Ingavirin, 90 mg capsules 10 pcs

Antiviral drug.

In preclinical and clinical studies demonstrated the effectiveness of Ingavirin® 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. In clinical research in outpatients with mild course COVID-19 Ingavirin® shortened time to clinical recovery.

The mechanism of action is realized at the level of infected cells through activation of innate immunity factors suppressed by viral proteins. Experimental studies showed that Ingavirin® increases the expression of the interferon receptor of the first type IFNAR on the surface of epithelial and immunocompetent cells. The increase in the 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 signals to the cell nucleus for induction of synthesis of antiviral genes. It was shown that under infection conditions 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 virus action signs, reducing the number of infected cells, restriction of pathological process, normalization of cell composition and structure and tissue morphological pattern in the infectious process zone both at early and late stages.

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

In experimental studies it was shown that combined usage of Ingavirin® with antibiotics improves the efficiency of therapy on the model of bacterial sepsis including that caused by penicillin – resistant strains of Staphylococcus aureus.

The conducted experimental toxicological studies demonstrate the 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 lethal doses of the drug were not determined).

The drug has no mutagenic, immunotoxic, allergic and carcinogenic properties. Ingavirin® has no effect on reproductive function, has no embryotoxic and teratogenic effect.

There is no effect of Ingavirin® on the hematopoietic system when using the age appropriate dose in the recommended scheme and course.

absorption and distribution.

In the experiment using the radioactive label it was found: the drug quickly enters the blood from the gastrointestinal tract, distributing to internal organs. Maximum concentrations in blood, plasma and most organs are reached 30 minutes after drug administration. 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 administered once daily the drug is accumulated in internal organs and tissues. In this case qualitative characteristics of pharmacokinetic curves after each drug administration are identical: rapid increase of the drug concentration after each administration in 0.5-1 hour after the administration and then slow decrease by 24 hours.

Metabolism.

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

Elimation.

The main process of excretion occurs within 24 hours. During this period 80 % of taken 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 % are excreted through the intestine and 23 % – through the kidneys.

Metabolism.

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

Elimation.

The main process of excretion occurs within 24 hours. During this period 80 % of taken 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% 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

One capsule contains:

active ingredient: imidazolylethanamide pentandioic acid (vitaglutam) in terms of 100% substance – 90.00 mg;

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

solid gelatin capsules:

for a dose of 90 mg -titanium dioxide E 171, crimson [Ponceau 4 R] dye E 124, azorubin dye E 122, quinoline yellow dye E 104, gelatin;

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

How to take, the dosage

Orally. Regardless of the meal.

In children from 3 to 6 years who have difficulty swallowing the capsule may dilute the contents of the capsule in water or apple juice. To do this you should gently open the capsule over a bowl with a small amount (50-70 ml) of boiled water or apple juice at room temperature, pour the contents of the capsule into the water or juice, stir the mixture for 20 seconds and drink it in whole. It is allowed to add sugar.

The mixture should be prepared immediately before taking it; the ready mix should not be stored.
For the treatment and prevention of influenza and acute respiratory viral infections in adults 90 mg once a day, in children over 7 years – 60 mg once a day, children from 3 to 6 years – 30 mg once a day.

Duration of treatment of influenza and acute respiratory viral infections in adults and children over 7 years old – 5-7 days (depending on the severity of the condition). Duration of treatment of influenza and acute respiratory viral infections in children from 3 to 6 years old – 5 days. The preparation is begun from the moment of the disease symptoms appearance, it is better not later than within 2 days after the disease beginning.

Adults and children with severe symptoms and also in presence of accompanying diseases (respiratory and cardio-vascular diseases, diabetes, obesity) should take double dose during the first three days of the disease and then continue taking the preparation in the usual dosage during 2-4 days.

For prevention of flu and acute respiratory viral infections after contact with sick people the preparation is prescribed to adults and children over 7 years old for 7 days, children from 3 to 6 years old – for 5 days.

If after 5 days of treatment the improvement is not observed or the symptoms worsen, or new symptoms appear, you should consult a physician. Use the drug only according to the indications, the method of administration and in the doses specified in the instructions.

Interaction

Drug interaction of Ingavirin® has not been described.

Special Instructions

It is not recommended to take other antiviral drugs at the same time without first consulting your doctor.

Keep the instructions. You may need it again.

If you have any questions, consult your doctor.

Synopsis

Capsules № 2 or № 3 are red (for 90 mg dosage). 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 – pellets and powder of white or almost white; conglomerates are allowed to form, falling apart easily under light pressure.

Contraindications

• High sensitivity to the active ingredient or any other component of the drug.
• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
• Pregnancy.
• Breast-feeding period.
• Children under 3 years old.

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Side effects

Allergic reactions (rare).

If any of the side effects listed in the instructions are aggravated 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 lactation, stop breastfeeding.

Similarities

Inhavirin for children