Arbidol tab. p / o film 50mg # 20

Release form, composition and packaging

Tablets, film-coated from white to white with a creamy shade, round, biconvex

at the break - from white to white with a greenish-yellowish or cream shade.

1 tab.

umifenovir hydrochloride monohydrate

51.75 mg,

which corresponds to the content of umifenovir hydrochloride

50 mg

potato starch - 31.86 mg, microcrystalline cellulose - 57.926 mg, povidone K30 (Kollidon 30) - 8.137 mg, calcium stearate - 0.535 mg, croscarmellose sodium (primellose) - 1.542 mg.

Shell composition: hypromellose (hydroxypropyl methylcellulose) - 4.225 mg, titanium dioxide - 1.207 mg, macrogol 4000 (polyethylene glycol 4000) - 0.471 mg, polysorbate 80 (tween 80) - 0.097 mg

or Aquarius PrimeBAP318008 White (Aquarius PrimeBAP318008 White) - 6 mg [hypromellose (hydroxypropyl methylcellulose) - 4.225 mg, titanium dioxide - 1.207 mg, macrogol 4000 (polyethylene glycol 4000) - 0.471 mg, polysorbate 80 (tween 80) - 0.097 mg].

10 pieces.

- contour cell packaging (1) - cardboard packs.

10 pieces.

- contour cell packages (2) - cardboard packs.

10 pieces.

- contour cell packages (3) - cardboard packs.

10 pieces. - contour cell packaging (4) - cardboard packs. Pharmachologic effect. Antiviral drug. Specifically suppresses in vitro influenza A and B viruses (Influenza virus A, B), including highly pathogenic subtypes A (H1N1) pdm09 and A (H5N1), as well as other viruses that cause ARVI (Coronavirus 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 (fusion), 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, increases the body's resistance to viral infections.It has interferon-inducing activity - in a study on mice, the induction of interferons was noted already after 16 hours, and high titers of interferons remained in the blood up to 48 hours after administration. Stimulates cellular and humoral reactions of immunity: increases the number of lymphocytes in the blood, especially 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 cells (NK cells).without affecting the level of T-suppressors (CD8), it normalizes the immunoregulatory index, stimulates the phagocytic function of macrophages and increases the number of natural killer cells (NK cells).without affecting the level of T-suppressors (CD8), it normalizes the immunoregulatory index, stimulates the phagocytic function of macrophages and increases the number of natural killer cells (NK cells).

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

Refers to low-toxic drugs (4 g / kg).

Does not have any negative effects on the human body when taken orally in recommended doses.

Pharmacokinetics.

Absorption and distribution

It is quickly absorbed and distributed to organs and tissues.

in blood plasma when taken at a dose of 50 mg, it is achieved after 1.2 hours, at a dose of 100 mg - after 1.5 hours.

Metabolism and excretion

Metabolized in the liver.

T1 / 2 is 17-21 hours. About 40% is excreted unchanged, mainly with bile (38.9%) and a small amount by the kidneys (0.12%).

During the first day, 90% of the administered dose is removed.

Indications for use prevention and treatment in adults and children: influenza A and B, other acute respiratory viral infections

complex therapy of acute intestinal infections of rotavirus etiology in children over 3 years old

complex therapy of chronic bronchitis, pneumonia and recurrent herpes infection

prevention of postoperative infectious complications.

Contraindications for use hypersensitivity to umifenovir or any

Name ENG

ARBIDOL

Clinical and pharmacological group

Antiviral drug

ATX code

Umifenovir

Dosage

50mg

Structure

1 tablet contains arbidol (ethyl ester of 6-bromo-5-hydroxy-1-methyl-4-dimethylaminomethyl-2-phenylthiomethylindole-3-carboxylic acid hydrochloride monohydrate) 50 mg

excipients: methylcellulose, potato starch, calcium stearate, stearic acid, sugar, polyvinylpyrrolidone, aerosil, basic magnesium carbonate, talc, titanium dioxide pigment, beeswax

Indications

Prevention and treatment in adults and children:

influenza A and B, SARS, severe acute respiratory syndrome (SARS), incl.

complicated by bronchitis and pneumonia

secondary immunodeficiency states

complex therapy of chronic bronchitis, pneumonia and recurrent herpes infection.

Prevention of postoperative infectious complications and normalization of the immune status.

As part of the complex therapy of acute intestinal infections of rotavirus etiology in children over 3 years old.

Contraindications

children under 3 years old

hypersensitivity to drug components.

INN / Active ingredient

umifenovir hydrochloride

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 3 years

Specifications

Category

Antiviral

,

Antimicrobial agents

Scope of the medicinal product

General

Release form

Tablet

Manufacturer country

Russia

Package quantity, pcs

twenty

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

OTCPharm

The amount of the dosage form in the primary package

10 pieces.

Primary packaging type

Blister

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Antiviral agent

Anatomical and therapeutic characteristics

J05AX13 Umifenovir

Dosage form

Film-coated tablets

Expiration date in days

1095

The target audience

Children

Package weight, g

ten

Mode of application

:

Inside, before meals. For the prevention of influenza and acute respiratory viral infections (in contact with patients) - adults and children over 12 years old - 200 mg / day, children from 6 to 12 years old - 100 mg / day, children from 2 to 6 years old - 50 mg / day. The course is 10-14 days. < br> During the period of influenza epidemic, seasonal increase in the incidence of ARVI, for the prevention of exacerbation of chronic bronchitis and recurrence of herpetic infection for adults and children over 12 years of age, the drug is prescribed in a single dose of 200 mg, children from 6 to 12 years old - 100 mg, children from 2 to 6 years old - 50 mg. The drug is taken 2 times a week for 3 weeks. < br> For the treatment of influenza and other acute respiratory viral infections without complications, the drug is prescribed for adults and children over 12 years old 200 mg 4 times / day (every 6 hours), for children from 6 to 12 years old - 100 mg 4 times / day (every 6 hours), from 2 to 6 years - 50 mg 4 times / day (every 6 hours). Course - 5 days. < br> For the treatment of influenza and other acute respiratory viral infections, complicated by bronchitis, pneumonia, adults and children over 12 years old appoint 200 mg 4 times / day (every 6 hours) for 5 days, then switch to taking 200 mg 1 time per week for 4 weeks. For children from 6 to 12 years old, a single dose of the drug is 100 mg, from 2 to 6 years old - 50 mg < br> the drug is taken 4 times / day (every 6 hours) for 5 days, then they switch to taking the drug once a week for 4 weeks. < br> In chronic bronchitis and recurrent herpes infection, adults and children over 12 years old are prescribed the drug according to 200 mg 4 times / day (every 6 hours) children from 6 to 12 years old, 100 mg 4 times / day (every 6 hours) from 2 to 6 years old - 50 mg 4 times / day (every 6 hours) for 5-7 days then a single dose 2 times a week for 4 weeks. < br> As part of the complex therapy of acute intestinal infections of rotavirus etiology for children from 2 to 6 years old - 50 mg from 6 to 12 years old - 100 mg, over 12 years old - 200 mg 4 times / day (every 6 hours) for 5 days. < br> For the prevention of postoperative infectious complications for children from 2 to 6 years old - 50 mg from 6 to 12 years old - 100 mg, over 12 years old and adults - 200 mg is prescribed in a dose of 200 mg 2 days before the operation, then on the second and fifth days after the operation.

Dosage (volume) of the substance in the preparation

:

umifenovir (as umifenovir hydrochloride monohydrate) 50 mu

Information on technical characteristics, delivery set, country of manufacture