INGAVIRIN syrup 30 mg

Composition

5 ml of syrup contains: active substance: pentanedioic acid imidazolylethanamide - 30 mg; excipients: maltitol (liquid maltitol), glycerol, citric acid monohydrate, xanthan gum, sodium methyl parahydroxybenzoate, pear flavor, purified water.

Dosage form

syrup

Description

transparent colorless slightly viscous liquid with a characteristic odor.

Action

Antiviral drug

Pharmacodynamics

Antiviral drug. Preclinical and clinical studies have shown the effectiveness of Ingavirin® against influenza A (A (H1N1) viruses, 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, shortens 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 experimental studies, in particular, it has been shown that Ingavirin® increases the expression of the first type of interferon IFNAR receptor 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 signals from endogenous interferon. The process is accompanied by the activation (phosphorylation) of the STAT1 transmitter protein, 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 antiviral response factor 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 Ingavirin® is a significant decrease in the signs of the cytopathic and cytodestructive action of the virus, a decrease in the number of infected cells, limitation of the pathological process, normalization of the composition and structure of cells and the morphological picture of tissues in the zone 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)), 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 strains of staphylococcus. The experimental toxicological studies carried out 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 possess mutagenic, immunotoxic, allergenic and carcinogenic properties, does not have a local irritating effect. Ingavirin® does not affect reproductive function, does not have embryotoxic and teratogenic effects. There is no effect of Ingavirin® on the hematopoietic system when taking the dose appropriate for the age using the recommended regimen and course.

Pharmacokinetics

Absorption and distribution In an experiment using a radioactive label, it was established that the active substance quickly enters the bloodstream from the gastrointestinal tract, being distributed throughout the internal organs. In a study in healthy volunteers with a single dose of the drug at a dose of 90 mg, the maximum concentration (Cmax) was 441.45 ± 252.99 ng / ml; the time to reach it (Tmax) - 1.30 ± 0.41 hours. In preclinical studies, it was found that during the course of taking the drug once a day, it accumulates in the 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 in 0.5-1 hour after administration 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 below the blood AUC. Metabolism The drug is not metabolized in the body and is excreted unchanged. Elimination In a study in healthy volunteers with a single dose of the drug at a dose of 90 mg, the half-life (T1 / 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 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.

Indications for use

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 from 3 years of age.

Contraindications

Hypersensitivity to the active substance or any other component of the drug. Sucrase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption. Pregnancy. Breastfeeding period. Children under 3 years old.

Application 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, therefore, if it is necessary to use the drug during breastfeeding, breastfeeding should be discontinued.

Application in children

from 3 years old

Side effects

Allergic reactions (rare). If any of the side effects indicated in the instructions are aggravated or you notice any other side effects not listed in the instructions, inform your doctor.

Interaction

The drug interaction of Ingavirin® has not been described.

Method of administration 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 to draw the syrup up 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) once a day, children from 7 years old - 60 mg (10 ml) once a day, children from 3 to 6 years old - 30 mg (5 ml) once a day. The duration of treatment for influenza and acute respiratory viral infections in adults and children from 7 years old 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. Taking the drug begins from the moment the first symptoms of the disease appear, preferably no later than 2 days from 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 illness, then continue taking at the usual dosage for 2-4 days. For the prevention of influenza and acute respiratory viral infections after contact with sick persons, adults and children from 7 years old are prescribed the drug within 7 days, children from 3 to 6 years old - within 5 days. If after 5 days of treatment there is no improvement or symptoms worsen, or new symptoms appear, you should consult your doctor. Use the drug only according to the indications, the method of administration and the doses indicated in the instructions.

Overdose

To date, no cases of overdose of Ingavirin® have been reported.

special instructions

It is not recommended to take other antiviral drugs at the same time without first consulting a doctor. Keep the instructions. You may need it again. If you have any questions, see your doctor.

Influence on the ability to drive vehicles and control mechanisms

the drug does not affect the ability to drive vehicles

Release form

Syrup 30 mg / 5 ml. Packing and packaging at ABC Pharmatsoitichi S.p.A., Italy: 50 ml or 90 ml each in brown bottles made of polyethylene terephthalate, equipped with an adapter ring, sealed with screw caps made of polypropylene with first opening control and protection against opening by children. One bottle, together with a measuring syringe and instructions for use, is placed in a cardboard box. Packaging at Valenta Pharm JSC, Russia: One bottle with a measuring syringe and instructions for use is placed in a cardboard box.

Conditions of dispensing from pharmacies

Over the counter.

Storage conditions

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

Shelf life

2 years. Do not use after the expiration date.