Polyoxidonium is an immunomodulator for activating the immune system and has a detoxifying effect. Increases the body's immune resistance against local and generalized infections. Restores immune responses in immunodeficiency states. In the range of indications: correction secondary immunodeficiencies; infectious and inflammatory diseases, incl. chronic recurrent (ENT organs, upper respiratory tract, urogenital, etc.); surgical infections; tuberculosis; allergic diseases with secondary immune deficiency; intestinal dysbiosis; rheumatoid arthritis; malignant neoplasms (during and after chemotherapy and radiation therapy); trophic ulcers and etc.
Compound
For 1 suppository: active substance: Polyoxidonium (Azoximer bromide) - 12 mg
Release form
Vaginal and rectal suppositories, 10 pieces per package
pharmachologic effect
Polyoxidonium has an immunomodulatory effect, increases the body's resistance to local and generalized infections. The basis of the mechanism of immunomodulatory action of Polyoxidonium is a direct effect on phagocytic cells and natural killer cells, as well as stimulation of antibody formation.
Polyoxidonium restores immunity in secondary immunodeficiency conditions caused by various infections, injuries, burns, autoimmune diseases, malignant neoplasms, complications after surgical operations, the use of chemotherapeutic agents, cytostatics, steroid hormones.
Along with the immunomodulatory effect, Polyoxidonium has a pronounced detoxification and antioxidant activity, has the ability to remove toxins and salts from the body heavy metals, inhibits lipid peroxidation.
These properties are determined by the structure and high-molecular nature of Polyoxidonium. The inclusion of Polyoxidonium in the complex therapy of cancer patients reduces intoxication during chemotherapy and radiation therapy, in most cases allows treatment without changing the standard therapy regimen 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 can increase 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, does not have mitogenic, polyclonal activity, antigenic properties, does not have allergenic, mutagenic, embryotoxic, teratogenic and carcinogenic effects.
Indications for use
In adults and children over 6 years of age complex therapy to correct immune deficiency:
- chronic recurrent infectious and inflammatory diseases that are not amenable to standard therapy, both in the acute stage and in the remission stage;
- acute viral, bacterial and fungal infections;
- inflammatory diseases of the urogenital tract, including urethritis, cystitis, pyelonephritis, prostatitis, salpingoophoritis, endomyometritis, colpitis, cervicitis, cervicosis, bacterial vaginosis, including viral etiology;
- various forms tuberculosis;
- allergic diseases complicated by recurrent bacterial, fungal and viral infection(including hay fever, bronchial asthma, atopic dermatitis);
- rheumatoid arthritis, long-term treatment with immunosuppressants; with a complicated acute respiratory infection or acute respiratory viral infection;
- to activate regenerative processes (fractures, burns, trophic ulcers);
- for the rehabilitation of frequently and long-term (more than 4-5 times a year) ill persons;
- during and after chemotherapy and radiation therapy of tumors;
- to reduce the nephro- and hepatotoxic effects of drugs.
As monotherapy:
- for the prevention of recurrent herpetic infection;
- For seasonal prevention exacerbations of chronic foci of infections; for the prevention of influenza and acute respiratory infections in the pre-epidemic period;
- for the correction of secondary immunodeficiencies resulting from aging or exposure to adverse factors.
Directions for use and doses
Polyoxidonium suppositories 6 mg and 12 mg are used rectally and vaginally once a day. The method and dosage regimen is determined by the doctor depending on the diagnosis, severity and severity of the process. Polyoxidonium can be used rectally and vaginally daily, every other day or 2 times a week.
- Polyoxidonium suppositories 12 mg are used rectally in adults, 1 suppository 1 time per day after bowel cleansing;
for gynecological diseases and vaginally, 1 suppository 1 time per day (at night) is inserted into the vagina in a lying position.
- Polyoxidonium suppositories 6 mg is used:
in children over 6 years old, 1 suppository rectally 1 time per day after cleansing the intestines;
in adults, rectally and vaginally as a maintenance dose, 1 suppository 1 time per day (at night) is inserted into the vagina in a lying position.
