Arbidol powder for oral suspension, 25mg/5ml bottle 37g

Composition

Composition per 5 ml:

Active ingredient:  

umifenovir (umifenovir hydrochloride monohydrate-25.88 mg),

(in terms of umifenovir hydrochloride — 25.00 mg);

excipients:  

sodium chloride — 26,85 mg,

maltodextrin (Kleptuza of Lineups) — 750,00 mg,

sucrose (sugar) — 840,42 mg,

silicon dioxide colloid (Aerosil) — 24,60 mg,

titanium dioxide — 25,00 mg,

starch pregelatinization (type PA5PH) — 129,50 mg

sodium benzoate — 9,25 mg,

the banana flavor — of 12.40 mg,

cherry flavor — 6,10 mg.

Pharmacological action

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 — pathogens of acute respiratory viral infections associated with severe acute respiratory syndrome (SARS), rhinovirus (Rhinovirus), adenovirus (Adenovirus), respiratory 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 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.

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 taking the drug at a dose of 200 mg of umifenovir is reached in 1 hour, the volume of distribution (Vd) is 1432 liters.

It is metabolized in the liver. The average elimination half-life is 11 hours. About 40% is excreted unchanged, mainly in the bile (38.9%) and, in a small amount, in the kidneys (0.12%). During the first day,90% of the administered dose is removed.

Indications

-Prevention and treatment of influenza A and B, other acute respiratory viral infections in children from 2 years of age and adults;

– complex therapy of acute intestinal infections of rotavirus etiology in children from 2 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. The use of Arbidol® in the first trimester of pregnancy is contraindicated. In the second and third trimester of pregnancy, Arbidol®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 into 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.

Up to 2 years old. First trimester of pregnancy. Breast-feeding period.

Sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

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 – pruritus, rash, angioedema, urticaria; very rarely-anaphylactic 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.

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

Inside, before meals.

Preparation of the suspension. In the bottle containing the powder, add 30 ml (or about 2/3 of the volume of the bottle) of boiled and cooled to room temperature water. Close the bottle with a lid, turn it over and shake it thoroughly until a homogeneous suspension is obtained. Add the boiled and cooled water to a volume of 100 ml (up to the label on the bottle) and shake again. Before each dose, shake the contents of the bottle thoroughly until a homogeneous suspension is obtained. Measure a single dose using the supplied measuring spoon.

Single dose (depending on age):

from 2 to 6 years – 10 ml (50 mg)

from 6 to 12 years – 20 ml (100 mg)

older than 12 years and adults – 40 ml (200 mg)

For children from 2 years of age and adults:

Non-specific prevention during the epidemic of influenza and other acute respiratory viral infections – in a single dose 2 times a week for 3 weeks.

Non-specific prophylaxis in direct contact with patients with influenza and other acute respiratory viral infections – in a single dose once a day for 10-14 days.

Treatment of influenza and other acute respiratory viral infections with an uncomplicated course – in a single dose 4 times a day (every 6 hours) for 5 days.

For children from 2 years of age:

Complex therapy of acute intestinal infections of rotavirus etiology – in a single dose 4 times a day (every 6 hours) for 5 days.

For non-specific prevention and treatment of severe acute respiratory syndrome (SARS):  For non-specific prevention of SARS (in contact with a patient) in children from 6 years of age and adults:  children from 6 to 12 years — 20 ml (100 mg), children over 12 years and adults-40 ml (200 mg) once a day for 12-14 days. For the treatment of SARS in children from 12 years of age and adults:  children over 12 years of age and adults — 40 ml (200 mg) 2 times a day for 8-10 days.

Special instructions

When prescribing to patients with diabetes mellitus, as well as with a low-calorie diet, it should be taken into account that the suspension contains sucrose (0.8 g/5 ml or 0.06 XE/5 ml).

It is necessary to follow the scheme recommended in the instructions and the duration of taking the drug. If you miss taking 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 the severity of the symptoms of the disease, including a high temperature (38 °C or more), persists after the use of Arbidol®for three days in the treatment of influenza and other acute respiratory viral infections, then you should consult a doctor to assess the validity of taking the drug.

When calculating the amount of suspension required for the course of use, it is necessary to take into account the shelf life of the prepared suspension, which is 10 days. Two vials of Arbidol®will be required for the course of admission for the indication of non-specific prevention during the epidemic of influenza and other acute respiratory viral infections in children from 2 to 6 years of age.

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. ).

Storage conditions

Store at a temperature not exceeding 25 °C. Store the prepared suspension at a temperature not exceeding 8 °C (in the refrigerator). Do not freeze it. Keep out of reach of children.

Shelf

life is 2 years. Prepared suspension – 10 days in a tightly closed bottle.

Active ingredient

Umifenovir

Dosage form

suspension for oral use

Purpose

Children over 2 years old, For adults

Indications

for acute respiratory viral infections, Colds, Flu, Flu and cold prevention