Composition
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
Pharmacological action
Pharmacotherapy group: immunomodulatory agent. ATX code: [L0 H]Pharmacological properti Espharmacodynam Icazoximer bromide has a complex effect: immunomodulatory, detoxifying, antioxidant, moderate anti-inflammatory. The mechanism of immunomodulatory action of Azoximer bromide is based on direct action on phagocytic cells and natural killers, as well as stimulation of antibody formation and synthesis of interferon-alpha and interferon-gamma. 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, and complications after surgery. A characteristic feature of Azoximer bromide with local (sublingual) application is the ability to activate factors of early protection of the body 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 upper respiratory tract mucosa. 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 Fe2+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, and does not have allergenic, mutagenic, embryotoxic, teratogenic, or carcinogenic effects. Azoximer bromide is odorless and tasteless, and has no local irritant effect when applied to the mucous membranes of the nose and oropharynx. Pharmacokinetics of azoximer bromide after oral use is rapidly absorbed from the gastrointestinal tract, the bioavailability of the drug with oral use is more than 70%. The maximum concentration in blood plasma is reached 3 hours after ingestion. The pharmacokinetics of azoximer bromide are linear (the 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 intercellular fluid. The half-absorption period is 35 minutes, the half-life is 18 hours. Azoximer bromide is rapidly distributed to all organs and tissues of the body, penetrates through the blood-brain and blood-ophthalmic barriers. There is no cumulative effect. In the body of AZOXIMER, bromide is biodegradable to low-molecular-weight oligomers, and is excreted mainly by the kidneys, with feces – no more than 3%.
Indications
in adults and adolescents over 12 years of age for the treatment and prevention of infectious and inflammatory diseases (viral, bacterial and fungal etiology) that do not respond to standard therapy both in the acute stage and in remission.
In complex therapy:
- acute and chronic recurrent infectious and inflammatory diseases of the oropharynx, paranasal sinuses, upper respiratory tract, inner and middle ear;
- allergic diseases complicated by recurrent bacterial, fungal and viral infections (including pollinosis, bronchial asthma);
- for rehabilitation of frequently and long-term (more than 4-5 times a year) patients.
As monotherapy:
- for the prevention of recurrent herpetic infection;
- for seasonal prevention of exacerbations of chronic foci of infections of the oropharynx, paranasal sinuses, upper respiratory tract, inner and middle ear;
- in immunocompromised persons for the prevention of influenza and other acute respiratory infections in the pre-epidemic period;
- for the correction of secondary immunodeficiency that occurs due to aging or exposure to adverse factors.
Use during pregnancy and lactation
Polyoxidonium is contraindicated in pregnancy, breast-feeding and children under 6 months of age (there is no clinical experience with its use).
Contraindications
- Increased individual sensitivity;
- pregnancy, breast-feeding;
- children under 3 years of age;
- acute renal failure;
- rare hereditary problems of lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.
With caution
If you have any of the medical conditions listed in this section, consult your doctor before taking this medicine. :
– chronic renal failure (used no more than 2 times a week).
Side effects
No side effects have been reported.
If you notice any side effects that are not listed in the instructions, tell your doctor.
Interaction
Azoximer bromide does not inhibit the isoenzymes CYP1A2, CYP2C9, CYP2C19, CYP2D6, cytochrome P-450, so 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), please consult your doctor before taking Polyoxidonium.
How to take, course of use and dosage
Use the drug only according to the indications, the method of use and in the doses indicated in the instructions.
If there is no improvement after treatment, or if the 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 and adults-1 tablet, children from 3 to 10 years – ½ tablet (6 mg).
If necessary, it is possible to conduct repeated courses of therapy in 3-4 months. With repeated use of the drug, its effectiveness does not decrease.
Recommended treatment regimens
Sublingual
For adult treatment:
- influenza and acute respiratory infections – 1 tablet 2 times a day for 7 days;
- inflammation of the oropharynx – 1 tablet 2 times in denv 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 hay fever, asthma), complicated by recurrent bacterial, fungal and viral infection– 1 tablet 2 times a day for 10 days.
For treatment of children from 3 to 10 years of age: Â
- flu and acute respiratory infections – ½ tablet 2 times a day for 7 days;
- oropharyngeal inflammatory processes – 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 of children over 10 years of age:
- influenza and acute respiratory infections – 1 tablet 2 times a day for 7 days;
- inflammation 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 hay fever, asthma), complicated by recurrent bacterial, fungal and viral infection – 1 tablet 2 times a day for 7 days.
For prevention for adults:
- influenza and acute respiratory infections in the pre – epidemic period is 1 tablet a day for 10 days;
- recurrent herpetic infection nasal and labiales region – 1 tablet 2 times a day for 10 days;
- exacerbations of chronic foci of infection of the oropharynx, paranasal sinuses, upper respiratory tract, inner and middle ear – 1 tablet once a day for 10 days;
- secondary immunodeficiencies resulting from aging or exposure to adverse factors – 1 tablet 1 time a day for 10 days.
For prevention of children from 3 to 10 years of age:
- influenza and acute respiratory infections in the pre – epidemic period is half a tablet per day for 7 days;
- recurrent herpetic infection nasal and labiales region – ½ tablet 2 times a day for 7 days;
- exacerbations of chronic foci of infection of the oropharynx, paranasal sinuses, upper respiratory tract, inner and middle ear – half a tablet once a day for 10 days.
For prevention of children over 10 years of age:
- influenza and acute respiratory infections in the pre-epidemic period – 1 tablet daily for 7 days;
- recurrent herpetic infection nasal and labiales region – 1 tablet 2 times a day for 7 days;
- exacerbations of chronic foci of infection of the oropharynx, paranasal sinuses, upper respiratory tract, inner and middle ear 1 tablet once a day for 10 days.
By mouth
For adult treatment:Â
- diseases of the upper and lower respiratory tract – 1 tablet 2 times 10 days.
For treatment of children over 10 years of age:
- diseases of the upper and lower respiratory tract – 1 tablet 2 times 10 days
Overdose
No overdose cases have been reported.
Special instructions
If an allergic reaction develops, stop using Polyoxidonium® and consult a doctor. If it is necessary to stop taking the drug Polyoxidonium®, withdrawal can be carried out 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 be given 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). Effects on the ability to drive vehicles and other mechanisms The use of Polyoxidonium® does not affect the ability to perform potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions (including driving vehicles, working with moving mechanisms).
Form of production
Tablets
Storage conditions
At a temperature of 2 to 25 °C. Keep out of reach of children.
Shelf
life is 2 years. Do not use the drug after the expiration date indicated on the package.
Active ingredient
Azoximer bromide
Dosage form
Tablets
Purpose
Children over 3 years old, For adults
Indications
Chronic infections, Sinusitis, Pollinosis, Cytomegalovirus infection, Pharyngitis, Flu, Exposure to adverse factors, Herpes, Bronchial asthma, Fungus, Otitis media, Cold, Immunodeficiency
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