Arbidol Maximum, capsules 200mg, 10pcs

Composition

Active ingredient: umifenovir hydrochloride monohydrate (based on umifenovir hydrochloride) – 200 mg.

Excipients: potato starch-52.67 mg, microcrystalline cellulose-11.20 mg, colloidal silicon dioxide (aerosil) – 2.80 mg, povidone (collidone 25) – 7.73 mg, calcium stearate-2.80 mg, croscarmellose sodium-2.80 mg, capsule content weight-280 mg.

Solid gelatin capsules No. 0:

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

Pharmacological action

Pharmacotherapeutic group: antiviral agent.

ATX Code: J05AX13

Pharmacological properties

Pharmacodynamics

Antiviral agent. Specifically suppresses in vitro influenza A and B viruses (Influenzavirus A, B), including highly pathogenic subtypes A(H1N1)pdm09 and A(H5N1), as well as other viruses that cause acute respiratory viral infections (ARVI) associated with severe acute respiratory syndrome (SARS), rhinovirus (Rhinovirus), adenovirus (Adenovirus syncytial virus (Pneumovirus) and parainfluenza virus (Paramyxovirus)).

According to the mechanism of antiviral action, it belongs to fusion inhibitors (fusions), interacts with viral hemagglutinin and prevents the fusion of the lipid envelope 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 mouse study, interferon induction was observed as early as 16 hours, and high interferon titers persisted in the blood up to 48 hours after use. It 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 killers (NK cells).

Therapeutic efficacy in viral infections is manifested in reducing the duration and severity of the course of the disease and its main symptoms, as well as in reducing the frequency of complications associated with viral infection and exacerbations of chronic bacterial diseases.

In the treatment of 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 of resolution of symptoms of the disease, a decrease in the severity of disease manifestations and a reduction in the time of virus elimination.

Treatment with the drug leads to a higher frequency of relief 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 influenza is more than 5 times higher 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-toxic drugs (LD₅₀ > 4 g / kg). It does not have any negative effects on the human body when administered orally at the recommended doses.

Pharmacokinetics. It is quickly absorbed and distributed to organs and tissues. The maximum concentration in blood plasma when taken at a dose of 50 mg is reached in 1.2 hours, at a dose of 100 mg – in 1.5 hours. It is metabolized in the liver. The average half-life is 17-21 hours. About 40% is excreted unchanged, mainly in the bile (38.9%) and in a small amount by the kidneys (0.12%). During the first day,90% of the administered dose is removed.

Indications

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

• Complex therapy of recurrent herpetic infection.

• Prevention of postoperative infectious complications.

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

Use during pregnancy and lactation

In animal studies, no harmful effects on the course of pregnancy, embryo and fetal development, labor and postnatal development were found.

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

In the second and third trimester of pregnancy, Arbidol® The maximum can only be used for the treatment and prevention of influenza and if the intended benefit to the mother exceeds the potential risk to the fetus. The benefit / risk ratio is determined by the attending physician.

It is not known whether Arbidol ® penetrates Maximum in breast milk in women during lactation. If necessary, use Arbidol®You should also stop breastfeeding.

Contraindications

Hypersensitivity to umifenovir or any component of the drug; children under 12 years of age. First trimester of pregnancy. Breast-feeding period.

With caution

Second and third trimesters of pregnancy.

Side effects

The drug Arbidol®Maximum refers to low-toxic drugs and is usually well tolerated.

Side effects are rare, usually mild to moderate, and transient.

The incidence of adverse drug reactions identified in accordance with the who classification: very often (with a frequency greater than 1/10), often (with a frequency of at least 1/100, but less than 1/10), infrequently (speed of at least 1/1000, but less than 1/100), rarely (with a frequency of not less than 1/10000, but less than 1/1000), very rare (with a frequency of less than 1/10000), frequency unknown (cannot be installed according to the available data).

Immune system disorders: rarely-allergic reactions.

If any of the side effects listed 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 observed.

Special clinical studies devoted to the study of interactions of the drug Arbidol® No studies have been performed with other medicinal products.

Data on the presence of undesirable interactions with antipyretic, mucolytic and local vasoconstrictor drugs in the clinical study were not revealed.

How to take, course of use and dosage

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

Taking the drug begins from the moment the first symptoms of influenza and other acute respiratory viral infections appear, preferably no later than 3 days after the onset of the disease.

If after the use of the drug Arbidol® For a maximum of three days during the treatment of influenza and other acute respiratory viral infections, the severity of symptoms of the disease remains, including a high temperature (38 °C or more), then it is necessary to consult a doctor to assess the validity of taking the drug.

Use the drug only according to the indications, the method of use and in the doses indicated in the instructions.

In the treatment of influenza and acute respiratory viral infections, concomitant symptomatic therapy is possible, including the use of antipyretics, mucolytic and local vasoconstrictors.

Special instructions

It is necessary to follow the scheme recommended in the instructions and the duration of taking the drug. If you miss 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 scheme you started.

If after the use of the drug Arbidol® For a maximum of three days during the treatment of influenza and other acute respiratory viral infections, the severity of symptoms of the disease remains, including a high temperature (38 °C or more), then it is necessary to consult a doctor to assess the validity of taking the drug.

Influence on the ability to drive vehicles and mechanisms

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

Form of production

Capsules

Storage conditions

Store in a dry place, protected from light.

Shelf

life is 2 years.

Active ingredient

Umifenovir

Dosage form

Capsules

Purpose

Children over 12 years old, For adults

Indications

Cold, Flu and cold prevention, SARS, Flu