Polyoxidonium, 10 pcs., 12 mg, vaginal and rectal suppositories


Polyoxidonium®

Methods of using the drug Polyoxidonium®: parenteral (intramuscular, intravenous), intranasal, sublingual.

Methods of application, dosage regimen, need and frequency of subsequent courses of therapy are selected by the doctor depending on the severity of the disease and the age of the patient.

For intravenous drip administration, the dose of the drug calculated for the patient is sterilely transferred from a syringe into a bottle/bag with 0.9% sodium chloride solution. The prepared solution for intravenous administration cannot be stored.

Recommended treatment regimens for adults:

Parenteral (intramuscular or intravenous)

: the drug is prescribed to adults in doses of 6-12 mg 1 time per day, every day, every other day, or 1-2 times a week, depending on the diagnosis and severity of the disease.

For acute viral and bacterial infections of the ENT organs, upper and lower respiratory tract, gynecological and urological diseases:

6 mg daily for 3 days, then every other day with a total course of 10 injections.

For chronic recurrent infectious and inflammatory diseases of various localization, bacterial, viral and fungal etiology, in the acute stage:

6 mg every other day for 5 injections, then 2 times a week for a total course of 10 injections.

For acute and chronic allergic diseases (including hay fever, bronchial asthma, atopic dermatitis), complicated by bacterial, viral and fungal infections:

6-12 mg, course of 5 injections, every other day.

For rheumatoid arthritis, complicated by bacterial, viral and fungal infections, against the background of long-term use of immunosuppressants:

6 mg every other day for 5 injections, then 2 times a week for a total course of 10 injections.

For generalized forms of surgical infections:

6 mg daily for 3 days, then every other day with a total course of 10 injections.

To activate regenerative processes (fractures, burns, trophic ulcers):

6 mg for 3 days, then every other day, for a total course of 10 injections.

For the prevention of postoperative infectious complications

: 6 mg every other day, 5 injections.

For pulmonary tuberculosis:

6 mg 2 times a week for a course of 20 injections.

In cancer patients:

  • before and during chemotherapy to reduce the immunosuppressive, hepato- and nephrotoxic effects of chemotherapeutic agents, mg every other day for a course of 10 injections; further, the frequency of administration is determined by the doctor depending on the tolerability and duration of chemotherapy and radiation therapy;
  • to prevent the immunosuppressive effect of the tumor, to correct immunodeficiency after chemotherapy and radiation therapy, after surgical removal of the tumor, long-term use of the drug Polyoxidonium® (from 2-3 months to 1 year) 6 mg 1-2 times a week is indicated. When prescribing a long course, there is no effect of accumulation, toxicity or addiction.

Intranasal or sublingual

(see section “Rules for use for sublingual and intranasal administration”):

  • for the treatment of acute and exacerbations of chronic infections of the ENT organs;
  • for the treatment and prevention of influenza and ARVI;
  • to enhance the regenerative processes of mucous membranes;
  • for the prevention of complications and relapses of chronic diseases. The total volume of the drug per day is 1 ml (20 drops) - 6 mg/ml syringe.

The daily dose of the drug is administered intranasally or sublingually in 3-4 doses per day.

Recommended treatment regimens for children:

Parenterally

(intramuscular or intravenous): prescribed to children from 6 months at a dose of 0.1-0.15 mg/kg daily, every other day or 2 times a week for a course of 5-10 injections.

For acute and exacerbation of chronic inflammatory diseases of any localization

(including ENT organs - sinusitis, rhinitis, adenoiditis, hypertrophy of the pharyngeal tonsil, ARVI),
caused by pathogens of bacterial, viral, fungal infections :
0.1 mg/kg 3 days in a row, then every other day with a total course of 10 injections .

For acute allergic and toxic-allergic conditions (including bronchial asthma, atopic dermatitis), complicated by bacterial, viral and fungal infections:

0.1 mg/kg 3 days daily, then every other day, with a total course of 10 injections in combination with basic therapy.