Standard regimen of use (unless otherwise prescribed by a doctor)
1 suppository 6 mg or 12 mg 1 time per day daily for 3 days, then every other day in a course of 10-20 suppositories. If necessary, the course of treatment is repeated after 3-4 months. For patients receiving immunosuppressive therapy for a long time, cancer patients with an acquired defect of the immune system - HIV, who have been exposed to radiation, long-term maintenance therapy with Polyoxidonium is indicated for 2-3 months to 1 year (adults 12 mg, children over 6 years old - 6 mg 1- 2 times per week).
Contraindications
- Increased individual sensitivity.
- Pregnancy, lactation ( clinical experience no application).
special instructions
Polyoxidonium is compatible with antibiotics, antiviral, antifungal and antihistamines, bronchodilators, glucocorticosteroids, cytostatics.
Do not exceed the indicated doses and duration of treatment without consulting your doctor.
Storage conditions
In a dry place, protected from light, at a temperature of 2 to 15°C. Keep away from children.
Polyoxidonium suppositories are an immunomodulating drug that helps increase the body's resistance to bacterial, viral and fungal infections. Applicable as prophylactic and in the complex therapeutic measures for diseases of various systems and organs in adults and children.
ATX
Composition and dosage forms
The main active ingredient of suppositories is azoximer bromide; Povidone, betacarotene, mannitol and cocoa butter were used as supplements.
The product is produced:
- suppositories for rectal or intravaginal use in dosages of 6 or 12 mg;
- tablets (12 mg);
- solution for injections and topical use, containing 3 mg or 6 mg of lyophilisate (dry matter).
Pharmacological group
Polyoxidonium suppositories belong to the subgroup of immunomodulators.
pharmachologic effect
Polyoxidonium is an immunomodulatory, anti-inflammatory and antioxidant agent. Active substance strengthens phagocyte cells and stimulates the formation of antibodies.
Azoximer bromide helps restore immune system in conditions of secondary immunodeficiency arising after previous infectious diseases, trauma, surgery, antibiotic treatment and hormonal drugs, chemotherapy or radiation for malignant neoplasms.
Due to the high-molecular structure of the substance, the drug has detoxifying properties (reduces toxicity chemical substance, promotes the removal of toxins from the body and increases the stability of cell membranes).
Why are Polyoxidonium suppositories prescribed?
Suppositories are often used as an element of complex therapy for acute and chronic diseases:
In addition, the drug is prescribed in the following cases:
- after skin transplantation for extensive burn lesions;
- for recovery after severe injuries;
- in gynecology for the treatment of endometritis, colpitis, cervicitis or thrush.
Immunologists prescribe Polyoxidonium to elderly patients, as well as to children who are often and long-term ill (those who suffer from ARVI more than 5-6 times during the year.)
Method of use and dosage of Polyoxidonium suppositories
Suppositories are administered vaginally or rectally in accordance with the recommendations of the attending physician (daily, every other day or twice a week).
Prophylactic course - 10 suppositories of 6 mg or 12 mg every other day.
With a standard regimen of use, adult patients are prescribed 1 12 mg suppository once a day for 3 days, then 1 suppository is administered every other day (10, 15 or 20 suppositories per course). The dosage may be adjusted; The maintenance course of treatment (1-2 times a week) is sometimes extended to 3 months, and for cancer patients after radiation therapy or patients with immunosuppressive conditions (HIV-infected) - up to 1 year.
Children's dosage - 6 mg; course - 10 procedures.
Repeated courses of treatment can be carried out after 3-4 months, without reducing the effectiveness of the drug.
The procedure is best done at night; Before placing a suppository in the rectum, you must empty your bowels and wash your hands thoroughly.
During treatment gynecological diseases depending on the degree of damage, Polyoxidonium can be administered intravaginally and rectally. Vaginal suppositories Do not use during menstruation; during this period it is recommended to insert suppositories into the rectum.
Candles: method of use and dosage
special instructions
You should not independently change the dosage of the drug and the duration of the course prescribed by a specialist.
Drinking alcohol during treatment is not recommended. The use of ethanol-containing medications must be agreed with your doctor.
