Umifenovir is an antiviral substance that is part of Arbidol, Immusstat and other similar drugs. Used to treat influenza and other respiratory diseases. The dosage, course of treatment and frequency of administration are determined in consultation with the doctor.
Umifenovir: trade name
Trade names of drugs may be different, even if they contain the same active ingredient. Thus, the component umifenovir is included in a number of well-known drugs:
- "Arpetolide";
- "Arbidol";
- "ARVI-tol";
- "Arpetol";
- "Immusstat" and others.
The component is characterized by antiviral activity, therefore it is used in the treatment of respiratory infections, including influenza and ARVI. Along with umifenovir, the drugs also contain other substances related to auxiliary substances.
Thus, umifenovir is only a compound. The trade names of drugs based on it are different - they are presented above. Therefore, it will not be possible to buy the drug “Umifenovir” in a pharmacy - it is not on sale.
All drugs must be stored under normal room conditions at temperatures up to 25 degrees. Access for children is prohibited. The shelf life depends on the type of medicine - as a rule, it is 3 years from the date of production.
Indications for the use of umifenovir-based products
Each of the described drugs is prescribed when a respiratory viral infection occurs. Indications for use depend on the specific product, but in general they are the same:
- influenza therapy (various modifications are amenable to treatment);
- treatment of other types of ARVI;
- disease prevention during a pandemic;
- prevention of disease when meeting an infected patient;
- prevention during the intensification of the epidemic;
- treatment of viral pathologies of the respiratory system.
Some of the listed drugs can be prescribed for the treatment of herpes, for relapses of respiratory and enteroviral infections, for strengthening the immune system, and for the treatment of chronic viral respiratory diseases. In all cases, only a doctor can determine the advisability of using a particular drug based on umifenovir.
Umifenovir: instructions for use
Products containing umifenovir are taken according to instructions. All drugs are produced in the form of tablets, which should be taken before meals, and not during or after them. A single dosage is set at 50-200 mg of umifenovir per 1 kg of patient body weight.
Tablets are taken from 1 time in 7 days to 4 times a day. The course of treatment lasts several days; more precise recommendations can be obtained from your doctor. If necessary, medications can be used for a long period, since they do not significantly affect the health of patients and do not cause frequent side effects.
Important!
The dosage of the active substance depends on the type of specific drug. As a rule, one tablet contains 50-400 mg of umifenovir. Therefore, the concentration must be clarified in advance, before taking the product.
Materials and methods
This article presents the most significant results that were established during the analysis of interim data obtained in the clinical trial ARBITR.
Patients and methods.
The multicenter post-registration double-blind randomized placebo-controlled clinical trial ARBITR is being conducted at 15 research centers providing outpatient treatment to patients in various regions of the Russian Federation, accredited by the authorized federal executive body in the manner established by the Government of the Russian Federation, in the period from September 22, 2011. until now. The ARBITR study is conducted in accordance with Russian regulatory requirements (Federal Law No. 61 “Law on the Circulation of Medicines” dated April 12, 2010) and the international standard for conducting clinical trials ICH-GCP. The study is conducted on the basis of a permit issued by the Ministry of Health and Social Development of Russia (No. 375 of September 22, 2011).
The study included outpatients aged 18 to 65 years with an uncomplicated form of influenza/ARVI, in whom no more than 36 hours had passed since the onset of the first symptoms, a body temperature of 38 °C or more, and the presence of at least one respiratory symptom (cough, sore throat, symptoms of rhinitis) and symptoms constituting the intoxication syndrome (headache, malaise, muscle pain, sweating and/or chills, weakness). A pregnancy test performed in women before starting treatment must be negative. Patients were not included in the study if they had received an influenza vaccination within the previous 12 months, had an acute chronic disease or HIV infection, received systemic corticosteroids or other drugs that affect the immune system, abused alcohol, or were drug addicts.
The study uses block randomization [47, 48]. Patients with influenza/URI are randomly assigned to one of 2 equal treatment groups: receiving umifenovir therapy or receiving placebo. Patients are randomly assigned to umifenovir (200 mg 4 times daily for 5 days) or placebo, with equal probability of assignment to either group. The study allowed symptomatic therapy, including antipyretic drugs, mucolytics and local vasoconstrictors.
