Arbidol, capsules 100 mg, 40 pcs.

Composition

Active ingredient: umifenovir hydrochloride monohydrate (based on umifenovir hydrochloride) – 100 mg.

Excipients: potato starch-30.14 mg, microcrystalline cellulose-55.76 mg, colloidal silicon dioxide (aerosil) – 2.0 mg, povidone K 25 (collidone 25) – 10.1 mg, calcium stearate-2.0 mg.

Solid gelatin capsules No.1:

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

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

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 administration.

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 Arbidol® 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.

Arbidol®therapy It leads to a higher rate 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 Arbidol®has been established the rate of elimination of the influenza virus, 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 is reached 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 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: influenza A and B, other acute respiratory infections.

• Complex therapy of recurrent herpetic infection.

• Prevention of postoperative infectious complications.

• Complex therapy of acute intestinal infections of rotavirus etiology in children over 6 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® it is contraindicated in the first trimester of pregnancy.

In the second and third trimester of pregnancy, Arbidol® it 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 in breast milk in women during lactation. If necessary, the use of Arbidol® should stop breastfeeding.

Contraindications

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

With caution: 

Second and third trimesters of pregnancy.

Side effects

Arbidol® 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 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.

No specific clinical studies have been conducted to investigate the interactions of Arbidol with other medicinal products.

There were no data on the presence of undesirable interactions with antipyretic, mucolytic and local vasoconstrictor drugs in a clinical study.

How to take, course of administration and dosage

Arbidol is taken orally, before meals.

Single dose: children from 3 to 6 years-50 mg, from 6 to 12 years-100 mg, older than 12 years and adults-200 mg (2 capsules of 100 mg or 4 capsules of 50 mg).

For non-specific prevention:

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

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

During the epidemic of influenza and other acute respiratory viral infections, to prevent exacerbations of chronic bronchitis, relapse of herpetic infection:

children from 3 to 6 years – 50 mg, from 6 to 12 years-100 mg, older than 12 years and adults-200 mg twice a week for 3 weeks.

For the prevention of SARS (in contact with the patient):

adults and children over 12 years of age are prescribed 200 mg once a day. Children from 6 to 12 years of age: 100 mg once a day (before meals) for 12-14 days.

Prevention of postoperative complications:

children from 3 to 6 years – 50 mg, from 6 to 12 years-100 mg, older than 12 years and adults-200 mg 2 days before surgery, then on the 2nd and 5th days after surgery.

For treatment purposes:

Flu, other acute respiratory infections without complications:

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

Influenza and other ARVI with the development of complications (bronchitis, pneumonia, etc. ):

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 days, then the dose 1 time per week for 4 weeks.

Severe acute respiratory syndrome (SARS):

children over 12 years of age and adults – 200 mg 2 times a day for 8-10 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, older than 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.

Complex therapy of acute intestinal infections of rotavirus etiology in children over 3 years of age:

from 3 to 6 years-50 mg, from 6 to 12 years-100 mg, older than 12 years-200 mg 4 times a day (every 6 hours) for 5 days.

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® during three days in 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 you should 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, at a temperature not exceeding 25 °C

Shelf

life is 3 years.

Active ingredient

Umifenovir

Dosage form

of the capsule

Purpose

For adults and Children over 6 years of age

Indications

Prevention of flu and colds, Colds, Flu, SARS

Weight

Weight: 27 gr.