During pregnancy and breastfeeding
There is no sufficient experience and statistical data on the use of suppositories by pregnant and lactating women, therefore, these conditions are listed in the contraindications section of the instructions.
For children
The vaginal form is not used in pediatric practice.
Side effects of Polyoxidonium suppositories
Side effects are not described in the manufacturer's instructions, but patients sometimes complain of a feeling of bloating in the intestines when the suppositories are administered rectally and burning or itching when administered vaginally.
Contraindications
Individual hypersensitivity, pregnancy and period breastfeeding, age up to 6 years.
In case of acute liver and kidney failure, the drug is prescribed with caution.
Overdose
Facts of complications after an overdose are not officially registered, but you should not violate the treatment regimen prescribed by your doctor.
Conditions for dispensing from pharmacies
Suppositories are an over-the-counter form of dispensing the drug.
Manufacturer
All dosage forms Polyoxidonium is produced by NPO Petrovax Pharm, located in the Moscow region.
Price
The cost of a package of 12 mg suppositories (10 pcs.) varies from 850 to 1200 rubles; in a dosage of 6 mg, suppositories are cheaper (from 700 to 900 rubles).
Conditions and shelf life
It is better to store suppositories in the refrigerator, permissible temperature-+2...+15ºС. All medications should be kept out of the reach of children. The drug can be used for 2 years from the date of release.
Analogues
Drugs with immunomodulatory properties:
- Immunal and Immunorm (tablets similar in composition);
- Immunoflazide (in syrup form);
- Wobenzym (tablets);
- Ribomunil (tablets and granules);
- Imunofan (suppositories, spray and solution);
- Cycloferon (coated tablets);
- Arbidol (capsules);
- Erbisol (ampoules with solution);
- Galavit (sublingual tablets).
Read these instructions carefully before you start using this medicine because they contain information that is important to you.
Save the instructions, you may need them again.
If you have any questions, consult your doctor.
This medicine is available without a prescription. To achieve optimal results, it should be used strictly following all recommendations outlined in the instructions.
Medicine The medicine you are being treated with is intended for you personally and should not be given to others as 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 (Azoximeri bromidum)
Chemical name: copolymer of 1,4-ethylenepiperazine N-oxide and (N-carboxymethyl)-1,4-ethylenepiperazinium bromide
Dosage form: pills
Composition per tablet:
Active ingredient: Azoximer bromide – 12 mg;
Excipients: mannitol – 3.6 mg, povidone K 17 – 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 tint, with a chamfer, with a score on one side and with the inscription “PO” on the other.
Pharmacotherapeutic group: immunomodulatory agent.
ATX code:
Pharmacodynamics
Azoximer bromide has complex action: immunomodulatory, detoxifying, antioxidant, moderate anti-inflammatory.
The basis of the mechanism of immunomodulatory action of Azoximer bromide is a direct effect on phagocytic cells and natural killer cells, as well as stimulation of antibody formation and the synthesis of interferon-alpha and interferon-gamma.
The detoxification 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. Restores immunity in secondary immunodeficiency conditions caused by various infections, injuries, complications after surgical operations.
Characteristic feature Azoximer bromide, when applied locally (sublingually), is able to activate factors of the body's early defense against infection: the drug stimulates the bactericidal properties of neutrophils, macrophages, enhances their ability to absorb bacteria, increases the bactericidal properties of saliva and secretions of the mucous membranes of the upper respiratory tract.
At oral administration Azoximer bromide also activates lymphoid cells in lymph nodes intestines.
Azoximer bromide blocks soluble toxic substances and microparticles, has the ability to remove toxins and heavy metal salts from the body, and inhibits lipid peroxidation, both by intercepting free radicals and by eliminating catalytically active Fe 2+ ions. Azoximer bromide reduces inflammatory reaction by normalizing the synthesis of pro- and anti-inflammatory cytokines.
Azoximer bromide is well tolerated, does not have mitogenic, polyclonal activity, antigenic properties, does not have allergenic, mutagenic, embryotoxic, teratogenic and carcinogenic effects.
