Ingavirin syrup 30mg/5ml, 90ml

Composition

5 ml of syrup contains:

Active ingredient:

pentanedioic acid imidazolylethanamide-30 mg;

excipients: maltitol (liquid maltitol), glycerol, citric acid monohydrate, xanthan gum, sodium methyl parahydroxybenzoate, pear flavor, purified water.

Pharmacological action

An antiviral drug.

In preclinical and clinical studies, the effectiveness of Ingavi-rin® against influenza viruses of 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.

Ingavirin ® reduces the viral load, accelerates the elimination of viruses, reduces the duration of the disease, and reduces the risk of complications. The mechanism of action is realized at the level of infected cells due to the activation of innate immunity factors suppressed by viral proteins. In particular, experimental studies have shown that Ingavirin increases the expression of the interferon type I 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 STAT1 transmitter protein, which transmits a signal to the cell nucleus to induce the synthesis of antiviral genes. It was shown that under the conditions of infection, the drug activates the synthesis of the MhA antiviral effector protein (an early antiviral response factor that inhibits 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 Ingavirin® is to significantly reduce the signs of cytopathic and cytodestructive action 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 at 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 Ingavirin® with antibiotics increases the effectiveness of therapy in the model of bacterial sepsis, including that caused by penicillin-resistant Staphylococcus strains.

The conducted experimental toxicological studies indicate a low level of toxicity and a high safety profile of the drug. According to the parameters of acute toxicity, Ingavirin® belongs to the 4th class of toxicity ‒ “Low-toxic substances” (when determining LD50 in experiments on acute toxicity, lethal doses of the drug could not be determined). The drug does not have mutagenic, immunotoxic, allergenic and carcinogenic properties, and does not have a local irritant effect. The drug Ingavirin® does not affect the reproductive function, does not have an embryotoxic and teratogenic effect.

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

Absorption and distributioni N an experiment using a radioactive label, it was found that the Active ingredient quickly enters the bloodstream from the gastrointestinal tract, being distributed to internal organs. In a study in healthy volunteers with a single dose of 90 mg, the maximum concentration (Cmax) was 441.45 ± 252.99 ng/ml; the time to reach it (Tmax) was 1.30 ± 0.41 hours. In preclinical studies, it was found that with a course of taking 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 drug use are identical: a rapid increase in the drug concentration after each use 0.5-1 hour after use and then a slow decrease by 24 hours. The AUC values (area under the concentration‒time pharmacokinetic curve) of the kidneys, liver, and lungs slightly exceed the AUC of blood. The AUC values for the spleen, adrenal glands, lymph nodes, and thymus are lower than the blood AUC.

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

Elimination In a study in healthy volunteers with a single dose of 90 mg of the drug, the half-life (T 1/2) was 1.82 ± 0.23 hours. In preclinical studies, it was found that the main process of elimination occurs within 24 hours. During this period,80% of the 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% is excreted through the intestines and 23% – through the kidneys.

Indications

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

Use during pregnancy and lactation

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 breastfeeding, breastfeeding should be discontinued.

Contraindications

Hypersensitivity to the Active ingredient or any other component of the drug. Sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption. Pregnancy. Breast-feeding period. Children under 3 years of age.

Side effects

Allergic reactions (rare). If any of the side effects listed in the instructions get worse or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

The drug interaction of Ingavirin® is not described.

How to take, course of use and dosage

Inside. Regardless of the meal. Insert the measuring syringe firmly into the neck of the bottle. Turn the bottle upside down and gently pull the plunger down, collecting the syrup to the desired mark. After use, rinse the syringe in warm water and dry it.

For the treatment and prevention of influenza and acute respiratory viral infections, adults are prescribed 90 mg (15 ml) 1 time a day, children from 7 years ‒ 60 mg (10 ml) 1 time a day, children from 3 to 6 years ‒ 30 mg (5 ml) 1 time a day.

The duration of treatment for influenza and acute respiratory viral infections in adults and children over 7 years of age is 5-7 days (depending on the severity of the condition). The duration of treatment for influenza and acute respiratory viral infections in children from 3 to 6 years is 5 days. The drug should be taken from the moment the first symptoms of the disease appear, preferably no later than 2 days after the onset of the disease. Adults and children with severe symptoms, as well as in the presence of concomitant diseases (diseases of the respiratory and cardiovascular systems, diabetes mellitus, obesity), should take a double dose of the drug in the first 3 days of the disease, then continue taking the usual dosage for 2-4 days. For the prevention of influenza and acute respiratory viral infections after contact with sick people, adults and children from 7 years of age are prescribed the drug for 7 days, children from 3 to 6 years – for 5 days.

If there is no improvement after 5 days of treatment, or if the symptoms worsen or new symptoms appear, consult your doctor. Use the drug only according to the indications, the method of use and in the doses indicated in the instructions.

Overdose

No cases of Ingavirin overdose have been reported to date.

Special instructions

Concomitant use of other antiviral drugs is not recommended without first consulting a doctor. Save the instructions. You may need it again. If you have any questions, contact your doctor.

Product form

A 90 ml bottle with a measuring syringe and instructions in a cardboard pack.

Storage conditions

In the original packaging at a temperature not exceeding 25 °C. After opening the bottle, store for no more than 7 days. Keep out of reach of children.

Shelf life

2

Active ingredient

Pentanedioic Acid Imidazolylethanamide

Dosage form

syrup