Groprinosin 500 mg No. 50 tablet.
Instructions for medical use of the drug Groprinosin Trade name Groprinosin International nonproprietary name Inosine Dosage form Tablets 500 mg Composition One tablet contains the active substance - inosine pranobex 500 mg, excipients: potato starch, povidone K-25, magnesium stearate. Description Tablets are white to cream in color, oval in shape with a biconvex surface, with a score line on one side, 17 mm long and 7 mm wide. Pharmacotherapeutic group: Direct acting antiviral drugs. Other antiviral drugs. ATC code J05AX05 Pharmacological properties Pharmacokinetics Absorption: inosine pranobex has high bioavailability and is rapidly absorbed. Distribution: the maximum concentration of inosine in plasma after oral administration is reached after 1 hour, the pharmacological effect appears after approximately 30 minutes and lasts up to 6 hours. Biotransformation and elimination: Inosine is metabolized in a cycle typical of purine nucleosides with the formation of uric acid, other components are excreted by the kidneys in the form of glucuronic and oxidized derivatives, as well as unchanged. No accumulation in the body was detected. Complete elimination of the drug and its metabolites occurs after 48 hours. Pharmacodynamics Groprinosin has an active substance - inosine pranobex, which exhibits direct antiviral and immunomodulatory effects. The direct antiviral effect is due to binding to the ribosomes of virus-infected 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 indirect effect is explained by the powerful induction of interferon formation. The immunomodulatory effect is due to the influence on T-lymphocytes (activation of cytokine synthesis) and an increase in the phagocytic activity of macrophages. Under the influence of the drug, the differentiation of pre-T-lymphocytes is enhanced, the proliferation of T- and B-lymphocytes induced by mitogens is stimulated, the functional activity of T-lymphocytes increases, including their ability to synthesize lymphokines, and the ratio between the subpopulations of T-helpers and T-suppressors is normalized. Groprinosin significantly enhances the production of interleukin-2 by lymphocytes and promotes the expression of receptors for this interleukin on lymphoid cells. Stimulates the activity of natural killer cells (NK cells) in healthy people, stimulates the activity of macrophages for phagocytosis, processing and presentation of antigen, which contributes to 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, the expression of membrane receptors and the ability to respond to lymphokines and chemotactic factors. With herpetic infection, the production of specific antiherpetic antibodies is accelerated, clinical manifestations and the frequency of relapses are reduced. The drug also prevents post-viral weakening of cellular RNA and protein synthesis in infected cells, which is especially important for cells involved in the body’s immune defense processes. As a result of this complex action, the viral load on the body is reduced, the activity of the immune system is normalized, and the synthesis of its own interferons is significantly activated, which contributes to resistance to infectious diseases and rapid localization of the source of infection if it occurs. Indications for use - infectious diseases of viral etiology in patients with a reduced immune status: influenza, parainfluenza, acute respiratory viral infections, including rhinovirus and adenoviral infections, bronchitis of viral etiology, mumps, measles - herpetic infection caused by Herpes simplex I and II type (herpes of the lips, facial skin, oral mucosa, skin of the hands, ophthalmoherpes, genital herpes), Herpes (Varicella) zoster (chicken pox, shingles, including recurrent in patients with immunodeficiency) - infection caused by the human papillomavirus (HPV) types 16 and 18 - subacute sclerosing panencephalitis of viral etiology - chronic recurrent infections of the respiratory tract and genitourinary system in patients with weakened immune systems (chlamydia) Method of administration and dosage Groprinosin is taken orally, after meals and at regular intervals; If necessary, the tablet can be chewed, crushed and/or dissolved in a small amount of water immediately before use. The duration of treatment is determined individually, depending on the nosology, severity of the process and frequency of relapses; on average, the duration of treatment is 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 from 1 to 6 months. Recommended doses and regimens for use of the drug Influenza, parainfluenza, acute respiratory viral infections Children from 6 years to 12 years - a daily dose of 50 mg/kg body weight in 3-4 doses over 5-7 days. The drug is taken for another 1 - 2 days after the symptoms disappear; if necessary, treatment can be continued or repeated after 7-8 days. Adults and children over 12 years old - 2 tablets 3-4 times a day, to achieve the greatest effectiveness, it is better to start treatment at the first symptoms of the disease or from the first day of the disease. Bronchitis of viral etiology Adults and