Triazavirin^® (Capsules) Instructions for Use

Marketing Authorization Holder

Medsintez Plant, LLC (Russia)

ATC Code

J05AX (Other antiviral drugs)

Active Substance

Riamilovir (Rec.INN registered by WHO)

Dosage Form

Triazavirin®

Capsules 250 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Capsules are hard gelatin, size No. 1, with a yellow body and a red cap; the capsule contents are a fine-crystalline powder or granules of yellow or yellow-green color.

Excipients: calcium stearate; capsule (body) No. 1: titanium dioxide (E171), quinoline yellow dye (E104), sunset yellow FCF dye (E110), medical gelatin; capsule (cap) No. 1: titanium dioxide (E171), azorubine dye (E122), medical gelatin.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.

Clinical-Pharmacological Group

Antiviral drug

Pharmacotherapeutic Group

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

Pharmacological Action

Antiviral agent, a synthetic analog of purine nucleoside bases (guanine). It has a broad spectrum of antiviral activity against RNA-containing viruses. The main mechanism of action of the drug is the inhibition of viral RNA synthesis and replication of genomic fragments.

A clinical study of the efficacy and safety of riamilovir in patients with mild COVID-19 during therapeutic use showed a statistically significant acceleration in the onset of sustained improvement in clinical symptoms. In terms of safety, it does not differ from placebo.

A clinical study of the use of riamilovir for the prevention of COVID-19 infection in adults cohabiting with a person with symptomatic manifestations of a confirmed COVID-19 infection confirmed its efficacy and safety. In terms of safety, it does not differ from placebo.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract. C_max is reached on average after 1-1.5 hours and with the recommended dosage regimen averages 4.8 µg/ml. The AUC value is 12.8 µg/h×ml. T_1/2 is 1-1.5 hours. From 15% to 45% of riamilovir is excreted by the kidneys unchanged. The average estimated clearance value is 246 ml/min.

Indications

As part of the complex therapy of influenza and other acute respiratory viral infections in adult patients.

For the prevention of COVID-19 infection in adults cohabiting with a person with symptomatic manifestations of a confirmed COVID-19 infection.

ICD codes

Dosage Regimen

Take orally.

A single dose is 250 mg (one capsule).

For treatment of influenza and other acute respiratory viral infections, take one capsule three times daily for 5 days.

Initiate therapy within 48 hours of symptom onset.

For prevention of COVID-19 after exposure, take one capsule three times daily for 5 days.

Begin the prophylactic course within 24 hours of identifying a symptomatic, confirmed COVID-19 case in your household.

Swallow the capsule whole with a sufficient amount of water.

Take with or without food.

Do not exceed the recommended daily dose of 750 mg (three capsules).

Complete the full prescribed course, even if symptoms improve.

Consult a physician if no improvement is observed after 5 days of treatment for influenza or other acute respiratory viral infections.

Adverse Reactions

Blood and lymphatic system disorders: increased number of eosinophils, monocytes in the blood.

Immune system disorders: allergic reactions (rash, itching), urticaria, angioedema.

Nervous system disorders: headache, dizziness.

Gastrointestinal disorders: dyspeptic phenomena (nausea, vomiting, bloating, pasty stools, flatulence, heartburn, abdominal pain, diarrhea, dry mouth, bitter taste in the mouth).

Urinary system disorders: hematuria, increased content of leukocytes, squamous epithelium in the urine, appearance of bacteria in the urine.

General disorders: weakness.

Laboratory data: increased activity of ALT, AST, glucose, creatinine in blood plasma.

Contraindications

Hypersensitivity to riamilovir, hepatic insufficiency, renal insufficiency, pregnancy, breastfeeding period, childhood and adolescence under 18 years.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and breastfeeding.

Use in Hepatic Impairment

Use is contraindicated in hepatic insufficiency.

Use in Renal Impairment

Use is contraindicated in renal insufficiency.

Pediatric Use

Use is contraindicated in children and adolescents under 18 years of age.

Special Precautions

If, when taken for influenza or other acute respiratory viral infections, improvement does not occur within 5 days of treatment, or the symptoms worsen, or new symptoms appear, it is necessary to consult a doctor.

If symptoms of COVID-19 occur, or if laboratory confirmation of infection occurs in persons cohabiting with COVID-19 patients, it is necessary to consult a doctor.

If the patient is taking any other medications, it is necessary to consult a doctor before taking riamilovir.

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.