INOSINUM PRANOBEX* J05A X05
THE COMPOSITION AND FORM OF ISSUE:
tablets 500mg blister pack, № 20, № 40
Inosine pranobex 500 mg C
pharmacodynamics. The active substance is inosine pranobex (molecular complex of inosine: p-acetamidobenzoic acid: N,N-dimethylamino-2-propanol in the ratio 1:3:3) has a direct antiviral and immunomodulatory effects. Direct antiviral action is caused by binding with the ribosomes in virus-infected cells, which slows down the synthesis of viral-RNA (disruption of transcription and translation) and leads to inhibition of the replication of RNA - and DNA-genomic viruses; indirect action is due to potent induction of interferonbeta. Immunomodulatory effect due to the influence of T-lymphocytes (activation of cytokine synthesis) and increase phagocytic activity of macrophages. Under the influence of the drug increases the differentiation of pre-T lymphocytes, stimulated by mitogens induced proliferation of T - and b-lymphocytes, increased functional activity of T-lymphocytes, including their ability to produce lymphokines, normalizes the balance between subpopulations of T-helpers and T-suppressors (restored the immunoregulatory index CD4/CD8). The drug significantly enhanced production of interleukin-2 by lymphocytes and promotes the expression of receptors for this interleukin on lymphoid cells; stimulates the activity of natural killers (NK-cells) even in healthy people; stimulates the activity of macrophages to phagocytosis, processing and presentation of antigen, which contributes to the increase in the number antitelomerase cells in the body from the first days of treatment. Also stimulates the synthesis of interleukin-1, microbicides, the expression of membrane receptors and ability to respond to lymphokines and chemotactic factors. During the herpetic infection significantly accelerates the formation of specific antiherpetic antibodies, reduced clinical symptoms and frequency of recurrences. The drug also prevents postirochnoy the weakening of cellular RNA and protein synthesis in infected cells, which is especially important for cells engaged in processes of the immune defense of the body. As a result of this complex action reduced the viral load on the organism, normalizes the immune system, significantly aktiviziruyutsya the synthesis of interferon, which promotes resistance to infectious disease and the rapid localization of the source of infection in case of its occurrence.
Pharmacokinetics. The drug has a high bioavailability after intake of rapidly absorbed, Cmax of inosine in the blood plasma is reached after 1 h; pharmacological effect after about 30 minutes and lasts for up to 6 h Inosine is metabolized in the cycle, typical for purine nucleosides by formation of uric acid; other components excreted by the kidneys in the form of glucuronic and oxidized derivatives also unchanged. Cumulation in the body is not revealed. Complete excretion of the drug and its metabolites occurs within 48 hours.
infectious diseases of viral etiology in patients with normal and reduced immune status: influenza, parainfluenza, respiratory catarrh, a bronchitis of viral etiology, Rhino - and adenoviral infection; mumps, measles;
diseases caused by viruses of simple herpes I or Herpes simplex type II (herpes lips, facial skin, mucous membranes of the oral cavity, skin, eye herpes), subacute sclerosing panencephalitis, genital herpes; Varicella zoster virus (chickenpox and herpes zoster, including recurrent disease in the immunocompromised patient); Epstein — Barr (infectious mononucleosis); cytomegalovirus; human papilloma virus; acute and chronic viral hepatitis b;
chronic recurrent infections of the respiratory tract and the genitourinary system in patients with weakened immunity (chlamydia and other diseases caused by intracellular pathogens).
the drug is taken orally, preferably after meals and at equal intervals of time; if necessary, the tablet can be chewed, crushed and/or dissolved in a little water immediately before use. The duration of treatment is determined individually, depending on nosology, severity and frequency of recurrences; the average duration of treatment is 5-14 days, if necessary after 7-10-day break, repeat the treatment; treatment interruptions and dose can last for 1-6 months. The maximum daily dose for adults is 8 tablets (4 g).
Recommended dose and regimen of the drug
Influenza, parainfluenza, SARS: adults — 2 tablets 3-4 times a day; children — day dose at the rate of 50 mg/kg of body weight in 3-4 divided doses for 5-7 days; if necessary, the treatment should be continued or repeated after 7-8 days. To achieve the greatest effectiveness in SARS treatment it is better to start at the first symptoms of the disease or the first days of the disease. Usually the drug is taken 1-2 days after disappearance of symptoms.