children over 12 years old - 2 tablets 3 times a day. Children from 6 years to 12 years - a daily dose of 50 mg/kg in 3 - 4 doses for 2 - 4 weeks. Mumps: daily dose at the rate of 70 mg/kg in 3 - 4 divided doses for 7-10 days. Measles: daily dose of 100 mg/kg in 3-4 divided doses for 7-14 days. Herpes of the oral mucosa Adults and children over 12 years old - in the acute phase, 2 tablets 4 times a day, subacute phase - 2 tablets 3 times a day. Children from 6 years to 12 years in the acute phase - a daily dose of 70 mg/kg in 3 - 4 divided doses for 6 - 8 days, in the subacute phase - 50 mg/kg/day in 3 - 4 divided doses 2 times a week within 6 weeks. Shingles and labial herpes Adults and children over 12 years old - 2 tablets 3-4 times a day. Children from 6 years to 12 years - a daily dose of 50 mg/kg in 3 - 4 divided doses for 10-14 days (until symptoms disappear). Genital herpes Adults and children over 12 years of age during the acute period - 2 tablets 3 times a day for 5 - 6 days; during the period of remission, the maintenance dose is 2 tablets (1000 mg) 1 time per day for up to 6 months. Subacute sclerosing panencephalitis daily dose at the rate of 50 - 100 mg/kg in 6 doses every 4 hours for 8-10 days, after an 8-day break for moderate severity, an additional 1 - 3 courses, for severe severity - up to 9 courses . Acute candylomas caused by HPV, 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 . Chronic recurrent infections of the respiratory tract and genitourinary system in patients with weakened immune systems (as part of complex therapy) Adults and children over 12 years old - 2 tablets 3-4 times a day, course of treatment from 2 weeks to 3 months. Children from 6 years to 12 years - a daily dose of 50 mg/kg in 3-4 doses for 21 days (or 3 courses of 7-10 days). To restore the function of the immune system and achieve a sustainable immunomodulatory effect in patients with weakened immune systems, the course of treatment should last from 3 to 9 weeks. Use in elderly patients Dose adjustment depending on age is not required. Side effects Very common (≥1/10) - transient increase in the concentration of uric acid in the blood serum and urine caused by the metabolism of inosine Common (≥1/100 to <1/10) - headaches, dizziness - nausea, vomiting epigastric pain - allergic reactions: itching, skin rash - fatigue, weakness - joint pain - increased activity of aminotransferases, alkaline phosphatase or nitrogen in the blood - hyperurecemia Uncommon (≥1/1,000 to <1/100) - nervousness, drowsiness or insomnia - diarrhea, constipation - polyuria Contraindications - hypersensitivity to any component of the drug - gout, as well as patients with increased concentrations of uric acid in the blood and urine - urolithiasis - severe renal failure of the third degree - pregnancy and lactation (due to lack of experience in use) - children age up to 6 years Drug interactions Immunosuppressive agents may weaken the immunostimulating effect of Groprinosin. The drug should be used with caution in patients taking concomitant xanthine oxidase inhibitors, agents that increase uric acid excretion in urine, or diuretics. Special instructions Groprinosin is metabolized to uric acid. With continuous treatment for more than 14 days, it is necessary to monitor the level of uric acid in the blood serum and urine; for treatment for more than 21 days, it is advisable to monthly monitor liver and kidney function (transaminase activity, creatinine level), and the composition of peripheral blood. If uric acid levels increase during treatment, patients can be prescribed medications that lower their levels. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms The effect of the drug on the reaction rate when driving vehicles or other mechanisms has not been studied. Overdose There has not been a single case of Groprinosin overdose. Symptoms: in case of overdose, an increase in the concentration of uric acid in the blood serum and urine is observed. Treatment: gastric lavage, symptomatic. Release form and packaging 10 tablets each in a blister pack made of aluminum foil and polyvinyl chloride film. 2 or 5 contour packages together with instructions for medical use in the state and Russian languages are placed in a cardboard box. Storage conditions Store in the original packaging, at a temperature from +15 °C to +25 °C, in a dry place, protected from light. Keep out of the reach of children! Shelf life: 3 years Do not use after the expiration date indicated on the package. Conditions for dispensing from pharmacies Without a prescription, Grodzisk Mazowiecki, Poland Owner of the registration certificate JSC Gedeon Richter, Budapest, Hungary Address of the organization that accepts claims from consumers regarding product quality on the territory of the Republic of Kazakhstan: Representative office of JSC Gedeon Richter in the Republic of Kazakhstan E-mail: [email protected] richter.kz Phone: 8-(7272)-58-26-22, 8-(7272)-58-26-23
Groprinosin® (Groprinosin®)
The tablets are taken orally, after meals, with a small amount of water. The drug is taken at regular intervals (8 or 6 hours) 3-4 times a day.
