Ingavirin, 90 mg capsules 10 pcs

Antiviral drug.

In preclinical and clinical studies demonstrated the effectiveness of Ingavirin® against influenza viruses of type A (A(H1N1), including pandemic strain A(H1N1)pdm09 (“pig”), A(H3N2), A(H5N1)) and type B, adenovirus, parainfluenza virus, respiratory syncytial virus; in preclinical studies: coronavirus, metapneumovirus, enteroviruses, including coxsackievirus and rhinovirus. In clinical research in outpatients with mild course COVID-19 Ingavirin® shortened time to clinical recovery.

The mechanism of action is realized at the level of infected cells through activation of innate immunity factors suppressed by viral proteins. Experimental studies showed that Ingavirin® increases the expression of the interferon receptor of the first type IFNAR on the surface of epithelial and immunocompetent cells. The increase in the density of interferon receptors leads to increased sensitivity of cells to signals of endogenous interferon.

The process is accompanied by activation (phosphorylation) of protein-transmitter STAT1, transmitting signals to the cell nucleus for induction of synthesis of antiviral genes. It was shown that under infection conditions the preparation activates synthesis of antiviral effector protein MxA (early antiviral response factor inhibiting intracellular transport of ribonucleoprotein complexes of various viruses) and phosphorylated form of PKR inhibiting translation of viral proteins thus slowing down and stopping viral reproduction process.

The action of Ingavirin® preparation is based on significant decrease of cytopathic and cytodestructive virus action signs, reducing the number of infected cells, restriction of pathological process, normalization of cell composition and structure and tissue morphological pattern in the infectious process zone both at early and late stages.

Anti-inflammatory activity is caused by the suppression of production of key pro-inflammatory cytokines (tumor necrosis factor (TNF-α), interleukins (IL-1β and IL-6), the decrease of myeloperoxidase activity.

In experimental studies it was shown that combined usage of Ingavirin® with antibiotics improves the efficiency of therapy on the model of bacterial sepsis including that caused by penicillin – resistant strains of Staphylococcus aureus.

The conducted experimental toxicological studies demonstrate the low level of toxicity and high safety profile of the drug.

According to the parameters of acute toxicity Ingavirin® belongs to the 4th class of toxicity – “Low-toxic substances” (by determining the LD50 in acute toxicity experiments lethal doses of the drug were not determined).

The drug has no mutagenic, immunotoxic, allergic and carcinogenic properties. Ingavirin® has no effect on reproductive function, has no embryotoxic and teratogenic effect.

There is no effect of Ingavirin® on the hematopoietic system when using the age appropriate dose in the recommended scheme and course.

absorption and distribution.

In the experiment using the radioactive label it was found: the drug quickly enters the blood from the gastrointestinal tract, distributing to internal organs. Maximum concentrations in blood, plasma and most organs are reached 30 minutes after drug administration. AUC values (area under the pharmacokinetic curve “concentration – time”) of kidney, liver and lung are slightly higher than AUC in blood (43.77 µg.h/g). The AUC values for the spleen, adrenal glands, lymph nodes and thymus are lower than the blood AUC. MRT (Mean Drug Retention Time) in blood is 37.2 hours.

When administered once daily the drug is accumulated in internal organs and tissues. In this case qualitative characteristics of pharmacokinetic curves after each drug administration are identical: rapid increase of the drug concentration after each administration in 0.5-1 hour after the administration and then slow decrease by 24 hours.

Metabolism.

The drug is not metabolized in the body and is excreted unchanged.

Elimation.

The main process of excretion occurs within 24 hours. During this period 80 % of taken dose is eliminated: 34.8 % is eliminated in the time interval from 0 to 5 hours and 45.2 % in the time interval from 5 to 24 hours. Of these, 77 % are excreted through the intestine and 23 % – through the kidneys.

Metabolism.

The drug is not metabolized in the body and is excreted unchanged.

Elimation.

The main process of excretion occurs within 24 hours. During this period 80 % of taken dose is eliminated: 34.8 % is eliminated in the time interval from 0 to 5 hours and 45.2 % in the time interval from 5 to 24 hours. Of these, 77% are excreted through the intestines and 23% through the kidneys.

Indications

Treatment and prevention of influenza A and B and other acute respiratory viral infections (adenoviral infection, parainfluenza, respiratory syncytial infection, rhinovirus infection) in adults and children over 3 years of age.

Pharmacological effect

Antiviral drug.

Preclinical and clinical studies have shown the effectiveness of the drug Ingavirin® against influenza viruses type A (A(H1N1), including pandemic strain A(H1N1)pdm09 (“swine”), A(H3N2), A(H5N1)) and type B, adenovirus, parainfluenza virus, respiratory syncytial virus; in preclinical studies: coronavirus, metapneumovirus, enteroviruses, including Coxsackie virus and rhinovirus. In a clinical study in outpatients with mild COVID-19, Ingavirin® reduced the time to clinical recovery.