Intranasal or sublingual

(see section “Rules for use for sublingual and intranasal administration”):

  • for acute and chronic rhinitis, rhinosinusitis, adenoiditis (treatment and prevention of exacerbations);
  • for preoperative preparation of patients during surgical interventions for ENT pathology, as well as in the postoperative period for the purpose of preventing infectious complications or relapses of the disease;
  • treatment and prevention of influenza and other acute respiratory viral infections (within 1 month before the expected epidemic), at any time after the onset of the disease and during the period of convalescence).
  • for the treatment of intestinal dysbiosis (used sublingually) in combination with basic therapy - for 10 days.

For children

from 6 months to 18 years, it is recommended to use syringes with a dosage of 3 mg/ml.

The total volume of the drug per day is prescribed at the rate of 1 drop (0.15 mg) per 1 kg of weight.

For a child weighing up to 20 kg, no more than 20 drops (3 mg of active ingredient).

For a child weighing more than 20 kg, no more than 40 drops (6 mg of active ingredient).

Table 1. Calculation of doses for intranasal and sublingual administration in children.

See Fig.

The daily dose of the drug is administered intranasally or sublingually in 3-4 doses per day.

Course duration is 5-10 days.

Rules of use for sublingual and intranasal administration

Preparation for use

Figure 1: Wash your hands thoroughly.

Polyoxidonium

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.

Recommended treatment regimens

Sublingual:

For treatment in adults:

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 media - 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:

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.

For treatment in children over 10 years of age:

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:

diseases of the upper and lower respiratory tract - 1 tablet 2 times 10 days.

For treatment in children over 10 years of age:

diseases of the upper and lower respiratory tract - 1 tablet 2 times 10 days.

Polyoxidonium 6mg/ml solution for injection and topical use, 5 bottles

Registration Certificate Holder

NPO PETROVAX PHARM (Russia)

Dosage form

Medicine – Polyoxidonium® (Polyoxidonium)

Description

Solution for injection and topical use

colorless or with a yellowish tint.

1 ml

azoximer bromide 6 mg

Excipients

: mannitol - 1.8 mg, povidone K17 - 1.2 mg, water for injection - up to 1 ml.

1 ml - syringes (1) - contour cell packaging (1) - cardboard packs. 1 ml - syringes (1) - contour cell packaging (5) - cardboard packs.

Indications

For oral administration

Treatment and prevention of infectious and inflammatory diseases (viral, bacterial and fungal etiology) that are not amenable to standard therapy in adults and adolescents over 12 years of age, both in the acute and remission stages.

As part of complex therapy: acute and chronic 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 hay fever, bronchial asthma); for the rehabilitation of frequently and long-term (more than 4-5 times a year) ill persons.

As monotherapy:

prevention of recurrent herpes infection; seasonal prevention of exacerbations of chronic foci of infections of the oropharynx, paranasal sinuses, upper respiratory tract, inner and middle ear; in immunocompromised individuals for the prevention of influenza and other acute respiratory infections in the pre-epidemic period; for the correction of secondary immunodeficiencies resulting from aging or exposure to adverse factors.

For injection and topical use

Correction of immunity in adults and children from 6 months.

In adults, as part of complex therapy: chronic recurrent infectious and inflammatory diseases that are not amenable to standard therapy in the acute stage and in remission; acute and chronic viral and bacterial infections (including urogenital infectious and inflammatory diseases); tuberculosis; acute and chronic allergic diseases (including hay fever, bronchial asthma, atopic dermatitis), complicated by chronic recurrent bacterial and viral infections; in oncology during and after chemotherapy and radiation therapy to reduce the immunosuppressive, nephro- and hepatotoxic effects of drugs; to activate regenerative processes (fractures, burns, trophic ulcers); rheumatoid arthritis treated for a long time with immunosuppressants; with rheumatoid arthritis complicated by acute respiratory infections; for the prevention of postoperative infectious complications; for the prevention of influenza and acute respiratory infections.

