ARBIDOL POWDER FOR SUSPENSION 0.025/5ML 37G

Release form

Powder for the preparation of suspensions for oral administration

Packaging

Bottle 37 g

Mechanism of action

Antiviral agent. It specifically inhibits in vitro influenza A and B viruses (Influenzavirus A, B), including highly pathogenic subtypes A (H1N1) pdm09 and A (H5N1), as well as other viruses that cause acute respiratory viral infections (Coronavirus) associated with severe acute respiratory syndrome ( SARS), rhinovirus (Rhinovirus), adenovirus (Adenovirus), respiratory syncytial virus (Pneumovirus) and parainfluenza virus (Paramyxovirus)). The mechanism of antiviral action refers 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 Interferon was observed already after 16 hours, and high titers of interferon remained in the blood up to 48 hours after administration. Stimulates cellular and humoral immunity reactions: 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 efficacy in viral infections manifests itself in reducing the duration and severity of the disease and its mainsymptoms, as well as in reducing the incidence of complications associated with viral infection and exacerbations of chronic bacterial diseases.
It refers to low-toxic drugs (LD50> 4 g / kg). It does not have any negative effects on the human body when administered orally at recommended doses.
Pharmacokinetics. It is rapidly absorbed and distributed in organs and tissues. The maximum concentration in the blood plasma when taking the drug in a dose of 200 mg of umiphenovir is reached after 1 hour, the volume of distribution (Vd) is 1432 l. Metabolized in the liver. The average half-life averages 11 hours. About 40% is excreted unchanged, mainly with bile (38.9%) and, in small amounts, by the kidneys (0.12%). During the first day, 90% of the injected dose is eliminated.

Indications

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

Contraindications

Hypersensitivity to umifenovir or any component of the drug.
Age up to 2 years; age up to 6 years (according to the indication non-specific prevention of SARS); age up to 12 years (according to indications treatment of SARS).
Surase / 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 notes

When prescribing to patients with diabetes mellitus, as well as with a low-calorie diet, it is necessary to take into account that sucrose is included in the suspension (0.8 g / 5 ml or 0.06 XE / 5 ml).
It is necessary to comply with the recommended in the instructions scheme and the duration of the drug. In case of skipping a single 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 started.
When calculating the required amount of suspension for the course of reception, it is necessary to consider the shelf life of the prepared suspension, which is 10 days. According to the indications, non-specific prophylaxis during the epidemic of influenza and other acute respiratory viral infections in children from 2 to 6 years old will require two bottles of Arbidol®.

Influence on ability to drive vehicles and mechanisms

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

Composition

Composition 5 ml:
active ingredient: umifenovir (umifenovir hydrochloride monohydrate - 25.88 mg), (in terms of umifenovir hydrochloride - 25.00 mg);
excipients: sodium chloride - 26.85 mg, maltodextrin (Kleptoza 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 flavoring - 12.40 mg, cherry flavoring - 6.10 mg.

Dosage and Administration

The drug should be taken orally, before eating.

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

Single dose (depending on age):

from 2 to 6 years old - 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 prophylaxis during the epidemic of influenza and other acute respiratory viral infections - in a single dose 2 times a week for 3 weeks.

Nonspecific 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 with 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 nonspecific 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 old - 20 ml (100 mg), children over 12 years old 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 old 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) - pruritus, rash, angioedema, urticaria; very rarely (with a frequency of less than 1/10000) - Anaphylactic reactions.
If any of the side effects indicated in the instruction are aggravated, or you have noticed any other side effects that are not indicated in the instruction, inform your doctor.

Drug interaction

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

Overdosage

Unchecked.

Storage conditions

Store at a temperature not exceeding 25 ° C.
To store the prepared suspension at a temperature not higher than 8 ° C (in the refrigerator). Do not freeze.
Keep out of the reach of children.