Instructions for Novirin syrup 50 mg/ml bottle 120 ml
Composition
active ingredient: inosine pranobex;
1 ml of syrup contains 50 mg of inosine pranobex (50 mg/ml);
excipients: sucrose, glycerin, methylparaben (methyl parahydroxybenzoate) (E 218), propylparaben (propyl parahydroxybenzoate) (E 216), citrus flavoring, purified water.
Dosage form
Syrup.
Main physicochemical properties: transparent, light yellow liquid with a characteristic fruity odor.
Pharmacotherapeutic group
Direct-acting antivirals. ATX code J05A X05.
Pharmacological properties
Pharmacodynamics.
Inosine pranobex consists of two components: inosine - the active component, which is a purine metabolite, and the salt of 4-cetamidobenzoic acid with N, N-dimethylamino-2-propanol - an auxiliary component that increases the availability of inosine to lymphocytes.
The active substance inosine pranobex has a direct antiviral and immunomodulatory effect. The direct antiviral effect is due to binding to the ribosomes of virus-infected cells, which slows down the synthesis of viral mRNA (mRNA) and leads to inhibition of the replication of RNA and DNA genomic viruses; the indirect effect is due to the induction of interferon production.
In vivo studies have shown that inosine pranobex activates reduced synthesis of lymphocyte mRNA (mRNA) proteins and the efficiency of the translation process with simultaneous inhibition of viral RNA synthesis by the following mechanisms: incorporation of inosine-bound orotic acid into polyribosomes, inhibition of polyadenylic acid incorporation into viral mRNA (mRNA), and restructuring of lymphocyte intramembrane plasma particles (IMP), which almost triples their density.
The immunomodulatory effect is due to the effect on T-lymphocytes (activation of cytokine synthesis) and increased phagocytic activity of macrophages. Inosine pranobex enhances the differentiation of pre-T-lymphocytes, stimulates mitogen-induced proliferation of T- and B-lymphocytes, increases the functional activity of T-lymphocytes, including their ability to produce lymphokines, normalizes the ratio between the main regulatory subpopulations CD4+/CD8+ and contributes to the normalization of the formation of memory T-cells.
Inosine pranobex significantly enhances the production of interleukin-2 (IL-2) by lymphocytes and promotes the expression of receptors for this interleukin on lymphoid cells; it also stimulates the activity of natural killer (NK) cells; it stimulates the activity of macrophages for phagocytosis, processing and presentation of antigen, which contributes to the increase in antibody-producing cells in the body from the first days of treatment. Inosine pranobex also regulates the mechanisms of cytotoxicity of T-lymphocytes and NK cells.
Inosine pranobex stimulates interleukin-1 (IL-1) synthesis, microbicidal activity, membrane receptor expression, and the ability to respond to lymphokines and chemotactic factors.
In the course of well-known in vivo studies, a significant increase in endogenous gamma interferon (IFN-γ) production and a decrease in interleukin-4 (IL-4) production were observed.
In case of herpes infection, the formation of specific anti-herpetic antibodies is significantly accelerated, clinical manifestations and the frequency of relapses are reduced.
Inosine pranobex prevents post-viral weakening of cellular RNA and protein synthesis in infected cells, which is especially important for cells involved in the body's immune defense processes. As a result of such a complex action, the viral load on the body is reduced, the activity of the immune system is normalized, and the synthesis of its own interferons is significantly activated, which contributes to resistance to infectious diseases and rapid localization of the focus of infection in case of its occurrence.
Pharmacokinetics.
Inosine pranobex has high bioavailability. After oral administration, it is rapidly absorbed, the maximum concentration of inosine in plasma is reached after 1 hour; after 2 hours this concentration decreases to a level that cannot be determined. The half-life is 50 minutes. The pharmacological effect manifests itself after approximately 30 minutes and lasts up to 6 hours.
Inosine pranobex is rapidly metabolized and excreted by the kidneys.
Inosine is metabolized according to a cycle typical of purine nucleosides, with the formation of uric acid (the first metabolite), the concentration of which in the blood serum can sometimes increase, and the second metabolite (1-(dimethylamine)-2-propanol-(4-acetamidobenzoate)) is excreted by the kidneys in the form of glucuronides and partly in unchanged form.
