Coronavir pills 200mg, 50pcs

Composition

One film-coated tablet contains:

Active ingredient:  favipiravir – 200.0 mg.

Auxiliary substances:  microcrystalline cellulose 101, colloidal silicon dioxide, povidone-K 25, crospovidone, sodium stearyl fumarate.

Film shell:  Opadray II 85F220031 yellow [polyvinyl alcohol, titanium dioxide, macrogol 4000, talc, iron oxide yellow dye].

Pharmacological action

Pharmacotherapy group: antiviral agent ATX code: J05AX27 Pharmacological properties

Pharmacodynamics

Antiviral activity in vitro

Favipiravir has antiviral activity against laboratory strains of influenza A and B viruses (half maximum effective concentration (EC50) 0.014-0.55 mcg / ml).

For strains of influenza A and B viruses that are resistant to adamantane (amantadine and rimantadine), oseltamivir or zanamivir, the EC 50 is 0.03-0.94 mcg / ml and 0.09-0.83 mcg/ml, respectively. For influenza A virus strains (including strains resistant to adamantane, oseltamivir and zanamivir), such as swine flu type A and avian influenza type A, including highly pathogenic strains (including H5N1 and H7N9), the EC50 is 0.06-3.53 micrograms / ml.

For strains of influenza A and B viruses resistant to adamantane, oseltamivir and zanamivir, EC50 is 0.09-0.47 mcg / ml; no cross-resistance is observed.

Favipiravir inhibits the SARS-CoV-2 virus, which causes a new coronavirus infection (COVID-19). EC50 in Vero E6 cells is 61.88 mmol, which corresponds to 9.72 mcg / ml.

Favipiravir is

metabolized in cells to favipiravir ribosyl triphosphate (favipiravir RTP) and selectively inhibits RNA-dependent RNA polymerase involved in influenza virus replication. The RTF of favipiravir (1000 mmol / L) did not show an inhibitory effect on human a DNA, but showed an inhibitory effect in the range from 9.1 to 13.5% on β and in the range from 11.7 to 41.2% on human γ DNA. The RTP inhibitory concentration (IC50) of favipiravir for human RNA polymerase II was 905 mmol/l.

Resistance

After 30 replantings in the presence of favipiravir, no changes were observed in the susceptibility of influenza A viruses to favipiravir, and no resistant strains were observed. No influenza viruses resistant to favipiravir were detected in clinical studies.

Pharmacokinetics

Absorption

Favipiravir is easily absorbed in the gastrointestinal tract. Time to reach the maximum concentration (Tmax) – 1.5 hours –

Distribution

Binding to plasma proteins is about 54%.

Favipiravir is primarily metabolized by aldehyde oxidase and partially metabolized to the hydroxylated form by xanthine oxidase. Favipiravir RTP is metabolized in cells. From other metabolites, in addition to hydroxylate, a glucuronate conjugate was also recorded in human blood plasma and urine.

Deduction

Basically, favipiravir is excreted by the kidneys as an active metabolite of hydroxylate, a small amount-in unchanged form. The half-life (T 1/2) is about 5 hours.

Patients with impaired liver function

When taking favipiravir in patients with mild and moderate hepatic insufficiency (Child-Pugh class A and B), Cmax and AUC increased 1.5 and 1.8 times, respectively, compared with healthy volunteers. Data on Cmax and AUC increases for patients with severe hepatic insufficiency (Child-Pugh class C) were 2.1 and 6.3 times, respectively.

Patients with impaired renal function

In patients with moderate renal insufficiency (GFR In patients with severe and terminal renal insufficiency (GFR

Indications

Treatment of a new coronavirus infection (COVID-19).

Use during pregnancy and lactation

In preclinical studies of favipiravir at dosages similar to clinical or lower, early embryo death and teratogenicity were observed.

The drug CORONAVIR is contraindicated in pregnant women, as well as men and women during pregnancy planning. When prescribing the drug CORONAVIR to women who are capable of childbearing (including postmenopausal women less than 2 years old), it is necessary to confirm a negative pregnancy test result before starting treatment. A second pregnancy test should be performed after the end of taking the drug. It is necessary to use effective methods of contraception (a condom with spermicide) during and after taking the drug: for 1 month for women and for 3 months for men.