In children in 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 tonsil, ARVI); acute allergic and toxic-allergic conditions; bronchial asthma complicated by chronic respiratory tract infections; atopic dermatitis complicated by purulent infection; intestinal dysbiosis (in combination with specific therapy); for the rehabilitation of those who are often and long-term ill; prevention of influenza and acute respiratory infections.

For rectal use

As part of complex therapy for the correction of immune deficiency in adults and children over 6 years of age: for chronic recurrent infectious and inflammatory diseases that are not amenable to standard therapy, both in the acute and remission stages; for acute viral, bacterial and fungal infections; for inflammatory diseases of the urogenital tract, incl. urethritis, cystitis, pyelonephritis, prostatitis, salpingoophoritis, endomyometritis, colpitis, cervicitis, cervicosis, bacterial vaginosis, incl. viral etiology; for various forms of tuberculosis; for allergic diseases complicated by recurrent bacterial, fungal and viral infections (including hay fever, bronchial asthma, atopic dermatitis); with rheumatoid arthritis treated for a long time with immunosuppressants; for rheumatoid arthritis complicated by acute respiratory infections or acute respiratory viral infections; to activate regenerative processes (including fractures, burns, trophic ulcers); for the rehabilitation of frequently and long-term (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 infections; for seasonal prevention of 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.

Contraindications for use

Pregnancy, lactation (breastfeeding), children under 12 years of age (for oral administration), hypersensitivity to azoximer bromide.

pharmachologic effect

Immunomodulatory agent. Increases the body's resistance to local and generalized infections. The mechanism of the immunomodulatory effect of azoximer bromide is based on a direct effect on phagocytic cells and natural killer cells, as well as stimulation of antibody formation.

Azoximer bromide restores immunity in secondary immunodeficiency conditions caused by various infections, injuries, burns, autoimmune diseases, malignant neoplasms, complications after surgery, the use of chemotherapeutic agents, cytostatics, steroid hormones.

Along with the immunomodulatory effect, azoximer bromide has pronounced detoxification and antioxidant activity, has the ability to remove toxins and heavy metal salts from the body, and inhibits lipid peroxidation. These properties are determined by the structure and high-molecular nature of the bromide azoximer.

Does not have mitogenic, polyclonal activity, antigenic properties, does not have allergenic, mutagenic, embryotoxic, teratogenic and carcinogenic effects.

Dosage regimen

For oral, parenteral, intranasal, rectal administration. Doses, route of administration and regimen of use are determined by the doctor depending on the diagnosis, severity of the disease, and age of the patient.

Side effect

Local reactions:

pain at the injection site with intramuscular injection.

special instructions

Use with caution in acute renal failure.

Use intranasally or sublingually with caution in children under 6 months of age (clinical experience is limited).

Use during pregnancy and breastfeeding

Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - Contraindicated.

Contraindicated for use during pregnancy and lactation (breastfeeding).

Polyoxidonium tablets 12 mg - official instructions

Instructions for use of the drug

Please read this leaflet carefully before you start using this medicine because it contains important information for 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. The medicine you are using 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: 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 tint, with a chamfer, with a score on one side and embossed “PO” on the other. Pharmacotherapeutic group : immunomodulatory agent. ATX code: [LO3].

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 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, 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

Azoximer bromide after oral administration 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 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

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, you should consult your doctor before using Polyoxidonium®.

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, 2 times a day: children over 10 years of age and adults - 1 tablet, children from 3 to 10 years - 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:

  • 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 media - 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:

  • 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.

For treatment in children over 10 years of age:

  • 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 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 - one tablet once a day for 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 reported.

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 starting to take 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®, discontinuation 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).

Impact on the ability to drive vehicles and other mechanisms

The use of the drug Polyoxidonium® does not affect the ability to perform potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions (including driving vehicles, working with moving mechanisms).

Release form

Tablets, 12 mg. 10 tablets in a blister pack made of polyvinyl chloride film and aluminum foil. One or two blister packs along with instructions for use are placed in a cardboard pack.

Best before date

3 years. Do not use after expiration date.

Storage conditions

At temperatures from 2 to 25 °C. Keep out of the reach of children.