Recommended doses and dosage regimens:
Adults: 6 to 8 tablets per day, divided into 3-4 doses.
Children aged 3 years and older (body weight over 15-20 kg): 50 mg/kg body weight (1/2 tablet per 5 kg body weight) per day, divided into 3-4 doses.
In both adults and children, in case of severe infectious diseases, the dose can be increased individually to 100 mg/kg body weight per day, divided into 4-6 doses. The maximum daily dose in adults is 3-4 g per day, the maximum daily dose in children aged 3 years and older is 50 mg/kg per day.
Duration of treatment
For acute diseases:
treatment usually lasts from 5 to 14 days. After symptoms disappear, treatment should be continued for 1-2 days or more, depending on the indications. If necessary, the duration of treatment can be increased individually under the supervision of a physician.
For chronic recurrent diseases:
Treatment in adults and children is carried out in courses lasting 5-10 days at intervals of 8 days. The duration of maintenance treatment can be up to 30 days, and the dose can be reduced to 500-1000 mg/day.
Herpetic infection,
treatment continues for 5-10 days until symptoms disappear. To reduce the number of relapses during the asymptomatic period, the drug is prescribed 500 mg 2 times a day for 30 days.
Human papillomavirus infections:
as monotherapy, the drug is prescribed for 14-28 days for adults at a dose of 1000 mg 3 times a day, for children - 250 mg (1/2 tablet) per 5 kg of body weight 3-4 times a day.
Recurrent genital warts:
as monotherapy or in combination with surgical treatment, the drug is prescribed to adults at a dose of 1000 mg 3 times a day, to children - at a dose of 250 mg per 5 kg of body weight in 3-4 doses. 3 courses are carried out for 14-28 days with an interval of 1 month.
Cervical dysplasia,
associated with human papillomavirus: 2-3 courses of 1000 mg 3 times a day for 10 days with an interval of 10-14 days.
Special patient groups
Use in elderly patients (over 65 years of age)
There is no need for dose adjustment; the drug is used in the same way as in middle-aged patients. It should be taken into account that in elderly patients, increases in the concentration of uric acid in the blood serum and urine are more common than in middle-aged patients.
Use in patients with renal and hepatic insufficiency
During treatment with Groprinosin®, uric acid levels in the blood serum and urine should be monitored every 2 weeks. Monitoring the activity of liver enzymes is recommended every 4 weeks during long courses of treatment with the drug.
Groprinosin 500 mg No. 20 tablets
Groprinosin® (GROPRINOSIN)
Groprinosin®-Richter (GROPRINOSIN RICHTER)
Compound
Groprinosin® tablets - each tablet contains inosine pranobex - 500 mg
Syrup Groprinosin®-Richter - 5 ml of syrup contains inosine pranobex - 250.00 mg
Pharmacotherapeutic group
Direct acting antivirals
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 in a molar ratio of 1: 3) exhibits direct antiviral and immunomodulatory effects. The direct antiviral effect is due to binding to the ribosomes of virus-infected 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 indirect effect is explained by the powerful induction of interferon formation. The immunomodulatory effect is due to the effect on T-
lymphocytes (activation of cytokine synthesis) and increased phagocytic activity
macrophages. Under the influence of the drug, the differentiation of pre-T-lymphocytes is enhanced, the proliferation of T- and B-lymphocytes induced by mitogens is stimulated, the functional activity of T-lymphocytes increases, including their ability to form lymphokines, the ratio between the subpopulations of T-helpers and T-suppressors is normalized ( the CD4/CD8 immunoregulatory index is restored). The drug significantly enhances the production of interleukin-2 by lymphocytes and promotes the expression of receptors for this interleukin on lymphoid cells; also stimulates the activity of natural killer cells (NK cells) even in healthy people; stimulates the activity of macrophages for phagocytosis, processing and presentation of antigen, which contributes to 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, the expression of membrane receptors and the ability to respond to lymphokines and chemotactic factors. With herpetic infection, the formation of specific antiherpetic antibodies is significantly accelerated, clinical manifestations and the frequency of relapses are reduced. The drug also prevents post-viral weakening of cellular RNA and protein synthesis in infected cells, which is especially important for cells involved in the body’s immune defense processes. As a result of this complex action, the viral load on the body is reduced, the activity of the immune system is normalized, and the synthesis of its own interferons is significantly activated, which contributes to resistance to infectious diseases and rapid localization of the source of infection if it occurs.