For 19 days, 2 times a day, the severity of 7 main symptoms of ARVI (cough, nasal congestion, sore throat, weakness, headache, muscle pain and chills) was assessed using a 4-point scale (0 - no symptom, 3 - the symptom is very pronounced). In their diaries, patients noted the severity of each of the 7 symptoms and recorded body temperature in the armpit, which they measured with a mercury thermometer 2 times a day. As part of the study, doctor visits were made to the patient on days 1, 3 and 19 (for all patients), and additionally from days 4 to 8 (for patients with laboratory-confirmed influenza). As part of these visits, the doctor recorded the patient's complaints, collected information about adverse events, monitored the patient's filling out the diary and swabs from the mucous membrane of the nasopharynx and oropharynx.
During the work, studies were carried out using polymerase chain reaction (PCR) to verify the pathogen and assess the rate of elimination of the influenza virus. Laboratory verification of the virus using the PCR method was carried out using the following sets of reagents: 1) a set of reagents for detecting RNA of influenza A and influenza B viruses using real-time RT-PCR (GrippKompleks) according to TU 9398-055-46482062-2011, produced by LLC " NPO DNA-Technology”, Russia; 2) a set of reagents for detecting RNA of human ARVI pathogens using real-time RT-PCR (ARI VirusComplex) according to TU 9398−056−46482062—2011, produced by NPO DNA-Technology LLC, Russia.
In accordance with the ARBITR clinical trial protocol, an interim statistical analysis was carried out after including 50% of the planned sample size of study subjects (at least 420 patients/contact persons of the sick person). Processing of data obtained during the clinical trial was carried out in accordance with the instructions of the study organizer, the requirements of the Federal Law of the Russian Federation No. 61-FZ “On the Circulation of Medicines”, GOST R52379-2005 “Good Clinical Practice”.
The purpose of the analysis presented in this article was to evaluate the effectiveness of the drug Arbidol (umifenovir) in patients with influenza. Patients in the group with a diagnosis of influenza were included on the basis of PCR results, and in the absence of a positive PCR analysis - on the basis of the clinical picture of the disease, the correspondence of the date of onset of the disease with information about the epidemic situation on the incidence of influenza in the region, and epidemiological anamnesis data on people with influenza in the family or at the place of work/study. Clinical criteria on the basis of which a patient was assumed to have a diagnosis of influenza were the presence in history or during the period of therapy of at least one episode of increased body temperature above 38 °C in combination with cough and the prevalence at the time of randomization of greater severity of symptoms characterizing intoxication (headache , myalgia, chills, weakness), compared with catarrhal symptoms (cough, sore throat, runny nose/stuffy nose).
Statistical analysis.
Statistical processing of the data obtained during the study was carried out using the statistical software package Statistica 12.0 (StatSoft, USA).
For quantitative indicators, standard descriptive statistics were calculated in the study groups - mean, standard deviation ( SD
), median (Me), interquartile range (Q1; Q3), for qualitative indicators - frequency characteristics of characteristics in the study groups.
For intergroup comparisons of quantitative indicators, t
test for independent samples and its nonparametric analogue,
the Mann-Whitney U To compare two samples according to the frequency of detection of the event under study, the multifunctional Fisher ϕ test (Fisher angular transformation) was used [49].
When using statistical procedures, intra- and intergroup differences were considered statistically significant at p
≤0,05.
Each patient was compared with a vector of 38 values of the severity of the main symptoms (cough, sore throat, runny nose, headache, weakness, myalgia, chills) in points (from 0 to 3) and in degrees Celsius for the symptom “body temperature”.
The following criteria for the effectiveness of therapy were assessed.
1. The severity of the symptom/syndrome and the severity of the disease. To assess the severity of symptoms, syndromes (catarrhal and intoxication) or the severity of the disease, the overall median value for this indicator was calculated. The proportion of patients in the main and control groups with milder symptoms was defined as the number of patients with symptom severity less than the overall median value at each time point in the observed period. This indicator was assessed during the first 3 days from the start of therapy, i.e., at the time when the clinical manifestations of influenza are most pronounced and the effect of therapy on the severity is most significant for the patient.
