Amixin^® (Tablets) Instructions for Use

Marketing Authorization Holder

Otisipharm, JSC (Russia)

Manufactured By

Pharmstandard-Tomskkhimpharm OJSC (Russia)

Or

Pharmstandard-Lexredstva OJSC (Russia)

ATC Code

J05AX19 (Tilorone)

Active Substance

Tilorone (Rec.INN registered by WHO)

Dosage Forms

	Amixin®	Film-coated tablets, 60 mg: 6, 10, 12 or 20 pcs.
		Film-coated tablets, 125 mg: 6, 10, 12 or 20 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets orange in color, round, biconvex; orange on the cross-section, minor inclusions of orange or white color are allowed.

Excipients: potato starch, microcrystalline cellulose, povidone (kollidon 30), calcium stearate, croscarmellose sodium (primellose).

Shell composition hypromellose (hydroxypropyl methylcellulose), titanium dioxide, macrogol 4000 (polyethylene glycol 4000), polysorbate 80 (tween 80), quinoline yellow (E104), sicovit yellow-orange 85 (E110).

6 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
6 pcs. – polymer jars (1) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.

Film-coated tablets orange in color, round, biconvex; orange on the cross-section, minor inclusions of orange or white color are allowed.

Excipients: potato starch, microcrystalline cellulose, povidone (kollidon 30), calcium stearate, croscarmellose sodium (primellose).

Shell composition hypromellose (hydroxypropyl methylcellulose), titanium dioxide, macrogol 4000 (polyethylene glycol 4000), polysorbate 80 (tween 80), quinoline yellow (E104), sicovit yellow-orange 85 (E110).

6 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
6 pcs. – polymer jars (1) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.

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 synthetic interferon inducer that stimulates the production of alpha, beta, and gamma interferons in the body. The main structures producing interferon in response to tilorone administration are intestinal epithelial cells, hepatocytes, T-lymphocytes, neutrophils, and granulocytes. After oral administration of the drug, the maximum interferon production is determined in the sequence intestine-liver-blood within 4-24 hours. Amixin^® has an immunomodulatory and antiviral effect.

It induces interferon synthesis in human leukocytes. 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 those caused by influenza viruses, other pathogens of acute respiratory viral infections, hepatitis viruses, 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

Absorption

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

Distribution

Plasma protein binding is about 80%.

Metabolism and Elimination

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

Indications

In adults

• For the prevention and treatment of influenza and ARVI;
• For the treatment of viral hepatitis A, B, and C;
• For the treatment of herpetic infection;
• For the treatment of cytomegalovirus infection;
• As part of complex therapy for allergic and viral encephalomyelitis (including multiple sclerosis, leukoencephalitis, uveoencephalitis);
• As part of complex therapy for urogenital and respiratory chlamydia;
• As part of complex therapy for pulmonary tuberculosis.

In children over 7 years old

• For the treatment of influenza and ARVI.

ICD codes

Dosage Regimen

The drug is taken orally after meals.

In adults for nonspecific prophylaxis of viral hepatitis A the drug is prescribed at a dose of 125 mg once a week for 6 weeks. The course dose is 750 mg (6 tablets).

For treatment of viral hepatitis A the drug dose on the first day is 125 mg twice/day, then switch to taking 125 mg every 48 hours. The course of treatment is 1.25 g (10 tablets).

For treatment of acute hepatitis B in the initial phase of treatment on the first and second day the drug dose is 125 mg/day, and then 125 mg every 48 hours. The course of treatment is 2 g (16 tablets).

For protracted course of hepatitis B on the first day the drug dose is 125 mg twice/day, then 125 mg every 48 hours. The course dose is 2.5 g (20 tablets).

For chronic hepatitis B in the initial phase of treatment the total dose is 2.5 g (20 tablets). In the first 2 days the daily dose is 250 mg, then switch to taking 125 mg every 48 hours. In the continuation phase of treatment the total dose is from 1.25 g (10 tablets) to 2.5 g (20 tablets), while the drug is prescribed at a dose of 125 mg per week. The course dose of Amixin^® varies from 3.75 to 5 g, the duration of treatment is 3.5-6 months depending on the results of biochemical, immunological and morphological studies reflecting the degree of process activity.

For acute hepatitis C on the first and second day of treatment Amixin^® is prescribed at a dose of 125 mg/day, then 125 mg every 48 hours. The course dose is 2.5 g (20 tablets).

For chronic hepatitis C in the initial phase of treatment the total dose is 2.5 g (20 tablets). In the first 2 days the drug is taken at a dose of 250 mg/day, then 125 mg every 48 hours. In the continuation phase of treatment the total dose is 2.5 g (20 tablets), while the drug is prescribed at a dose of 125 mg per week. The course dose of Amixin^® is 5 g (40 tablets), the duration of treatment is 6 months depending on the results of biochemical, immunological and morphological studies reflecting the degree of process activity.

For complex therapy of neuroviral infections – 125-250 mg/day on the first two days of treatment, then 125 mg every 48 hours. The dose is set individually, the duration of the treatment course is 3-4 weeks.

For treatment of influenza and other ARVI in the first 2 days of the illness Amixin^® is prescribed at a dose of 125 mg/day, then 125 mg every 48 hours. The course dose is 750 mg (6 tablets).

For prevention of influenza and ARVI Amixin^® is prescribed at a dose of 125 mg once a week for 6 weeks. The course dose is 750 mg (6 tablets).

For treatment of herpetic, cytomegalovirus infection the drug dose in the first 2 days is 125 mg, then take 125 mg every 48 hours. The course dose is 1.25-2.5 g (10-20 tablets).

For urogenital and respiratory chlamydia Amixin^® is prescribed at a dose of 125 mg/day for the first 2 days, then 125 mg every 48 hours. The course dose is 1.25 g (10 tablets).

For complex therapy of pulmonary tuberculosis in the first 2 days the drug is prescribed at 250 mg/day, then 125 mg every 48 hours. The course dose is 2.5 g (20 tablets).

Children over 7 years old with uncomplicated forms of influenza or other ARVI the drug is prescribed at a dose of 60 mg (1 tablet) once/day after meals on the 1st, 2nd and 4th day from the start of treatment. The course dose is 180 mg (3 tablets).

With development of complications of influenza and other ARVI the drug is taken at 60 mg once/day on the 1st, 2nd, 4th, 6th day from the start of treatment. The course dose is 240 mg (4 tablets).

Adverse Reactions

From the digestive system dyspepsia symptoms are possible.

Other short-term chills, allergic reactions are possible.

Contraindications

• Pregnancy;
• Breastfeeding period;
• Children under 7 years of age;
• Hypersensitivity to the drug.

Use in Pregnancy and Lactation

Amixin^® is contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindication: children under 7 years of age.

Special Precautions

Amixin^® is compatible with antibiotics and means of traditional treatment of viral and bacterial infections.

Overdose

To date, cases of overdose of Amixin^® are unknown.

Drug Interactions

No clinically significant drug interaction of Amixin^® with antibiotics and means of traditional treatment of viral and bacterial infections 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 30°C (86°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed 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.