Bronchitis of viral etiology: adults — 2 tablets 3 times a day, children daily dose at the rate of 50 mg/kg in 3-4 doses for 2-4 weeks.
Mumps daily dose at the rate of 70 mg/kg body weight in 3-4 divided doses for 7-10 days.
Measles: the daily dose rate of 100 mg/kg in 3-4 divided doses for 7-14 days.
Aphthous stomatitis: adults — 2 tablets 4 times a day, children daily dose at the rate of 70 mg/kg in 3-4 divided doses for 6-8 days (acute phase), then adults — 2 tablets 3 times a day, children — 50 mg/kg for 3-4 hours 2 times a week for 6 weeks.
Infectious mononucleosis: a daily dose of 50 mg/kg in 3-4 divided doses for 8 days.
Cytomegalovirus infection: a daily dose of 50 mg/kg body weight over 3-4 hours for 25-30 days.
Labially shingles and herpes: adults — 2 tablets 3-4 times a day; children — day dose at the rate of 50 mg/kg in 3-4 divided doses for 10-14 days (until disappearance of symptoms).
Genital herpes: in acute phase: 2 tablets 3 times a day for 5-6 days; during remission maintenance dose — 2 tablets (1000 mg) 1 times a day — up to 6 months.
Subacute sclerosing panencephalitis: a daily dose rate of 50-100 mg/kg of body weight over 6 doses (every 4 hours) for 8-10 days; after 8-day break with a light for an additional 1-3 courses, severe — up to 9 courses.
Infection caused by Human papilloma virus (genital warts): 2 tablets 3 times a day, treatment 14 to 28 days; in combination with cryotherapy or CO2-laser therapy — 2 tablets 3 times a day for 5 days, 3 courses at intervals of 1 month.
Hepatitis b: adults: 2 tablets 3-4 times a day for 15-30 days; then maintenance dose — 2 tablets (1000 mg) 1 times a day for 2-6 months.
Chronic recurrent infections of the respiratory tract and the genitourinary system in patients with weakened immune systems (in complex treatment): adults — 2 tablets 3-4 times a day, treatment course — from 2 weeks to 3 months; children — day dose at the rate of 50 mg/kg of body weight in 3-4 divided doses for 21 days (or 3 courses for 7-10 days with the same breaks).
To restore the function of the immune system and achieving sustained immunomodulatory effect in patients with a weakened immune system the course of treatment should last 3-9 months.
Patients of advanced age. The drug can be used in the usual doses for adults, the need for dose adjustment no.
increased sensitivity to inosine pranobex and other components of the drug; gout, kidney stone disease, severe renal insufficiency III degree, hyperuricemia.
the drug is usually well tolerated even with prolonged use. The most common adverse reaction is transient and minor (usually within the normal range) increase the concentration of uric acid in plasma and urine (caused by the metabolism of inosine), which is normalized a few days after treatment.
There have also been reports of other adverse reactions, which are classified as frequent (>1% of cases), infrequently (<1%) and rare (<0,01%).
From the nervous system: often — headache, dizziness, fatigue, malaise; rarely nervousness, drowsiness or insomnia.
From the digestive tract: often — nausea, vomiting, pain in nabroshena area; rare — diarrhea, constipation; rarely — a lack of appetite.
The skin and subcutaneous tissue: often — itching, skin rash; rare — urticaria.
The immune system: rarely — hypersensitivity reactions (including angioedema).
The liver and biliary tract: often — increase of transaminase level, alkaline phosphatase or urea nitrogen in the blood.
From the side of musculoskeletal system and connective tissue: often — pain in the joints.
The kidneys and urinary tract: rarely — polyuria (increased urine volume).
it should be remembered that Noirin, as with other antivirals in acute viral infections is most effective if treatment is started at an early stage of the disease (preferably the first day). The drug is used both for monotherapy and in complex treatment with antibiotics, antiviral and other causal agents.
The active ingredient of the drug is metabolized to uric acid and can cause a significant increase of its concentration in the urine. In this regard, Noirin be used with caution in patients with gout and hyperuricemia in history, urolithiasis and renal insufficiency. If necessary, the drug in these patients should be carefully monitor the concentration of uric acid. Long-term use (3 months or more) appropriate on a monthly basis to monitor the concentration of uric acid in plasma and urine, liver function, peripheral blood and parameters of renal function.