Pharmacodynamics. The active substance is inosine pranobex (molecular complex inosine: p-acetamidobenzoic acid: n, n-dimethylamino-2-propanol in a ratio of 1: 3: 3) has a direct antiviral and immunomodulatory effect. The direct antiviral effect is due to the binding of cells affected by the virus to the ribosomes, which slows down the synthesis of viral i-RNA (violation of transcription and translation) and leads to inhibition of the replication of RNA and DNA genomic viruses; the mediated effect is explained by the powerful induction of interferon production. The immunomodulatory effect is due to the effect on t-lymphocytes (activation of cytokine synthesis) and an increase in the phagocytic activity of macrophages. under the influence of the preparation, the differentiation of pre-t-lymphocytes is enhanced, the proliferation of t- and b-lymphocytes induced by mitogens is stimulated, the functional activity of t-lymphocytes increases, including their ability to form lymphokines, the ratio between subpopulations of t-helpers and t-suppressors is normalized ( the immunoregulatory index cd4 / cd8 is restored). The preparation significantly enhances the production of interleukin-2 by lymphocytes and promotes the expression of receptors for this interleukin on lymphoid cells; also stimulates the activity of natural killer cells (nk cells) even in healthy people; stimulates the activity of macrophages to phagocytosis, processing and presentation of antigen, which contributes to an increase in the number of antibody-producing cells in the body from the very first days of treatment. It also stimulates the synthesis of interleukin-1, microbicidal activity, the expression of membrane receptors and the ability to respond to lymphokines and chemotactic factors. With herpes infection, the formation of specific antiherpetic antibodies is significantly accelerated, clinical manifestations and the frequency of relapses decrease. The preparation also prevents post-viral weakening of cell synthesis of rna and protein in infected cells, which is especially important for cells involved in the processes of the body's immune defense. As a result of such a complex action, the viral load on the body decreases, the activity of the immune system is normalized, the synthesis of its own interferons is significantly activated, which contributes to resistance to infectious diseases and the rapid localization of the focus of infection in case of its occurrence.
Pharmacokinetics. The preparation has a high bioavailability, after oral administration it is rapidly absorbed, Cmax of inosine in blood plasma is reached after 1 hour; the pharmacological action appears after about 30 minutes and lasts up to 6 hours. Inosine is metabolized in a cycle typical for purine nucleosides with the formation of uric acid; other components are excreted by the kidneys in the form of glucuronic and oxidized derivatives, as well as unchanged. No cumulation was detected in the body. Complete elimination of the preparation and its metabolites occurs after 48 hours.
Infectious diseases of viral etiology in patients with normal and reduced immune status: influenza, parainfluenza, ARVI, bronchitis of viral etiology, rhinitis and adenovirus infections; mumps, measles;
diseases caused by herpes simplex viruses Herpes simplex type I or II (herpes of the lips, facial skin, oral mucosa, skin of the hands, ophthalmic herpes), subacute sclerosing panencephalitis, genital herpes; Varicella zoster virus (chickenpox and shingles, including recurrent in patients with immunodeficiency); Epstein-Barr virus (infectious mononucleosis); cytomegalovirus; human papillomavirus; acute and chronic viral hepatitis B;
chronic recurrent infections of the respiratory tract and genitourinary system in patients with weakened immunity (chlamydia and other diseases caused by intracellular pathogens).
Recommended doses and dosage regimens of the medicinal product:
bronchitis of viral etiology:
aphthous stomatitis:
shingles and herpes labialis:
genital herpes: in the acute period - 20 ml of syrup 3 times a day for 5-6 days; during the period of remission, the maintenance dose is 20 ml of syrup (1000 mg) once a day for up to 6 months;
Hepatitis B:
To restore the function of the immune system and achieve a stable immunomodulatory effect in patients with weakened immunity, the course of treatment should last from 3 to 9 weeks.