2. Time until all symptoms of the disease resolve. Defined as the period from the start of therapy until the moment when the severity for each of the 7 main symptoms simultaneously turned out to be minimal, i.e. 1 point or less, and the body temperature was less than 37.2 ° C while maintaining this level of severity of symptoms and body temperature over the next 24 hours. The proportion of patients who, within a certain period of time from the start of therapy, experienced a decrease in the severity of all symptoms to the minimum clinically significant level was calculated.
3. The rate of elimination of the influenza virus. When assessing the rate of virus elimination, the duration of the period until the moment of virus elimination and the proportion of patients in whom virus elimination occurred on the 4th day from the start of therapy were calculated.
Contraindications and side effects
Products containing umifenovir are almost completely safe - they have few contraindications. However, in some cases you cannot take pills:
- children up to 5 years old inclusive;
- hypersensitivity to the active or auxiliary components;
- initial stage of pregnancy (during the first trimester, use is excluded).
As for the second and third trimesters, umifenovir can only be taken with caution when the expected benefits far outweigh the potential risks. It is worth considering that there is no data yet on the release of the active substance through breast milk, since relevant studies have not been conducted. Therefore, taking medications during breastfeeding is started only with the approval of a doctor. Moreover, during the period of treatment you should refuse breastfeeding.
Side effects are extremely rare - only allergic reactions are possible. In this case, symptomatic treatment is indicated. It is recommended to consult a doctor to change the drug. No cases of overdose have been recorded to date. Umifenovir is quite safe in the indicated quantities.
results
By September 2014, a total of 448 patients from 15 research centers of the Russian Federation were included in the study: Yekaterinburg (62 patients, 36 contact persons), St. Petersburg (60 patients, 27 contact persons), Perm (40 patients, 4 contact persons ), Chelyabinsk (33 patients, 33 contact persons), Ryazan (27 patients, 16 contact persons), Arkhangelsk (21 patient, 20 contact persons), Novosibirsk (16 patients, 13 contact persons), Yaroslavl (14 patients, 2 contact persons ), Saratov (9 patients, 4 contact persons), Kazan (8 patients), Ufa (3 patients). Of the 448 patients, 293 were included in the therapy group.
To assess the effectiveness of umifenovir in the treatment of influenza, the analysis of interim data obtained in the clinical trial ARBITR included 119 patients with proven disease caused by the influenza virus ( n
=45) or suspected (based on the clinical picture) (
n
=74). The distribution of patients into groups, the demographic characteristics of patients and the clinical picture of the disease at the time of inclusion in the study are presented in Table. 1. At the time of inclusion in the study, there were no significant differences between the main and control groups in these parameters.
Table 1. Characteristics of patients with influenza at the time of inclusion in the study.
Effect of umifenovir on the severity of the disease.
During therapy with umifenovir, patients with influenza experienced rapid relief of the disease in a greater number of cases (Fig. 1).
Already by the end of the first day from the start of therapy, the number of patients with a milder course of the disease in the main group was 35% higher than the same indicator in the control group ( p
<0.001) and these differences persisted during the next day of therapy.
Less severity of the disease in a larger number of patients with influenza in the main group was achieved mainly due to the effect of umifenovir therapy on the severity of intoxication syndrome and, to a lesser extent, manifestations of catarrhal syndrome (Table 2). The effect of umifenovir on the severity of the disease in general and the clinical manifestations of symptoms characterizing the severity of intoxication is most pronounced in the group of patients with laboratory confirmed influenza (Table 3). In the absence of significant differences in the severity of the disease and the severity of the main symptoms and syndromes at the time of initiation of therapy, already 36 hours after the start of treatment, the number of patients who had a milder course of the disease in the main group was 37.5% more than in the control group ( p
<0.05).
For other indicators, a similar picture was observed: after 36 hours from the start of therapy, the number of patients with less severe headache was by 21% ( p
<0.05), chills - by 42% (
p
<0.05), fever - by 46 % and intoxication syndrome - by 30% (
p
<0.1) (see Table 3; Fig. 2).
Table 2. Disease severity during umifenovir therapy in patients with influenza
Table 3. Severity of the disease and severity of symptoms of intoxication in patients with laboratory confirmed influenza
Rice. 1. Dynamics of the severity of the disease in patients with influenza (the number of patients with a mild course of the disease).
Rice.
