Novirin tablets 500mg №10×4

NameNewirin. Forms of release Tablets. MNNinosine pranobex. Basic physical and chemical properties Round-shaped tablets with a biconvex surface with a score on one side of the tablet, from almost white to yellowish white. Composition Active ingredient: 1 tablet contains inosine pranobex 500 mg; excipients: potato starch, povidone, magnesium stearate. Pharmacotherapeutic group Antiviral agents of direct action. Code ATX J05A X05. Pharmacological properties Pharmacodynamics. The active substance – inosine pranobex (a molecular complex of inosine and a salt of 4-acetamidobenzoic acid with N,N-dimethylamino-2-propanol) exhibits a direct antiviral and immunomodulatory effect. The antiviral effect is due to binding to the ribosomes of virus-affected cells, which slows down the synthesis of viral mRNA (impaired transcription and translation) and leads to inhibition of the replication of RNA and DNA genomic viruses. The mediated action is explained by the induction of the formation of interferon. The immunomodulatory effect is due to the effect on T-lymphocytes (activation of cytokine synthesis) and an increase in the phagocytic activity of macrophages. Inosine pranobex affects the differentiation of pre-T-lymphocytes, their ability to form lymphokines, the ratio between subpopulations of T-helpers and T-suppressors (the CD4/CD8 immunoregulatory index is restored). Inosine increases the production of interleukin-2 by lymphocytes and promotes the expression of receptors for this interleukin on lymphoid cells; stimulates the phagocytic activity of macrophages, promotes an increase in antibody-producing cells in the body from the first days of treatment. It also stimulates the synthesis of interleukin-1, microbicidal activity, expression of membrane receptors and the ability to respond to lymphokines and chemotactic factors. The use of inosine pranobex in herpes infection accelerates the formation of specific anti-herpetic antibodies, reduces the severity of clinical manifestations and the frequency of relapses. The drug has low toxicity. Pharmacokinetics. Suction. After oral administration, it is well absorbed from the gastrointestinal tract. Eating does not affect the absorption of inosine pranobex and the linearity of its pharmacokinetics in the blood. Cmax of the active substance (inosine) in blood plasma is determined after 1-2 hours. Pharmacological action appears after about 30 minutes and lasts up to 6 hours. Metabolism. Rapidly metabolized. The active component inosine is metabolized similarly to endogenous purine nucleotides with the formation of uric acid, the level of which in the blood serum can sometimes increase. As a result, uric acid crystals may form in the urinary tract. Auxiliary components of the active substance are metabolized to oxidized and glucuronic derivatives (N, N-dimethylamino-2-propranolone to N-oxide, and para-acetamidooenzoate to o-acylglucuronide). No cumulative effect was found in the body. Breeding. The half-life (T½) of inosine is 50 minutes. The active and auxiliary components of the active substance are excreted from the body by the kidneys in the urine unchanged and in the form of metabolites. Elimination of the active ingredient and its metabolites from the body occurs within 24-48 hours. Indications Infections of the skin and mucous membranes caused by herpes simplex viruses type I or type II (herpes simplex), as well as diseases caused by the Varicella zoster virus (chicken pox and shingles). Papillomavirus infection of the anogenital region, genital warts, as an adjunct to the therapy of chemical, CO2 laser, cryo and electrocoagulation destruction. Subacute sclerosing panencephalitis. Immunodeficiency states caused by viral infections in patients with a weakened immune system. Contraindications – Gout; – urolithiasis disease; – severe renal failure III degree; – arrhythmia; – children’s age up to 1 year; – pregnancy; – lactation period (breastfeeding); – hypersensitivity to the components of the finished dosage form. Interaction with other medicinal products With the simultaneous use of immunosuppressants may reduce the effectiveness of the drug. Xanthine oxidase inhibitors and uricosuric agents (including diuretics) may contribute to the risk of increasing serum uric acid levels in patients taking Novirin. The combined use of inosine pranobex with zidovudine leads to an increase in the level of the latter in the blood and an increase in its half-life. This allows you to prescribe lower doses of zidovudine and increase the intervals between doses when used together with inosine pranobex. If you are taking any other medicines, consult your doctor about the possibility of using the drug. Special instructionsBefore starting treatment, consult your doctor! It should be remembered 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). It is used both for monotherapy and in complex treatment with antibiotics, antiviral and other etiotropic agents. With