Under natural conditions (in vivo), inosine pranobex promotes the potentiation of reduced mRNA synthesis and transcription rates in lymphocytes, while preventing the synthesis of viral RNA to an extent still to be clarified, by:
1) incorporation of inosine-mediated orotic acid into polyribosomes,
2) inhibition of attachment of polyadenylic acid to viral messenger RNA,
3) molecular rearrangement of intramembrane particles (IMP) of lymphocytes, which leads to an almost threefold increase in density.
Inosine pranobex inhibits cGMP phosphodiesterase in vitro only at high concentrations, and in vivo at levels that do not cause immunopharmacological effects.
Pharmacokinetics
The drug has high bioavailability, after oral administration it is quickly absorbed, the maximum concentration of inosine in plasma is achieved after 1 hour; the pharmacological effect appears after approximately 30 minutes and lasts up to 6 hours. Inosine is metabolized in reactions typical of purine metabolism with the formation of uric acid, the level of which in the blood serum may transiently increase when taking the drug; other components are excreted by the kidneys in the form of glucuronic and oxidized derivatives, as well as unchanged. No accumulation in the body was detected. Complete elimination of the drug and its metabolites occurs after 48 hours.
Indications
— infectious diseases of viral etiology in patients with normal and reduced immune status: acute respiratory viral infections, rhinovirus and adenovirus infections, measles;
- diseases caused by: herpes simplex viruses (herpes of the lips, facial skin, oral mucosa, hand skin, ophthalmic herpes), subacute sclerosing panencephalitis, genital herpes; Varicella zoster virus (chickenpox and herpes zoster, including recurrent in patients with immunodeficiency); Epstein-Barr virus (infectious mononucleosis); human papillomavirus, viral hepatitis;
— nonspecific prevention during the period of rising incidence of ARVI;
- as an immunostimulating agent, it is indicated for patients with immunodeficiencies.
Directions for use and doses
Pills
The drug is taken orally, preferably after meals, at regular intervals 3-4 times a day; If necessary, the tablet can be chewed, crushed and/or dissolved in a small amount of water immediately before use. The duration of treatment is determined individually, depending on the nosology, severity of the process and frequency of relapses. On average, the duration of treatment is 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 from 1 to 6 months.
- acute respiratory viral infections:
adults - 2 tablets 3 - 4 times a day; children - daily dose at the rate of 50 mg/kg body weight in 3 - 4 doses over 5 - 7 days; If necessary, continue treatment or repeat it after 7-8 days. To achieve the greatest effectiveness in acute respiratory viral infections, it is better to start treatment at the first symptoms of the disease or from the first day of the disease. As a rule, the drug is taken for another 1 - 2 days after the symptoms disappear;
— measles: daily dose at the rate of 100 mg/kg in 3–4 doses over 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 doses for 6 - 8 days (acute phase), then - adults 2 tablets 3 times a day , children - 50 mg/kg in 3 - 4 doses 2 times a week for 6 weeks;
— infectious mononucleosis: daily dose of 50 mg/kg in 3–4 doses over 8 days;
- chickenpox, herpes zoster and herpes labialis: adults - 2 tablets 3 - 4 times a day, children - 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 the period of remission, maintenance dose - 2 tablets (1000 mg) 1 time per day - up to 6 months;
- subacute sclerosing panencephalitis: daily dose of 50 - 100 mg/kg in 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;
- viral hepatitis - adults - 2 tablets 3-4 times a day for 15 - 30 days; then a maintenance dose - 2 tablets (1000 mg) 1 time per day for 2-6 months.
- human papillomavirus infection (genital warts, laryngeal papillomatosis, plantar and palmar warts, cervical neoplasia): for low cancer risk - 2 tablets 3 times a day, course of treatment - 14 - 28 days; for high cancer risk - in combination with cryotherapy or CO2 laser therapy - 2 tablets 3 times a day for 5 days, 3 courses with an interval of 1 month;
A stable immunomodulatory effect is achieved when taking the drug at a dose of 50 mg/kg body weight per day for 3-9 weeks.
