Arbidol, 50 mg 10 pcs

Pharmacotherapeutic group: antiviral drug.

ATX code: J05AX13

Pharmacological properties

Pharmacodynamics.

Antiviral agent. Specifically suppresses influenza viruses A and B (Influenzavirus A, B), including highly pathogenic subtypes A(H1N1)pdm09 and A(H5N1), as well as other viruses – causative agents of acute respiratory viral infections (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 the lipid shell of the virus and cell membranes. It has a moderate immunomodulatory effect, increases the body’s resistance to viral infections.

It has interferon-inducing activity – in studies on mice interferon induction was observed after 16 hours, and high titers of interferon were maintained in blood up to 48 hours after administration.

Stimulates cellular and humoral immune reactions: it increases number of lymphocytes in blood, in particular of T-cells (CD3), increases number of T-helpers (CD4) without affecting the level of T-suppressors (CD8), normalizes immunoregulatory index, stimulates phagocytic function of macrophages and increases number of natural killer (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.

In treatment of influenza or acute respiratory viral infections in adults the clinical trial showed that the effect of Arbidol^® in adults is most pronounced in acute period of disease and shows shorter time of resolution of disease symptoms, less severe manifestations of disease and shorter time of virus elimination.

Therapy with Arbidol^® results in higher rate of resolution of symptoms on the third day of therapy compared to placebo: 60 hours after the start of therapy the resolution of all symptoms of laboratory confirmed flu is more than 5 times higher than in the placebo group.

A significant effect of Arbidol^® on the rate of elimination of the influenza virus was found, which, in particular, was manifested by a decrease in the frequency of detection of RNA of the virus on the 4th day.

It belongs to low-toxic drugs (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 blood plasma is reached after 1.2 hours when administered in dose of 50 mg, in dose of 100 mg – after 1.5 hours. It is metabolized in the liver. The elimination half-life is 17-21 hours. About 40% is excreted unchanged, mainly in bile (38.9%) and in small amount in kidney (0.12%). During the first day 90% of the administered dose is eliminated.

Indications

Prevention and treatment in adults and children: influenza A and B, other ARI.

The complex therapy of acute intestinal infections of rotavirus etiology in children over 3 years.

The complex therapy of chronic bronchitis, pneumonia and recurrent herpetic infection.

Active ingredient

Composition

One tablet contains:

the active substance:

umiphenovir hydrochloride monohydrate – 51.75 mg (in terms of umiphenovir hydrochloride -50.00 mg);

excipients:

Core: potato starch – 31.860 mg, microcrystalline cellulose -57.926 mg, povidone (povidone K30) – 8.137 mg, calcium stearate – 0.535 mg, croscarmellose (croscarmellose sodium) – 1.542 mg;

How to take, the dosage

Ingestion, before meals.

Dose (depending on age):

Age

Daily dose of the drug

3 to 6 years

50 mg (1 tablet)

6 to 12 years

100 mg (2 tablets)

older than 12 years and adults

200 mg (4 tablets)

The indication

The drug regimen

In children from 3 years and adults:

Non-specific prophylaxis during epidemics of influenza and other SARS

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

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In a single dose once a day for 10-14 days.

The treatment of influenza and other acute respiratory infections

in a single dose 4 times a day (every 6 hours) for 5 days.

In children from 3 years old:

Complex therapy of acute intestinal infections of rotavirus etiology

A single dose 4 times a day (every 6 hours) for 5 days.

In children from 3 years and adults:

Comprehensive therapy of chronic bronchitis, pneumonia, herpetic infection

In a single dose 4 times a day (every 6 hours) for 5-7 days, then a single dose 2 times a week for 4 weeks.

Prevention of postoperative infectious complications

in a single dose 2 days before surgery, then 2 and 5 days after surgery.

The drug shall be taken from the moment of the first symptoms of influenza and other SARS, preferably within 3 days from the beginning of the disease.

If after three days of using the drug Arbidol ® when treating influenza and other SARS the severity of symptoms, including high fever (38 ° C or more) persists, then the patient should see a doctor to assess the appropriateness of taking the drug.

The drug should only be used according to the indication, route of administration, and dosage listed in the directions.

When treating influenza and acute respiratory infections, concomitant symptomatic therapy is possible, including antipyretics, mucolytic and local vasoconstrictors.

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.

In the conditions of clinical trials no adverse interactions with antipyretics, mucolytic and local vasoconstrictors have been revealed.

Special Instructions

It is necessary to follow the recommended regimen and duration of administration of the drug. If one dose of the drug is missed, the missed dose should be taken as soon as possible and the course of the drug should be continued 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 °С or more) persists, it is necessary to see a doctor to evaluate the appropriateness of the drug.

Impact on the ability to drive vehicles and mechanisms

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

Contraindications

Hypersensitivity to ubifenovir or any component of the drug, children under 3 years of age. The first trimester of pregnancy. Breast-feeding.

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.

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

Pregnancy use

No adverse effects on pregnancy, embryo and fetal development, labor and postnatal development were 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 the treatment and prevention of influenza and if the estimated benefit to the mother exceeds the potential risk to the fetus. The benefit/risk ratio is determined by the treating physician.

Similarities