Mechanism of action of the drug
read

The drug is used to treat a wide range of diseases both on its own and as part of a complex therapy.

back
next
Prevention Prevention Prevention Prevention
Treatment of influenza and ARVI
read

In 2019, a meta-analysis of controlled clinical trials evaluating the efficacy of azoximer bromide in the treatment of respiratory tract inflammatory infections in children and adolescents was conducted.

Meta-analysis
Five clinical trials including data from 540 patients aged 3 to 18 years were selected. They were used to compare the efficacy of standard treatment and therapy with azoximer bromide.
The use of the drug accelerated normalization of temperature by almost two days, reduced the duration of symptoms of fever and intoxication by 1.4 days; clinical symptoms of acute inflammation of the upper respiratory tract — by 1.23 days; headache — by 0.53 days; muscle and joint pain — by 1.59 days.
Meta-analysis Meta-analysis

Meta-analysis of controlled clinical trials with respect to the use of azoximer bromide in the therapy of respiratory system inflammatory infections in children.

5 trials involving 540 children with inflammatory infections of the respiratory tract (aged 3 to 18 years) were analyzed:

  • 334 patients received azoximer bromide as part of a complex therapy;
  • 206 patients were in the control group.

2 trials were placebo-controlled, double-blind trials.

3 trials were open-label, randomized trials with a control group.

Reduction in the time to symptom relief with Polyoxidonium therapy (days) compared with placebo or standard therapy

Polyoxidonium infographics Polyoxidonium infographics

The results were demonstrated in another meta-analysis, which evaluated the effect of Polyoxidonium on the risk of acute respiratory infection and coronavirus in medical staff. 718 people took one tablet of the drug for 30–40 days, while 423 people made up the control group. Taking Polyoxidonium increased the odds of health professionals not getting ARI and COVID-19 by 3.02 times, and not getting COVID-19 alone — by 2.65 times.

Meta-analysis
The highest level of evidence is the meta-analysis of the use of Polyoxidonium. The probability of COVID-19 and ARI was analyzed on 1,141 patients, and it was found that it was reduced by more than 3 times when using the drug.
Meta-analysis Meta-analysis

Another review of the results of randomized, placebo-controlled, double-blind multi-center phase II and III clinical trials analyzed the results of azoximer bromide use for the treatment of influenza and ARVI in children aged 3 to 14 years (228 people).

Double-blind trials
In the participants of the test group, who received Polyoxidonium tablets 2 times a day for a week, the period of normalization of the body temperature was reduced by 20 hours (from 100 to 80 hours). The proportion of the participants, whose temperature normalized on the third day, increased to 20–23% (in the placebo group it was 0–3%). The duration of fever and intoxication decreased statistically significant: from 3.2 to 2.6 days.
Clinical data were confirmed by laboratory data on activation of the T-cellular component of the immune system and phagocytic activity of neutrophils.
Double-blind trials Double-blind trials
Treatment of coronavirus
read

During the coronavirus pandemic, studies were conducted on the efficacy of azoximer bromide in the therapy of the disease and post-COVID syndrome.

Today, Polyoxidonium is included in the methodological recommendationsof FMBA on prevention and treatment of influenza and other ARVI during the COVID-19 pandemic, clinical recommendations of the Ministry of Health of the Russian Federation on the treatment of influenza, as well as in the clinical recommendations of Slovakia on the treatment of COVID-19.

The possibility of including azoximer bromide in the therapy of coronavirus was confirmed by clinical trials. In 2022, the results of a study on the use of the drug in patients with COVID-19 (81 patients) were published.

A study on the use of azoximer bromide in patients hospitalized with COVID-19
Patients hospitalized with COVID-19
9 research centers
Investigational treatment group
Investigational treatment group
81
persons
Historical control group
Historical control group
100
persons
Azoximer bromide 12 mg intravenously one time daily for 3 days, then intramuscularly every other day until day 17.


The primary endpoint included clinical status on the 15th day compared to baseline. Data on 100 patients from a randomized controlled open-label study conducted in China were used as the control group.

The average length of hospital stay was comparable in the both groups. By the 28th day, the mortality rate of patients in the control group was 25%; none of the azoximer bromide group patients died during the study (one patient died on the 34th day after the end of the study).

