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 and treatment in adults and children over 12 years of age: influenza A and B, other acute respiratory viral infections.

Complex therapy of recurrent herpes infection.

Prevention of postoperative infectious complications.

Complex therapy of acute intestinal infections of rotavirus etiology in children over 12 years of age.

Pharmacological effect

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), as well as other viruses – causative agents of acute respiratory viral infections (ARVI), associated with severe acute respiratory syndrome (SARS), rhinovirus (Rhinovirus), adenovirus (Adenovirus), respiratory syncytial virus (Pneumovirus) and parainfluenza virus (Paramyxovirus)).

In in vitro studies, it specifically inhibits the SARS-CoV-2 virus, which causes novel coronavirus infection (COVID-19). The EC50 (half maximal effective concentration) in Vero E6 cells is 4.11 µM, which corresponds to 2.11 µg/ml. The clinical significance of this requires further study.

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 a moderate immunomodulatory effect and increases the body’s resistance to viral infections.

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-suppressors (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.

When treating influenza or ARVI in adult patients, a clinical study showed that the effect of the drug in adult patients is most pronounced in the acute period of the disease and is manifested by a reduction in the time for resolution of symptoms of the disease, a decrease in the severity of the manifestations of the disease and a reduction in the time for elimination of the virus.

Therapy with the drug leads to a higher frequency of relief of symptoms of the disease on the third day of therapy compared to placebo – 60 hours after the start of therapy, the resolution of all symptoms of laboratory-confirmed influenza is more than 5 times higher than the same indicator in the placebo group.

A significant effect of the drug on the rate of elimination of the influenza virus was established, which, in particular, was manifested by a decrease in the frequency of detection of viral RNA on the 4th day.

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 taken at a dose of 50 mg is achieved after 1.2 hours, at a dose of 100 mg – after 1.5 hours. Metabolized in the liver. The half-life is on average 17-21 hours. About 40% is excreted unchanged, mainly with bile (38.9%) and in small amounts by the kidneys (0.12%). During the first day, 90% of the administered dose is eliminated.

Special instructions

It is necessary to follow the regimen and duration of taking the drug recommended in the instructions. If you miss one dose of the drug, the missed dose should be taken as early as possible and continue taking the drug according to the started regimen.

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

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

Active substance: umifenovir hydrochloride monohydrate (in terms of umifenovir hydrochloride) – 200 mg.

Excipients: potato starch – 52.67 mg, microcrystalline cellulose – 11.20 mg, colloidal silicon dioxide (Aerosil) – 2.80 mg, povidone (kollidon 25) – 7.73 mg, calcium stearate – 2.80 mg, croscarmellose sodium – 2.80 mg, weight of capsule contents – 280 mg.

Hard gelatin capsules No. 0:

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

Pregnancy

In animal studies, no harmful effects on pregnancy, embryonic and fetal development, labor or postnatal development were identified.

The use of Arbidol® Maximum in the first trimester of pregnancy is contraindicated.

In the second and third trimester of pregnancy, Arbidol® Maximum can be used only 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 unknown whether Arbidol® Maximum penetrates into the chest
milk in women during lactation. If necessary, use Arbidol®
At most, breastfeeding should be stopped.

Contraindications

Hypersensitivity to umifenovir or any component of the drug; children’s age up to 12 years. First trimester of pregnancy. Breastfeeding period.

With caution

Second and third trimesters of pregnancy.

Side Effects

Arbidol® drug
Maximum 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.

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.

No special clinical studies have been conducted to study the interactions of the drug Arbidol® Maximum with other drugs.

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

Storage conditions

Store in a dry place, protected from light.

Shelf life

2 years.

Manufacturer

Pharmstandard-Leksredstva, Russia