Arbidol Maximum - instructions for use, dose, side effects, contraindications

Excipients: potato starch - 52.67 mg, cellulose microcrystalline - 11.20 mg, silicon dioxide colloid (aerosil) - 2.80 mg, povidone (collidon 25) - 7.73 mg, calcium stearate - 2.80 mg, croscarmellose sodium - 2.80 mg, weight of the contents of the capsule - 280 mg.

Capsules hard gelatinous №0:

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

Description:

Capsules hard gelatinous № 0 of white color. Contents of the capsule - a mixture containing granules and powder from white or white with a greenish-yellow or cream tint of color to light yellow or light yellow with a greenish tinge.

Pharmacotherapeutic group:Antiviral agent

ATX: & nbsp

J.05.A.X.13 Umifenovir

Pharmacodynamics:

An 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 ARVI (coronavirus (Coronavirus), associated with severe acute respiratory syndrome (SARS), rhinovirus (Rhinovirus), adenovirus (Adenovirus), respiratory syncytial virus (Pneumovirus) and parainfluenza virus (Paramyxovirus)). By the mechanism of antiviral action refers to the inhibitors of fusion (fusion), interacts with the hemagglutinin of the virus and prevents the fusion of the lipid envelope of the virus and cell membranes. Has a moderate immunomodulatory effect, increases the body's resistance to viral infections. Has interferon-inducing activity - in a study in mice, induction of interferons was observed already after 16 hours, and high titers of interferons remained in the blood up to 48 hours after administration. Stimulates cellular and humoral immunity reactions: increases the number of lymphocytes in the blood, in particular 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 killers (NKcells).

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

Refers to low-toxic drugs (LD₅₀>4 g / kg). Does not have any negative effects on the human body when administered orally at recommended doses.

Pharmacokinetics:Quickly absorbed and distributed to organs and tissues. The maximum concentration in blood plasma when taken in 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. Half-life is 17-21 hours. About 40% is excreted unchanged, mainly with bile (38.9%) and in an insignificant number of kidneys (0.12%). During the first day, 90% of the administered dose is withdrawn.

Indications:

Prevention and treatment in adults and children from the age of 12: influenza A and B, other acute respiratory infections (including those complicated by bronchitis, pneumonia), severe acute respiratory syndrome (SARS);

Complex therapy of acute intestinal infections of rotavirus etiology in children older than 12 years.

Complex therapy of chronic bronchitis, pneumonia and recurrent herpetic infection.

Prevention of postoperative infectious complications.

Contraindications:

Hypersensitivity to the drug, age 12 years.

Pregnancy and lactation:

In animal studies, no adverse effects were observed on the course of pregnancy, embryo and fetus development, labor and postnatal development.

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

In the second and third trimester of pregnancy, Arbidol® Maximum can only be used for the treatment and prevention of influenza, 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® Maximum penetrates into breast milk in women during lactation. If necessary, use Arbidol® Maximum should stop breastfeeding.

Dosing and Administration:

Inside, before eating. Single dose for adults and children over 12 years - 200 mg (1 capsule).

For non-specific prevention and treatment of influenza and other acute respiratory viral infections:

Nonspecific prevention of influenza and other acute respiratory infections:

- for nonspecific prophylaxis during the epidemic of influenza and other acute respiratory viral infections:

200 mg (1 capsule) 2 times a week for 3 weeks.

- with direct contact with patients with influenza and other SARS:

200 mg (1 capsule) once a day for 10-14 days.

Treatment of influenza and other SARS:

- in uncomplicated flow:

200 mg (1 capsule) 4 times a day (every 6 hours) for 5 days.

- with the development of complications (bronchitis, pneumonia, etc.):

200 mg (1 capsule) 4 times a day (every 6 hours) for 5 days then 1 single dose once a week for 4 weeks.

Combined therapy of acute intestinal infection rotavirus in children over 12 years:

- 200 mg (1 capsule) 4 times a day (every 6 hours) for 5 days.

For non-specific prophylaxis and treatment of severe acute respiratory syndrome (SARS):

For non-specific prevention of SARS (on contact with the patient):

- 200 mg (1 capsule) once a day for 12-14 days.

For the treatment of SARS:

200 mg (1 capsule) 2 times a day for 8-10 days.

In the complex therapy of chronic bronchitis, pneumonia and herpetic infection:

- 200 mg (1 capsule) 4 times a day (every 6 hours) for 5-7 days, then a single dose 2 times a week for 4 weeks.

Prevention of postoperative complications:

- 200 mg (1 capsule) for 2 days before the operation, then 2 and 5 days after the operation.

Side effects:

Rarely, allergic reactions.

Overdose:

Not checked.

Interaction:

In the appointment with other drugs, no negative effects were noted.

Effect on the ability to drive transp. cf. and fur:

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

Form release / dosage:

Capsules 200 mg.

Packaging:

10 capsules per contour cell packaging made of polyvinylchloride film and aluminum foil printed lacquered.

1 or 2 contour packs with instructions for use are placed in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002690

Date of registration:31.10.2014

Expiration Date:31.10.2019

The owner of the registration certificate:PHARMSTANDART-FORESTRY, OJSC PHARMSTANDART-FORESTRY, OJSC Russia

Manufacturer: & nbsp

PHARMSTANDART-FORESTRY, OJSC Russia

Information update date: & nbsp11.09.2017

Illustrated instructions

Instructions

Arbidol® Maximum (Arbidol® Maximum)