Tilorone 60 mg 10 tablets, film-coated

As part of combination therapy:
In children aged 7 to 18 years:
• treatment of influenza and other acute respiratory viral infections (ARVI).
In adults aged 18 years and older:
• treatment of influenza and other ARVI;
• treatment of herpes infection.
Prevention of influenza and other ARVI in adults.

The medication is taken orally, after meals.
Dosage regimen
Adults
For the treatment of influenza and other acute respiratory viral infections (ARVI) - 125 mg per day for the first 2 days of treatment, then 125 mg every 48 hours. Total course - 750 mg (6 tablets).
For the prevention of influenza and other ARVI - 125 mg once a week for 6 weeks. Total course - 750 mg (6 tablets).
For the treatment of herpes infection - for the first two days, 125 mg, then every 48 hours, 125 mg. Total course dose - 1.25-2.5 g (10-20 tablets).
In the case of persistent symptoms of influenza and other ARVI for more than 4 days, the patient should consult a doctor.
Children
Children aged 7 to 18 years
For uncomplicated forms of influenza and other ARVI - 60 mg once a day on the 1st, 2nd, and 4th days of treatment. Total course dose - 180 mg (3 tablets).
As indicated: treatment of herpes infection, prevention of influenza and other ARVI in children under 18 years is not applicable (see the section "Indications for use").
Children under 7 years
The medication is contraindicated in children under 7 years (see the section "Contraindications").
The safety and efficacy of Tilorone in children aged 0 to 7 years have not been established. Data is unavailable.

1 tablet 60 mg contains:
Active ingredient: tilorone dihydrochloride (tilorone) - 60.00 mg.
Excipients: microcrystalline cellulose (MCC-101) - 112.90 mg; croscarmellose sodium - 7.60 mg; povidone-K25 - 7.60 mg; magnesium stearate - 1.90 mg.
Coating composition: hypromellose - 3.40 mg; titanium dioxide - 1.16 mg; macrogol-4000 - 0.84 mg; iron oxide yellow dye - 0.60 mg.

Round, biconvex film-coated tablets ranging in color from light yellow to brownish-yellow. On cross-section, the tablet shows a film coating and an orange core, with permissible specks of white or orange of various shades.

• hypersensitivity to tilorone and other components of the drug;
• pregnancy and breastfeeding;
• pediatric age under 7 years (for the 60 mg dosage), pediatric age under 18 years (for the 125 mg dosage).

The frequency of side effects is presented in the following gradation: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1/10000); frequency unknown (cannot be estimated based on available data).Immune system disorders Frequency unknown: allergic reactions.Gastrointestinal disorders Frequency unknown: dyspeptic phenomena.General disorders and administration site reactions Frequency unknown: transient chills.If any of the side effects listed in the instructions worsen, or if you notice any other side effects not listed in the instructions, inform your doctor.Cases of tilorone overdose are unknown.Compatible with antibiotics and traditional medications for the treatment of viral and bacterial diseases. No clinically significant interaction of tilorone with antibiotics or traditional medications for viral and bacterial diseases has been identified.

Low molecular weight synthetic interferon inducer that stimulates the production of all types of interferons (alpha, beta, gamma, and lambda) in the body. The main producers of interferon in response to the administration of tilorone are intestinal epithelial cells, hepatocytes, T-lymphocytes, neutrophils, and granulocytes. After oral administration, the peak production of interferon is observed in the sequence of intestine - liver - blood within 4-24 hours. Tilorone has immunomodulatory and antiviral effects.

According to experimental studies, after a single oral administration of tilorone at a dose equivalent to the maximum daily dose for humans, the maximum concentration of lambda interferon in lung tissue is detected after 24 hours, and alpha interferon after 48 hours. The induction of lambda interferon in lung tissue contributes to increased antiviral protection of the respiratory tract during influenza and other respiratory viral infections.

In human leukocytes, it induces the synthesis of interferon. It stimulates bone marrow stem cells, enhances antibody formation depending on the dose, reduces the degree of immunosuppression, and restores the ratio of T-suppressors to T-helpers. It is effective against various viral infections, including influenza viruses, other acute respiratory viral infections (ARVI), hepatitis viruses, and herpesviruses. The mechanism of antiviral action is associated with the inhibition of the translation of virus-specific proteins in infected cells, resulting in the suppression of virus reproduction.

Absorption
After oral administration, tilorone is rapidly absorbed from the gastrointestinal tract. The bioavailability is 60%.
Distribution
Approximately 80% of tilorone binds to plasma proteins.
Biotransformation
Tilorone is not subject to biotransformation and does not accumulate in the body.
Elimination
Tilorone is excreted almost unchanged through the intestines (70%) and through the kidneys (9%). The half-life is 48 hours.