Azoximer bromide is odorless and tasteless, and does not have a local irritating effect when applied to the mucous membranes of the nose and oropharynx.
Pharmacokinetics
After oral administration, azoximer bromide is rapidly absorbed from the gastrointestinal tract; the bioavailability of the drug when administered orally is more than 70%. Maximum concentration in blood plasma is achieved 3 hours after oral administration. The pharmacokinetics of Azoximer bromide is linear (plasma concentration is proportional to the dose taken).
Azoximer bromide is a hydrophilic compound. The apparent volume of distribution is approximately 0.5 l/kg, which indicates that the drug is distributed mainly in the interstitial fluid. The half-life of absorption is 35 minutes, the half-life is 18 hours.
Azoximer bromide is quickly distributed throughout all organs and tissues of the body, penetrates the blood-brain and blood-ophthalmic barriers. There is no cumulative effect. In the body of Azoximer, bromide undergoes biodegradation to low molecular weight oligomers, is excreted mainly by the kidneys, with feces - no more than 3%.
Indications for use
Used in adults and children over 3 years of age for the treatment and prevention of acute and chronic respiratory diseases in the stage of exacerbation and remission.
For treatment (in complex therapy):
- acute and exacerbation of chronic recurrent infectious and inflammatory diseases of the oropharynx, paranasal sinuses, upper and lower respiratory tract, inner and middle ear;
- allergic diseases (including hay fever, bronchial asthma), complicated by recurrent bacterial, fungal and viral infections;
For prevention (monotherapy):
- 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 conditions arising due to aging or exposure to adverse factors.
Contraindications
- increased individual sensitivity;
- pregnancy, breastfeeding period;
- childhood up to 3 years;
- acute renal failure;
- rare hereditary lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.
Carefully
If you have the diseases listed in this section, consult your doctor before starting to take this medicine:
- chronic renal failure (used no more than 2 times a week).
Use during pregnancy and breastfeeding
The use of the drug Polyoxidonium ® is contraindicated for pregnant women and women during breastfeeding (there is no clinical experience of use).
Experimental use of the drug Polyoxidonium ® in animals did not reveal embryotoxic or teratogenic effects or effects on fetal development.
Before using Polyoxidonium ® , if you are pregnant, or think you might be pregnant, or are planning a pregnancy, you should consult your doctor.
During breastfeeding, before using the drug Polyoxidonium ®, you should consult your doctor.
Directions for use and doses
Use the drug only according to the indications, method of administration and in the doses indicated in the instructions.
If there is no improvement after treatment, or symptoms worsen, or new symptoms appear, you should consult your doctor.
Orally and sublingually 20-30 minutes before meals every day, 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 are possible after 3-4 months. When the drug is re-prescribed, its effectiveness does not decrease.
Sublingual:
For treatment in adults:
- flu
- inflammatory processes oropharynx – 1 tablet 2 times a day for 10 days;
- exacerbations chronic diseases upper respiratory tract, paranasal paranasal sinuses, chronic otitis– 1 tablet 2 times a day for 10 days;
- allergic diseases (including hay fever, bronchial asthma), complicated by recurrent bacterial, fungal and viral infections - 1 tablet 2 times a day for 10 days.
For treatment in children aged 3 to 10 years:
- flu 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 hay fever, bronchial asthma), complicated by recurrent bacterial, fungal and viral infections - ½ tablet 2 times a day for 7 days.
- 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 media - 1 tablet 2 times a day for 7 days;
- allergic diseases (including hay fever, bronchial asthma), complicated by recurrent bacterial, fungal and viral infections - 1 tablet 2 times a day for 7 days.
For prevention in adults:
- influenza and acute respiratory infections in the pre-epidemic period - 1 tablet per day 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 once a day for 10 days;
- secondary immunodeficiencies arising due to aging or exposure to adverse factors - 1 tablet once a day for 10 days
For prevention in children aged 3 to 10 years:
- influenza and acute respiratory infections in the pre-epidemic period - ½ tablet per day 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 once a day for 10 days.
For prevention in children over 10 years of age:
- influenza and acute respiratory infections in the pre-epidemic period - 1 tablet per day 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 once a day for 10 days.
