Afludol 100 mg 40 tablets, film-coated

Indications

- Prevention and treatment in adults and children: influenza A and B, other acute respiratory viral infections (ARVI).
Comprehensive therapy for recurrent herpes infection.
- Prevention of postoperative infectious complications.

Orally, before meals.

Single dose (depending on age):

Age
Single dose of the drug

From 3 to 6 years
50 mg (1 tablet of 50 mg)

From 6 to 12 years
100 mg (2 tablets of 50 mg or 1 tablet of 100 mg)

Older than 12 years and adults
200 mg (4 tablets of 50 mg or 2 tablets of 100 mg)

Dosing regimen (depending on age)

Indication
Dosing schedule

In children from 3 years and adults:

Non-specific prevention during an epidemic of influenza and other
ARVI
at a single dose 2 times a week for 3 weeks

Non-specific prevention with direct contact with
patients with influenza and other ARVI
at a single dose once a day for 10-14 days

Treatment of influenza and other ARVI
at a single dose 4 times a day (every 6 hours) for 5 days

Complex therapy of recurrent herpes infection
at a single dose 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 infectious complications
at a single dose 2 days before surgery, then on days 2 and 5 after surgery

The drug should be started at the onset of the first symptoms of influenza and other ARVI, preferably no later than 3 days from the onset of the illness.

If after taking Aflyudol® for three days in the treatment of influenza and other ARVI the severity of symptoms persists, including high fever (38 °C and above), it is necessary to consult a doctor to assess the justification for taking the drug.

Use the drug only according to the indications, method of administration, and doses specified in the instructions.

In the treatment of influenza and ARVI, concomitant symptomatic therapy is possible, including the use of antipyretic agents, mucolytics, and local vasoconstrictors.

Section: Composition

1 film-coated tablet, 100 mg contains:
Active ingredient: umifenovir hydrochloride monohydrate, calculated as umifenovir hydrochloride – 100 mg.
Excipients: lactose monohydrate, povidone K-25 (medium molecular weight polyvinylpyrrolidone), crospovidone, colloidal silicon dioxide (aerosil), magnesium stearate.
Excipients of the coating: Opadry® II white (OY-L-28900) [lactose monohydrate, hypromellose, titanium dioxide, macrogol/PEG].

Round biconvex tablets coated with a film, white or almost white in color. In a cross-section, the core is white to white with a greenish-yellow or brownish tint. Surface roughness of the tablets is permissible.

• hypersensitivity to umifenovir or to any component of the drug;

• children under 3 years of age (for the 50 mg dosage);

• children under 6 years of age (for the 100 mg dosage);

• first trimester of pregnancy;

• breastfeeding period;

• lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
With caution
Second and third trimesters of pregnancy.

Special instructions

It is necessary to follow the recommended scheme and duration of the drug intake as stated in the instructions. In case of missing a dose of the drug, the missed dose should be taken as soon as possible, and the course of the drug intake should continue according to the established scheme.
If, after using the drug Aflyudol® for three days in the treatment of influenza and other ARVI, the severity of the disease symptoms persists, including high fever (38 °C and above), it is necessary to consult a doctor to assess the justification for taking the drug.
Excipients
Patients with lactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this drug.

Section: Side Effects

The drug Aflyudol® is classified as a low-toxicity medication and is usually well tolerated. Side effects occur rarely, are typically mild or moderate in severity, and are transient in nature.
The frequency of adverse reactions was determined according to the World Health Organization classification: very common (> 1/10); common (> 1/100 and 1/1000 and 1/10000 and < 1/1000); very rare (< 1/10000); frequency unknown (cannot be established from the available data). Immune system disorders: rare - allergic reactions. If any of the side effects listed in the instructions worsen, or if you notice any other side effects not mentioned in the instructions, inform your doctor.OverdoseNot noted.InteractionWhen prescribed with other medications, no negative effects have been noted. Special clinical studies dedicated to the investigation of interactions of the drug Aflyudol® with other medications have not been conducted. Information regarding the presence of undesirable interactions with antipyretics, mucolytics, and local vasoconstrictors in clinical research conditions has not been identified.

Pharmacodynamics

Antiviral agent. Specifically inhibits in vitro influenza viruses A and B (Influenza virus A, B), including highly pathogenic subtypes A(H1N1)pdm09 and A(H5N1), as well as other viruses that cause acute respiratory viral infections (ARVI) (coronavirus (Coronavirus)), associated with severe acute respiratory syndrome (SARS), rhinovirus (Rhinovirus), adenovirus (Adenovirus), respiratory syncytial virus (Pneumovirus), and parainfluenza virus (Paramyxovirus).

In in vitro studies, it specifically inhibits the SARS-CoV-2 virus, which causes the new coronavirus infection (COVID-19). The EC50 (half-maximal effective concentration) in Vero E6 cells is 4.11 μmol, which corresponds to 2.11 μg/ml. The clinical significance of this requires further study.
By the mechanism of antiviral action, it belongs to fusion inhibitors, interacts with the virus's hemagglutinin, and prevents the fusion of the virus's lipid envelope with cell membranes. It has a moderate immunomodulatory effect, increasing the body's resistance to viral infections. It possesses interferon-inducing activity - in a study on mice, interferon induction was noted as early as 16 hours, and high levels of interferons were maintained in the blood for 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).
The therapeutic efficacy in viral infections is manifested in the reduction of the duration and severity of the disease and its main symptoms, as well as in the decrease in the frequency of complications associated with viral infection and exacerbations of chronic bacterial diseases.
In the treatment of influenza or ARVI in adult patients, clinical studies have shown that the effect of umifenovir in adult patients is most pronounced in the acute period of the disease and is manifested by a reduction in the duration of symptom resolution, a decrease in the severity of disease manifestations, and a reduction in the duration of virus elimination.
Therapy with umifenovir leads to a higher frequency of symptom relief 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 exceeds the corresponding indicator in the placebo group by more than 5 times.
A significant effect of umifenovir on the rate of influenza virus elimination has been established, which, in particular, was manifested by a decrease in the frequency of RNA virus detection on the 4th day.
It belongs to low-toxicity drugs (LD50 > 4 g/kg). It does not have any negative effects on the human body when taken orally at recommended doses.

Section: Pharmacokinetics

Quickly absorbed and distributed to organs and tissues. The maximum concentration in plasma after taking a dose of 50 mg is reached in 1.2 hours, and in a dose of 100 mg - in 1.5 hours. Metabolized in the liver. The half-life is on average 17-21 hours. About 40% is excreted unchanged, mainly with bile (38.9%) and in a small amount by the kidneys (0.12%). Within the first day, 90% of the administered dose is excreted.