Vacation conditions

Over the counter.

Manufacturer / Legal entity in whose name the registration certificate was issued

The owner of the registration certificate and.

Legal address / Address for submitting consumer claims:

Russian Federation, 142143, Moscow region, Podolsk, p. Pokrov, st. Sosnovaya, 1, tel./fax, e-mail: [email protected] ; to make claims: tel., 8 (800) 234-44-80, e-mail Production / Packaging (primary packaging): Russian Federation, 115598, Moscow, st. Zagoryevskaya, 10, bldg. 4, tel./fax: 8 (495) 329-17-18. Secondary (consumer) packaging / Issue quality control: Russian Federation, 142143, Moscow region, Podolsk, p. Pokrov, st. Sosnovaya, 1, tel./fax.

Experience of clinical use of Polyoxidonium in complex therapy of respiratory diseases

We chose the drug Polyoxidonium as an immunomodulatory agent. Its mechanism of action is based on direct activation of phagocytic cells and natural killer cells, increased interaction between T and B lymphocytes, and activation of antibody formation. At the same time, Polyoxidonium does not affect indicators that are within normal values, does not disrupt the natural mechanisms of inhibition of immune reactions, and does not deplete the reserve capabilities of the hematopoietic system. Polyoxidonium can be prescribed to patients with both identified and undiagnosed disorders of the immune status, based on clinical data. Along with immunomodulatory properties, Polyoxidonium also has detoxification and antioxidant properties, and also activates reparative and regenerative processes. An important feature of Polyoxidonium, which distinguishes it from other immunomodulators, is that it can be used both for the treatment of acute and chronic infectious processes of various etiologies, as well as for atopic diseases. These properties of the drug determined our choice of using it in patients with bronchopulmonary pathology. We used polyoxidonium in addition to complex therapy carried out in accordance with accepted standards of treatment. The study included 89 people. aged from 32 to 68 years, of which 60.7% were men, 39.3% were women. The study group of patients was represented by the following respiratory diseases: chronic obstructive pulmonary disease – 25 people. (28.1%), bronchial asthma – 38 people. (42.7%), bronchiectasis – 24 people. (27%), bronchopulmonary aspergillosis – 2 people. (2.2%). 22 people (35% of patients in the first two groups) fungal superinfection of the bronchi was detected. In 64% of cases, patients, in addition to bronchopulmonary diseases, had concomitant pathology, namely: duodenal ulcer, gastroesophageal reflux disease, intestinal dysbiosis, hypertension, myocardial dystrophy, fungal skin lesions. Methods of administration of Polyoxidonium were determined by the specific clinical situation. Patients received the drug intravenously, 6–12 mg, up to 5 injections per course (23 cases), intramuscularly, 6 mg up to 5–10 injections per course (13 cases), endobronchially, 6–12 mg, 1–2 procedures per course ( 53 cases). In 17 cases there was a combination of different methods of drug administration (intravenous and endobronchial). The endobronchial route of administration is possible due to the fact that Polyoxidonium is highly soluble in saline, quickly distributed in body tissues and does not cause local irritation. Endobronchial administration was carried out in the form of pouring a solution of the drug in a dose of 6 mg into the bronchi, as well as according to the well-known method of introducing 6 mg of Polyoxidonium, dissolved in 3 ml of saline solution into the carina of the trachea. For comparison, we took a group of patients comparable to the study group in terms of size, nosology, severity, age and gender. The dynamics of the patients' condition was assessed according to clinical indicators, data from laboratory, biochemical, radiological, bacteriological, endoscopic, and cytological research methods. The completeness of the therapeutic effect, the time of normalization of parameters, and the tolerability of treatment were compared in patients of the study and control groups. The assessment of the main clinical symptoms of exacerbation of the disease (cough, shortness of breath, volume and character of sputum, the presence of suffocation) was carried out in points (Table 1), by analogy with the criteria proposed by N. Anthonisen (1987). Patients in the study and control groups received standard therapy appropriate to the diagnosis and severity of the disease. The results of therapy were assessed according to the instrumental examination of patients, the severity of clinical symptoms (in points) and the rate of their regression (in days). Statistical data processing was carried out using variation statistics methods. As our observations showed, in the