Orally
For treatment in adults:
For treatment in children over 10 years of age:
- diseases of the upper and lower respiratory tract - 1 tablet 2 times 10 days.
Side effect
No side effects have been reported.
If you notice any side effects, not listed in the instructions, please inform your doctor.
As monotherapy:
- prevention of recurrent herpetic infection of the nasal and labial area;
- prevention of exacerbations of chronic foci of infections of the oropharynx, paranasal sinuses, upper respiratory tract, inner and middle ear;
- prevention of secondary immunodeficiencies that occur due to aging or exposure to adverse factors.
Contraindications
- children under 3 years of age;
- pregnancy;
- lactation period (breastfeeding);
- rare hereditary lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome;
- increased individual sensitivity to the drug.
Carefully
Dosage
The drug is administered orally and sublingually 20-30 minutes before meals daily, 2 times a day.
Prescribe 1 tablet, - 1/2 tablet. (6 mg).
If necessary, repeated courses of therapy are possible after 3-4 months. When the drug is re-prescribed, its effectiveness does not decrease.
Sublingual
For treatment of influenza and acute respiratory infections adults and children over 10 years old 1 tablet is prescribed. 2 times/day 7 days; children aged 3 to 10 years
At inflammatory diseases oral cavity and throats adults children over 10 years old children aged 3 to 10 years
At exacerbation of chronic diseases of the upper respiratory tract, paranasal sinuses, chronic otitis media adults Prescribe 1 tablet 2 times a day for 10 days; children over 10 years old- 1 tab. 2 times/day for 7 days.
For treatment of allergic diseases (including hay fever, bronchial asthma) complicated by recurrent bacterial, fungal and viral infections adults 1 tablet is prescribed. 2 times/day for 10 days; children over 10 years old- 1 tab. 2 times/day for 7 days; children aged 3 to 10 years- 1/2 tab. 2 times/day for 7 days.
For prevention of influenza and acute respiratory infections in the pre-epidemic period adults prescribed 1 tablet/day for 10 days; children over 10 years old- 1 tablet/day per day for 7 days; children aged 3 to 10 years- 1/2 tablet/day for 7 days.
For prevention of recurrent herpes infection of the nasal and labial area adults 1 tablet is prescribed. 2 times/day 10 days; children over 10 years old- 1 tab. 2 times/day 7 days; children aged 3 to 10 years- 1/2 tab. 2 times/day 7 days.
For prevention of exacerbations of chronic foci of infections of the oropharynx, paranasal sinuses, upper respiratory tract, inner and middle ear adults and children over 10 years old 1 tablet is prescribed. 1 time/day for 10 days; children aged 3 to 10 years- 1/2 tab. 1 time/day for 10 days.
For prevention of secondary immunodeficiencies arising due to aging or exposure to adverse factors adults 1 tablet is prescribed. 1 time/day for 10 days.
Orally
At diseases of the upper and lower respiratory tract adults and children over 10 years old 1 tablet is prescribed. 2 times/day for 10 days.
Side effects
No side effects have been reported.
If the patient notices any side effects, he should inform the doctor.
Overdose
No cases of overdose have been registered.
Drug interactions
Azoximer bromide does not inhibit cytochrome P450 isoenzymes - CYP1A2, CYP2C9, CYP2C19, CYP2D6, therefore the drug is compatible with antibiotics, antifungal and antihistamines, corticosteroids and cytostatics.
If the patient is taking the above or other medications(including over-the-counter medications), you should consult your doctor before starting to take the drug.
special instructions
During development allergic reaction the patient should stop using the drug Polyoxidonium and consult a doctor.
If it is necessary to stop taking the drug Polyoxidonium, discontinuation can be done immediately, without gradually reducing the dose.
If the next dose of the drug is missed, its subsequent use should be carried out as usual, as indicated in the instructions or recommended by the doctor. Do not take a double dose to compensate for missed doses.
The drug should not be used if there are visual signs of its unsuitability (packaging defect, change in color of the tablet).
