Composition, form of production and packaging
? Capsules size 2, blue, on the cap of the capsule, a white logo in the form of a ring and the letter "H" inside the ring; the contents of the capsules are granules and white or white powder; conglomerates can be formed, easily crumbling with slight pressure.
1 caps.
imidazolylethanamide pentanedioic acid (vitaglutam) 30 mg
Excipients: lactose monohydrate - 30 mg, potato starch - 11.88 mg, silicon dioxide colloid (aerosil) - 0.73 mg, magnesium stearate - 0.73 mg.
The composition of the capsule shell: 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%.
Ink composition for the logo: shellac, propylene glycol (E1520), titanium dioxide (E171).
7 pcs. - packings of cellular contour (1) - packs.
7 pcs. - packings of cellular outline (2) - packs.
? Capsules size 2, red, on the cap of the capsule, a white logo in the form of a ring and the letter "H" inside the ring; the contents of the capsules are granules and white or white powder; conglomerates can be formed, easily crumbling with slight pressure.
1 caps.
imidazolylethanamide pentanedioic acid (vitaglutam) 90 mg
Excipients: lactose monohydrate - 90 mg, potato starch - 35.6 mg, silicon dioxide colloid (aerosil) - 2.2 mg, magnesium stearate - 2.2 mg.
The composition of the capsule shell: 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).
7 pcs. - packings of cellular contour (1) - packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
PHARMACHOLOGIC EFFECT
Antiviral drug.
In preclinical and clinical studies, the effectiveness of Ingavirin В® against influenza A viruses (A / H1N1, including "pork" A / H1N1 pdm09, A / H3N2), A / H5N1)) and type B, adenovirus, parainfluenza virus, respiratory syncytial virus; in preclinical studies: coronavirus, metapneumovirus, enteroviruses, incl. Coxsackie virus and rhinovirus.
Ingavirin В® helps accelerate 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 В® 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 the signals of endogenous interferon. The process is accompanied by the activation (phosphorylation) of the transmitting protein STAT1, which transmits the 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.
Preparation Ingavirin В® causes an increase in the content of interferon in the blood to the physiological norm, stimulates and normalizes the reduced ОІ-interferon producing ability of blood leukocytes, stimulates ОІ-interferon producing capacity 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 (tumor necrosis factor (TNF-?), Interleukins (IL-1? And IL-6)), decreased myeloperoxidase activity.
In experimental studies, it was shown that the combined use of Ingavirin В® 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 profile of the drug safety.
PHARMACOKINETICS
Suction and distribution
When used in recommended doses, the determination of the drug in blood plasma by available techniques is not possible.
In experimental studies using a radioactive label, it was found that the drug quickly enters the blood from the digestive tract and is evenly distributed throughout the internal organs.
C max in the blood, blood plasma and most organs are achieved 30 minutes after the administration of the drug. The values ​​of AUC of the kidneys, liver and lungs are slightly higher than the blood AUC (43.77 μg · h / g). The values ​​of AUC of the spleen, adrenal glands, lymph nodes and thymus are below the blood AUC. The average retention time of the drug in the blood is 37.2 h.
With a course of taking the drug 1 time / day, it accumulates in the internal organs and tissues. In this case, 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 and excretion
It is not metabolized in the body and is excreted unchanged .
The main elimination process occurs within 24 hours. During this time, 80% of the dose is taken out. During the first 5 hours, 34.8% are withdrawn, in the following hours - 45.2%. Of these, 77% are excreted through the intestine, 23% through the kidneys.
INDICATIONS
- treatment of influenza A and B and other ARVI (adenovirus infection, parainfluenza, respiratory syncytial infection) in adults;
- prevention of influenza A and B and other ARVI in adults;
- treatment of influenza A and B and other ARVI (adenovirus infection, parainfluenza, respiratory syncytial infection) in children from 7 to 17 years (for Ingavirin В®60 mg).
DOSING MODE
The drug should be taken orally, regardless of food intake.
To treat influenza and SARS, adults are prescribed 90 mg once a day, children and adolescents aged 13 to 17 years - 60 mg 1 time / day.
The duration of treatment is 5-7 days (depending on the severity of the condition).
The drug should be taken from the moment the first symptoms appear, preferably no later than 2 days after the onset of the disease.
For the prevention of influenza and SARS after contact with sick persons, adults are prescribed 90 mg 1 time / day for 7 days.
SIDE EFFECT
Rarely: allergic reactions.
CONTRAINDICATIONS
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
- Pregnancy;
- lactation period;
- children and adolescents under 18 years for the indication "Prevention of influenza A and B and other ARI";
- Children under 7 years old (for Ingavirin В® 60 mg) for indication "Treatment of influenza A and B and other ARVI (adenovirus infection, parainfluenza, respiratory syncytial infection)";
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
The use of the drug in pregnancy has not been studied.
The use of the drug in the lactation period has not been studied, therefore, if it is necessary to use the drug during lactation, breastfeeding should be stopped.
APPLICATION FOR CHILDREN
Contraindicated in children and adolescents under 18 years for the indication "Prevention of influenza A and B and other ARI"; in children under 7 years (for Ingavirin В® 60 mg) for the indication "Treatment of influenza A and B and other ARVI (adenovirus infection, parainfluenza, respiratory syncytial infection)."
SPECIAL INSTRUCTIONS
In terms of acute toxicity, Ingavirin В® belongs to the 4th toxicity class - "Malotoxic substances" (when determining LD 50 in acute toxicity experiments, it was not possible to determine the lethal dose of the drug).
The drug does not have mutagenic, immunotoxic, allergic and carcinogenic properties, does not have a local irritant effect. The drug Ingavirin В® does not affect reproductive function, does not have embryotoxic and teratogenic effects.
Impact on the ability to drive vehicles and manage mechanisms
It has not been studied, however, considering the mechanism of action and the profile of adverse reactions, it can be assumed that the drug does not affect the ability to drive vehicles and mechanisms.
Ingavirin В® does not have a sedative effect, does not affect the rate of psychomotor reaction, the drug can be used in people of various professions, including. requiring increased attention and coordination of movements.
OVERDOSE
Cases of drug overdose are not described.
DRUG INTERACTION
The cases of interaction of Ingavirin В® with other medications have not been revealed.
It is not recommended to take other antiviral drugs at the same time.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, protected from light at a temperature of no higher than 25 В° C. Shelf life - 3 years.