group of patients who received Polyoxidonium as part of complex therapy, there was a more rapid improvement in well-being, increased physical activity, and positive dynamics in the symptoms of the main and concomitant diseases. All patients tolerated the drug administration well. Only in three cases of endobronchial administration were short-term low-grade fever, tachycardia, and a transient increase in blood pressure noted, which we regarded as a general reaction of the body to the procedure; At the same time, bronchospasm was not recorded in any case of observation, with any method of drug administration. Tracking the clinical effects of Polyoxidonium in various nosologies, the following can be noted: the most clear result in our study was obtained when Polyoxidonium was prescribed to patients with exacerbation of bronchiectasis. The number of this group is 24 people, ages from 32 to 65 years, of which 66.7% are men, 33.3% are women. It should be noted that patients in the study and control groups had a long history of the disease, repeated exacerbations, requiring hospital treatment and the use of various antibiotics. Polyoxidonium in the study group of patients was prescribed at a dose of 6–12 mg in the form of intravenous infusions (5 procedures per course) in cases and (or) by endobronchial administration (1–2 procedures per course) in 20 cases; in 7 cases there was a combination of both methods of administration. Changes in the main clinical symptoms were assessed using a scoring system (according to Table 1) before the start of therapy, 1–2 days, 3–5 and 10–12 days from the start of treatment. The results of clinical observation are presented in Figure 1, where the columns of the chart reflect the severity of individual clinical symptoms (in points) in patients in the study group who received Polyoxidonium, and the graphs show the severity of the same symptoms (in points) in patients in the control group who did not receive this drug. As can be seen from the presented graphs and diagrams, patients in the study group experienced a more pronounced and rapid decrease in cough and “purulence” of sputum compared to the control group. The volume of sputum remains significant in the first days of treatment, and by days 10–12 it decreases significantly compared to the control group. Thus, in this case, the positive effects of Polyoxidonium include a faster and more pronounced reduction in the clinical symptoms of inflammation and improvement in bronchial drainage. This pattern was confirmed by the results of laboratory, bacteriological and endoscopic studies. The rapid detoxification effect was also noteworthy, literally from the first procedure of administering the drug. All this made it possible to reduce the dose of antibacterial drugs when carrying out the necessary sanitation of the bronchial tree. The indicated positive effects of Polyoxidonium with varying degrees of severity were observed in 100% of cases in the patients of the study group with bronchiectasis observed by us. The other study group consisted of patients with bronchial asthma (23 women, 15 men) aged from 38 to 60 years, all with polysensitization. The duration of the disease was 10 years or more. Moderate doses of systemic and inhaled glucocorticosteroids were used as basic anti-inflammatory therapy for 8 years or more. In addition, all patients in this group were characterized by a torpid course of the disease, with frequent exacerbations; the majority had side effects of glucocorticoid therapy (Cushingoid syndrome, osteoporosis). In 31.5% of cases, patients had mucosal and cutaneous candidiasis, requiring the addition of antifungal agents to therapy. Polyoxidonium was prescribed at a dose of 6 mg intravenously in 19 cases, intramuscularly in 6 cases, endobronchially (1-2 procedures per course) in 20 cases, in 7 cases there was a combination of different methods of administration. At the same time, no deterioration during the asthmatic process or manifestations of drug intolerance were recorded. In general, we observed a positive effect in 81.6% of cases. In 18.4% there were no significant clinical and functional changes. The dynamics of the main clinical symptoms before treatment and during observation were also assessed using a scoring system (Table 1). The results of clinical observation of the study group are summarized in a graph/diagram presented in Figure 2. Here, the columns of the chart reflect the indicators of the study group, and the graphs reflect the indicators of the control group (in points). As can be seen from Figure 2, with the introduction of Polyoxidonium, a more complete and rapid “effect of inflammation subsidence” is achieved, an increase in sputum production is observed due to improved bronchial drainage, and bronchial patency improves. More