Lavomax^® (Tablets) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Contact Information

NIZHPHARM group of companies (Russia)

ATC Code

J05AX19 (Tilorone)

Active Substance

Tilorone (Rec.INN registered by WHO)

Dosage Form

Lavomax®

Coated tablets, 125 mg: 3, 4, 6, 8, 10, 12, or 20 pcs.

Dosage Form, Packaging, and Composition

Coated tablets from yellow to orange in color, round; the tablet core is orange in color.

Excipients: magnesium hydroxycarbonate (heavy magnesium carbonate), povidone K30, calcium stearate.

Shell composition: sucrose, povidone K17, copovidone, magnesium hydroxycarbonate (light magnesium carbonate), titanium dioxide, colloidal silicon dioxide (aerosil A-380), quinoline yellow dye, sunset yellow FCF dye, macrogol 6000, beeswax, liquid paraffin, talc.

3 pcs. – contour cell packs (1) – cardboard packs.
3 pcs. – contour cell packs (2) – cardboard packs.
4 pcs. – contour cell packs (1) – cardboard packs.
4 pcs. – contour cell packs (2) – cardboard packs.
6 pcs. – contour cell packs (1) – cardboard packs.
6 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.

Clinical-Pharmacological Group

Antiviral immunostimulating drug – inducer of interferon formation

Pharmacotherapeutic Group

Antiviral immunostimulating agent – inducer of interferon formation

Pharmacological Action

A 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 tilorone administration are intestinal epithelial cells, hepatocytes, T-lymphocytes, neutrophils, and granulocytes. After oral administration, the peak interferon production is detected in the sequence intestine – liver – blood within 4-24 hours. Tilorone has an immunomodulatory and antiviral effect.

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

Induces interferon synthesis in human leukocytes. 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. Effective against various viral infections, including influenza viruses, other acute respiratory viral infections, 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.

Pharmacokinetics

Absorption

After oral administration of the drug, Tilorone is rapidly absorbed from the gastrointestinal tract. Bioavailability is 60%.

Distribution

Plasma protein binding is about 80%.

Metabolism and Excretion

Tilorone does not undergo biotransformation and does not accumulate in the body. It is excreted almost unchanged in feces (about 70%) and by the kidneys (about 9%). T_1/2 is 48 hours.

Indications

As part of complex therapy in adults

• Treatment of influenza and other acute respiratory viral infections;
• Treatment of herpes infection.

Prevention of influenza and other acute respiratory viral infections in adults.

ICD codes

Dosage Regimen

The drug is taken orally, after meals.

For the treatment of influenza and other acute respiratory viral infections – 125 mg/day for the first 2 days of treatment, then 125 mg every 48 hours. The course dose is 750 mg (6 tablets).

For the prevention of influenza and other acute respiratory viral infections – 125 mg once a week for 6 weeks. The course dose is 750 mg (6 tablets).

For the treatment of herpes infection – 125 mg for the first two days, then 125 mg every 48 hours. The course dose is 1.25-2.5 g (10-20 tablets).

When treating influenza and other acute respiratory viral infections, if symptoms persist for more than 4 days, you should consult a doctor.

Adverse Reactions

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

If any of the listed side effects worsen, or the patient notices any other side effects, they should inform their doctor.

Contraindications

• Pregnancy;
• Lactation period (breastfeeding);
• Children under 18 years of age;
• Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption (the drug contains sucrose);
• Hypersensitivity to tilorone or other components of the drug.

Use in Pregnancy and Lactation

The use of the drug during pregnancy is contraindicated. If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

Effect on the ability to drive vehicles and machinery

The use of the drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Cases of Lavomax^® overdose are unknown.

Drug Interactions

Compatible with antibiotics and means of traditional treatment of viral and bacterial diseases.

No clinically significant interaction of Lavomax^®* with antibiotics, means of traditional treatment of viral and bacterial diseases, or alcohol has been identified.

Storage Conditions

The drug should be stored out of the reach of children, in a dry, light-protected place at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 2 years.

Dispensing Status

The drug is available without a prescription.

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.