Pharmacological properties

Pharmacodynamics. active agent — inosine pranobex (a molecular complex inosine: p-acetamidobenzoic acid: n, n-dimethylamino-2-propyl alcohol in the ratio 1:3:3) has direct antiviral and immunomodulatory effect. direct antiviral action is caused by linking with ribosomes of the cells affected with a virus that slows down synthesis virus and-rnk (disturbance of a transcription and broadcasting) and leads to RNA replication oppression - and dnk-genomic viruses; the mediated action is explained by powerful induction of an interferonoobrazovaniye. the immunomodulatory effect is caused by influence on T lymphocytes (activization of synthesis of cytokines) and increase in phagocytal activity of macrophages. under the influence of medicament the differentiation of pre-T lymphocytes amplifies, the proliferation of t induced by mitogens - and in - lymphocytes is stimulated, the functional activity of T lymphocytes, including their ability to formation of lymphokines increases, the ratio between subpopulations of t-helperov and t suppressors is normalized (immunoregulatory cd4/cd8 index is restored). medicament considerably strengthens products of interleukin-2 lymphocytes and promotes an expression of receptors for this interleukin on lymphoid cells; also the activity of natural killers (nk-cells) even at healthy people stimulates; the activity of macrophages to phagocytosis, processing and the presentation of antigen stimulates that promotes increase in number of antibody producers in an organism from the first days of treatment. also interleukin-1 synthesis, a mikrobitsidnost, an expression of membrane receptors and ability to react to lymphokines and chemotactic factors stimulates. in a herpes infection the formation of specific antiherpetic antibodies considerably accelerates, clinical manifestations and frequency of a recurrence decrease. medicament also prevents post-virus weakening of cellular synthesis of RNA and protein in the infected cells that is especially important for the cells occupied in processes of host defense of an organism. as a result of such complex action viral load on an organism decreases, activity of the immune system is normalized, synthesis of own interferon is considerably activated that promotes resistance to infectious diseases and fast localization of the center of an infection in case of its emergence.

Pharmacokinetics. Drug has high biological availability, after intake is quickly soaked up, the C _max inosine in blood plasma is reached in 1 h; pharmacological action is shown approximately in 30 min. and lasts up to 6 h. Inosine is metabolized on the cycle typical for purine nucleosides with formation of uric acid; other components are allocated with kidneys in the form of the glucuronic and oxidized derivatives and also in not changed look. Cumulation in an organism is not revealed. Full removal of medicament and its metabolites comes in 48 h

Indication

Infectious diseases of a virus etiology at patients with the normal and reduced immune status: flu, parainfluenza, SARS, bronchitis of a virus etiology, rino- and adenoviral infections; epidemic parotitis, measles;

• a disease, caused by viruses of a herpes simplex Herpes simplex I or the II type (herpes of lips, face skin, mucous membrane of an oral cavity, skin of hands, oftalmogerpes), a subacute sclerosing panencephalitis, genital herpes; the Varicella zoster virus (chicken pox and the shingles including recuring at patients with an immunodeficiency); Epstein's virus — Barre (infectious mononucleosis); cytomegalovirus; papillomavirus of the person; an acute and chronic viral hepatitis In;
• chronic recurrent respiratory infections and an urinogenital system at patients with the weakened immunity (the clamidiosis and other diseases caused by intracellular activators).

Use

Drug is taken inside, it is better after a meal and at regular intervals; if necessary the tablet can be chewed, crushed and/or dissolved in a small amount of water just before use. duration of treatment is determined individually, depending on a nosology, by weights of a course and frequency of a recurrence; duration of treatment averages 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 1–6 months the maximum daily dose for adults — 4 g (8 tablets or 80 ml of syrup).

Tablet.

Recommended doses and schemes of use of medicament

Flu, a parainfluenza, a SARS: adults — on 2 tablets 3–4 times a day; children — a daily dose at the rate of 50 mg/kg of body weight on 3–4 receptions within 5–7 days; if necessary treatment should be continued or repeated in 7–8 days. For achievement of the greatest efficiency in a SARS it is better to begin treatment at the first symptoms of a disease or from first day of a disease. As a rule, the medicament is taken by 1-2 more days after disappearance of symptoms.

Bronchitis of a virus etiology: adult — 2 tablets 3 times a day, children — a daily dose at the rate of 50 mg/kg on 3–4 receptions during 2–4 weeks

Epidemic parotitis: a daily dose at the rate of 70 mg/kg of body weight in 3–4 receptions within 7–10 days.

Measles: a daily dose at the rate of 100 mg/kg in 3–4 receptions within 7–14 days.

