Composition
One capsule contains:
Active ingredient:
Imidazolylidene pentandiol acid (betaglucan) in terms of 100% substance to 60.00 mg;
excipients: lactose monohydrate, potato starch, silicon dioxide colloid (Aerosil), magnesium stearate;
capsule hard gelatin, titanium dioxide E 171, dye iron oxide yellow E 172, gelatin;
ink composition for logo: shellac, propylene glycol E 1520, titanium dioxide E 171.
Pharmacological action
Antiviral agent. Anti-inflammatory agent.
ATX code: [J05AX].
Pharmacological properties
Pharmacodynamics
An antiviral drug.
In preclinical and clinical studies, the effectiveness of Ingavirin® 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 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 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 of Ingavirin® it 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. Ingavirin® it does not affect the reproductive function, does not have embryotoxic and teratogenic effects.
No effect of Ingavirin® effect on the hematopoietic system when taking an age-appropriate dose by the recommended regimen and course.
Pharmacokinetics
Suction and distribution.
In an experiment using a radioactive label, it was found that the drug quickly enters the bloodstream from the gastrointestinal tract, being distributed to internal organs. Maximum concentrations in the blood, blood plasma, and most organs are reached 30 minutes after use of the drug. The AUC values (area under the pharmacokinetic curve “concentration – time”) of the kidneys, liver and lungs slightly exceed the AUC of blood (43.77 mcg. h/g). The AUC values for the spleen, adrenal glands, lymph nodes, and thymus are lower than the blood AUC. MRT (average drug retention time) in the blood is 37.2 hours.
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 use of the drug are identical: a rapid increase in the concentration of the drug after each use in 0.5-1 hour after use and then a slow decrease by 24 hours.
Metabolism.
The drug is not metabolized in the body and is excreted unchanged.
Output.
The main elimination process takes place 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 of influenza A and B and other acute respiratory viral infections (adenovirus infection, 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.
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 lactation, breastfeeding should be discontinued.
Contraindications
Hypersensitivity to the Active ingredient or any other component of the drug.
Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
Pregnancy.
Breast-feeding period.
Children under 7 years of age.
This dosage form is not intended for use in persons 18 years and older (it is necessary to use dosage forms that provide the possibility of taking Ingavirin® at a dose of 90 mg).
Side effects
Allergic reactions (rare).
Interaction
The drug interaction of Ingavirin® is not described.
How to take, course of use and dosage
Inside. Regardless of the meal.
For the treatment of influenza and acute respiratory viral infections, children from 7 to 17 years of age are prescribed 1 capsule (60 mg) 1 time a day. The duration of treatment is 5-7 days (depending on the severity of the condition). 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.
With severe symptoms, as well as in the presence of concomitant diseases (diseases of the respiratory and cardiovascular systems, diabetes mellitus, obesity), you should take a double dose of the drug in the first three days of the disease, then continue taking it in the usual dosage for 2-4 days.
For the prevention of influenza and acute respiratory viral infections after contact with sick people, children from 7 to 17 years of age are prescribed 1 capsule (60 mg) 1 time a day, for 7 days.
If there is no improvement after 5 days of treatment, or if symptoms worsen, or new symptoms appear, you should consult your doctor. Use the drug only according to the indications, the method of application and in the doses indicated in the instructions.
Overdose
No cases of Ingavirin overdose have been reported to date.
Description
Capsules are yellow in color. The capsule cap has a white logo in the form of a ring and a letter And inside the ring.
The contents of the capsules are granules and powder of white or almost white color; conglomerates are allowed to form, which easily crumble with light pressure.
Special instructions
It is not recommended to take other antiviral drugs at the same time without first consulting a doctor.
Save the instructions. You may need it again. If you have any questions, contact your doctor.
Form of production
Capsules of 60 mg.
7 or 10 capsules in a contour cell package or in a contour cell package with perforation made of polyvinyl chloride film and aluminum foil printed varnished.
One contour package together with the instructions for use is placed in a pack.
Storage conditions
In a dry place, protected from light and out of reach of children, at a temperature not exceeding 25°C.
Shelf
life is 3 years. Do not use after the expiration date indicated on the package.
Active ingredient
Pentanedioic Acid Imidazolylethanamide
Dosage form
Capsules
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Side effects of Ingavirin capsules 60mg, 10pcs.
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