The mechanism of action is realized at the level of infected cells due to the activation of innate immune factors suppressed by viral proteins. In experimental studies, in particular, it was shown that the drug Ingavirin® increases the expression of the first type interferon receptor IFNAR on the surface of epithelial and immunocompetent cells. An increase in the density of interferon receptors leads to an increase in the sensitivity of cells to endogenous interferon signals.

The process is accompanied by activation (phosphorylation) of the transmitter protein STAT1, which transmits a signal to the cell nucleus to induce the synthesis of antiviral genes. It has been shown that under conditions of infection, the drug activates the synthesis of the antiviral effector protein MxA (an early factor of the antiviral response that inhibits the intracellular transport of ribonucleoprotein complexes of various viruses) and the phosphorylated form of PKR, which suppresses the translation of viral proteins, thus slowing down and stopping the process of viral reproduction.

The effect of the drug Ingavirin® is to significantly reduce the signs of the cytopathic and cytodestructive effects of the virus, reduce the number of infected cells, limit the pathological process, normalize the composition and structure of cells and the morphological picture of tissues in the area of ​​the infectious process, both in its early and late stages.

The anti-inflammatory effect is due to the suppression of the production of key pro-inflammatory cytokines (tumor necrosis factor (TNF-α), interleukins (IL-1β and IL-6)), and a decrease in the activity of myeloperoxidase.

Experimental studies have shown that the combined use of the drug Ingavirin® with antibiotics increases the effectiveness of therapy in a model of bacterial sepsis, including that caused by penicillin-resistant strains of staphylococcus.

Experimental toxicological studies conducted indicate a low level of toxicity and a high safety profile of the drug.

According to the parameters of acute toxicity, the drug Ingavirin® belongs to toxicity class 4 – “Low toxic substances” (when determining LD50 in acute toxicity experiments, lethal doses of the drug could not be determined).

The drug does not have mutagenic, immunotoxic, allergenic or carcinogenic properties, and does not have a local irritant effect. The drug Ingavirin® does not affect reproductive function, does not have embryotoxic or teratogenic effects.

There is no effect of the drug Ingavirin® on the hematopoietic system when taking an age-appropriate dose in the recommended regimen and course.

Absorption and distribution.

An experiment using a radioactive label established that the drug quickly enters the blood from the gastrointestinal tract, distributing throughout the internal organs. Maximum concentrations in the blood, blood plasma and most organs are reached 30 minutes after administration of the drug. The AUC values ​​(area under the pharmacokinetic concentration-time curve) of the kidneys, liver and lungs are slightly higher than the AUC of blood (43.77 mcg.h/g). AUC values ​​for the spleen, adrenal glands, lymph nodes and thymus are lower than blood AUC. MRT (mean drug retention time) in the blood – 37.2 hours.

When taking a course of the drug once a day, it accumulates in internal organs and tissues. At the same time, the qualitative characteristics of the pharmacokinetic curves after each administration of the drug are identical: a rapid increase in the concentration of the drug after each administration 0.5-1 hour after administration and then a slow decrease by 24 hours.

Metabolism.

The drug is not metabolized in the body and is excreted unchanged.

Removal.

The main elimination process occurs within 24 hours. During this period, 80% of the dose taken is excreted: 34.8% is excreted in the time interval from 0 to 5 hours and 45.2% in the time interval from 5 to 24 hours. Of these, 77% is excreted through the intestines and 23% through the kidneys.

Metabolism.

The drug is not metabolized in the body and is excreted unchanged.

Removal.

The main elimination process occurs within 24 hours. During this period, 80% of the dose taken is excreted: 34.8% is excreted in the time interval from 0 to 5 hours and 45.2% in the time interval from 5 to 24 hours. Of these, 77% is excreted through the intestines and 23% through the kidneys.

Special instructions

It is not recommended to take other antiviral drugs at the same time without first consulting a doctor.

Save the instructions. It may be needed again.

If you have any questions, consult your doctor.

Active ingredient

Pentanedioic acid imidazolylethanamide

Composition

One capsule contains:

active ingredient: pentanedioic acid imidazolylethanamide (vitaglutam) in terms of 100% substance – 90.00 mg;

excipients: lactose monohydrate, potato starch, colloidal silicon dioxide (aerosil), magnesium stearate;

hard gelatin capsules:

for a dosage of 90 mg – titanium dioxide E 171, crimson dye [Ponceau 4 R] E 124, azorubine dye E 122, quinoline yellow dye E 104, gelatin;

ink composition for the logo: shellac, propylene glycol E 1520, titanium dioxide E 171.

Pregnancy

The use of the drug during pregnancy has not been studied.

The use of the drug during lactation has not been studied, therefore, if it is necessary to use the drug during lactation, breastfeeding should be stopped.

Contraindications

Hypersensitivity to the active substance or any other component of the drug.
Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
Pregnancy.
Breastfeeding period.
Children under 3 years of age.

Side Effects

Allergic reactions (rare).

If any of the side effects indicated in the instructions get worse or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Drug interactions with Ingavirin® have not been described.

Overdose

Cases of overdose of the drug Ingavirin® have not been reported to date.

Storage conditions

In a place protected from light at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf life

3 years

Do not use after the expiration date stated on the package.

Manufacturer

Valenta Pharm JSC, Russia