No accumulation in the body has been detected. Complete elimination of metabolites occurs after 48 hours.
Indication
- Infectious diseases of viral etiology in patients with normal and reduced immune status: influenza, parainfluenza, acute respiratory viral infections, bronchitis of viral etiology, rhinovirus and adenovirus infections; mumps, measles.
- Chronic recurrent infections of the respiratory tract and genitourinary system in patients with weakened immunity (including chlamydia and other diseases caused by intracellular pathogens).
Contraindication
- Hypersensitivity to the active substance or to any of the excipients of the medicinal product.
- Acute attack of gout.
- Hyperuricemia.
Interaction with other medicinal products and other types of interactions
The drug should be prescribed with caution to patients taking xanthine oxidase inhibitors (e.g. allopurinol) and agents that increase urinary uric acid excretion, including thiazide diuretics (e.g. hydrochlorothiazide, chlorthalidone, indapamide) and loop diuretics (e.g. furosemide, torasemide, ethacrynic acid).
NovirinÒ, syrup, is not used simultaneously with immunosuppressants due to possible pharmacokinetic interactions, which may affect the expected therapeutic effect.
Concomitant use with zidovudine (azidothymidine) enhances nucleotide formation by zidovudine through various mechanisms, leading to increased serum bioavailability of zidovudine and increased intracellular phosphorylation in monocytes. This results in enhanced effects of zidovudine under the influence of Novirin.
Application features
It should be noted that Novirin, like other antiviral agents, is most effective in acute viral infections if treatment is started at an early stage of the disease (preferably on the first day). The drug is used both as monotherapy and in complex treatment with antibiotics and other etiotropic agents.
The active substance of the drug is metabolized to uric acid and can cause a significant increase in its concentration in the urine. In this regard, NovirinÒ is used with caution in patients with gout and hyperuricemia in history, urolithiasis and renal failure. If necessary, the use of the drug in these patients should be carefully monitored for uric acid concentration. With long-term use (3 months or longer), it is advisable to monitor the concentration of uric acid in the blood serum and urine, liver function, peripheral blood composition and kidney function parameters monthly.
Elderly patients. There is no need to change the dose, the drug is used in the dosage for adults. Elderly patients are more likely than middle-aged people to have an increase in serum and urine uric acid levels.
The syrup contains sucrose (sucrose), so it should be used with caution in patients with diabetes.
The preparation contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (possibly delayed) and in some cases, bronchospasm.
Use during pregnancy or breastfeeding
The drug is not recommended for use during pregnancy or breastfeeding due to the lack of clinical studies on its use during this period.
Ability to influence reaction speed when driving vehicles or other mechanisms
The effect of the drug on the reaction rate when driving or operating other mechanisms has not been studied. However, when making a decision about driving or operating other mechanisms, it should be taken into account that the drug may cause dizziness or other adverse reactions from the nervous system (see section "Adverse reactions").
Method of administration and doses
The drug should be taken orally, preferably after meals, at equal intervals of time. The duration of treatment is determined individually, depending on the nosology, severity of the process and the frequency of relapses; on average, the duration of treatment is 5-14 days, if necessary, after a 7-10-day break, the course of treatment is repeated. Treatment with breaks and maintenance doses can last up to 1-6 months. The dosage is determined individually depending on age, body weight, severity of the process.
The maximum daily dose for adults is 4 g of inosine pranobex, which corresponds to 80 ml of syrup.