2. The number of patients with laboratory-confirmed influenza who, 36 hours after the start of therapy, had a mild course of the disease and mild severity of the main symptoms of intoxication. Effect of umifenovir on the time to resolution of all symptoms.
During therapy with umifenovir, patients with influenza experienced a faster resolution of all symptoms, which is especially noticeable in the first 5 days from the start of therapy, i.e., during the period of drug therapy.
In the main group, the number of patients who showed resolution of all flu symptoms exceeded the same indicator in the placebo group by 3.7, 3.4 and 1.8 times after 48, 60 and 72 hours from the start of therapy, respectively (Fig. 3 ). The difference between the groups is most pronounced in patients with laboratory-confirmed influenza, in whom, during therapy with umifenovir, this indicator after 60 hours from the start of therapy exceeded that in the placebo group by 5.7 times, and after 72 and 84 hours - by 3.2 times ( p
<0.05) (Fig. 4).
In addition, there was a significant effect of umifenovir therapy on the duration of the period of resolution of all symptoms that make up the intoxication syndrome (headache, myalgia, chills, weakness, fever), the differences between the main and control groups were 14.6 hours ( p
<0.05).
Rice. 3. Duration of manifestation of the main symptoms of the acute period in patients with influenza (with laboratory confirmed influenza and patients with a clinical diagnosis of influenza, i.e. with negative PCR results).
Rice.
4. Duration of manifestation of the main symptoms of the acute period in patients with laboratory-confirmed influenza, A and B. The effect of umifenovir on the rate of elimination of the influenza virus.
In patients with influenza treated with umifenovir, there was a reduction in the period of detection of influenza virus RNA compared to that in patients in the control group by 17 hours (84.4 and 103.4 hours;
p
= 0.232).
When analyzing the data separately by the seasons 2011-2012, 2012-2013 and 2013-2014, during which the study was conducted, it was found that significant differences in the rate of virus elimination in the main and control groups were obtained for patients included in the study during the seasons 2011-2012 and 2012-2013, and the difference in the duration of periods of detection of influenza virus RNA between the main and control groups in these seasons was 44 hours (88 and 132 hours; p
<0.05).
In addition, it was found that during therapy with umifenovir, there is an increase in the number of patients in whom elimination of the influenza virus was achieved by the 4th day from the start of treatment (Table 4). Thus, the influenza virus was not detected on the 4th day from the start of therapy in 75% of patients in the main group and in 47% of the control group ( p
<0.05).
For patients included in the study during the 2011–2012 and 2012–2013 seasons, these differences between the study and control groups were 72.7 and 18.2%, respectively ( p
<0.01).
Table 4. Time frame for elimination of influenza virus during umifenovir therapy
Complications of influenza were observed in 3.2% of patients in the main group (2 cases of bacterial bronchitis) and in 7% of patients in the control group (2 cases of sinusitis, one case of bacterial bronchitis and one case of pneumonia).
The therapy was well tolerated. The incidence of side effects in the main group was 6.5%, in the control group - 12.3%.
special instructions
During treatment, you must carefully follow the course of treatment prescribed by your doctor. If one dose is missed, it should be taken as early as possible, and then return to the previous regimen. There is no effect on driving or other mechanisms. Umifenovir does not have neurotropic activity, so it can be taken by different patients, including operators and transport drivers.
It is allowed to take it with any other medicines - both simultaneously and at intervals of time (for example, with an interval of 3-4 hours). Strengthening or weakening of the therapeutic effects of other drugs is not observed.
Umifenovir 100 mg, 20 capsules (Ozone)
Registration Certificate Holder
ATOLL (Russia)
Dosage form
Medicine - Umifenovir (Umifenovir)
Description
Capsules
hard gelatin, size No. 2, white body, yellow cap, opaque; the contents of the capsules are a mixture of powder and granules from white to white with a greenish-yellow or beige tint; It is allowed to compact the contents of the capsule into lumps that disintegrate when pressed.
1 caps.
umifenovir hydrochloride monohydrate 103.5 mg, which corresponds to the content of umifenovir hydrochloride 100 mg
Excipients
: microcrystalline cellulose - 63.7 mg, potato starch - 33 mg, povidone K25 - 11 mg, croscarmellose sodium - 4.4 mg, colloidal silicon dioxide - 2.2 mg, magnesium stearate - 2.2 mg.