Impact on the ability to drive vehicles and operate machinery
The use of the drug Polyoxidonium does not affect the ability to perform potentially dangerous species activities requiring increased concentration attention and speed of psychomotor reactions (including driving vehicles, working with moving mechanisms).
Pregnancy and lactation
The use of the drug Polyoxidonium is contraindicated for pregnant women and women during breastfeeding (there is no clinical experience of use).
IN experimental studies The drug Polyoxidonium has not been shown to have any embryotoxic or teratogenic effects in animals or influence the development of the fetus.
If pregnancy occurs or is planning pregnancy, the patient should consult a doctor.
During breastfeeding, the patient should consult a doctor before using Polyoxidonium.
Use in childhood
The use of the drug is contraindicated in children under 3 years of age.
For impaired renal function
The use of the drug is contraindicated in acute renal failure.
WITH caution the drug should be prescribed for chronic renal failure (used no more than 2 times a week).
Conditions for dispensing from pharmacies
The drug is available without a prescription.
Storage conditions and periods
The drug should be stored out of the reach of children at a temperature of 2° to 25°C. Shelf life - 2 years. Do not use after expiration date.
Catad_pgroup Immunomodulators
Polyoxidonium tablets - instructions for use
Registration number:
P N002935/04
Trade name:
Polyoxidonium ®
International nonproprietary name:
Azoximer bromide (Azoximeri bromidum)
Chemical name:
copolymer of 1,4-ethylenepiperazine N-oxide and (N-carboxymethyl)-
1,4-ethylenepiperazinium bromide
Dosage form:
pills
Composition per tablet:
Active ingredient: Azoximer bromide – 12 mg;
Excipients: mannitol - 3.6 mg, povidone K 17 - 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 tint, with a chamfer, with a score on one side and with the inscription “PO” on the other.
Pharmacotherapeutic group:
immunomodulatory agent.
ATX code:
Pharmacological properties
Pharmacodynamics
Azoximer bromide has a complex effect: immunomodulatory, detoxifying, antioxidant, moderate anti-inflammatory.
The basis of the mechanism of immunomodulatory action of Azoximer bromide is a direct effect on phagocytic cells and natural killer cells, as well as stimulation of antibody formation and the synthesis of interferon-alpha and interferon-gamma.
The detoxification 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. Restores immunity in secondary immunodeficiency conditions caused by various infections, injuries, complications after surgical operations.
A characteristic feature of Azoximer bromide when applied topically (sublingually) is the ability to activate factors of the body's early defense against infection: the drug stimulates the bactericidal properties of neutrophils, macrophages, enhances their ability to absorb bacteria, increases the bactericidal properties of saliva and secretions of the mucous membranes 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 remove toxins and heavy metal salts from the body, and inhibits lipid peroxidation, both by intercepting free radicals and by eliminating catalytically active Fe 2+ ions. Azoximer bromide reduces the inflammatory response by normalizing the synthesis of pro- and anti-inflammatory cytokines.
Azoximer bromide is well tolerated, does not have mitogenic, polyclonal activity, antigenic properties, does not have allergenic, mutagenic, embryotoxic, teratogenic and carcinogenic effects.
Azoximer bromide is odorless and tasteless, and does not have a local irritating effect when applied to the mucous membranes of the nose and oropharynx.
Pharmacokinetics
After oral administration, azoximer bromide is rapidly absorbed from the gastrointestinal tract; the bioavailability of the drug when administered orally is more than 70%. The maximum concentration in blood plasma is achieved 3 hours after ingestion. The pharmacokinetics of Azoximer bromide is linear (plasma concentration is proportional to the dose taken).
Azoximer bromide is a hydrophilic compound. The apparent volume of distribution is approximately 0.5 l/kg, which indicates that the drug is distributed mainly in the interstitial fluid. The half-life of absorption is 35 minutes, the half-life is 18 hours.
Azoximer bromide is quickly distributed throughout all organs and tissues of the body, penetrates the blood-brain and blood-ophthalmic barriers. There is no cumulative effect. In the body of Azoximer, bromide undergoes biodegradation to low molecular weight oligomers, is excreted mainly by the kidneys, with feces - no more than 3%.