When prescribing the drug KORONAVIR to nursing women, it is necessary to stop breastfeeding for the duration of taking the drug and within 7 days after its end, since the main metabolite of favipiravir enters breast milk.

Contraindications

Hypersensitivity to favipiravir or any component of the drug KORONAVIR.

Severe hepatic insufficiency (Child-Pugh class C).

Severe and end-stage renal failure (GFR

Pregnancy or pregnancy planning.

Breast-feeding period.

Children under 18 years of age.

With caution

In patients with a history of gout and hyperuricemia (possibly increased uric acid levels in the blood and exacerbation of symptoms), in elderly patients with mild to moderate hepatic insufficiency (Child-Pugh class A and B), in patients with moderate renal insufficiency (GFR

Side effects

In a clinical study of the drug CORONAVIR, adverse reactions were observed in 29 patients out of 37 (78.4%), including: hyperuricemia (in 23 patients (62.2%)), increased ALT (in 8 patients (21.6%)), increased ACT (in 6 patients (16.2%)), diarrhea (in 7 patients (18.9%)), increased creatine kinase (in 5 patients (13.5%)), hyperglycemia (in 4 patients (10.8%)), nausea (in 2 patients (5.4%)), epigastric pain (2 patients (5.4%)), increased LDH (1 patient (2.7%)), increased ferritin levels (1 patient (2.7%)), skin rash (2 patients (5.4%)), increased sweating of the feet (1 patient (2.7%)), chilly feet (1 patient (2.7%)), headache (1 patient (2.7%)), weakness in the hand (1 patient (2.7%)), hematuria (in 1 patient (2.7%)).

Adverse reactions observed in clinical trials in patients with influenza infection (data from the analysis in the aggregate population combined for safety assessment) are presented in table 1.

The assessment of the frequency of adverse reactions is based on the WHO classification: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10 000, <1/1000); very rare (

Table 1. Adverse reactions

Interaction

The drug CORONAVIR is not metabolized by cytochrome P450, mainly metabolized by aldehyde oxidase and partially metabolized by xanthine oxidase. The drug CORONAVIR inhibits aldehyde oxidase and cytochrome CYP2C8, but does not induce cytochrome P450.

Table 2. Inter-drug interactions

How to take, course of use and dosage

Therapy scheme:

The drug should be taken orally,30 minutes before meals.

The following dosage regimen is recommended for the treatment of a new coronavirus infection caused by the SARS-CoV-2 (COVID-19) virus:

• for patients with body weight <75 kg: 1600 mg (8 tablets) 2 times a day 1-day therapy, then 600 mg (3 tablets) 2 times a day from the 2nd to the 10th day of therapy, respectively; in the course requires 70 tablets
• for patients with body weight ≥75 kg: 1800 mg (9 tablets) 2 times a day 1-day therapy, then 800 mg (4 tablets) 2 times a day from the 2nd to the 10th day of therapy, respectively; in the course requires 90 tablets.

The drug should be taken after laboratory confirmation of the diagnosis and / or in the presence of characteristic clinical symptoms.

Description

Tablets are round, biconvex, covered with a film-coated light yellow with a brownish tinge of color. On a cross-section, the tablet core is white to light yellow in color.

Special instructions

If a side effect develops, it is necessary to report it in accordance with the established procedure for the implementation of pharmacovigilance measures.

Before starting taking the drug KORONAVIR, the patient must provide written information about the effectiveness of the drug and the risks associated with its use (including the risk of affecting the embryo and fetus), and obtain written consent to use the drug.

Since fetal death and teratogenicity have been observed in animal studies of favipiravir, the drug CORONAVIR should not be prescribed to pregnant and presumably pregnant women.

Influence on the ability to drive vehicles and mechanisms

Care should be taken when driving vehicles and working with mechanisms.

Form of production

Film-coated tablets,200 mg.

50 tablets in a polymer jar (made of polyethylene) for medicines, sealed with a polymer lid (made of polypropylene) with the control of the first opening.

A label made of label or writing paper or a self-adhesive label is pasted on the jar.

Each jar together with the instructions for use is placed in a pack of cardboard boxed.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 1 year. Do not use after the expiration date.

Active ingredient

Favipiravir

Conditions of release from pharmacies

By prescription

Dosage form

Tablets