Composition of the capsule body:
titanium dioxide - 2%, gelatin - up to 100%.
Composition of the capsule cap:
quinoline yellow dye - 0.75%, sunset yellow dye - 0.0059%, titanium dioxide - 2%, gelatin - up to 100%.
5 pieces. — cellular contour packages (1) — cardboard packs. 5 pieces. — contour cell packaging (2) — cardboard packs. 5 pieces. — cellular contour packages (3) — cardboard packs. 5 pieces. — contour cell packaging (4) — cardboard packs. 5 pieces. — contour cell packaging (5) — cardboard packs. 5 pieces. — contour cell packaging (6) — cardboard packs. 5 pieces. — contour cell packaging (8) — cardboard packs. 5 pieces. — contour cell packaging (10) — cardboard packs. 10 pieces. — cellular contour packages (1) — cardboard packs. 10 pieces. — contour cell packaging (2) — cardboard packs. 10 pieces. — cellular contour packages (3) — cardboard packs. 10 pieces. — contour cell packaging (4) — cardboard packs. 10 pieces. — contour cell packaging (5) — cardboard packs. 10 pieces. — contour cell packaging (6) — cardboard packs. 10 pieces. — contour cell packaging (8) — cardboard packs. 10 pieces. — contour cell packaging (10) — cardboard packs. 10 pieces. - cans made of polyethylene terephthalate (1) - cardboard packs. 20 pcs. - cans made of polyethylene terephthalate (1) - cardboard packs. 30 pcs. - cans made of polyethylene terephthalate (1) - cardboard packs. 40 pcs. - cans made of polyethylene terephthalate (1) - cardboard packs. 50 pcs. - cans made of polyethylene terephthalate (1) - cardboard packs. 80 pcs. - cans made of polyethylene terephthalate (1) - cardboard packs. 100 pieces. - cans made of polyethylene terephthalate (1) - cardboard packs. 10 pieces. - polypropylene cans (1) - cardboard packs. 20 pcs. - polypropylene cans (1) - cardboard packs. 30 pcs. - polypropylene cans (1) - cardboard packs. 40 pcs. - polypropylene cans (1) - cardboard packs. 50 pcs. - polypropylene cans (1) - cardboard packs. 80 pcs. - polypropylene cans (1) - cardboard packs. 100 pieces. - polypropylene cans (1) - cardboard packs.
Indications
Prevention and treatment in adults and children: influenza A and B, ARVI, severe acute respiratory syndrome (including those complicated by bronchitis, pneumonia); secondary immunodeficiency states; complex therapy of chronic bronchitis, pneumonia and recurrent herpes infection.
Prevention of postoperative infectious complications and normalization of immune status.
Complex therapy of acute intestinal infections of rotavirus etiology in children over 3 years of age.
Contraindications for use
Children under 3 years of age; hypersensitivity to umifenovir.
pharmachologic effect
Antiviral agent. Specifically suppresses influenza A and B viruses, coronavirus associated with severe acute respiratory syndrome. According to the mechanism of antiviral action, it belongs to fusion inhibitors, interacts with the hemagglutinin of the virus and prevents the fusion of the lipid membrane of the virus and cell membranes. Has a moderate immunomodulatory effect. It has interferon-inducing activity, stimulates humoral and cellular immune responses, the phagocytic function of macrophages, and increases the body's resistance to viral infections. Reduces the incidence of complications associated with viral infection, as well as exacerbations of chronic bacterial diseases.
Therapeutic effectiveness for viral infections is manifested in reducing the severity of general intoxication and clinical phenomena, reducing the duration of the disease, and reducing the risk of complications.
Refers to low-toxic compounds (LD50 >4 g/kg). Does not have any negative effects on the human body when administered orally in recommended doses.
Dosage regimen
Taken orally.
The dose, frequency of administration, and duration of use are determined depending on the patient’s age, indications, prophylaxis or therapy regimen.
Single dose - 50-200 mg.
Side effect
Rarely:
allergic reactions.
special instructions
It does not exhibit central neurotropic activity and can be used in medical practice for preventive purposes in practically healthy individuals of various professions, incl. requiring increased attention and coordination of movements (transport drivers, operators, etc.).
