Arbidol powder for suspension 25 mg/5 ml, 37

5 ml composition: 

active substance: 

Umifenovir (Umifenovir hydrochloride monohydrate - 25.88 mg),

(in terms of umifenovir hydrochloride - 25.00 mg);

Excipients: 

sodium chloride - 26.85 mg,

maltodextrin (Kleptose Linecaps) - 750.00 mg, 

sucrose (sugar) - 840.42 mg,

colloidal silicon dioxide (aerosil) - 24.60 mg, 

titanium dioxide - 25.00 mg,

Pregelatinized starch (type PA5PH) - 129.50 mg, 

sodium benzoate - 9.25 mg,

banana flavor - 12.40 mg, 

cherry flavor - 6.10 mg.

Antiviral agent. Specifically suppresses in vitro influenza A and B viruses (Influenzavirus A, B), including the highly pathogenic subtypes A (H1N1) pdm09 and A (H5N1), as well as other ARVI pathogens associated with severe acute respiratory syndrome (SARS), rhinovirus ( Rhinovirus), adenovirus (Adenovirus), respiratory syncytial virus (Pneumovirus) and parainfluenza virus (Paramyxovirus)).

According to the mechanism of antiviral action, it belongs to fusion (fusion) inhibitors, interacts with the hemagglutinin of the virus and prevents the fusion of the lipid membrane of the virus and cell membranes.

It has interferon-inducing activity - in a mouse study, the induction of interferons was observed after 16 hours, and high titers of interferons remained in the blood until 48 hours after administration. Stimulates cellular and humoral immune responses: increases the number of lymphocytes in the blood, especially T-cells (CD3), increases the number of T-helpers (CD4), without affecting the level of T-suppressors (CD8), normalizes the immunoregulatory index, stimulates the phagocytic function of macrophages and increases the number of natural killer cells (NK cells).

Therapeutic efficacy in viral infections is manifested in a decrease in the duration and severity of the course of the disease and its main symptoms, as well as in a decrease in the frequency of development of complications associated with a viral infection and exacerbations of chronic bacterial diseases.

Belongs to low toxic drugs (LD50> 4 g / kg). It does not have any negative effects on the human body when administered orally in recommended doses.

Pharmacokinetics It is rapidly absorbed and distributed to organs and tissues. The maximum plasma concentration when taking the drug at a dose of 200 mg of umifenovir is reached after 1 hour, the volume of distribution (Vd) is 1432 liters.

Metabolized in the liver. The elimination half-life averages 11 hours. About 40% is excreted unchanged, mainly with bile (38.9%) and, in a small amount, by the kidneys (0.12%). During the first day, 90% of the administered dose is excreted.

- Prevention and treatment of influenza A and B, other acute respiratory viral infections in children from 2 years old and adults;

Animal studies have not revealed harmful effects on pregnancy, the development of the embryo and fetus, labor and postnatal development. The use of the drug Arbidol ^® in the first trimester of pregnancy is contraindicated. In the second and third trimester of pregnancy, Arbidol ^® can be used only for the treatment and prevention of influenza, and if the intended benefit to the mother outweighs the potential risk to the fetus. The benefit / risk ratio is determined by the attending physician.

Hypersensitivity to umifenovir or any component of the drug.

Age up to 2 years. The first trimester of pregnancy. The period of breastfeeding.

Sucrose / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

Carefully       

The second and third trimesters of pregnancy.

Arbidol ^® is a low-toxic drug and is usually well tolerated.

Side effects are rare, usually mild or moderate, and are transient.

The frequency of adverse drug reactions is determined in accordance with the WHO classification: very often (with a frequency of more than 1/10), often (with a frequency of at least 1/100, but less than 1/10), infrequently (with a frequency of at least 1/1000, but less than 1/100), rarely (with a frequency of at least 1/10000, but less than 1/1000), very rarely (with a frequency of less than 1/10000), the frequency is unknown (cannot be established according to available data).

Disorders from the immune system: rarely - allergic reactions - itching, rash, angioedema, urticaria; very rarely - anaphylactic reactions.

If any of the side effects indicated in the instructions are aggravated, or if you notice any other side effects not listed in the instructions, inform your doctor.

When prescribed with other drugs, no negative effects were noted.

Special clinical studies devoted to the study of the interactions of the drug Arbidol ^® with other drugs have not been conducted.

Information about the presence of undesirable interactions with antipyretic, mucolytic and local vasoconstrictor drugs in a clinical trial were not identified.

Inside, before eating.

Suspension preparation.
In a bottle containing powder, add 30 ml (or up to about 2/3 of the volume of the bottle) of boiled water and cooled to room temperature. Close the bottle with a cap, turn over and shake thoroughly until a homogeneous suspension is obtained. Add boiled and chilled water to a volume of 100 ml (to the mark on the vial) and shake again. Before each dose, shake the contents of the vial thoroughly until a homogeneous suspension is obtained. Measure a single dose using the attached measuring spoon.

Single dose (depending on age):

from 2 to 6 years - 10 ml (50 mg)

from 6 to 12 years old - 20 ml (100 mg)

over 12 years old and adults - 40 ml (200 mg)

In children from 2 years and adults:

Nonspecific prevention during the period of the epidemic of influenza and other acute respiratory viral infections - in a single dose 2 times a week for 3 weeks.

Non-specific prophylaxis in direct contact with patients with influenza and other acute respiratory viral infections - in a single dose once a day for 10-14 days.

Treatment of influenza and other acute respiratory viral infections in uncomplicated course - in a single dose 4 times a day (every 6 hours) for 5 days.

In children from 2 years:

Combined therapy of acute intestinal infections of rotavirus etiology - in a single dose 4 times a day (every 6 hours) for 5 days.

For non-specific prevention and treatment of severe acute respiratory syndrome (SARS): 
For non-specific prevention of SARS (in contact with the patient) in children from 6 years old and adults: for 
children from 6 to 12 years old - 20 ml (100 mg), for children over 12 years of age and adults - 40 ml (200 mg) once a day for 12-14 days.
For the treatment of SARS in children from 12 years old and adults: 
children over 12 years old and adults - 40 ml (200 mg) 2 times a day for 8-10 days.

When prescribing to patients with diabetes mellitus, as well as with a low-calorie diet, it is necessary to take into account that the suspension contains sucrose (0.8 g / 5 ml or 0.06 XE / 5 ml).

It is necessary to observe the recommended scheme and the duration of the drug. If you miss one dose of the drug, the missed dose should be taken as early as possible and continue the course of taking the drug according to the scheme begun.

If after using the drug Arbidol ^® for three days during the treatment of influenza and other acute respiratory viral infections, the severity of the symptoms of the disease, including high temperature (38 ° C or more), remains, then you must consult a doctor to assess the validity of taking the drug.

When calculating the amount of suspension necessary for the course of taking, it is necessary to take into account the shelf life of the prepared suspension, which is 10 days. For the admission course, if indicated, non-specific prophylaxis during the period of the flu epidemic and other acute respiratory viral infections in children from 2 to 6 years old will require two bottles of Arbidol ^® .

Impact on the ability to drive vehicles and mechanisms

It does not show central neurotropic activity and can be used in medical practice in people of various professions, including requiring increased attention and coordination of movements (drivers of vehicles, operators, etc.).