Instruction for use: Ingavirin

Dosage form: Capsules

Active substance: Acidi pentandioici imidazolylaethanamidum

ATX

J05AX Other antivirals

Pharmacological group:

Anti-inflammatory and immunomodulating agent [Other immunomodulators]

The nosological classification (ICD-10)

B34.0 Adenovirus infection, unspecified: Adenovirus infection

B97.4 Respiratory syncytial virus

J10 Influenza caused by an identified influenza virus: Influenza A; Influenza B; Influenza A type; Influenza A of type B

J11 Influenza, virus not identified: Influenza; Influenza in the early stages of the disease; Influenza in children; cold in the chest; Begins flu-like condition; Acute disease parainfluenza; parainfluenza; parainfluenza state; influenza epidemics; The pains of the influenza

J12.1 Pneumonia caused by respiratory syncytial virus: Respiratory-syncytial infection

J22 Acute respiratory infection of lower respiratory tract, unspecified: Bacterial respiratory disease; Bacterial infections of the lower respiratory tract; Bacterial infections of the respiratory system; Viral respiratory disease; Viral respiratory tract infections; Inflammatory respiratory disease;; Difficult sputum separation in acute and chronic respiratory diseases; Respiratory tract infections; Respiratory and lung infections; Lower respiratory tract infections; Infections of the lower respiratory tract; Infectious inflammation of the respiratory tract; Infectious diseases of the respiratory tract; Infectious diseases of the lungs; Infectious diseases of the respiratory system; Respiratory tract infection; Cough for colds; Pulmonary infection; Acute respiratory tract infection; Acute respiratory viral infection; Acute inflammatory airway disease; Acute respiratory disease; Respiratory infection; Respiratory and viral infections; Respiratory syncytial viral infection in young children; Respiratory diseases; Respiratory infections

Composition

Capsules - 1 caps.

active substance: Imidazolylethanamide pentanedioic acid (vitaglutam) 30/90 mg

(In terms of 100% of the substance)

Auxiliary substances: lactose monohydrate - 30/90 mg; Potato starch - 11.88 / 35.60 mg; Silicon dioxide colloid (aerosil) - 0.73 / 2.2 mg; Magnesium stearate - 0.73 / 2.2 mg

Capsule shell

Capsules, 30 mg: titanium dioxide (E171) - 2%; Dye diamond black (E151) - 0.1533%; Dye blue patented (E131) - 0.1314%; Dye crimson (Ponso 4R) (E124) - 0.0192%; Dye azorubin (E122) - 0.0821%; Gelatin - up to 100%

Capsules, 90 mg: titanium dioxide (E171) - 1.3333%; Dye crimson (Ponso 4R) (E124) - 0.0008%; Dye azorubin (E122) - 0.3066%; Dye quinoline yellow (E104) - 0.4207%; Gelatin - up to 100%

Ink composition for the logo: shellac; Propylene glycol (E1520); Titanium dioxide (E171)

Description of dosage form

Capsules, 30 mg: size 2, blue.

Capsules, 90 mg: size 2, red. The cap of the capsule has a white logo in the form of a ring and the letter "I" inside the ring.

Contents of capsules: granules and powder of white or almost white color; It is possible to form conglomerates, easily crumbling with slight pressure.

Pharmachologic effect

Mode of action - antiviral, anti-inflammatory, immunomodulating.

Pharmacodynamics

Antiviral drug.

In pre-clinical and clinical studies, the effectiveness of Ingavirin® against influenza A (A (H1N1)) viruses, including pork A (H1N1) pdm09, A (H3N2), A (H5N1) and type B, adenovirus, virus Parainfluenza, respiratory syncytial virus, preclinical studies: coronavirus, metapneumovirus, enteroviruses, including the Coxsackie virus and rhinovirus.

Ingavirin ® helps to speed up the elimination of viruses, reduce the duration of the disease, reduce the risk of complications.

The mechanism of action is realized at the level of infected cells due to stimulation of the factors of innate immunity, suppressed by viral proteins. In experimental studies, in particular, it was shown that the Ingavirin® preparation increases the expression of IFNAR-1 interferon 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 of endogenous interferon. The process is accompanied by the activation (phosphorylation) of the protein - the STAT1 transmitter, which transmits a signal to the nucleus of the cell to induce antiviral genes. It is shown that under the conditions of infection the preparation stimulates the production of the antiviral effector protein MxA, which inhibits the intracellular transport of ribonucleoproteins of various viruses, slowing the process of viral replication.

