Description
Release form
Powder for oral suspension
packaging 37 g bottle
Pharmacological action
Antiviral. Specifically suppresses in vitro influenza A and B viruses (Influenzavirus A, B), including the highly pathogenic subtypes A (H1N1) pdm09 and A (H5N1), as well as other ARVI pathogens (Coronavirus) associated with severe acute respiratory syndrome ( SARS), rhinovirus (Rhinovirus), adenovirus (Adenovirus), respiratory syncytial virus (Pneumovirus) and parainfluenza virus (Paramyxovirus)).
According to the antiviral mechanism of action, it belongs to fusion (fusion) inhibitors, interacts with the hemagglutinin of the virus and prevents the fusion of the lipid membrane of the virus and cell membranes.
Possesses interferon-inducing activity – in a mouse study, interferon induction was observed after 16 hours, and high interferon titers remained in the blood until 48 hours after administration. Stimulates cellular and humoral immunity reactions: 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 killers (NK cells).
Therapeutic efficacy in 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 (LD50> 4 g / kg). It does not have any negative effects on the human body when administered orally in recommended doses.
Pharmacokinetics. It is rapidly 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 after 1 hour, the volume of distribution (Vd) is 1432 liters. Metabolized in the liver. The elimination half-life averages 11 hours.
About 40% is excreted unchanged, mainly with bile (38.9%) and, in a small amount, by the kidneys (0.12%). During the first day, 90% of the administered dose is excreted.
Indications
– prevention and treatment of influenza A and B, other acute respiratory viral infections in children from 2 years old and adults
– complex therapy of acute intestinal infections of rotavirus etiology in children from 2 years old
– nonspecific prevention of severe acute respiratory syndrome (SARS) in children from 6 years old and adults
– treatment of severe acute respiratory syndrome (SARS ) in children over 12 years old and adults.
Contraindications
Hypersensitivity to umifenovir or any component of the drug.
Age up to 2 years, age up to 6 years (according to indications of non-specific prevention of SARS) age up to 12 years (according to indications, treatment of SARS).
Sucrose / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.
Pregnancy and lactation
The use of Arbidol ® during pregnancy is contraindicated.
It is not known whether the active substance of the drug Arbidol ® or its metabolites passes into breast milk in women during lactation.
If you need to use Arbidol ®, you should stop breastfeeding.
Special instructions
When prescribing to patients with diabetes mellitus, as well as with a low-calorie diet, it must be borne in mind that the suspension contains sucrose (0.8 g / 5 ml or 0.06 XE / 5 ml).
It is necessary to observe the recommended schedule and the duration of 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 begun.
When calculating the amount of suspension required for a course of administration, the Expiration of the prepared suspension must be taken into account, which is 10 days. For the course of admission, if indicated, non-specific prophylaxis during the period of the flu epidemic and other acute respiratory viral infections in children from 2 to 6 years old will require two bottles of Arbidol ®.
Influence on the ability to drive vehicles and mechanisms
Does not show central neurotropic activity and can be used in medical practice in people of various professions, including requiring increased attention and coordination of movements (drivers of transport, operators, etc.).
Composition
5 ml composition:
active substance:
umifenovir (ufifenovir hydrochloride monohydrate – 25.88 mg),
remeat (based on 25, 00 mg)
excipients:
sodium chloride – 26.85 mg,
maltodextrin (Kleptose Linecaps) – 750.00 mg,
sucrose (sugar) – 840.42 mg,
silicon dioxide colloidal (aerosil) – 24.60 mg,
titanium dioxide – 25.00 mg,
pregelatinized starch (type PA5PH) – 129.50 mg,
sodium benzoate – 9.25 mg,
banana flavor – 12.40 mg,
cherry flavor – 6.10 mg .
Dosage and administration
Inside, before meals.
suspension preparation.
Add 30 ml (or up to about 2/3 of the volume of the vial) of boiled and cooled water to room temperature in a bottle containing powder. Close the bottle cap, turn over and shake thoroughly until a homogeneous suspension. Add boiled and chilled water to a volume of 100 ml (to the mark on the vial) and shake again. Before each dose, shake the contents of the vial thoroughly until a homogeneous suspension is obtained. Measure a single dose using the attached measuring spoon.
Single dose (depending on age):
from 2 to 6 years old – 10 ml (50 mg)
from 6 to 12 years old – 20 ml (100 mg)
over 12 years old and adults – 40 ml (200 mg)
In children from 2 years old and adults:
Nonspecific prevention during the period of 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 in uncomplicated course – in a single dose 4 times a day (every 6 hours) for 5 days.
In children from 2 years:
Combined 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 prophylaxis and treatment of severe acute respiratory syndrome (SARS):
For non-specific prevention of SARS (in contact with the patient) in children from 6 years old and adults:
for children from 6 to 12 years old – 20 ml (100 mg), children over 12 years old and adults – 40 ml (200 mg) once a day for 12-14 days.
For the treatment of SARS in children from 12 years old and adults:
for children over 12 years old and adults – 40 ml (200 mg) 2 times a day for 8-10 days.
Side effects
Allergic reactions: rarely (with a frequency of at least 1/10000, but less than 1/1000) – skin itching, rash, angioedema, urticaria very rarely (with a frequency of less than 1/10000) – anaphylactic reactions.
If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.
Drug Interactions
No adverse effects were observed with other drugs.
Overdose
Not noted.
Storage conditions
Do not store above 25 ° C.
Store the reconstituted suspension at a temperature not exceeding 8 ° C (in the refrigerator).
Do not freeze.
Keep out of the reach and sight of children.
Shelf life
Powder for the preparation of suspension for oral administration – 2 years.
Prepared suspension – no more than 10 days.
Do not use after the expiration date printed on the package.
Deystvuyushtee substance
Umifenovir
Conditions for drugstore from
Without a prescription
Formulation
oral suspension
Prescribing
Prescribing
For adults, Children older 2 years old
Pharmstandard-Leksredstva, Russia