Comparison of survival rates

The survival rate was statistically significantly higher in the azoximer bromide group than in the control group

Mortality rate at day 28, n (%) Azoximer bromide group, n = 77 Historical control group, n = 100
Alive 77 (100,0) 75 (75,0)
Died 0 (0,0) 25 (25,0)

The patients’ state was assessed using a 7-point validated standardized scale. By day 14–15, in the control group the improvement was insignificant (3.87 points compared to 3.99 at the beginning of the treatment), in the drug group a significant improvement was observed: 2.90 points compared to 4.36 at the beginning of the therapy. Thus, the drug showed its important role as part of a complex therapy.

In another study, which evaluated the effect of azoximer bromide on the number of COVID-19 infections among healthcare professionals and on the level of chronic fatigue, the efficacy of the drug was also shown. There were 78 participants in the study (41 of them took azoximer bromide for 38 days, the comparison group had 37 participants).

The number of those who contracted COVID-19 in the experimental group was lower than in the comparison group. There was a statistically significant faster reduction in the manifestations of the chronic fatigue syndrome in the study participants who took azoximer bromide.

Effect of prophylactic azoximer bromide administration on the incidence of COVID-19 during the 68-day study period

Effect Effect

The incidence of the SARS-CoV-2 infection was statistically significantly lower in study participants, which received azoximer bromide as a prophylactic drug, than in the comparison group.

These findings were confirmed in another independent study involving 913 healthcare professionals working in hospital ‘red zones’. The use of azoximer bromide reduced the number of ARVI and coronavirus infections, as well as reduced the risk of pneumonia.

Prevention of ARVI and COVID-19: a study of doctors working in «red zones»

Prevention Prevention

* Difference with the control group is statistically significant (p < 0.0001).
No cases of pneumonia in the investigational treatment group.
In 88.2% of the cases, it was caused by SARS-CoV2.

With Polyoxidonium, 0.70% participants had ARVI and 0.3% participants had COVID-19. In the control group, 12.2% had ARVI and 5.1% had COVID-19.

In the study of the effectiveness of Polyoxidonium in the therapy of post-COVID syndrome, it was shown that after 10 days of taking the drug, joint and muscle pain, headache, olfactory disorders were noted less frequently, and dizziness became less pronounced. Already on the fifth day of the experiment, the patients of the experimental group showed significantly less general weakness compared to the control group.

A study to investigate the effect of Polyoxidonium on the severity and duration of clinical manifestations of post-COVID syndrome

Polyoxidonium Polyoxidonium
Joint and muscle pain
Headache
Anosmia
As early as on the 10th day of monitoring, the frequency of joint and muscle pain, headache decreased on average by 2.5–3 times.
Pediatrics
read

Azoximer bromide is suitable for the treatment and prevention of influenza and ARVI in children, as well as for the treatment of acute and chronic infectious diseases of the ENT organs, upper and lower respiratory tract. For children from 6 months of age, Polyoxidonium in the form of solution can be administered intramuscularly, intravenously, intranasally or sublingually.

For children over 1 year old, the drug in the form of suppositories is suitable, and patients over 3 years old can be given the drug in the form of tablets.

back
next

Tablets

From 3 years of age Tablets 12 mg, sublingually.
Tablets
Prevention Treatment
Child’s age, years 3—10 > 10 3—10 > 10
Number of tablets, pcs. 1/2 tablet 1 time a day under the tongue 1 tablet 1 time a day under the tongue 1/2 tablet 2 times a day under the tongue 1 tablet 2 times a day under the tongue
back
next

Suppositories

From 1 year of age Suppositories 6 mg. Course of treatment — 5–10 suppositories.
Child’s age, years > 1 > 6
Number of suppositories, pcs. 1 suppository/6 mg 1 time a day every other day 1 suppository/6 mg daily
Course of supp. 5 10
back
next

Solution

Solution 6 mg/mL, intranasally and sublingually. Course of treatment — 5–10 days, daily administration.
Solution
Child’s weight, kg 8 12 16 20 > 20
Number of drops per day 4 6 8 10 1 drop per 2 kg of weight, but no more than 20 drops
Volume of injected solution 0,2 mL 0,3 mL 0,4 mL 0,5 mL not more than 1 mL

Solution 6 mg/mL, parenterally.
Treatment of moderate and severe forms of a disease, parenterally (intravenously and intramuscularly) 0.1 mg/kg for 3 consecutive days. Then every other day. Total course of treatment — 10 days. Prepared solution for parenteral administration should not be stored.

