Gropivirin of the tab. of 500 mg No. 20

Pharmacological properties

Pharmacodynamics. gropivirin — antiviral means with immunomodulatory properties. medicament eliminates deficit or normalizes (indvidualny) dysfunction of cell-mediated immunity, inducing ripening and a differentiation of T lymphocytes and t1-helper, exponentiating induction of the limfoproliferativny answer in mitogenetic or antigen - active cells. gropivirin models cytotoxicity of T lymphocytes and natural killers, function of t8-suppressors) and t4-helper) and also increases quantity of igg and surface markers of a complement. gropivirin increases synthesis of interleukin (il)-1 and synthesis of il-2, regulates an expression of receptors of il-2. gropivirin significantly increases secretion of endogenous γ-interferon and reduces products of il-4 in an organism. gropivirin strengthens action of neutrocytes, a chemotaxis and phagocytosis of monocytes and macrophages. gropivirin synthesis of a virus by embedding acid inosine-orotovoy in polyribosomes of the cell affected with a virus oppresses and accession of adenylic acid to a virus irnk oppresses.

Pharmacokinetics. After administration of medicament inside in a dose of 1.5 g of the C _max inosine of a pranobex in blood plasma is reached in 1 h and makes 600 mkg/ml. In an inosine organism pranobex it is metabolized in a liver with formation of uric acid. T _½ 4-(atsetilamino) of benzoate makes 50 min., 1 (dimethylamines)-2-of propyl alcohol — 3.5 h. It is removed with urine in the form of metabolites.

Indication

Viral infections caused by a virus of a herpes simplex of the 1st and 2nd type, a virus of chicken pox, a cytomegalovirus, Epstein's virus — Barre, a measles virus, a parotitis virus, including at patients with immunodeficiency; viral respiratory infections; human papillomavirus infections of skin and mucous membrane: peaked condylomas, a human papillomavirus infection of a vulva, vagina and neck of the uterus (as a part of complex therapy); acute viral encephalitis (as a part of complex therapy); a viral hepatitis (as a part of complex therapy); a subacute sclerosing panencephalitis (as a part of complex therapy).

Use

to use Drug inside.

Daily dose depends on body weight, the course and severity of a disease, a condition of the patient.

Adults and children are aged more senior than 12 years: 50 mg/kg of body weight (usually 6–8 tablets distributed on 3–4 receptions), the maximum daily dose — 4 g

Children aged from 1 year up to 12 years: 50 mg/kg (usually 1 tablet on 10 kg of body weight for the child with the body weight of 10-20 kg, at the body weight of 20 kg to appoint a dose, as for adults) for 3–4 receptions a day, the maximum daily dose — 4 g. For ingestion simplification the tablet can be pounded.

treatment Duration

Acute diseases: in diseases with a short-term course the course of treatment makes from 5 to 14 days. After decrease in expressiveness of symptoms of a disease it is necessary to continue treatment 1-2 more days or longer, depending on the course of the disease, a condition of the patient.

Viral diseases with a long course: treatment should be continued during 1–2 weeks after reduction of expressiveness of symptoms of a disease or longer, depending on the course of the disease, a condition of the patient.

Recurrent diseases: at an initial stage of treatment apply the same recommendations, as to acute diseases. During maintenance therapy the dose can be reduced to 500–1000 mg (1–2 tablets) a day. At emergence of the first signs of a recurrence it is necessary to resume reception of the daily dose recommended for acute diseases and it is necessary to continue to accept this dose within 1–2 days after disappearance of symptoms. The course of treatment can be repeated several times according to the recommendation of the doctor, depending on a condition of the patient.

Chronic diseases use medicament in a daily dose 50 mg/kg according to the following schemes:

within 30 days with a break of 60 days;

a disease with moderate symptoms within 60 days with a break of 30 days;

a disease with heavy symptoms within 90 days with a break of 30 days.

should repeat the Course of treatment so many time how many it will be required, at the same time it is necessary to carry out continuous monitoring of the state of health of the patient and indications for therapy extension.

