Groprinosin tablets 500mg, No. 20

• Influenza and acute respiratory viral infections;

• infections caused by the herpes simplex virus types 1, 2, 3 and 4: genital and labial herpes, herpetic keratitis, herpes zoster, chickenpox, infectious mononucleosis caused by the Epstein-Barr virus;

• cytomegalovirus infection;

• severe measles;

• papillomavirus infection: papillomas of the larynx and vocal cords (fibrous type), genital papillomavirus infections in men and women, warts;

• subacute sclerosing panencephalitis;

• molluscum contagiosum.

Inside, after meals, with a small amount of water, at regular intervals (8 or 6 hours) 3-4 times a day.

Adults: from 6 to 8 tab. per day, in 3-4 admission.

Children from 3 to 12 years old: 50 mg / kg / day, 3-4 divided doses.

Adults and children with severe infectious diseases: the dose can be increased to 100 mg / kg / day, in 4-6 doses. The maximum daily dose in adults is 3-4 g per day, in children - 50 mg / kg / day.

For acute illnesses: Treatment usually lasts 5 to 14 days. After the symptoms disappear, treatment should be continued for 1Ц2 days or more, depending on the indication.

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, while the dose can be reduced to 500-1000 mg / day.

Treatment of infections caused by the herpes virus in adults and children: several courses of 5-10 days duration should be carried out until the symptoms disappear. To reduce the number of relapses, it is recommended to carry out maintenance treatment in 1 table. 2 times a day for 30 days.

Special patient groups

Elderly. There is no need for dose adjustment, the drug is used in the same way as in middle-aged patients. In elderly patients, an increase in the concentration of uric acid in serum and in urine occurs more often than in middle-aged patients.

Children. It is used in children over 3 years old.

Renal and hepatic impairment. Against the background of treatment with GroprinosinЃ, the uric acid content in blood serum and urine should be monitored every 2 weeks. It is recommended to monitor the activity of liver enzymes every 4 weeks with long courses of drug treatment.

The tablets are white or almost white, oblong, biconvex, with a score on one side.

1 tab.

inosine pranobex 500 mg

Excipients: potato starch, povidone K25, magnesium stearate.

• Gout;

• urolithiasis disease;

• chronic renal failure;

• arrhythmia;

• children under 3 years of age (body weight up to 15-20 kg);

• pregnancy;

• lactation period (breastfeeding);

• hypersensitivity to inosine pranobex and other components of the drug.

• With caution, the drug should be prescribed simultaneously with xanthine oxidase inhibitors, diuretics, zidovudine; with acute liver failure.

pharmachologic effect

Inosine pranobex, a synthetic purine derivative, is a complex containing inosine and N, N-dimethylamino-2-propanol in a molar ratio of 1: 3. It has immunostimulating activity and nonspecific antiviral action. The effectiveness of the complex is determined by the presence of inosine, the second component increases its availability for lymphocytes.

Restores the functions of lymphocytes under conditions of immunosuppression, increases blastogenesis in the monocyte population, stimulates the expression of membrane receptors on the surface of T-helpers, prevents a decrease in lymphocyte activity under the influence of glucocorticoids, and normalizes the inclusion of thymidine in them. Inosine pranobex stimulates the activity of T-lymphocytes and natural killer cells, the function of T-suppressors and T-helpers, increases the production of immunoglobulin G (IgG), interferon gamma, interleukins IL-1 and IL-2, reduces the formation of anti-inflammatory cytokines - IL-4 and IL -10, potentiates the chemotaxis of neutrophils, monocytes and macrophages.

The drug exhibits antiviral activity in vivo against herpes simplex virus, cytomegalovirus, measles virus, human T-cell lymphoma virus (type III), polioviruses, influenza A and B viruses, ECHO virus (enterocytopathogenic human virus), encephalomyocarditis and equine encephalitis viruses ... The mechanism of the antiviral action of inosine pranobex is associated with inhibition of viral RNA and dihydropteroate synthetase, which is involved in the replication of some viruses, enhances the synthesis of mRNA of lymphocytes suppressed by viruses, which is accompanied by a decrease in the synthesis of viral RNA and translation of viral proteins, increases the production of antiviral alpha and gamma interferons by lymphocytes. When administered in combination, it enhances the effect of interferon alfa, acyclovir and zidovudine.