continuous treatment for more than 14 days, it is necessary to monitor the level of uric acid in the blood serum and urine, with treatment for more than 21 days, it is advisable to monthly monitor the function of the liver and kidneys (transaminase activity, creatinine level), the composition of peripheral blood. Novirin should not be prescribed to patients with hyperuricemia due to the possibility of increasing the content of uric acid in serum and urine. If it is necessary to use the drug in this category of patients, the content of uric acid in the body should be regularly monitored. Patients with a significant increase in uric acid levels are advised to simultaneously take drugs that lower its level. Patients with acute liver failure require a dose reduction of the drug Novirin, tk. the process of metabolism of inosine pranobex occurs in the liver. Children. It is used in children over 1 year old. Elderly patients. In elderly patients, dose adjustment is not required, the drug is used as in adults. Application during pregnancy or lactation Novirin is contraindicated during pregnancy and lactation (breastfeeding), because. its safety in this category of patients has not been established. The ability to influence the reaction rate when driving vehicles or operating other mechanisms For patients taking Novirin, there are no special contraindications for driving vehicles and servicing moving mechanisms. Dosage and administration The drug is taken orally after meals at regular intervals 3-4 times a day with a small amount of water. If necessary, the tablet can be chewed. In children under 6 years of age, the Novirin tablet must be crushed and / or dissolved in a small amount of liquid before use, due to an increased risk of aspiration. The duration of treatment is determined by the nature, severity of the disease, the frequency of relapses, etc. The course of treatment averages 5-14 days. After a 7-10-day break, if necessary, the course can be repeated. Treatment with interruptions and maintenance doses can last from 1 to 6 months. Recommended doses and regimens for the use of the drug: Labial herpes, chickenpox and herpes zoster: adults – 2 tablets 3-4 times a day; children – a daily dose of 50 mg / kg in 3-4 doses for 10-14 days (until symptoms disappear). Genital herpes: in the acute period, 2 tablets 3 times a day for 5-6 days; during remission maintenance dose – 2 tablets (1000 mg) 1 time per day – up to 6 months. Infections caused by human papillomavirus: 2 tablets 3 times a day, course of treatment 14-28 days; when combined with cryotherapy or CO2 laser therapy – 2 tablets 3 times a day for 5 days, 3 courses with an interval of 1 month. Subacute sclerosing panencephalitis: daily dose at the rate of 50-100 mg / kg for 6 doses (every 4 hours) for 8-10 days; after an 8-day break with a mild course, an additional 1-3 courses, with a severe course – up to 9 courses. Patients with a weakened immune system (in complex treatment): adults – 2 tablets 3-4 times a day, the course of treatment is from 2 weeks to 3 months; children – a daily dose of 50 mg / kg in 3-4 doses for 21 days (or 3 courses of 7-10 days with the same breaks). When correcting immunodeficiency states, the duration of the course of treatment can be from 3 to 9 weeks. Overdose Cases of overdose have not been observed. An overdose can cause an increase in the concentration of uric acid in the blood serum and in the urine. In case of overdose, gastric lavage and symptomatic therapy are indicated. Side effects Determination of the frequency of adverse reactions: often (≥1% and <10%), sometimes (≥0.1% and <1%). The drug is well tolerated even with prolonged use. Most often, a short-term slight increase in the concentration of uric acid in the blood serum and urine, caused by the metabolism of inosine, is noted. On the part of the digestive system: often - nausea, vomiting, epigastric pain, a temporary increase in the activity of transaminases and alkaline phosphatase (alkaline phosphatase). Dermatological reactions: often - itching. From the side of the central nervous system: often - headache, dizziness, weakness; sometimes - drowsiness, insomnia. From the urinary system: sometimes - polyuria. From the musculoskeletal system: often - pain in the joints. On the part of metabolism: often - exacerbation of gout, an increase in the content of uric acid in the blood plasma. If the above adverse reactions occur, discontinue use and consult a doctor as soon as possible. Shelf life 3 years. The drug should not be used after the expiration date indicated on the package. Storage conditions Store in the original packaging at a temperature not exceeding 25 °C. Keep out of the reach of children. Vacation Rules By prescription. Packing: 10 tablets in a blister made of opaque PVC film and printed lacquered aluminum foil. 2 or 4 blisters, together with the leaflet, are put into a pack of cardboard for consumer packaging. Buy Novirin tablets 500mg No. 10x4