Ingavirin, capsules 60 mg 10 pcs

An antiviral agent. Anti-inflammatory agent.

TAC code: [J05AX].

Pharmacological properties

Pharmacodynamics

Antiviral drug.

In preclinical and clinical studies showed the effectiveness of Ingavirin^® against influenza viruses of type A (A(H1N1), including pandemic A(H1N1)pdm09 (“swine”), A(H3N2), A(H5N1)) and type B, adenovirus, parainfluenza virus, respiratory syncytial virus; in preclinical studies: coronavirus, metapneumovirus, enteroviruses, including coxsackievirus and rhinovirus.

Ingavirin^® reduces the viral load, accelerates viral elimination, reduces the duration of the disease and reduces the risk of complications.

The mechanism of action is realized at the level of infected cells through activation of innate immunity factors that are suppressed by viral proteins. In particular it was shown in experimental studies that Ingavirin ^® increases expression of the interferon receptor of the first type IFNAR on the surface of epithelial and immunocompetent cells. Increased 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 a signal to the cell nucleus for induction of synthesis of antiviral genes. It was shown that under the conditions of infection 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 the process of viral reproduction.

The action of the preparation Ingavirin^® consists in significant decrease of symptoms of cytopathic and cytodestructive action of the virus, decrease of number of infected cells, restriction of pathological process, normalization of composition and structure of cells and morphological pattern of tissues in the zone of infection both at early and late stages of the process.

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

In experimental studies it is shown that combined use of Ingavirin^® with antibiotics improves the effectiveness of therapy in models of bacterial sepsis including that caused by penicillin-resistant strains of Staphylococcus aureus.

The 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 the 4th class of toxicity – “Low-toxic substances” (when determining LD₅₀ in acute toxicity experiments lethal doses of the drug could not be determined).

The drug has no mutagenic, immunotoxic, allergic and carcinogenic properties, it has no local irritant effect. The drug Ingavirin^® has no effect on reproductive function, does not have embryotoxic and teratogenic effects.

There is no effect of the drug Ingavirin^® on the hematopoietic system when the age-appropriate dose is taken with the recommended regimen and course.

Pharmacokinetics

Intake and distribution.

In an experiment using radioactive labeling it was found that the drug quickly enters the blood from the gastrointestinal tract, distributing to internal organs. Maximal concentrations in blood, plasma and most organs are reached 30 minutes after drug administration. The 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 taking the drug once a day, it accumulates in the internal organs and tissues. At that qualitative characteristics of pharmacokinetic curves after each administration of the drug are identical: rapid increase of the drug concentration after each administration 0.5-1 hour after administration and then slow decrease by 24 hours.

Metabolism.

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

Extracted.

The main process of excretion occurs within 24 hours. During this period, 80% of the dose taken 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 of influenza A and B and other acute respiratory viral infections (adenovirus, parainfluenza, respiratory syncytial infection, rhinovirus infection) in children from 7 to 17 years.

Prevention of influenza A and B and other acute respiratory viral infections in children from 7 to 17 years.

Active ingredient

Imidazolylethanamide of pentandioic acid

Composition

One capsule contains:

The active ingredient:

Imidazolylethanamide of pentandioic acid (vitaglutam) in terms of 100% substance – 60.00 mg;

Auxiliary substances: lactose monohydrate, potato starch, colloidal silica (aerosil), magnesium stearate;

solid gelatin capsules: titanium dioxide E 171, iron oxide yellow dye E 172, gelatin;

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

How to take, the dosage

Ingestion. Regardless of meals.

For the treatment of influenza and acute respiratory viral infections in children from 7 to 17 years old, 1 capsule (60 mg) once a day. The duration of treatment is 5-7 days (depending on the severity of the condition). The drug is started from the onset of the first symptoms of the disease, preferably not later than 2 days from the beginning of the disease.

In case of strong symptoms and concomitant diseases (respiratory and cardiovascular diseases, diabetes, obesity) double dose of the drug should be taken in the first three days of the disease; after that the usual dosage should be continued for 2-4 days.

For the prevention of flu and acute respiratory viral infections after contact with sick people, children from 7 to 17 years are prescribed 1 capsule (60 mg) once a day, for 7 days.

If after 5 days of treatment there is no improvement or symptoms worsen, or new symptoms appear, consult a physician. Use the drug only according to the indications, the route of administration and the dosage indicated in the instructions.

Interaction

Drug interaction of Ingavirin® has not been described.

Special Instructions

The simultaneous use of other antiviral medications is not recommended without first consulting a physician.

Keep the instructions in a safe place. You may need it again. If you have any questions, talk to your doctor.

Synopsis

The capsules are yellow in color. The cap of the capsule has a white logo in the form of a ring and the letter AND inside the ring.

The contents of the capsules are granules and powder of white or almost white color; formation of conglomerates easily crumbling under light pressure is allowed.

Contraindications

Hypersensitivity to the active substance or any other component of the drug.

Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Pregnancy.

The period of breastfeeding.

Children under 7 years of age.

This dosage form is not suitable for use in people 18 years of age or older (dosage forms that allow taking Ingavirin® at a dose of 90 mg must be used).

Side effects

Allergic reactions (rare).

Overdose

No cases of overdose of Ingavirin® have been reported so far.

Pregnancy use

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

Similarities

Ingavirin