In case of tenderness at the injection site, Polyoxidonium solution can be used in the same syringe with procaine (novocaine) if a patient has no hypersensitivity to it. For this purpose, 1 mL of 0.5% procaine (novocaine) solution is added when transferring the drug solution from a vial to a syringe.

Store at the temperature from 2 to 8 °C. Within the specified shelf life, when applied topically, the drug after initial opening should be stored not more than for 7 days at the temperature from 2 to 8 °C.

Azoximer bromide strengthens the body’s response to infection at any stage of a disease, reduces the risk of viral, bacterial, and fungal infections. Polyoxidonium reduces the frequency of repeated ARVI: the results of a placebo-controlled, double-blind trial showed that the frequency of viral respiratory diseases in children, who underwent a 7-day treatment course, decreased 2-fold six months after the therapy.

In 2022, the results of an open-label, comparative, cohort study of the efficacy of Polyoxidonium as a means of preventing ARVI, influenza and coronavirus in children attending kindergartens and schools, were published. The children from the first and second groups (300 participants in each) received Polyoxidonium for 3 months and underwent 3 and 6 prophylactic courses, respectively. The children from the third control group (also 300 participants) did not receive the drug.

back
next
A study of Polyoxidonium in prevention of ARVI and COVID-19 in children A study of Polyoxidonium in prevention of ARVI and COVID-19 in children

In the azoximer bromide groups, a significant reduction in the number of ARVI and COVID-19 infections was recorded. The drug reduced the risks of complications (pneumonia), increased nonspecific resistance of the upper respiratory tract mucosa.

As shown in a meta-analysis in 2019, the use of azoximer bromide also accelerates patient recovery and provides relief. Analysis of data from 540 people aged 3 to 18 years showed that: Polyoxidonium accelerates normalization of temperature, reduces the duration of symptoms of fever and intoxication, headache, muscle and joint pain, as well as the duration of clinical symptoms of acute inflammation of the upper respiratory tract.

Otorhinolaryngology
read

Polyoxidonium is used as part of a complex therapy of ENT organs, it is included in the Standards of Medical Care in otorhinolaryngology.

Azoximer bromide in the treatment of acute and chronic infectious diseases of ENT organs can help normalize nasal breathing already by the 4th day of treatment, reduce the size of inflamed tonsils, 2 times reduce the duration of cough and running nose, normalize the microbial composition of the nasopharynx. The drug helps reduce the risk of repeated respiratory tract diseases and complications.

back
next
Носоглоточная инфекция исследование Носоглоточная инфекция исследование

Another study, conducted with the participation of 110 children aged 3 to 7 years, showed that the use of Polyoxidonium in patients with hypertrophy of the palatine tonsils reduces the manifestation of nasal breathing disorders, reduces the frequency of ARVI and increases antimicrobial peptide gene expression.

Pulmonology
read

Polyoxidonium is used for the treatment of pneumonia. It was shown that inclusion of azoximer bromide in the complex therapy of out-of-hospital pneumonia alleviates the course of the disease and shortens the period of intoxication.

High safety profile
High safety profile
The drug does not contain components of animal or plant origin, which can cause allergies.
High safety profile</div>
Gynecology and urology
read

Azoximer bromide can increase the efficacy of therapy of inflammatory infections of the genitourinary system and female genital organs, including:

Vaginitis
Cystitis
Cervicitis
Urethritis
Candidiasis
Prostatitis

The drug enhances the effect of anti-inflammatory drugs, accelerates tissue regeneration after surgery, reduces the period of manifestation of inflammatory processes and irritation of the mucous membrane, increases the body’s resistance to infections.

back
next
anti-inflammatory drugs
Asc a question
If you have a non-standard question, please contact us. Attention! Referring to the site is not a substitute for consulting a doctor.
* Required fields
Asc a question
The question has been successfully sent, we will contact you shortly.