Arbidol Maximum, capsules 200 mg 10 pcs

Pharmacotherapeutic group: antiviral drug.

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 invitro studies, it specifically suppresses SARS-CoV-2 virus, which causes a new coronavirus infection (COVID-19). The EC₅₀ (half-maximum effective concentration) in Vero E6 cells is 4.11 µmol, corresponding to 2.11 µg/mL. The clinical significance of this requires further study.

In terms of the mechanism of antiviral action, it refers to fusion (fusion) inhibitors, 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 a study on mice interferon induction was observed after 16 hours, and high titers of interferon were maintained in blood up to 48 hours after administration. 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 (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 adult patients the clinical trial showed that the effect of the drug in adult patients was most pronounced in the acute period of the disease and was manifested by shorter time of resolution of disease symptoms, less severe manifestations of the disease and shorter time of virus elimination.

Therapy with the drug leads to higher rate of resolution of symptoms on the third day of therapy compared to placebo: 60 h after the start of therapy the resolution of all symptoms of laboratory confirmed flu is more than 5 times greater than in the placebo group.

A significant effect of the drug 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-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 1.2 hours in a dose of 50 mg, in a dose of 100 mg – after 1.5 hours. It is metabolized in the liver. The elimination half-life is 17-21 hours on average. 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 of flu and colds, SARS, Flu, Colds

• Prevention and treatment in adults and children from 12 years: influenza A and B, other SARS.

• Comprehensive therapy of recurrent herpes infection.

• Prevention of postoperative infectious complications.

• Comprehensive therapy of acute intestinal infections of rotavirus etiology in children over 12 years

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Active ingredient

Umifenovir

Composition

Active ingredient: umiphenovir hydrochloride monohydrate (in terms of umiphenovir hydrochloride) – 200 mg.

Excipients: potato starch – 52.67 mg, microcrystalline cellulose – 11.20 mg, colloidal silica (aerosil) – 2.80 mg, povidone (collidon 25) – 7.73 mg, calcium stearate – 2.80 mg, croscarmellose sodium – 2.80 mg, capsule contents weight – 280 mg.

Solid gelatin capsules №0:

Capsule shell (body and cap) composition: titanium dioxide (E 171) – 1.92 mg, gelatin – 94.08 mg. The total mass of the capsule is 376 mg.

How to take, the dosage

The single dose for adults and children over 12 years is 200 mg (1 capsule).

The drug should be taken when the first symptoms of influenza and other SARS appear, preferably within 3 days of the disease onset.

If after the use of Arbidol^® within maximum 3 days in treatment of flu and other acute respiratory viral infections the severity of symptoms, including high temperature (38 °С or higher) persists, then the patient should see a doctor to assess the appropriateness of the drug.

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

In the treatment of influenza and acute respiratory infections, there may be associated symptomatic therapy, including antipyretics, mucolytic medications, 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^® Maximum 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 conditions of clinical trials.

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 initial regimen.

If after the use of Arbidol^® at most for three days in treatment of influenza and other acute respiratory infections the severity of symptoms, including high temperature (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 12 years of age. First trimester of pregnancy. Breast-feeding period.

With caution

The second and third trimesters of pregnancy.

Side effects

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

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® Maximum is contraindicated in the first trimester of pregnancy.

In the second and third trimesters of pregnancy Arbidol® Maximum may be used only for 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 attending physician.

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

Similarities

Arbidol, Arpeflu, Afludol, Umifenovir