Flogardin^® (Tablets) Instructions for Use

ATC Code

J05AX19 (Tilorone)

Active Substance

Tilorone (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antiviral and immunomodulatory drug. Interferon synthesis inducer

Pharmacotherapeutic Group

Systemic antiviral agents; direct-acting antiviral agents; other antiviral agents

Pharmacological Action

A low-molecular-weight inducer of endogenous interferon. It is a synthetic compound of the aromatic series, belonging to the class of fluorenones. It stimulates the production of alpha, beta, gamma, and lambda interferons in the body.

The main structures producing interferon in response to tilorone administration are intestinal epithelial cells, hepatocytes, T-lymphocytes, and granulocytes. Tilorone has immunomodulatory and antiviral effects.

Induction of lambda interferon in lung tissue helps to enhance the antiviral protection of the respiratory tract during influenza and other respiratory viral infections.

In human leukocytes, it induces interferon synthesis. It stimulates bone marrow stem cells, dose-dependently enhances antibody production, reduces the degree of immunosuppression, and restores the ratio of T-suppressors and T-helpers.

It is effective against various viral infections, including influenza viruses, other acute respiratory viral infections, hepatitis viruses, and herpes viruses. 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.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract. Bioavailability is 60%. Plasma protein binding is about 80%.

Tilorone is excreted almost unchanged through the intestines (70%) and through the kidneys (9%). The T_1/2 is 48 hours.

Tilorone does not undergo biotransformation and does not accumulate in the body.

Indications

As part of complex therapy for influenza and other acute respiratory viral infections, herpetic infection.

Prevention of influenza and other acute respiratory viral infections.

ICD codes

Dosage Regimen

Administer Flogardin^® tablets orally with a sufficient amount of water.

For treatment of influenza and other acute respiratory viral infections (ARVI) in adults: take 125 mg on the first day. On the second and third days, take 125 mg once every 48 hours. The total course dose is 750 mg (6 tablets).

For prevention of influenza and ARVI in adults: take 125 mg once weekly for 6 weeks. The total prophylactic course dose is 750 mg (6 tablets).

For treatment of herpetic infection in adults: take 125 mg on the first two days. Then, take 125 mg once every 48 hours for the subsequent 18 days. The total course dose is 2.5 grams (20 tablets).

Do not exceed the recommended dosage. The maximum single dose is 125 mg. The maximum weekly dose for prophylaxis is 125 mg.

Initiate therapy at the first signs of illness for optimal efficacy. Adhere strictly to the specified dosing schedule to maintain effective drug concentrations.

For any deviations from the standard regimen, follow the precise instructions provided by the attending physician.

Adverse Reactions

Possible allergic reactions, dyspeptic symptoms, short-term chills.

Contraindications

Hypersensitivity to tilorone; pregnancy, lactation (breastfeeding); children’s age – depending on the dosage form.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding). If use during lactation is necessary, the issue of discontinuing breastfeeding should be considered.

Pediatric Use

Use in children is possible according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the tilorone drug labels regarding contraindications for the use of specific tilorone dosage forms in children of different ages.

Special Precautions

It is not recommended to use Tilorone in doses exceeding the recommended ones to avoid possible short-term depletion of immunocompetent cells.

Drug Interactions

Tilorone is compatible with antibiotics and traditional treatments for viral and bacterial diseases.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.