Lavomax^® NEO (Tablets) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Chemopharm, LLC (Russia)

ATC Code

J05AX19 (Tilorone)

Active Substance

Tilorone (Rec.INN registered by WHO)

Dosage Form

Lavomax® NEO

Film-coated tablets, 125 mg: 3, 4, 6, 8, 10, 12, or 20 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow in color, round, biconvex, with an orange core on the cross-section.

Excipients: potato starch, microcrystalline cellulose, povidone K30, croscarmellose sodium, calcium stearate.

Shell composition: polyvinyl alcohol, titanium dioxide, macrogol 4000, quinoline yellow dye, sunset yellow FCF (E110), yellow iron oxide, talc.

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

Clinical-Pharmacological Group

Antiviral immunostimulating drug – inducer of interferon formation

Pharmacotherapeutic Group

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

Pharmacological Action

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 the administration of tilorone 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, depending on the dose, 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 (ARVI), 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 the complex therapy of influenza and other acute respiratory viral infections (ARVI), herpetic infection.

Prophylaxis of influenza and other acute respiratory viral infections (ARVI).

ICD codes

Dosage Regimen

Administer orally. Swallow the tablet whole with water. Take after a meal.

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

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

For treatment of herpetic infection in adults: take 125 mg once on the first two days. Then take 125 mg every 48 hours. The total course dose is 1.25 g to 2.5 g (10 to 20 tablets).

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

Strictly adhere to the 48-hour interval between doses during treatment courses. Do not use in children under 18 years of age. The duration of therapy is determined by the physician based on the clinical situation.

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

Can be used in children according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions for tilorone preparations 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.