Indications for use
It is used in adults and children over 3 years of age for the treatment and prevention of acute and chronic respiratory diseases in the stage of exacerbation and remission.
For treatment (in complex therapy):
· acute and exacerbation of chronic recurrent infectious and inflammatory diseases of the oropharynx, paranasal sinuses, upper and lower respiratory tract, inner and middle ear;
· allergic diseases (including hay fever, bronchial asthma), complicated by recurrent bacterial, fungal and viral infections;
For prevention (monotherapy):
· 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 conditions arising due to aging or exposure to adverse factors.
Contraindications
· increased individual sensitivity;
· pregnancy, breastfeeding period;
· children under 3 years of age;
acute renal failure;
· rare hereditary lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.
Carefully
If you have the diseases listed in this section, consult your doctor before starting to take the drug:
Chronic renal failure (used no more than 2 times a week).
Use during pregnancy and breastfeeding
The use of the drug Polyoxidonium ® is contraindicated for pregnant women and women during breastfeeding (there is no clinical experience of use).
Experimental use of the drug Polyoxidonium ® in animals did not reveal embryotoxic or teratogenic effects or effects on fetal development.
Before using Polyoxidonium ® if you are pregnant, or think you might be pregnant, or are planning a pregnancy, you should consult your doctor.
During breastfeeding, before using the drug Polyoxidonium ®, you should consult your doctor.
Directions for use and doses
Use the drug only according to the indications, method of administration and in the doses indicated in the instructions.
If there is no improvement after treatment, or symptoms worsen, or new symptoms appear, you should consult your doctor.
Orally and sublingually 20-30 minutes before meals every day, 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 are possible after 3-4 months. When the drug is re-prescribed, its effectiveness does not decrease.
Sublingual
For treatment in adults:
10 days;
10 days;
· allergic diseases (including hay fever, bronchial asthma), complicated by recurrent bacterial, fungal and viral infections - 1 tablet 2 times a day for 10 days.
For treatment in children aged 3 to 10 years:
· 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 hay fever, bronchial asthma), complicated by recurrent bacterial, fungal and viral infections - ½ tablet 2 times a day for 7 days.
· 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 media - 1 tablet 2 times a day for
7 days;
· allergic diseases (including hay fever, bronchial asthma), complicated by recurrent bacterial, fungal and viral infections - 1 tablet 2 times a day for 7 days.
For prevention in adults:
By
1 tablet per day for 10 days;
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 once a day for 10 days;
· secondary immunodeficiencies arising due to aging or exposure to adverse factors - 1 tablet 1 time per day for 10 days.
For prevention in children aged 3 to 10 years:
· influenza and acute respiratory infections in the pre-epidemic period –
½ tablet per day 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 once a day for 10 days.
For prevention in children over 10 years of age:
· influenza and acute respiratory infections in the pre-epidemic period –
1 tablet per day 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 once a day for 10 days.
Orally
For treatment in adults:
For treatment in children over 10 years of age:
- diseases of the upper and lower respiratory tract - 1 tablet 2 times 10 days.
Side effect
No side effects have been reported.
If you notice any side effects not listed in the instructions, tell your doctor.
Overdose
No cases of overdose have been registered.
Interaction with other drugs
Azoximer bromide does not inhibit the isoenzymes CYP1A2, CYP2C9, CYP2C19, CYP2D6, cytochrome P-450, therefore the drug is compatible with antibiotics, antiviral, antifungal and antihistamines, glucocorticosteroids and cytostatics.
If you are taking the above or other medications (including over-the-counter medications), consult your doctor before taking Polyoxidonium.
special instructions
If an allergic reaction develops, you should stop using the drug Polyoxidonium ® and consult a doctor.
If it is necessary to stop taking the drug Polyoxidonium ®, cancellation can be done immediately, without gradually reducing the dose.
If you miss the next dose of the drug, its subsequent use should be carried out as usual, as indicated in these instructions or recommended by your doctor. The patient should not administer a double dose to compensate for missed doses.
Do not use the drug if there are visual signs of its unsuitability (defective packaging, discoloration of the tablet).
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