Arbidol, capsules 100 mg 10 pcs

Pharmacotherapeutic group: antiviral agent

ATX code: J05AX13

Pharmacological properties:

Pharmacodynamics.

Antiviral agent. Specifically suppresses in vitro influenza viruses A and B (Influenzavirus A, B), including highly pathogenic subtypes A(H1N1)pdm09 and A(H5N1), and 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 possesses interferon-inducing activity – in researches on mice interferon induction was noticed 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 the immunoregulatory index, stimulates phagocytic function of macrophages and increases the 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. In 60 hours after the beginning 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 was manifested, in particular, by a decrease in the frequency of detection of RNA of the virus on the 4th day.

Related to low-toxicity 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 1.5 hours. It is metabolized in the liver. Period of half-life is 17-21 hours. About 40% is eliminated 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 SARS.

Comprehensive therapy of recurrent herpetic infection.

Prevention of postoperative infectious complications.

Active ingredient

Composition

Active ingredient: umiphenovir hydrochloride monohydrate (in terms of umiphenovir hydrochloride) – 100 mg.

Excipients: potato starch – 30.14 mg, microcrystalline cellulose – 55.76 mg, colloidal silica (aerosil) – 2.0 mg, povidone K 25 (collidon 25) – 10.1 mg, calcium stearate – 2.0 mg.

Solid gelatin capsules № 1:

Case: titanium dioxide (E 171) – 2.0000%, gelatin – up to 100%.

Lid: titanium dioxide (E 171) – 1.3333 %, sunset yellow dye (E 110) – 0.0044 %, quinoline yellow (E 104) – 0.9197 %, gelatin – up to 100%.

How to take, the dosage

Arbidol is taken orally, before meals.

A single dose: for children from 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years and adults – 200 mg (2 capsules of 100 mg or 4 capsules of 50 mg).

For non-specific prophylaxis:

In direct contact with patients with influenza and other acute respiratory infections:

children 3 to 6 years – 50 mg, 6 to 12 years – 100 mg, over 12 years and adults – 200 mg once a day for 10-14 days.

During epidemics of influenza and other acute respiratory infections, to prevent exacerbations of chronic bronchitis, recurrence of herpetic infection:

Children from 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years and adults – 200 mg twice a week for 3 weeks.

For the prevention of SARS (in contact with a sick person):

Adults and children over 12 years of age are prescribed 200 mg once daily. In children from 6 to 12 years old 100 mg once a day (before meals) for 12-14 days.

Prevention of postoperative complications:

In children 3 to 6 years old, 50 mg; 6 to 12 years old, 100 mg; over 12 years old and adults, 200 mg 2 days before surgery, then on the 2nd and 5th day after surgery.

To treat:

Influenza, other acute respiratory infections without complications:

For children 3 to 6 years – 50 mg, 6 to 12 years – 100 mg, over 12 years and adults – 200 mg 4 times a day (every 6 hours) for 5 days.

The flu, other acute respiratory infections with the development of complications (bronchitis, pneumonia, etc.):

For children 3 to 6 years – 50 mg, 6 to 12 years – 100 mg, over 12 years and adults – 200 mg 4 times a day (every 6 hours) for 5 days, then a single dose once a week for 4 weeks.

Severe acute respiratory syndrome (SARS):

Children over 12 years of age and adults, 200 mg 2 times daily for 8 to 10 days.

In the complex treatment of chronic bronchitis, herpetic infection:

Children from 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years and adults – 200 mg 4 times a day (every 6 hours) for 5-7 days, then a single dose 2 times a week for 4 weeks.

The complex therapy of acute intestinal infections of rotavirus aetiology in children over 3 years of age:

From 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years – 200 mg 4 times a day (every 6 hours) for 5 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.

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 drug administration. 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 original schedule.

If after three days of using the drug Arbidol® 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 exhibit central neurotropic activity and may be used in medical practice in persons of various professions, including those requiring increased attention and coordination of movement (drivers of transport, operators, etc.).

Contraindications

Hypersensitivity to ubifenovir or any component of the drug; children under 6 years of age. First trimester of pregnancy. Breast-feeding period.

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

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 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.

It is unknown whether Arbidol® penetrates into the breast milk in women during lactation. If it is necessary to use Arbidol®, breastfeeding should be stopped.

Similarities