Instructions for Nuklex capsules 250 mg blister No. 20
Composition
active ingredient: ribonucleic acid;
1 capsule contains 250 mg of ribonucleic acid;
excipients: mannitol (E 421), magnesium stearate;
capsule composition: gelatin, titanium dioxide (E 171).
Dosage form
Capsules.
Main physical and chemical properties: hard gelatin capsules No. 0 with a white cap and body. Capsule contents – powder and granules from light yellow to dark yellow. The presence of compressed columns or lumps that disintegrate when pressed is allowed.
Pharmacotherapeutic group
Antiviral agents. ATX code J05.
Drugs affecting the cardiovascular system. Cardiological drugs. ATX code C01E B.
Pharmacological properties
Pharmacodynamics
It has specific antiviral activity. The antiviral action is based on mechanisms of influence on the conformation of surface antigens and virus receptors. It inhibits the hemagglutination and neuraminidase activity of influenza and parainfluenza viruses, blocking the penetration of viruses into the cell and their replication, thus providing a preventive and therapeutic antiviral effect. It inhibits the growth of the concentration of other viruses that cause acute respiratory viral infections.
Stimulates the migration of stem cells in the bone marrow, restores differentiation, quantitative and qualitative composition of bone marrow and peripheral blood cells. Normalizes cellular immunity, increasing the migration and cooperation of T and B lymphocytes and the phagocytic activity of macrophages, enhancing the activity of nonspecific resistance factors. Has anti-inflammatory, immunomodulatory, antioxidant, organoprotective, anti-ischemic and hematopoietic activity and inhibits increased platelet aggregation.
The pharmacotherapeutic effects of the drug are based on the following mechanisms: stimulation of cellular metabolic processes, enhanced biosynthesis of endogenous nucleic acids, specific enzymes and proteins, enhanced mitotic activity of bone marrow cells, acceleration of regeneration processes, increased energy supply of cells by stimulating the synthesis of macroergic compounds, such as ATP.
Anti-inflammatory activity is provided by regulation of the adenosine Ade1 receptor, normalization of NO synthetase activity, inhibition of oxidative processes in cell membranes, stabilization of cell membranes, and optimization of redox processes in tissues.
Specific antiviral activity is provided by changing the conformation of neuraminidase and hemagglutinin receptors of influenza and parainfluenza viruses, and nonspecific activity is provided by increasing interferon production in vivo and stimulating nonspecific antiviral protection.
Specific cardioprotective effect is provided by a positive effect on the dynamics of myocardial necrosis zone formation and a decrease in the final mass of the necrosis zone, an increase in the left ventricular ejection fraction.
Regulation of the hormonal system is accompanied by activation of the pituitary-adrenal system with an increase in the level of endogenous glucocorticoids. The drug optimizes adrenergic and cholinergic regulation of heart activity, coronary and systemic blood circulation with the participation of the sympathetic and parasympathetic nervous systems. NUKLEX relaxes coronary vessels against the background of their adrenaline contraction and reduces blood pressure.
Nephroprotective properties are provided by increasing the global indicator of kidney function - glomerular filtration rate.
Antiviral efficacy. In phase II clinical trials, patients received Nuclex throughout the entire treatment period after the onset of symptoms of influenza or SARS. Treatment apparently reduced the duration of clinically significant complaints and objective symptoms by 1-3 days. The effectiveness of treatment in patients with a verified diagnosis of influenza or SARS who took NUCLEX was almost 30% higher than in the control group. Nuclex significantly reduced the frequency of complications of influenza and SARS (bronchitis, pneumonia, sinusitis, otitis media) requiring antibiotic therapy. Data obtained during studies in patients with concomitant diseases of the cardiovascular and/or respiratory systems show that taking Nuclex was accompanied by a clinically significant reduction in symptoms of the concomitant disease.
During the study of the efficacy and safety of the drug Nuclex for the treatment of influenza and SARS in patients with cardiovascular diseases, taking the drug Nuclex compared to the control group contributed to: reducing the clinical manifestations of influenza and SARS 1-3 days earlier; stabilizing hemodynamic parameters 1.5 days earlier; significantly improving or normalizing echocardiography and ECG parameters. The drug Nuclex was well tolerated by patients.
Pharmacokinetics
Didn't study.
Indication
As an antiviral drug for the prevention and treatment of acute respiratory viral infections and influenza. In the complex therapy of chronic viral hepatitis, urogenital herpes. As a cardioprotective agent in the complex therapy of ischemic heart disease, acute myocardial infarction, ischemic cardiomyopathy.
Contraindication
Individual intolerance to the components of the drug, hemoblastoses (leukemia, malignant lymphomas). Gout.
Interaction with other medicinal products and other types of interactions
When treating with antibiotics and vitamins, the use of the drug in complex therapy significantly enhances the therapeutic effectiveness of treatment. When used simultaneously with antiplatelet agents and anticoagulants, due to the increased risk of bleeding, it is necessary to monitor blood clotting parameters. If necessary, the drug is recommended for use in patients with a history of high uric acid levels in combination with allopurinol.
Application features
Treatment should be carried out under the control of immune status and uric acid levels.
Ability to influence reaction speed when driving vehicles or other mechanisms
Nuklex does not affect the reaction speed when driving or working with other mechanisms.
Use during pregnancy or breastfeeding
There is no sufficient clinical experience with the use of the drug during pregnancy or breastfeeding, therefore the drug should not be used in these categories of patients.
Method of administration and doses
As a cardioprotective drug, orally prescribe 500 mg 2-3 times a day after meals. The course of treatment is 10-15 days. As an antiviral drug, orally prescribe adults 500 mg 2-3 times a day, before or after meals for 5-7 days, and then 250 mg 2 times a day for 7-14 days. Prophylactically orally - 250 mg before or after meals during the period of the epidemic of acute respiratory viral infections and influenza.
Children
Currently, there is insufficient experience with the use of Nuclex in children, so the drug should not be prescribed to this age group of patients.
Overdose
No symptoms of overdose have been identified.
Adverse reactions
From the digestive tract: when taken orally on an empty stomach, epigastric pain and dyspeptic symptoms are possible.
Metabolic: increased serum uric acid levels.
Immune system disorders: hypersensitivity reactions.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25ºС.
Keep out of reach of children.
Packaging
10 capsules in a blister, 2 blisters in a pack.
Vacation category
Without a prescription.
Producer
LLC "VALARTIN PHARMA".
Location of the manufacturer and its business address
Ukraine, 08135, Kyiv region, Kyiv–Svyatoshyn district, Chayky village, Hrushevskoho st., building 60.