Aphthous stomatitis: adults — on 2 tablets 4 times a day, children — a daily dose at the rate of 70 mg/kg for 3–4 receptions within 6–8 days (sharp phase), then adult — 2 tablets 3 times a day, children — 50 mg/kg for 3–4 receptions 2 times a week during 6 weeks

Infectious mononucleosis: a daily dose at the rate of 50 mg/kg for 3–4 receptions within 8 days.

Cytomegaloviral infection: a daily dose at the rate of 50 mg/kg of body weight for 3–4 receptions within 25–30 days.

Shingles and labial herpes: adults — on 2 tablets 3–4 times a day; children — a daily dose at the rate of 50 mg/kg for 3–4 receptions within 10–14 days (before disappearance of symptoms).

Genital herpes: during an acute period on 2 tablets 3 times a day within 5–6 days; during remission a maintenance dose — on 2 tablets (1000 mg) of 1 times a day — up to 6 months

Subacute sclerosing panencephalitis: a daily dose at the rate of 50–100 mg/kg of body weight for 6 receptions (each 4 h) within 8–10 days; after a 8-day break at an easy course in addition 1-3 more courses, at a heavy course — up to 9 courses.

Infection, the caused Human papilloma virus (peaked condylomas): on 2 tablets 3 times a day, a course of treatment — 14–28 days; at a combination with cryotherapy or CO ₂ - laser therapy — on 2 tablets 3 times a day within 5 days, 3 courses at an interval of 1 month

Hepatitis B: adults — on 2 tablets 3–4 times a day within 15–30 days; then a maintenance dose — on 2 tablets (1000 mg) of 1 times a day within 2–6 months

Chronic recurrent respiratory infections and an urinogenital system at patients with the weakened immunity (in complex treatment): adults — on 2 tablets 3–4 times a day, a course of treatment — of 2 weeks up to 3 months; children — a daily dose at the rate of 50 mg/kg of body weight for 3–4 receptions within 21 days (or 3 courses for 7–10 days with the same breaks).

For restoration of function of the immune system and achievement of steady immunomodulatory effect at patients with the weakened immunity the course of treatment has to last 3–9 weeks

Patients of advanced age. Drug can be used in usual doses for adults, there is no need for dose adjustment.

Syrup.

Recommended doses and schemes of use of medicine:

• flu, parainfluenza, acute respiratory viral infections:

adult — on 20 ml of syrup 3–4 times a day;

children — a daily dose — at the rate of 50 mg/kg (that is 1 ml of syrup/kg) body weights for 3–4 receptions within 5–7 days; if necessary treatment to continue or repeat in 7–8 days; for achievement of the greatest efficiency in a SARS it is better to begin treatment at the first symptoms of a disease or from first day of a disease; as a rule, medicine is accepted by 1-2 more days after disappearance of symptoms;

• bronchitis of a virus etiology:

adult — on 20 ml of syrup 3 times a day;

children — a daily dose — at the rate of 50 mg/kg (that is 1 ml of syrup/kg) for 3–4 receptions during 2–4 weeks;

• epidemic parotitis: a daily dose — at the rate of 70 mg/kg (that is 1.4 ml of syrup/kg) for 3–4 receptions within 7–10 days;
• measles: a daily dose — at the rate of 100 mg/kg (that is 2 ml of syrup/kg) for 3–4 receptions within 7–14 days;
• aphthous stomatitis:

adult — on 20 ml of syrup 4 times a day;

children — a daily dose — at the rate of 70 mg/kg (that is 1.4 ml of syrup/kg) for 3–4 receptions within 6–8 days (sharp phase), then adults — on 20 ml of syrup 3 times a day, children — 50 mg/kg (that is 1 ml of syrup/kg) for 3–4 receptions 2 times a week during 6 weeks;

• infectious mononucleosis: a daily dose — at the rate of 50 mg/kg (that is 1 ml of syrup/kg) for 3–4 receptions within 8 days;
• Cytomegaloviral infection: a daily dose — at the rate of 50 mg/kg (that is 1 ml of syrup/kg) for 3–4 receptions within 25–30 days;
• shingles and labial herpes:

adult — on 20 ml of syrup 3–4 times a day;

children — a daily dose — at the rate of 50 mg/kg (that is 1 ml of syrup/kg) for 3–4 receptions within 10–14 days (before disappearance of symptoms);

• genital herpes: during an acute period — on 20 ml of syrup 3 times a day within 5–6 days; during remission a maintenance dose — on 20 ml of syrup (1000 mg) of 1 times a day up to 6 months;
• subacute sclerosing panencephalitis: a daily dose — at the rate of 50–100 mg/kg (that is 1–2 ml of syrup/kg) for 6 receptions (each 4 h) within 8–10 days; after a 8-day break at an easy course in addition 1-3 more courses, at a heavy course — up to 9 courses;
• an infection, the caused Human papilloma virus (peaked condylomas): on 20 ml of syrup 3 times a day, a course of treatment — 14–28 days or in a combination with cryotherapy or CO2 laser therapy — on 20 ml of syrup 3 times a day 3 courses at an interval of 1 month;
• hepatitis B:

adult — on 20 ml of syrup 3–4 times a day within 15–30 days; then a maintenance dose — on 20 ml of syrup (1000 mg) of 1 times a day within 2–6 months;