For nonspecific prophylaxis during the period of rising incidence of ARVI
adults and children daily dose at the rate of 50 mg/kg in 3 doses, 3 times a week for 4 weeks.
In direct contact with ARVI patients, the daily dose is calculated as follows:
50-100 mg/kg in 3 doses daily for 5 days.
Syrup
For oral administration only!
The dose is determined depending on the patient’s weight and the severity of the disease. The daily dose should be divided into equal parts to be taken several times a day. The duration of treatment is usually 5-14 days. The drug should be continued for another 1-2 days after the severity of symptoms has subsided.
Dosage regimen for adult patients, including the elderly.
1 ml of Groprinosin®-RICHTER syrup contains 50 mg of inosine pranobex. The recommended daily dose is 50 mg/kg body weight (1 ml/1 kg body weight per day): usually only 3 g (60 ml syrup per day), divided into 3 or 4 doses. The maximum daily dose is 4 g (80 ml of syrup per day).
Dosage regimen for children over 1 year of age
The recommended daily dose is 50 mg/kg body weight per day: usually 1 ml/1 kg body weight 3-4 times a day. To calculate the dose, use the table:
Body weightDose
- 10 – 14 kg3 x 5 ml
- 15 - 20 kg3 x 5 to 7.5 ml
- 21 - 30 kg3 x 7.5 to 10 ml
- 31 - 40 kg3 x 10 to 15 ml
- 41 - 50 kg3 x 15 to 17.5 ml
For correct dosing, use the included syringe with a measuring scale.
In children and adolescents with reduced immunity
The drug should be taken for 10 days for 3 months in a row.
Dosage regimen for subacute sclerosing panencephalitis
In the acute phase of the disease, the dose can be increased to 100 mg/kg body weight per day (maximum 4 g per day) with regular assessment of the patient's condition.
Elderly patients
There is no need to change the dose; the drug is used as in middle-aged adult patients.
In elderly people, more often than in middle-aged people, there is an increase in the level of uric acid in the blood serum and urine.
Contraindications
- hypersensitivity to inosine pranobex and other components of the drug;
- gout;
- urolithiasis disease;
- severe renal failure stage III;
- children under 1 year of age;
- periods of pregnancy and lactation.
Side effect
The drug is well tolerated even with long-term use. All side effects quickly disappear after discontinuation of the drug and do not require additional treatment.
With normal kidney function, during the use of the drug, a temporary slight increase (however, within normal limits) in the level of uric acid in the blood serum and urine (more often in older people) may occur.
Commonly observed adverse reactions (>1% of cases) include:
- from the digestive system: loss of appetite, nausea, sometimes leading to vomiting, pain in the epigastric region;
- from the liver: increased activity of aminotransferases, alkaline phosphatase and carbamide nitrogen in the blood;
-skin changes: itching, rash;
- from the nervous system: headache and dizziness, fatigue, poor health;
- other reactions: joint pain.
Rarely observed adverse reactions (
- from the digestive system: diarrhea, constipation;
- from the nervous system: nervousness, drowsiness or insomnia;
- from the genitourinary system: polyuria (increased volume of urine);
-allergic reactions: maculopapular rash, urticaria, itching, angioedema.
special instructions
Groprinosin, like other antiviral drugs, is most effective for acute viral infections if treatment is started at an early stage of the disease (preferably on the first day). The drug is used both for monotherapy and in complex treatment with antibiotics, antiviral and other etiotropic drugs. With continuous treatment for more than 14 days, it is necessary to monitor the level of uric acid in the blood serum and urine; for treatment for more than 21 days, it is advisable to monthly check the most important parameters of liver and kidney function (transaminase activity, creatinine level), the composition of peripheral blood. Patients with significantly elevated uric acid levels may be treated with drugs that lower their levels.
Interaction with other drugs and other types of interactions
Immunosuppressants weaken the effect of Groprinosin. Prescribe with caution to patients taking xanthine oxidase inhibitors, drugs that enhance the excretion of uric acid and diuretics.
The combined use of inosine pronabex with zidovudine leads to an increase in the level of zidovudine in the blood plasma and also increases its half-life.
Package
Tablets - 10 tablets in a blister made of aluminum foil and PVC/PE/PVDC film. 2 or 5 blisters in a cardboard box.
Syrup - 150 ml dark glass bottle with a polyethylene screw cap with a safety device and a sealing plug. One bottle complete with a plastic syringe, graduated from 0.5 ml to 5 ml, in a cardboard box.
