Amixin tablets 0.125 (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

Antiviral immunostimulating agent

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 an immunomodulatory and antiviral effect.

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

In human leukocytes, it induces interferon synthesis. It stimulates bone marrow stem cells, enhances antibody production in a dose-dependent manner, 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%). 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

Take orally after a meal. Do not exceed the recommended dosage.

For treatment of influenza and other acute respiratory viral infections in adults: take 125 mg (one 0.125 g tablet) on the first and second days of treatment. Thereafter, take 125 mg every 48 hours. The total course dose is 750 mg (6 tablets).

For prevention of influenza and other acute respiratory viral infections 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 and second days. Thereafter, take 125 mg every 48 hours. The total course dose is 1.25-2.5 g (10-20 tablets) as determined by the physician.

The duration of therapy and specific regimen are determined by the physician based on the clinical situation and severity of the condition.

Strictly adhere to the prescribed schedule of administration every 48 hours for treatment courses to maintain effective concentrations.

For prophylactic use, maintain the once-weekly interval. Do not use in children under 7 years of age. For children aged 7 years and older, use only the pediatric dosage form (60 mg tablets) according to its specific instructions.

Adverse Reactions

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

Contraindications

Hypersensitivity to tilorone; pregnancy, lactation (breastfeeding); childhood – 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.