objectively, the improvement in bronchial obstruction during treatment is reflected by spirometry indicators (in particular, FEV1) in experimental bronchial asthma patients (who received Polyoxidonium) and control groups (Fig. 3). The rapid subsidence of inflammatory changes and a decrease in the phenomena of bronchial hyperactivity in patients of the study group led to the possibility of reducing the maintenance dose of glucocorticoids, reducing the need for b2-agonists without worsening the patients' condition. In the group of patients with chronic obstructive pulmonary disease who were prescribed Polyoxidonium, there were 25 people, of which 92% were men. This group is represented by patients with moderate and severe disease who have stage II respiratory failure. The disease occurred with frequent exacerbations requiring hospital treatment, with repeated courses of antibacterial, anti-inflammatory and constant bronchodilator therapy. In 40% of cases, the course of the disease was complicated by the addition of fungal superinfection of the bronchi (mucosal candidiasis). These patients, in combination with traditionally used medications, were prescribed Polyoxidonium in the form of intramuscular injections (7 cases), intravenous infusions (8 cases), and endoscopically (13 cases); in 3 cases there was a combined administration of the drug by different routes. To analyze the effectiveness of the drug in a scoring system (Table 1), the main clinical symptoms (cough, volume and character of sputum, shortness of breath and the number of asthma attacks) were assessed before the start and during treatment according to observation days: 1–2, 7–10, 12– 14th days. The results of clinical observations are summarized in graphs/diagrams (Fig. 4, 5). Assessing the results of the study (Fig. 4), it can be noted that when Polyoxidonium is prescribed in patients with COPD, the cough decreases faster and more clearly, literally on the 2-3rd day from the start of therapy the nature of the sputum changes from purulent, mucopurulent to mucous, and the volume of sputum even increases compared to the control group. Thus, the administration of Polyoxidonium leads to improved bronchial drainage, gives a more complete anti-inflammatory effect, leading to the possibility of sanitation of the bronchi without the use of antibiotics or with their short courses. As can be seen from Figure 5, symptoms reflecting respiratory disorders changed little over 12–14 days of observation. Patients in the study group noted an improvement in general well-being, an increase in resistance to habitual physical activity, but the objective functional indicators of spirometry practically remained the same (Fig. 6). In general, in the group of patients with chronic obstructive pulmonary disease, in 92% of observations, the effect of using Polyoxidonium was assessed as positive, of varying degrees of severity. Neither subjective nor objective deterioration in the condition of patients in this group was recorded when using Polyoxidonium. The dependence of the severity of the therapeutic effect of Polyoxidonium on the method of its administration into the body was studied (Table 2). The medicinal properties of the drug, namely anti-inflammatory effect, detoxification effect, enhancing the antimicrobial effect of antibacterial drugs, improving bronchial drainage, and the possibility of reducing the dose of other medications are assessed using a 5-point system: (–) – no effect. (+–) – questionable effect, (+) – significantly positive effect, (++) – significant effect, (+++) – maximally pronounced effect. The results are shown in Table 2. According to our observations, to achieve a clinically significant effect there is no need for long courses of use of the drug. Already with the first administrations of Polyoxidonium, changes in the clinical condition of patients are noted, and with the endobronchial method, 1–2 procedures are sufficient to obtain a significant result. With injection methods, 5–10 procedures per course are sufficient. No side effects were observed with all methods of administration, including in patients with atonic diseases. The speed of onset of the therapeutic effect, the multifunctionality of the effect on the state of the bronchopulmonary system and the body as a whole, the short duration of the course of administration, the absence of side effects when prescribing Polyoxidonium - all this significantly increases the effectiveness of standard therapy and reduces the patient’s time in the hospital (Fig. 7). Thus, the use of Polyoxidonium in the treatment of respiratory diseases is highly effective, expedient and allows optimizing anti-inflammatory treatment regimens for chronic nonspecific lung diseases.

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