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 acute respiratory viral infections in children over 2 years of age and adults;

– complex therapy of acute intestinal infections of rotavirus etiology in
children from 2 years old.

Pharmacological effect

Antiviral agent. Specifically inhibits 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 that cause ARVI, 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 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 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 suppressor cells (CD8), normalizes the immunoregulatory index, stimulates the phagocytic function of macrophages and increases the number of natural killer cells (NK cells).

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

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

Pharmacokinetics. Quickly absorbed and distributed throughout organs and tissues. The maximum concentration in blood plasma when taking the drug at a dose of 200 mg of umifenovir is achieved after 1 hour, the volume of distribution (Vd) is 1432 l.

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

Special instructions

When prescribing to patients with diabetes mellitus, as well as on 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 follow the regimen and duration of taking the drug recommended in the instructions. 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 regimen.

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

When calculating the amount of suspension required for a course of administration, it is necessary to take into account the shelf life of the prepared suspension, which is 10 days. For a course of treatment indicated for nonspecific prophylaxis during an epidemic of influenza and other acute respiratory viral infections in children from 2 to 6 years old, two bottles of the drug Arbidol® will be required.

Impact on the ability to drive vehicles and machinery

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

Active ingredient

Umifenovir

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 (Kleptosa 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.

Pregnancy

In animal studies, no harmful effects on pregnancy, embryonic and fetal development, labor or postnatal development were identified. The use of Arbidol® in the first trimester of pregnancy is contraindicated. In the second and third trimester of pregnancy, the drug Arbidol®
can only be used for the treatment and prevention of influenza and if the expected benefit to the mother outweighs the potential risk to the fetus. The benefit/risk ratio is determined by the attending physician.

It is not known whether Arbidol® passes into breast milk in women during lactation. If necessary, use the drug Arbidol®
breastfeeding should be stopped.

Contraindications

Hypersensitivity to umifenovir or any component of the drug.

Age up to 2 years. First trimester of pregnancy. Breastfeeding period.

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

With caution

Second and third trimesters of pregnancy.

Side Effects

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

Side effects are rare, usually mild or moderate and 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 rare (with a frequency of less than 1/10000), frequency unknown (cannot be determined from available data).

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

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

Interaction

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

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

There was no evidence of undesirable interactions with antipyretic, mucolytic and local vasoconstrictor drugs in a clinical study.

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 the reach of children.

Shelf life

2 years. Prepared suspension – 10 days in a tightly closed bottle.

Manufacturer

Pharmstandard-Leksredstva, Russia