Pharmacokinetics

Absorption and distribution

After oral administration, the drug is well absorbed from the gastrointestinal tract. Cmax of ingredients in blood plasma is determined after 1-2 hours.

There was no accumulation of the drug in the body.

Metabolism and excretion

It is rapidly metabolized and excreted through the kidneys. It is metabolized similarly to endogenous purine nucleotides with the formation of uric acid. N, N-dimethylamino-2-propanol is metabolized to N-oxide, and 4-acetamidobenzoate is metabolized to o-acylglucuronide.

T1 / 2 is 3.5 hours for N, N-dimethylamino-2-propanol and 50 minutes for 4-acetamidobenzoate. Inosine pranobex and its metabolites are excreted from the body by the kidneys within 24-48 hours.

Side effect

The incidence of adverse reactions after using the drug is classified according to WHO recommendations: very often -> 10%; frequent (> 1% and <10%); infrequently (> 0.1% and <1%) and the frequency is unknown (cannot be determined from the available data).

From the immune system: infrequently - angioedema, urticaria; frequency is unknown - hypersensitivity reactions, anaphylactic reactions, anaphylactic shock.

From the nervous system: often - headache, dizziness, fatigue, feeling unwell, weakness; infrequently - nervousness, drowsiness, insomnia.

From the gastrointestinal tract: often - decreased appetite, nausea, vomiting, epigastric pain; infrequently - diarrhea, constipation.

On the part of the hepatobiliary system: often - a temporary increase in the activity of transaminases and alkaline phosphatase in the blood plasma.

On the part of the skin and subcutaneous fat: often - itching, rash; infrequently - maculopapular rash; frequency unknown - erythema.

From the urinary system: infrequently - polyuria.

From the musculoskeletal system: often - joint pain, exacerbation of gout.

Laboratory and instrumental data: very often - an increase in the concentration of urea in the blood plasma, an increase in the concentration of urea in the urine; often - an increase in the concentration of blood urea nitrogen.

Application during pregnancy and lactation

The drug is contraindicated during pregnancy and during breastfeeding, because its safety in this category of patients has not been established.

Application for violations of liver function

The drug should be prescribed with caution in acute liver failure.

Application for impaired renal function

The drug is contraindicated in urolithiasis, chronic renal failure.

Application in children

The use of the drug is contraindicated in children under 3 years of age (body weight up to 15-20 kg).

Use in elderly patients

There is no need for dose adjustment in elderly patients (over 65 years old).

special instructions

Inosine pranobex, like other antiviral agents, is most effective for acute viral infections if treatment is started at an early stage of the disease (preferably from the first day).

After 2 weeks of using the drug, the concentration of uric acid in serum and urine should be monitored.

With prolonged use (after 4 weeks of use), it is advisable to monitor the function of the liver and kidneys every month (transaminase activity, creatinine and uric acid levels in blood serum).

Patients with a significantly increased concentration of uric acid in the body can simultaneously take drugs that lower its concentration. During treatment, it is necessary to control the concentration of uric acid in the blood serum when prescribing the drug simultaneously with drugs that increase the concentration of uric acid or drugs that impair renal function.

Inosine pranobex should be used with caution in patients with acute hepatic failure, since the drug is metabolized in the liver.

Influence on the ability to drive vehicles and mechanisms

The effect of inosine pranobex on the psychomotor functions of the body and the ability to drive vehicles and moving mechanisms has not been studied. When using the drug, you should take into account the possibility of dizziness and drowsiness.

Overdose

In case of an overdose, gastric lavage and symptomatic therapy are indicated.

Drug interactions

Immunosuppressants weaken the immunostimulating effect of inosine pranobex.

Inosine pranobex should be used with caution in patients taking simultaneously xanthine oxidase inhibitors (allopurinol) or drugs that can block the tubular secretion of uric acid, for example, loop diuretics (furosemide, torasemide, ethacrynic acid), because this can lead to an increase in the concentration of uric acid in the blood serum.

The combined use of inosine pranobex with zidovudine leads to an increase in the concentration of zidovudine in the blood plasma and lengthens its T1 / 2. Thus, when inosine pranobex is used together with zidovudine, a dose adjustment of zidovudine may be required.