Hypersensitivity to inosine pranobex and other components of the preparation; gout, urolithiasis, severe renal failure, grade III, hyperuricemia.
The preparation is generally well tolerated even with prolonged use. the most common adverse reaction is a short-term and insignificant (usually within the normal range) increase in the concentration of uric acid in blood plasma and urine (caused by the metabolism of inosine), which normalizes a few days after the end of the preparation.
Laboratory tests: an increase in the level of uric acid in the blood, an increase in the level of uric acid in the urine, an increase in the level of urea nitrogen in the blood, an increase in the level of transaminases, an increase in the level of alkaline phosphatase in the blood.
From the nervous system: headache, dizziness, fatigue, malaise, sleep disturbances.
From the digestive tract: nausea, vomiting, pain in the abdominal region, diarrhea, constipation, lack of appetite.
On the part of the skin and subcutaneous tissue: itching, skin rashes, urticaria.
From the immune system: hypersensitivity reactions (including angioedema).
From the side of the psyche: nervousness.
From the liver and biliary tract: an increase in the level of transaminases, alkaline phosphatase or urea nitrogen in the blood.
From the musculoskeletal system and connective tissues: joint pain.
From the kidneys and urinary tract: polyuria (increased urine volume).
It is known that during the post-marketing study, adverse reactions were recorded, the frequency of which cannot be determined from the available data:
from the digestive tract: abdominal pain (in the upper abdomen);
from the immune system: anaphylactic reactions, anaphylactic shock, angioedema, hypersensitivity, urticaria;
on the part of the skin and subcutaneous tissue: erythema.
It should be remembered that novirin, like other antiviral agents, is most effective for acute viral infections if treatment is started at an early stage of the disease (preferably on the first day). the preparation is used both for monotherapy and in complex treatment with antibiotics, antiviral and other etiotropic agents.
The active substance of the preparation is metabolized to uric acid and can cause a significant increase in its concentration in the urine. In this regard, Novirin is used with caution in patients with a history of gout and hyperuricemia, urolithiasis and renal failure. If it is necessary to use the preparation in these patients, the concentration of uric acid should be carefully monitored. With prolonged use (3 months or longer), it is advisable to monthly monitor the concentration of uric acid in blood plasma and urine, liver function, peripheral blood composition and parameters of renal function.
Some people may experience acute hypersensitivity reactions (angioedema, anaphylactic shock, urticaria). In such cases, preparation therapy should be discontinued.
With prolonged use of the preparation, there is a risk of developing nephrolithiasis.
Elderly patients. There is no need to change the dose, the preparation is used in the dosage for adults. In elderly people more often than in middle-aged people, an increase in the level of uric acid in blood plasma and urine is noted.
Use during pregnancy and lactation. Due to the lack of studies on the safety of the preparation, it is not recommended to prescribe it during pregnancy or lactation.
Children. The preparation is used in children over the age of 1 year.
The ability to influence the reaction rate when driving or working with other mechanisms. The effect of the preparation on the reaction rate when driving vehicles or working with other mechanisms has not been studied. However, in order to make a decision about driving a car or working with other mechanisms, it is necessary to take into account that the preparation may cause dizziness or other adverse reactions from the nervous system.
Do not take this medicine at the same time as immunosuppressants. use with caution in patients taking xanthine oxidase inhibitors (for example allopurinol) and agents that increase the excretion of uric acid in the urine, including thiazide diuretics (for example hydrochlorothiazide, chlorthalidone, indapamide) and loop diuretics (simultaneous use with azidothymidine, an increase in the formation of azidothymidine increases the formation of azidothymidine) plasma and an increase in intracellular phosphorylation in human blood monocytes.
No cases of overdose were noted.
Overdose can cause an increase in the concentration of uric acid in blood plasma and urine. In case of an overdose, gastric lavage and symptomatic therapy are indicated.
At a temperature not exceeding 25 ° c.
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