 suppositories. After that, maintenance therapy is possible — suppositories 6 mg 2 times a week, a course of up to 2–3 months;
- In the complex therapy of cancer during chemotherapy and radiation therapy — suppositories 12 mg daily for 2–3 days before the beginning of the chemotherapy or radiation therapy course. Then 12 mg 2 times a week, a course of up to 20 suppositories;
- In allergic diseases complicated by infectious syndrome — suppositories 12 mg 1 time a day daily. Course of treatment — 10 suppositories;
- In rheumatoid arthritis — suppositories 12 mg every other day. Course of treatment — 10 suppositories.
For prevention (monotherapy) of:
- Exacerbations of chronic foci of infections, recurrent herpetic infection of the urogenital tract — suppositories 12 mg every other day. Course of treatment — 10 suppositories;
- Influenza and ARVI — suppositories 12 mg 1 time a day. Course of treatment — 10 suppositories;
- Secondary immunodeficiencies due to aging — suppositories 12 mg 2 times a week. Course of treatment — 10 suppositories, 2–3 times a year.
Administration in children
In children and adolescents from 1 to 18 years old suppositories are administered only rectally, 1 suppository 6 mg 1 time a day after colon cleanse.
For treatment in children and adolescents from 6 to 18 years:
- In chronic inflammatory infections in the stage of exacerbation — suppositories 6 mg 1 time a day daily for 3 days, then every other day. Course of treatment — 10 suppositories;
- In acute infectious processes and to activate regenerative processes (fractures, burns, trophic ulcers) — suppositories 6 mg 1 time a day daily. Course of treatment — 10 suppositories;
- In exacerbation of urological diseases (urethritis, pyelonephritis, cystitis) — suppositories 6 mg 1 time a day daily. Course of treatment — 10 suppositories;
- In pulmonary tuberculosis — suppositories 6 mg 1 time a day daily for 3 days, then every other day. Course of treatment — 20 suppositories. After that, maintenance therapy is possible — suppositories 6 mg 2 times a week, a course of up to 2–3 months;
- In the complex therapy of cancer during chemotherapy and radiation therapy — suppositories 6 mg daily for 2–3 days before the beginning of the chemotherapy or radiation therapy course. Then 6 mg 2 times a week, a course of up to 20 suppositories;
- In allergic diseases complicated by infectious syndrome — suppositories 6 mg 1 time a day daily. Course of treatment — 10 suppositories;
For prevention in children and adolescents from 6 to 18 years (monotherapy) of:
- Exacerbations of chronic foci of infections, recurrent herpetic infection of the urogenital tract — suppositories 6 mg every other day. Course of treatment — 10 suppositories;
- Influenza and ARVI — suppositories 6 mg 1 time a day. Course of treatment — 10 suppositories.
For treatment in children from 1 to 6 years:
- In chronic inflammatory infections in the stage of exacerbation — suppositories 6 mg 1 time a day, the first three doses every other day, then the interval between doses can be increased up to 3 days. Course of treatment — 5 suppositories;
- In acute infectious processes and to activate regenerative processes (fractures, burns, trophic ulcers) — suppositories 6 mg 1 time a day every other day. Course of treatment — 5 suppositories;
- In exacerbation of urological diseases (urethritis, pyelonephritis, cystitis) — suppositories 6 mg 1 time a day every other day. Course of treatment — 5 suppositories;
- In pulmonary tuberculosis — suppositories 6 mg 1 time a day, the first three doses every other day, then the interval between doses can be increased up to 3 days. Course of treatment — 10 suppositories;
- In allergic diseases complicated by infectious syndrome — suppositories 6 mg 1 time a day every other day. Course of treatment — 5 suppositories.
For prevention in children from 1 to 6 years (monotherapy) of:
- Exacerbations of chronic foci of infections, recurrent herpetic infection of the urogenital tract — suppositories 6 mg 1 time a day, with the interval between doses of 3 days. Course of treatment —5 suppositories;
- Influenza and ARVI — suppositories 6 mg 1 time a day every other day. Course of treatment — 5 suppositories
Long-term (from 2–3 months up to 1 year) maintenance therapy with the Polyoxidonium® drug (in adults — 12 mg, in children over 6 years — 6 mg 1–2 times a week) is indicated for patients receiving long-term immunosuppressive therapy, oncological, irradiated patients or patients with acquired immune system defect — HIV
Very rare: local reactions in the form of redness, swelling, itching of the perianal area, vaginal itching due to individual sensitivity to components of the drug.
If you notice any side effect not specified in the instructions, inform your doctor about it.
No cases of overdose have been reported.
Azoximer bromide does not inhibit isoenzymes CYP1A2, CYP2С9, CYP2С19, CYP2D6, cytochrome Р-450, therefore the drug is compatible with antibiotics, antiviral, antifungal, and antihistamine drugs, glucocorticosteroids and cytostatic drugs.
If you take any of the above or other drugs (including OTC drugs), consult your doctor before you start taking Polyoxidonium.
In case of allergic reaction, you should stop taking the Polyoxidonium® drug and consult your doctor.
If it is necessary to stop taking the Polyoxidonium® drug, it can be discontinued immediately, without gradual dose reduction.
In case of missed administration of a drug dose, its subsequent administration shall be carried out according to the usual regimen, as indicated in the instructions or recommended by your doctor. A patient should not administer a double dose to compensate for missed doses.
Do not use the drug if there are any visual signs of its unsuitability for use (package defect, changed color of a tablet).
Administration of the Polyoxidonium® drug does not affect the ability to perform potentially dangerous activities requiring increased concentration and quickness of psychomotor reactions (including driving vehicles, working with moving mechanisms).
Vaginal and rectal suppositories, 6 mg, 12 mg.
5 suppositories in each blister made of polyvinylchloride film. Two blisters together with the instructions for use are placed in a cardboard pack.
2 years. Do not use the drug after the expiration date.
Store at the temperature not exceeding 15 °С.
Do not freeze. Keep out of reach of children.
Over the counter.
NPO Petrovax Pharm, OOO
1, ul. Sosnovaya, s. Pokrov, Podolsk, Moscow Region, 142143, Russia
tel: +7 (495) 926-21-07,
e-mail: info@petrovax.ru;
NPO Petrovax Pharm, OOO
1, ul. Sosnovaya, s. Pokrov, Podolsk, Moscow Region, 142143, Russia
tel: +7 (495) 926-21-07,
e-mail: info@petrovax.ru;