In the infections caused by human papillomavirus (external genital warts (peaked condylomas) or a human papillomavirus infection of the canal of a neck of the uterus) to accept 3 g (2 tablets 3 times a day) within 14–28 days as monotherapy or as addition to local therapy or surgical treatment according to the following schemes:

• for treatment of patients of group of low risk (patients with normal immunity or patients with low risk of a recurrence) medicament is used within 14–28 days before achievement of the maximum eradikation of a virus, then it is necessary to take a break for 2 months. The course of treatment can be repeated using the same dose, at the same time it is necessary to carry out continuous monitoring of a condition of the patient and indications for therapy extension;
• for treatment of patients of group of high risk * (patients with an immunodeficiency or with high risk of a recurrence) medicament is used by 5 days a week, consistently 1–2 weeks a month within 3 months. It is necessary to repeat a course of treatment so many time how many it will be required, at the same time it is necessary to carry out continuous monitoring of the state of health of the patient and indications for therapy extension.

:

• immunodeficiency caused:

— existence in the anamnesis of persistent or recurrent infections or diseases, sexually transmitted;

— chemotherapy;

— an alcoholism;

• prolonged use of oral contraceptives (≥2 years);
• level of folates in erythrocytes the 660th nmol/l;
• presence of several sexual partners or replacement of the permanent sexual partner;
• frequent vaginal sexual contacts (≥2–6 times a week) or anal sex;
• atopy (genetic predisposition to hypersensitivity);
• badly controlled diabetes;
• smoking;
• a human papillomavirus infection of genitalias which lasts 2 years or has ≥3 recurrence in the anamnesis;
• existence at the patient of skin warts in the childhood.

In a subacute sclerosing panencephalitis the daily dose makes 100 mg/kg, the maximum dose — 3–4 g/days, at the same time it is necessary to carry out continuous monitoring of the state of health of the patient and indications for therapy extension.

Contraindication

Hypersensitivity to any component of drug, gout, a hyperuricemia.

Side effects

during treatment gropiviriny the only permanent side effect of medicament at adults and children is temporary increase in level of uric acid in blood plasma and in urine which are normalized in several days after the end of treatment.

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 the AlAT and AsAT level, increase in the SF level in blood.

General disturbances: fatigue, indisposition.

from skin and hypodermic cellulose: rash, itching.

from bodies of a digestive tract: nausea, vomiting, sensation of discomfort in epigastric area of a stomach, diarrhea, a constipation.

from nervous system: headache, dizziness, drowsiness, sleep disorders.

from the musculoskeletal system and muscles: arthralgia.

Mental disorders: nervousness.

from an urinary system: polyuria.

registered also other side reactions:

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

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

from nervous system: dizziness;

from skin and hypodermic cellulose: erythema.

Special instructions

As during treatment gropiviriny perhaps temporary increase in level of uric acid in blood plasma, especially at men and elderly people, it is not necessary to use medicament the patient with gout, a hyperuricemia and it is required to apply with care to patients with an urolithiasis and with reduced function of kidneys. at use of medicament of 3 months it is reasonable to check monthly laboratory indicators of function of a liver and kidneys (transaminases, creatinine), level of uric acid in blood plasma, to carry out blood test.

some persons can have acute reactions of hypersensitivity (Quincke's disease, an acute anaphylaxis, a small tortoiseshell). In that case therapy by Gropivirin should be stopped.

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

Use during pregnancy or feeding by a breast. Researches of possibility of pathologies at a fruit and disturbance of fertility at people were not conducted. It is unknown whether gets inosine pranobex into breast milk. It is not recommended to use medicament during pregnancy and feeding by a breast.

Children. Drug is used at children aged from 1 year.

Ability to influence speed of response at control of vehicles or work with other mechanisms. Influences of medicament on speed of response at control of vehicles or work with other mechanisms did not investigate. However patients need to consider that medicament can cause dizziness or other side reactions from nervous system.

Interaction

should not take the medicament along with immunodepressants. with care it is required to appoint medicament with the inhibitors of a xanthineoxidase or means promoting removal of uric acid including diuretic medicaments — thiazide diuretics (such as hydrochlorothiazide, Chlortalidonum, indapamid) and loopback diuretics (for example 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 were not observed by

. the overdose can cause increase in level of uric acid in blood plasma and in urine. symptomatic treatment.

Storage conditions

In original packing at a temperature not higher than 25 c.

Translation of the instruction Mose