Expiration date: 05/2025

Release form

Powder for preparation of suspension for oral administration

Packaging

Bottle 37 g

Pharmacological action

An 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 viruses that cause SARS (coronavirus (Coronavirus) associated with severe acute respiratory syndrome (SARS), rhinovirus (Rhinovirus), adenovirus (Adenovirus), respiratory viral infection (SARS), syncytial virus (Pneumovirus) and parainfluenza virus (Paramyxovirus)). According to the mechanism of antiviral action, it belongs to fusion inhibitors (fusions), interacts with the hemagglutinin of the virus and prevents the fusion of the lipid envelope of the virus and cell membranes. It has interferon-inducing activity — in a study on mice, the induction of interferons was noted after 16 hours, and high titers of interferons remained in the blood up to 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-helper cells (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 effectiveness in viral infections is shown in reducing the duration and severity of the disease and its main symptoms, as well as in reducing the frequency of complications associated with viral infection and exacerbations of chronic bacterial diseases.

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

Pharmacokinetics. It is quickly absorbed and distributed to organs and tissues. The maximum concentration in the blood plasma when taking the drug at a dose of 200 mg of umifenovir is reached after 1 hour, the volume of distribution (Vd) is 1432 l.It is metabolized in the liver. The average half-life is 11 hours. About 40% is excreted unchanged, mainly with bile (38.9%) and, in a small amount, with kidneys (0.12%). During the first day, 90% of the administered dose is eliminated.

Indications

• prevention and treatment of influenza A and B, other acute respiratory infections in children from 2 years and adults;
• complex therapy of acute intestinal infections of rotavirus etiology in children from 2 years of age;
• non-specific prevention of severe acute respiratory syndrome (SARS) for children from 6 years and adults;
• treatment of severe acute respiratory syndrome (SARS) in children over 12 years of age and adults.

Contraindications

Hypersensitivity to umifenovir or any component of the drug.

Age up to 2 years; age up to 6 years (as indicated by non-specific prevention of SARS); age up to 12 years (as indicated by treatment of SARS).

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

Use during pregnancy and lactation

The use of the drug Arbidol ® during pregnancy is contraindicated. It is not known whether the active substance of the drug Arbidol ® or its metabolites penetrates into breast milk in women during lactation. If necessary, the use of the drug Arbidol ® should stop breastfeeding.

Special instructions

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

It is necessary to follow the scheme recommended in the instructions and the duration of taking the drug. If you miss taking 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 started scheme.

When calculating the amount of suspension required for the course of administration, it is necessary to take into account the shelf life of the prepared suspension, which is 10 days. Two vials of Arbidol ® will be required for the course of administration according to the indication of non-specific prevention during the epidemic of influenza and other SARS in children from 2 to 6 years of age.

Influence on the ability to drive vehicles and mechanisms

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

Composition

Composition per 5 ml:

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, pre — gelatinized starch (type PA5PH) — 129.50 mg, sodium benzoate — 9.25 mg, banana flavor — 12.40 mg, cherry flavor-6.10 mg.

Method of administration and dosage

Inside, before eating.

Preparation of the suspension.

In the bottle containing the powder, add 30 ml (or about 2/3 of the volume of the bottle) of boiled and cooled to room temperature water. Close the bottle with a lid, turn it over and shake it thoroughly until a homogeneous suspension is obtained. Add the boiled and cooled water to a volume of 100 ml (up to the label on the bottle) and shake again. Before each dose, the contents of the bottle should be thoroughly shaken until a homogeneous suspension is obtained. Measure a single dose using the supplied measuring spoon.

Single dose (depending on age):

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

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

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

For children from 2 years and adults:

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

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

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

In children from 2 years of age:

Complex 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 and adults:

children from 6 to 12 years — 20 ml (100 mg), children over 12 years and adults — 40 ml (200 mg) once a day for 12-14 days.

For the treatment of SARS in children from 12 years and adults:

children over 12 years and adults-40 ml (200 mg) 2 times a day for 8-10 days.

Side effects

Allergic reactions: rarely (with a frequency of at least 1/10000, but less than 1/1000) — itching, rash, angioedema, urticaria; very rarely (with a frequency of less than 1/10000) — anaphylactic reactions.

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Drug interaction

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

Overdose

Not marked.

Storage conditions

Store at a temperature not exceeding 25 °C.

Store the prepared suspension at a temperature not exceeding 8 °C (in the refrigerator). Do not freeze.

Keep out of reach of children.

Expiration date

Powder for preparation of suspension for oral administration — 2 years.

The prepared suspension — no more than 10 days.

Do not use after the expiration date indicated on the package.