Arpeflu (Tablets, Capsules) Instructions for Use

ATC Code

J05AX13 (Umifenovir)

Active Substance

Umifenovir (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antiviral drug

Pharmacotherapeutic Group

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

Pharmacological Action

Antiviral agent, has immunomodulatory and anti-influenza action, specifically suppresses influenza A and B viruses.

It has interferon-inducing properties, stimulates humoral and cellular immune responses, the phagocytic function of macrophages, and increases the body’s resistance to viral infections. It prevents the development of post-influenza complications, reduces the frequency of exacerbations of chronic diseases, and normalizes immunological parameters. The antiviral action is due to the suppression of the fusion of the virus’s lipid envelope with cell membranes upon contact of the virus with the cell. The therapeutic efficacy in influenza is manifested in a reduction of intoxication and the severity of catarrhal phenomena, shortening the periods of fever and the total duration of the disease. It belongs to low-toxicity drugs (LD 50>4 g/kg). It does not have any negative effects on the human body when taken orally at the recommended doses.

Pharmacokinetics

Absorption is rapid. It is quickly distributed throughout organs and tissues. T_max when taken at a dose of 50 mg is 1.2 hours, 100 mg is 1.5 hours. It is metabolized in the liver. T_1/2 is 17-21 hours. About 40% is excreted unchanged, mainly with bile (38.9%) and in small amounts by the kidneys (0.12%). 90% of the administered dose is excreted within the first 24 hours.

Indications

Prevention and treatment in adults and children:

• Influenza caused by viruses A and B;
• Acute respiratory viral infections (ARVI) (including those complicated by bronchitis, pneumonia);
• Secondary immunodeficiency states.

Complex therapy of chronic bronchitis, pneumonia, and recurrent herpetic infection.

Prevention of postoperative infectious complications and normalization of immune status in adults.

ICD codes

Dosage Regimen

Capsules

Take orally.

The dose, frequency of administration, and duration of use are determined depending on the patient’s age, indications, and the scheme of prevention or therapy.

A single dose is 50-200 mg.

Tablets

Orally, before meals. Single dose: children from 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years and adults – 200 mg (2 tablets of 100 mg or 4 tablets of 50 mg).

For non-specific prophylaxis

In case of direct contact with patients with influenza and other ARVI: children from 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years and adults – 200 mg once a day for 10-14 days.

During an epidemic of influenza and other ARVI, to prevent exacerbations of chronic bronchitis, recurrence of herpetic infection: children from 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years and adults – 200 mg twice a week for 3 weeks.

Prevention of postoperative complications: children from 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years and adults – 200 mg 2 days before surgery, then on the 2nd and 5th day after surgery.

For treatment

Influenza, other ARVI without complications: children from 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years and adults – 200 mg 4 times a day (every 6 hours) for 5 days.

Influenza, other ARVI with the development of complications (bronchitis, pneumonia, and others): children from 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years and adults – 200 mg 4 times a day (every 6 hours) for 5 days, then a single dose once a week for 4 weeks.

Adverse Reactions

Allergic reactions.

Contraindications

• Children’s age (under 3 years);
• Presence of diseases such as galactose intolerance, lactase deficiency, glucose-galactose malabsorption;
• Hypersensitivity to the components of the drug.

Pediatric Use

Contraindicated in children under 3 years.

Special Precautions

It does not exhibit central neurotropic activity and can be used in medical practice for prophylactic purposes in practically healthy individuals of various professions, including those requiring increased attention and coordination of movements (vehicle drivers, operators, and so on).

Overdose

Not observed.

Drug Interactions

No negative effects were observed when co-administered with other drugs.

Storage Conditions

At a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

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.