Active substanceImidazolylethanamide of pentanedioic acidImidazolylethanamide of pentanedioic acid
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  • Ingavirin®
    capsules inwards 
    VALENTA PHARM, PAO     Russia
  • Ingavirin®
    capsules inwards 
    VALENTA PHARM, PAO     Russia
  • Dosage form: & nbspcapsules
    Composition:

    1 capsule contains:

    active substance: imidazolylethanamide pentanedioic acid (vitaglutam) in terms of 100% substance 60.00 mg;

    Excipients: lactose monohydrate 60.00 mg, potato starch 23.72 mg, silicon dioxide colloid (aerosil) 1.47 mg, magnesium stearate 1.47 mg;

    capsules, hard gelatinous: titanium dioxide E 171-10000%, iron oxide pigment yellow E 172 1.0000%, gelatin up to 100%:

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

    Description:

    Capsules of yellow color. 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 are granules and white or almost white powder; conglomerates can be formed, easily crumbling with slight pressure.

    Pharmacotherapeutic group:Antiviral and immunostimulating agent
    ATX: & nbsp

    J.05.A.X   Other antiviral drugs

    V.03.A.F   Drugs that reduce the toxicity of cytostatic therapy

    Pharmacodynamics:

    Antiviral drug.

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

    Ingavirin ® helps to 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® 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 causes an increase in the content of interferon in the blood to the 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 in relation 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-α), interleukins (IL-1β and IL-6)), a decrease in the activity of myeloperoxidase.

    In experimental studies, it has been shown that sharing the drug Ingavirin® with antibiotics increases the effectiveness of therapy on a model of bacterial sepsis, including those caused by penicillin-resistant strains and staphylococcus.

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

    According to the acute toxicity parameters, Ingavirin ® belongs to the 4th toxicity class - "Malotoxic 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, allergic and carcinogenic properties, does not have a local irritant effect. Ingavirin ® does not affect reproductive function, does not have embryotoxic and teratogenic effects.

    Efficacy in children

    In a double-blind, randomized, placebo-controlled, multicenter study to assess the clinical efficacy and safety Ingavirin drug in a daily dose of 60 mg for the treatment of influenza and other acute respiratory viral infections in 180 children aged 13-17 years it has shown that the drug Ingavirin significantly superior to placebo, faster normalizing body temperature, stopping intoxication, fever, catarrhal phenomena.

    Double-blind, randomized, placebo-controlled, multicenter study to assess the clinical efficacy and safety Ingavirin drug in a daily dose of 60 mg for the treatment of influenza and other acute respiratory viral infections in 310 children aged 7-12 years showed that the drug Yinggavirin® has significantly greater efficacy compared with placebo and provides a faster (an average of 18 hours) reductionbody temperature and the disappearance of symptoms of intoxication (sore throat, perspiration, swallowing pain, nasal congestion, runny nose).
    Pharmacokinetics:

    Suction 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 gastrointestinal tract. Evenly distributed to internal organs. Maximum concentrations in the blood, blood plasma and most organs are reached 30 minutes after the administration of the drug. The values ​​of AUC (the area under the pharmacokinetic curve "concentration-time") of the kidneys, liver and lungs slightly exceed the blood AUC (43.77 μg-h / g). The AUC values ​​for the spleen, adrenal glands, lymph nodes and thymus are lower than the blood AUC. MRT (average retention time) in the blood - 37.2 h.

    With a course of taking the drug once in day, it accumulates in 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 hour after administration and then a slow decrease to 24 hours.

    Metabolism

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

    Excretion

    The main elimination process takes place within 24 hours. During this period, 80% of the dose is taken: 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. Of these, 77% are excreted through the intestine and 23% through the kidneys.

    Indications:

    Treatment of influenza A and B and other acute respiratory viral infections (adenovirus infection, parainfluenza, respiratory syncytial 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.

    Contraindications:

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

    Deficiency of lactase, lactose intolerance, glucose-galaktose malabsorption.

    Pregnancy.

    Breastfeeding period.

    Children under 7 years.

    This dosage form is not intended for use in persons 18 years of age or older (it is necessary to use dosage forms that make it possible to take Ingavirin ® in a dose of 90 mg).

    Pregnancy and lactation:

    The use of the drug during pregnancy has not been studied, application of drug during lactation has not been studied, so if you need to use the drug during lactation should stop the difficult feeding.

    Dosing and Administration:

    Inside. Regardless of food intake.

    To treat influenza and acute respiratory viral infections, children from 7 to 17 years are prescribed 1 capsule (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. </ p> <p> For the prevention of influenza and acute respiratory viral infections after contact with sick persons, children from 7 to 17 years are prescribed 1 capsule (60 mg) 1 time per day for 7 days.

    Side effects:

    Allergic reactions (rarely).

    Overdose:

    On cases of drug overdose Ingavirin® to date not reported.

    Interaction:

    Drug interaction of Ingavirin ® is not described.

    Special instructions:

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

    Effect on the ability to drive transp. cf. and fur:

    Not studied. However, considering the mechanism of action and the profile of adverse reactions,that the drug does not affect the ability to drive vehicles, mechanisms.

    Form release / dosage:

    Capsules 60 mg.

    Packaging:

    For 7 capsules and a contour mesh package or in a contour cellular package with a perforation made of a polyvinylchloride film and aluminum foil printed lacquered.

    One outline package together with the instruction for use is placed in a bundle.

    Storage conditions:

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

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use, after the expiration date stated on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-002968
    Date of registration:23.04.2015 / 07.03.2017
    Expiration Date:23.04.2020
    The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia
    Manufacturer: & nbsp
    Representation: & nbspVALENTA PHARM, PAO VALENTA PHARM, PAO Russia
    Information update date: & nbsp06.11.2017
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