Ingavirin, syrup 30 mg/5 ml 90 ml

Antiviral drug.

In preclinical and clinical studies demonstrated the efficacy of Ingavi-rin® 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.

Ingavirin® reduces the viral load, accelerates viral elimination, reduces the duration of the disease, and decreases the risk of complications. The mechanism of action is realized at the level of infected cells through activation of the factors of innate immunity suppressed by viral proteins. In experimental studies, in particular, it was shown that Ingavirin® increases the 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 endogenous interferon signals. The process is accompanied by activation (phosphorylation) of protein-transmitter STAT1 transmitting a signal to cell nucleus for induction of antiviral gene synthesis. 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 viral reproduction process.

The action of Ingavirin® preparation is based on significant decrease of cytopathic and cytodestructive action of the virus, decrease of the number of infected cells, restriction of the pathological process, normalization of composition and structure of cells and morphological tissue pattern in the infectious process zone both at early and late stages. 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 increases the effectiveness of therapy in the model of bacterial sepsis including that caused by penicillin-resistant strains of Staphylococcus aureus.

The conducted experimental toxicological studies demonstrate 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 no lethal doses of the drug were determined).
The preparation possesses no mutagenic, immunotoxic, allergizing and carcinogenic properties. Ingavirin® has no effect on reproductive function, has no embryotoxic and teratogenic action.

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

Intake and distribution
In the experiment with the radioactive label it was found that The active ingredient quickly enters the blood from the gastrointestinal tract, distributing to internal organs. In studies in healthy volunteers at a single dose of 90 mg of the drug maximum concentration (Cmax) was 441.45 ± 252.99 ng / ml; time of its achievement (Tmax) – 1.30 ± 0.41 hours.
In preclinical studies it was found that when taking the drug once a day it is accumulated in the internal organs and tissues. At that qualitative characteristics of pharmacokinetic curves after each administration of the preparation are identical: rapid increase of the preparation’s concentration after each injection of 0.5-1 hour after the intake, and then slow decrease by 24 hours. The AUC values (area under the pharmacokinetic curve “concentration-time”) of kidney, liver and lung are slightly higher than the AUC of blood. AUC values for spleen, adrenal glands, lymph nodes and thymus are lower than AUC in blood.

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

Elimation
In studies in healthy volunteers when taking the drug in a single 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 excretion occurs within 24 hours. During this period 80 % of the taken dose was eliminated: 34.8 % was eliminated in a time interval from 0 to 5 hours, and 45.2 % in a 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 (adenovirus, parainfluenza, respiratory syncytial infection, rhinovirus infection) in adults and children from 3 years old.

Active ingredient

Imidazolylethanamide of pentandioic acid

Composition

5 ml of the syrup contains:

the active ingredient:

imidazolylethanamide pentandioic acid – 30 mg;

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

How to take, the dosage

Intravenously.
Insert the syringe measure firmly into the neck of the bottle. Turn the bottle upside down and gently pull the piston down, taking the syrup to the desired mark. After use, rinse the syringe in warm water and dry it.

For the treatment and prevention of flu 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 of influenza and acute respiratory viral infections in adults and children from 7 years old is 5-7 days (depending on the severity of condition). Duration of flu and acute respiratory viral infections treatment in children from 3 to 6 years old – 5 days.
The drug shall be administered from the moment of the disease onset, preferably within 2 days after the disease onset.
Adults and children with severe symptoms and concomitant diseases (respiratory and cardiovascular diseases, diabetes, obesity) should take a double dose during the first 3 days of the disease and then continue taking the drug in the usual dosage for 2-4 days.
For prevention of flu and acute respiratory viral infections after contact with sick people the drug is prescribed for 7 days to adults and children from 7 years old, and for 5 days to children from 3 to 6 years old.

If therapy has not improved after 5 days, or if symptoms worsen, or if new symptoms develop, you should talk to your doctor. Use only in the amount and according to the directions, route of administration, and strength of the drug.

Interaction

Drug interactions of Ingavirin® have not been described.

Special Instructions

The simultaneous use of other antiviral medications without prior medical advice is not recommended.
Keep the instructions. You may need it again. If you have any questions, talk to your doctor.

Contraindications

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

Side effects

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

Overdose

There have been no reported cases of overdose of Ingavirin® to date.

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 you need to use the drug during breast-feeding should stop breast-feeding.

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Similarities

Inhavirin for children