Triazavirin, 250 mg capsules 20 pcs

Antiviral agent.

ATX code: J05AX.

Pharmacological properties

Pharmacodynamics

The active substance of the drug TRIAZAVIRIN

sup>® – riamilovir is a synthetic analog of purine nucleoside bases (guanine) with expressed antiviral action. It has a broad spectrum of antiviral activity against RNA-containing viruses.

The basic mechanism of action of the preparation TRIAZAVIRIN ^® is inhibition of synthesis of viral RNA and replication of genomic fragments.

Pharmacokinetics

After oral administration, it is rapidly absorbed in the gastrointestinal tract. Maximum concentration (C_max) is reached on average in 1-1.5 h. C_max with the recommended dosing regimen is on average 4.8 µg/ml. Blood AUC (area under the pharmacokinetic curve “concentration – time”) is 12.8 µg/h*ml. The elimination half-life (T_1/2) is 1-1.5 h. 15 to 45% of riamilovir is excreted unchanged by the kidneys. The average value of estimated clearance is 246 ml/min.

Indications

– as part of complex therapy for influenza and other acute respiratory viral infections in adult patients.
– for the prevention of SOUT-19 infection in adults living together with a person with symptomatic manifestations of a confirmed COVID-19 infection.

Pharmacological effect

Pharmacotherapeutic group
Antiviral agent.
ATX code: J5AX.

Pharmacological properties
Pharmacodynamics
The active ingredient of the drug TRIAZAVIRIN® – riamilovir – is a synthetic analogue of purine nucleoside bases (guanine) with a pronounced antiviral effect. The main mechanism of action of the drug is inhibition of viral RNA synthesis and replication of genomic fragments.
Has a wide spectrum of antiviral activity against RNA viruses.
In a clinical study of the effectiveness and safety of the drug in patients with mild COVID-19, the therapeutic use of the drug showed a statistically significant acceleration in the onset of persistent improvement in clinical symptoms. The safety of the drug did not differ from placebo.
In a clinical study of the use of TRIAZAVIRIN® for the prevention of COVID-19 infection in adults living with a person with symptomatic manifestations of confirmed COVID-19 infection, its effectiveness and safety were confirmed. The relative risk of the disease in the group of participants taking the drug TRIAZAVIRIN® was 88.96% less than
in the group of participants taking placebo. The safety of the drug did not differ from placebo.

Pharmacokinetics
After oral administration, it is quickly absorbed from the gastrointestinal tract. The maximum concentration (Cmax) is achieved on average after 1-1.5 hours. Cmax with the recommended dosage regimen averages 4.8 mcg/ml. The APS value (area under the pharmacokinetic curve “concentration – time”) of blood is 12.8 mcg/h*ml.
The half-life (T!/2) is 1-1.5 hours. From 15 to 45% of riamilovir is excreted unchanged by the kidneys. The average calculated clearance is 246 ml/min.

Special instructions

The drug TRIAZAVIRIN® contains sunset yellow (E110) and azorubine (E122) dyes, which can cause allergic reactions.
Impact on the ability to drive vehicles and machinery
Not studied, however, based on the spectrum of adverse reactions, no effect on these activities is expected.

Active ingredient

Riamilovir

Composition

1 capsule contains:
Active ingredient:
Riamilovir (TRIAZAVIRIN®) – 250 mg

Excipients:
Calcium stearate – 2 mg
Weight of capsule contents – 252 mg

Composition of the capsule shell:
Capsule (body) No. 1: titanium dioxide (E171), quinoline yellow dye (E104), sunset yellow dye (E! 10), medical gelatin.
Capsule (cap) No. 1: titanium dioxide (E171), azorubine dye (E122), medical gelatin.

Weight of capsule with contents – 328 mg

Pregnancy

Due to the lack of strictly controlled studies in humans, the use of the drug during pregnancy is contraindicated (see section “Contraindications”).
The use of the drug during breastfeeding has not been studied, therefore, if it is necessary to use the drug during lactation, breastfeeding should be stopped.

Contraindications

– hypersensitivity to the components of the drug;
– pregnancy;
– period of breastfeeding;
– children under 18 years of age (efficacy and safety have not been determined)
– renal/liver failure (efficacy and safety have not been determined).

Side Effects

Disorders of the blood and lymphatic system: increased number of eosinophils, monocytes in the blood.
Immune system disorders: allergic reactions (rash, itching), urticaria, angioedema.
Nervous system disorders: headache, dizziness.
Gastrointestinal tract disorders: dyspepsia (nausea, vomiting, bloating, pasty stools, flatulence, heartburn, abdominal pain, diarrhea, dry mouth, bitterness in the mouth).
Renal and urinary tract disorders: increased erythrocytes, leukocytes, squamous epithelium in the urine, presence of bacteria in the urine.
Laboratory and instrumental data: increased levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), glucose, creatinine in blood plasma.
General disorders and reactions at the injection site: weakness.
If you experience the side effects listed in the instructions, or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

No special clinical studies have been conducted to study interactions with other drugs.
If you are using any medications (including over-the-counter medications), consult your doctor before using TRIAZAVIRIN®.

Overdose

Symptoms: nausea, vomiting, dyspeptic disorders, stomach pain.
Treatment: symptomatic therapy. If these symptoms occur, you should stop taking the drug and consult a doctor.

Storage conditions

In a place protected from light at a temperature not exceeding 25 °C.
The drug may be stored and transported in a place protected from light at a temperature of minus 50 to 50 °C for no more than 30 days.
Keep out of the reach of children.

Shelf life

5 years.
Do not use after expiration date.

Manufacturer

Plant Medsintez LLC, Russia