Arbidol, 25 mg/5 ml 37 g

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

In terms of the mechanism of antiviral action it refers to fusion inhibitors (fusion), interacts with hemagglutinin of the virus and prevents fusion of lipid coating of the virus and cell membranes.

It has interferon-inducing activity – in a study on mice interferon induction was noticed after 16 hours, and high titers of interferon were maintained in blood up to 48 hours after injection. It stimulates cellular and humoral immune reactions: it increases the number of lymphocytes in blood, especially the number of 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 effectiveness in viral infections is manifested in reduction of duration and severity of the course of the disease and its main symptoms as well as in the decrease of the rate of development of complications due to viral infection and exacerbations of chronic bacterial diseases.

The drug is low-toxic (LD50>4 g/kg). It does not have any negative effect on human body when administered orally in recommended doses.

Pharmacokinetics. It is rapidly absorbed and distributed to organs and tissues. Maximal concentration in plasma when administered in dose of 200 mg of Umifenovir is reached after 1 hour, volume of distribution (Vd) – 1432 l.

It is metabolized in the liver. Mean elimination half-life is 11 hours. About 40% is eliminated unchanged, mainly in the bile (38.9%) and in small amounts in the kidneys (0.12%). During the first day 90% of the administered dose is excreted.

Indications

– Prevention and treatment of influenza A and B, other ARI in children from 2 years and adults;

Active ingredient

Composition

Composition per 5 ml:

The active ingredient:

umiphenovir (umiphenovir hydrochloride monohydrate – 25.88 mg),

(in terms of umiphenovir hydrochloride – 25.00 mg);

excipients:

sodium chloride – 26.85 mg,

maltodextrin (Kleptose Linecaps) – 750.00 mg,

sucrose (sugar) – 840.42 mg,

silicon dioxide colloid (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.

How to take, the dosage

Ingestion, before meals.

Preparation of suspension.
In the vial containing the powder add 30 ml (or about 2/3 of the vial volume) of water boiled and cooled to room temperature. Close the bottle with the lid, invert and shake thoroughly until a homogeneous suspension is obtained. Add boiled and cooled water to the volume of 100 ml (to the mark on the bottle) and shake again. Shake the contents of the bottle thoroughly before each administration until a homogeneous suspension is obtained. Measure out the single dose using the measuring spoon supplied.

The 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 old and adults:

Non-specific prophylaxis during epidemics of influenza and other ARIs – 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 infections – in a single dose once a day for 10-14 days.

The 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 old:

The complex therapy of acute intestinal infections of rotavirus aetiology – in a single dose 4 times a day (every 6 hours) for 5 days.

For non-specific prophylaxis and treatment of severe acute respiratory syndrome (SARS):
For non-specific prevention of SARS (by contact with a patient) in children from 6 years old 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 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.

Interaction

No adverse effects have been observed when prescribed with other drugs.

Special clinical studies to study the interactions of the drug Arbidol ® with other medicinal products have not been conducted.

The presence of undesirable interactions with antipyretics, mucolytic and local vasoconstrictors has not been found in clinical trials.

In the clinical study.

Special Instructions

When prescribing to patients with diabetes mellitus and also on a low-calorie diet, note that the suspension contains sucrose (0.8 g/5 ml or 0.06 CFU/5 ml).

The regimen and duration of administration recommended in the instructions must be followed. If a dose of the drug is missed, take the missed dose as soon as possible and continue the course of the drug according to the initial regimen.

If after the use of the drug Arbidol® within three days in treatment of influenza and other acute respiratory infections the severity of symptoms, including high fever (38 ° C and more) persists, it is necessary to see a doctor to evaluate the validity of the drug.

When calculating the required amount for the course of administration of the suspension it is necessary to take into account the shelf life of the suspension prepared, which is 10 days. Two vials of Arbidol® are required for the course of administration for the indication of non-specific prophylaxis during epidemics of influenza and other acute respiratory viral infections in children from 2 to 6 years old.

Impact on the ability to drive vehicles and mechanisms

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

Contraindications

Hypersensitivity to ubifenovir or any component of the drug.

The age under 2 years. First trimester of pregnancy. Breastfeeding period.

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

With caution

The second and third trimesters of pregnancy.

Side effects

The drug Arbidol® is a low-toxicity drug and is usually well tolerated.

The side effects are rare, usually mild to moderate and transient.

The incidence of adverse drug reactions is defined according to the WHO classification: very common (more than 1/10), common (at least 1/100 but less than 1/10), infrequent (at least 1/1000 but less than 1/100), rare (at least 1/10000 but less than 1/1000), very rare (less than 1/10000), frequency unknown (cannot be known from available data).

Immune system disorders: rare – allergic reactions – skin itching, rash, angioedema, urticaria; very rare – anaphylactic reactions.

If any of the side effects mentioned in the instructions worsen, or if you notice any other side effects not specified in the instructions, tell your doctor.

Pregnancy use

Harmful effects on pregnancy, embryo and fetal development, labor and postnatal development have not been found in animal studies. The use of the drug Arbidol® in the first trimester of pregnancy is contraindicated. In the second and third trimesters of pregnancy Arbidol® may be used only for treatment and prophylaxis of influenza and in case when the estimated benefit to the mother exceeds the potential risk to the fetus. The benefit/risk ratio is determined by the treating physician.

Similarities