• chronic recurrent respiratory infections and an urinogenital system at patients with the weakened immunity (in complex treatment): adults — on 20 ml of syrup 3–4 times a day, a course of treatment — of 2 weeks up to 3 months;

children — a daily dose — at the rate of 50 mg/kg (that is 1 ml of syrup/kg) for 3–4 receptions within 21 days (or 3 courses for 7–10 days with the same breaks).

For restoration of function of the immune system and achievement of steady immunomodulatory effect at patients with the weakened immunity the course of treatment has to last from 3 to 9 weeks

Contraindication

Hypersensitivity to inosine to a pranobex and other components of drug; gout, urolithiasis, heavy renal failure of iii of degree, hyperuricemia.

Drug, as a rule, is well transferred by

even at prolonged use. the most frequent side reaction is short-term and insignificant (usually within norm) increase in concentration of uric acid in blood plasma and urine (caused by inosine metabolism) which is normalized in several days after the end of use of drug.

Laboratory researches: increase in level of uric acid in blood, increase in level of uric acid in urine, increase in level of urea nitrogen in blood, increase in level of transaminases, increase in the SF level in blood.

from nervous system: headache, dizziness, increased fatigue, indisposition, sleep disorders.

from a digestive tract: nausea, vomiting, pain in the nadbryushinny site, diarrhea, a constipation, lack of appetite.

from skin and hypodermic fabric: itching, skin rashes, urticaria.

from the immune system: reactions of hypersensitivity (including a Quincke's disease).

from mentality: nervousness.

from a liver and biliary tract: increase in level of transaminases, SF or urea nitrogen in blood.

from a musculoskeletal system and connecting fabrics: joint pain.

from kidneys and urinary tract: polyuria (increase in volume of urine).

Knows that during the post-market research side reactions which frequency of emergence cannot be established on the available data were registered:

from a digestive tract: an abdominal pain (in an upper part of a stomach);

from the immune system: anaphylactic reactions, acute anaphylaxis, Quincke's disease, hypersensitivity, small tortoiseshell;

from skin and hypodermic cellulose: erythema.

Special instructions

that novirin, as well as other antiviral means, in acute viral infections it is most effective if treatment is begun at an early stage of a disease (better in the first day). medicament is used both for monotherapy, and in complex treatment by antibiotics, antiviral and other etiotropic means.

to uric acid and can cause substantial increase of its concentration in urine. In this regard Novirin with care apply at patients with gout and a hyperuricemia in the anamnesis, an urolithiasis and a renal failure. In need of use of medicament for these patients it is necessary to control concentration of uric acid carefully. At prolonged use (3 months or longer) it is reasonable to control monthly concentration of uric acid in blood plasma and urine, function of a liver, composition of peripheral blood and parameters of function of kidneys.

some persons can have acute reactions of hypersensitivity (Quincke's disease, an acute anaphylaxis, a small tortoiseshell). In such cases the therapy by medicine should be stopped.

At prolonged use of medicine the risk of development of a nephrolithiasis exists.

Patients of advanced age. There is no need to change doses, medicament is used in a dosage for adults. At elderly people more often than at middle-aged persons, note increase in level of uric acid in blood plasma and urine.

Use during pregnancy and feeding by a breast. Due to the lack of researches on safety of medicament it is not recommended to appoint it during pregnancy or feeding a breast.

Children. Drug is used at children aged 1 years are more senior.

Ability to influence speed of response at control of vehicles or work with other mechanisms. Influence of medicament on speed of response at control of vehicles or work with other mechanisms was not investigated. However for making decision on driving or work with other mechanisms it is necessary to consider that medicament can cause dizziness or other side reactions from nervous system (see. Side EFFECTS).

Interaction

should not accept medicine along with immunodepressants. with care apply at the patients accepting xanthineoxidase inhibitors (for example Allopyrinolum) and the means strengthening removal of uric acid with urine including thiazide diuretics (for example a hydrochlorothiazide, Chlortalidonum, indapamid) and loopback diuretics (furosemide, torasemid, Acidum etacrynicum).

At simultaneous use with azidothymidine the formation of a nucleotide owing to increase in bioavailability of azidothymidine in plasma of blood and increase in intracellular phosphorylation in monocytes of blood of the person increases.

Cases of overdose did not note

.

Overdose can cause increase in concentration of uric acid in blood plasma and urine. At overdose the gastric lavage and symptomatic therapy are shown.

Storage conditions

At a temperature not above 25 °C.