The drug Ingavirin® causes an increase in the content of interferon in the blood to a physiological norm, stimulates and normalizes the reduced α-interferon producing ability of blood leukocytes, stimulates γ-interferon producing ability of leukocytes. Causes the generation of cytotoxic lymphocytes and increases the content of NK-T cells, which have a high killer activity with respect to virus-infected cells.

The anti-inflammatory effect is due to the suppression of the production of key pro-inflammatory cytokines (TNF-α), IL (IL-1β and IL-6), decreased myeloperoxidase activity.

In experimental studies, it was shown that the combined use of Ingavirin® with antibiotics increases the effectiveness of therapy on the model of bacterial sepsis, including. Caused by penicillin-resistant strains of staphylococcus.

The conducted experimental toxicological studies indicate a low level of toxicity and a high safety profile of the drug.

On the parameters of acute toxicity, Ingavirin ® belongs to the 4th toxicity class - "Malotoxic substances" (LD50 was not detected in acute toxicity experiments).

The drug does not have mutagenic, immunotoxic, allergic and carcinogenic properties, does not have a local irritant effect. Ingavirin ® does not affect reproductive function, does not have embryotoxic and teratogenic effects.

Pharmacokinetics

Absorption and distribution. In recommended doses, the determination of the drug in blood plasma by available techniques is not possible.

In an experiment using a radioactive label, it was found that the drug quickly enters the blood from the digestive tract. Evenly distributed to internal organs. Cmax in the blood plasma and most organs is achieved 30 minutes after the administration of the drug. The AUC values for the kidneys, liver and lungs are slightly higher than the blood AUC (43.77 mkg · h / ml). The AUC values for the spleen, adrenal glands, lymph nodes and thymus are lower than the AUC in the blood. MRT (average retention time) in the blood - 37.2 h.

With 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 were identical: a rapid increase in the drug concentration after each injection 0.5-1 h after administration and then a slow decrease to 24 h.

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

Excretion. The main elimination process occurs within 24 hours. During this period, 80% of the administered dose is withdrawn: 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. 77 % Of the drug and 23% through the kidneys.

Indication of the Ingavirin

Treatment of influenza A and B and other acute respiratory viral infections (adenovirus infection, parainfluenza, respiratory syncytial infection) in adults and children 13 years of age;

Prevention of influenza A and B and other acute respiratory viral infections in adults.

Contraindications

Hypersensitivity to the active substance or any other component of the drug;

Deficiency of lactase, lactose intolerance, glucose-galactose malabsorption;

pregnancy;

The period of breastfeeding;

Children under the age of 13 for "treatment of influenza A and B and other acute respiratory viral infections (adenovirus infection, parainfluenza, respiratory syncytial infection)";

Children under 18 years of age to testify "prevention of influenza A and B and other acute respiratory viral infections."

Application in pregnancy and breastfeeding

The use of the drug during pregnancy and lactation has not been studied. If it is necessary to use the drug during lactation, breastfeeding should be stopped.

Side effects

Allergic reactions (rarely).

Interaction

There were no cases of interaction of Ingavirin ® with other drugs.

Dosing and Administration

Inside, regardless of food intake.

For treatment of influenza and acute respiratory viral infections, adults are prescribed 90 mg once a day, children from 13 to 17 years - 60 mg once a day.

Duration of treatment is 5-7 days (depending on the severity of the condition). Acceptance of the drug begins with the appearance of the first symptoms of the disease, preferably no later than 2 days from the onset of the disease.

To prevent influenza and acute respiratory viral infections after contact with sick persons, adults are prescribed 90 mg once a day, for 7 days.

Overdose

Cases of drug overdose are not described.

Special instructions

The drug does not have a sedative effect, does not affect the speed of the psychomotor reaction and can be used in persons of various professions, including. Requiring increased attention and coordination of movements.

It is not recommended to take other antiviral drugs at the same time.

Influence on ability to drive vehicles, mechanisms. Not studied, but considering the mechanism of action and the profile of adverse reactions, it can be assumed that the drug has no effect on the ability to drive vehicles, mechanisms.

Release form

Capsules, 30 mg and 90 mg. For 7 caps. In a planar cell packaging made of PVC film and aluminum foil printed lacquered. 1 or 2 contiguous cell packs (for a dosage of 30 mg) or 1 circuit cell pack (for a dosage of 90 mg), together with the instructions for use, are placed in a cardboard pack.

Manufacturer

JSC "Valenta Pharmaceutics". Moscow Region

Claims from customers are accepted by the manufacturer: JSC "Valenta Pharmaceuticals", Russia, Moscow region

Conditions of supply of pharmacies

Without recipe.

Storage conditions of the drug Ingavirin

In dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Ingavirin

3 years.

Do not use after the expiry date printed on the package.