Recommended doses and regimens of the drug:
- influenza, parainfluenza, acute respiratory viral infections:
adults – 20 ml of syrup 3-4 times a day;
children – daily dose – at the rate of 50 mg/kg (i.e. 1 ml of syrup/kg) of body weight in 3-4 doses for 5-7 days; if necessary, continue or repeat treatment after 7-8 days; to achieve the greatest effectiveness in acute respiratory viral infections, it is better to start treatment at the first symptoms of the disease or on the first day of the disease; usually the drug is taken for another 1-2 days after the symptoms disappear;
- bronchitis of viral etiology:
adults – 20 ml of syrup 3 times a day;
children – daily dose – at the rate of 50 mg/kg (i.e. 1 ml of syrup/kg) in 3-4 doses for 2-4 weeks;
- mumps: daily dose - at the rate of 70 mg/kg (i.e. 1.4 ml of syrup/kg) in 3-4 doses for 7-10 days;
- measles: daily dose - at the rate of 100 mg/kg (i.e. 2 ml of syrup/kg) in 3-4 doses for 7-14 days;
- aphthous stomatitis:
children – daily dose – at the rate of 70 mg/kg (i.e. 1.4 ml of syrup/kg) in 3-4 doses for 6-8 days (acute phase), then adults – 20 ml of syrup 3 times a day, children – 50 mg/kg (i.e. 1 ml of syrup/kg) in 3-4 doses 2 times a week for 6 weeks;
- infectious mononucleosis: daily dose - at the rate of 50 mg/kg (i.e. 1 ml of syrup/kg) in 3-4 doses for 8 days;
- cytomegalovirus infection: daily dose - at the rate of 50 mg/kg (i.e. 1 ml of syrup/kg) in 3-4 doses for 25-30 days;
- shingles and cold sores:
adults – 20 ml of syrup 3-4 times a day;
children – daily dose – at the rate of 50 mg/kg (i.e. 1 ml of syrup/kg) in 3-4 doses for 10-14 days (until symptoms disappear);
- genital herpes: in the acute period - 20 ml of syrup 3 times a day for 5-6 days; during the remission period, the maintenance dose is 20 ml of syrup (1000 mg) 1 time a day for up to 6 months;
- subacute sclerosing panencephalitis: daily dose - at the rate of 50-100 mg/kg (i.e. 1-2 ml of syrup/kg) in 6 doses (every 4 hours) for 8-10 days; after an 8-day break, in mild cases, an additional 1-3 courses, in severe cases - up to 9 courses;
- infections caused by Human papilloma virus (condyloma acuminata): 20 ml of syrup 3 times a day, treatment course – 14-28 days or in combination with cryotherapy or CO2 laser therapy – 20 ml of syrup 3 times a day, 3 courses with an interval of 1 month;
- hepatitis B: adults – 20 ml of syrup 3-4 times a day for 15-30 days, then a maintenance dose of 20 ml of syrup (1000 mg) once a day for 2-6 months;
- chronic recurrent infections of the respiratory tract and genitourinary system in patients with weakened immunity (in complex treatment):
adults – 20 ml of syrup 3-4 times a day, course of treatment – from 2 weeks to 3 months;
children – daily dose – at the rate of 50 mg/kg (i.e. 1 ml of syrup/kg) in 3-4 doses for 21 days (or 3 courses of 7-10 days with the same breaks).
To restore immune system function and achieve a sustained immunomodulatory effect in immunocompromised patients, the course of treatment should last from 3 to 9 weeks.
Children
Used for children aged 1 year and over.
Overdose
No cases of overdose have been observed. Overdose may cause an increase in the concentration of uric acid in the blood serum and urine. In case of overdose, gastric lavage and symptomatic therapy are indicated.
Adverse reactions
The drug is usually well tolerated even with long-term use. The most common adverse reaction is a short-term and slight (usually within normal limits) increase in the concentration of uric acid in the blood serum and urine (caused by the metabolism of inosine), which normalizes within a few days after discontinuation of the drug.
From the nervous system: headache, dizziness, fatigue, malaise, nervousness, drowsiness or insomnia;
Gastrointestinal: nausea with or without vomiting, epigastric pain, diarrhea, constipation, lack of appetite;
Skin and subcutaneous tissue disorders: itching, skin rashes, urticaria;
Liver and biliary tract: increased levels of transaminases, alkaline phosphatase or blood urea nitrogen;
Musculoskeletal and connective tissue disorders: joint pain;
Kidney and urinary tract: polyuria (increased urine volume);
Immune system disorders: hypersensitivity reactions (including angioedema).
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
120 ml in a glass bottle complete with a measuring cup; 1 bottle in a pack.
Vacation category
According to the recipe.
Producer
1. JSC "KYIV VITAMIN FACTORY".
2. A.B.C.Pharmaceuticals S.P.A.
Location of the manufacturer and address of its place of business
1. 04073, Ukraine, Kyiv, Kopylivska St., 38.
Website: www.vitamin.com.ua.
2. Via Cantone Moretti, 29 (locality Localita San Bernardo) – 10015 Ivrea (TO), Italy.
