Groprinosin, pills 500 mg, 50 pcs.

Composition

Active ingredient:

inosine pranobex 500 mg;

Auxiliary substances:

potato starch-85 mg,

polyvinylpyrrolidone K 25-45 mg,

magnesium stearate-10 mg

. Pharmacological action

A drug with an immunostimulating and antiviral effect.

It is a complex containing inosine and a salt of 4-acetamidobenzoic acid with N, N-dimethylamino-2-propanol in a molar ratio of 1: 3.

The effectiveness of the complex is determined by the presence of inosine, the second component increases its availability for lymphocytes. Groprinosin blocks the reproduction of viral particles by damaging the genetic apparatus, stimulates macrophage activity, lymphocyte proliferation and cytokine formation.

Reduces the clinical manifestations of viral diseases, accelerates convalescence, increases the body’s resistance.

When Groprinosin is prescribed as an auxiliary drug for infectious lesions of the mucous membranes and skin caused by the Herpes simplex virus, faster healing of the affected surface occurs than with traditional treatment. New blisters, edema, erosions, and relapses of the disease are less common.

Timely use of the drug reduces the frequency of viral infections, reduces the duration and severity of the disease.

Indications

Immunodeficiency conditions caused by viral infections in patients with normal and weakened immune systems, including diseases caused by Herpes simplex viruses types 1 and 2 (including genital herpes and herpes of other localization); subacute sclerosing panencephalitis.

Contraindications

• gout;
• urolithiasis;
• arrhythmia;
• chronic renal failure;
• children under 3 years of age (body weight up to 15-20 kg);
• pregnancy;
• lactation (breastfeeding);
• hypersensitivity to the components of the drug.

With caution, the drug should be prescribed with xanthine oxidase inhibitors, diuretics, zidovudine, in acute renal failure.

Side effects

Side effects are defined as frequent (>1/100 and 1/1000 and>

Nervous system disorders: often – headache, dizziness, fatigue, poor health; infrequently-nervousness, drowsiness, insomnia.

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

From the side of the hepatobiliary system: often-increased activity of liver enzymes, alkaline phosphatase.

Skin and subcutaneous fat disorders: often – itching, rash.

From the side of the kidneys and urinary tract: infrequently-polyuria.

Allergic reactions: infrequently – maculopapular rash, urticaria, angioedema.

Musculoskeletal disorders: often-joint pain, exacerbation of gout.

Other services: often-an increase in the concentration of blood urea nitrogen.

Interaction

Immunosuppressants weaken the immunostimulating effect of Groprinosin.

Groprinosin should be used with caution in patients taking concomitant xanthine oxidase inhibitors (allopurinol) or loop diuretics (furosemide, torasemide, etacric acid), as this may lead to an increase in the concentration of uric acid in the blood serum.

Concomitant use of Groprinosine with zidovudine increases the concentration of zidovudine in blood plasma and prolongs its half-life. Thus, when Groprinosin is co-administered with zidovudine, a dose adjustment of zidovudine may be required.

How to take, course of administration and dosage

The drug is taken orally after meals, at regular intervals (8 or 6 hours) 3-4 times a day.

Tablets are taken with a small amount of water.

Adults are prescribed from 6 to 8 tablets/day in 3-4 doses.

Children aged 3 to 12 years are prescribed at a dose of 50 mg / kg / day, divided into 3-4 doses.

Both in adults and children, with severe infectious diseases, the dose can be increased individually to 100 mg/kg of body weight/day, divided into 4-6 doses. The maximum daily dose for adults is 3-4 g, the maximum daily dose for children is 50 mg / kg.

In 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.

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 0.5-1 g / day.

Treatment of herpes virus infections in adults and children: several courses should be taken, lasting 5-10 days before the symptoms disappear. To reduce the number of relapses, it is recommended to conduct maintenance treatment of 1 tab.2 times / day for 30 days.

There is no need to adjust the dose in elderly patients, the drug is used in the same way as in middle-aged patients. Elderly patients are more likely to have increased uric acid concentrations in the blood serum and urine than middle-aged patients.

The drug is used in children over 3 years of age.

During treatment with Groprinosin in patients with hepatic insufficiency, the uric acid content in the blood serum and urine should be monitored every 2 weeks. Monitoring of the activity of liver enzymes is recommended to be carried out every 4 weeks with long-term courses of treatment with the drug.

Overdose

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

Functional features

Suction

After oral administration, the drug is rapidly and almost completely absorbed (> 90%) and has good bioavailability. When taken orally at a dose of 1500 mg, the_max of inosine pranobex is reached in 1 h and is 600 mcg / ml. It is not detected in the blood 2 hours after ingestion.

Distribution and metabolism

Inosine pranobex consists of inosine and a salt of p-acetamidobenzoic acid with N, N-dimethylamino-2-propanol. Each of the components of pranobex inosine is rapidly metabolized. Almost 100% of the metabolites are detected in the urine between 8 and 24 hours after ingestion. Inosine is metabolized in a cycle typical of purine nucleotides, with the formation of uric acid, the concentration of which in the blood serum can increase.

As a result, uric acid crystals may form in the urinary tract. The increase in uric acid concentration is non-linear and can change by ± 10% within 1-3 hours after oral administration. As a result of the metabolism of p-acetamidobenzoic acid, O-acylglucuronide is formed; N, N-dimethylamino-2-propanol is metabolized to N-oxide. AUC of p-acetamidobenzoic acid >88%, AUC of N, N-dimethylamino-2-propanol > > 77%. Accumulation of the drug in the body was not detected.

Deduction

Inosine and its metabolites are excreted in the urine. When the equilibrium concentration is reached with a daily dose of 4 g, the daily urinary excretion of p-acetamidobenzoic acid and its metabolite is approximately 85% of the dose taken; T_1/2 — 50 min. T_1/2 of N, N-dimethylamino-2-propanol — 3-5 hours.

Complete elimination of inosine pranobex and its metabolites from the body occurs within 48 hours.

Special instructions

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

Since inosine is eliminated from the body in the form of uric acid, with prolonged use, it is recommended to periodically monitor the concentration of uric acid in the blood serum and urine. Patients with significantly increased concentrations of uric acid in the body can simultaneously take medications that lower its concentration.

It is necessary to monitor the concentration of uric acid in the blood serum when prescribing Groprinosin simultaneously with drugs that increase the concentration of uric acid, or drugs that violate renal function.

Groprinosin should be used with caution in patients with acute hepatic insufficiency, since the drug undergoes metabolism in the liver.

Influence on the ability to drive motor vehicles and manage mechanisms

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

Use in patients with liver function disorders

Patients with acute hepatic insufficiency need to reduce the dose of the drug, because the process of inosine pranobex metabolism occurs in the liver.

Use in patients with impaired renal function

The drug is contraindicated in urolithiasis.

Form of production

Tablets

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

3 years

Active ingredient

Inosine Pranobex

Conditions of release from pharmacies

By prescription

Dosage form

of the tablet

Purpose

Children as prescribed by a doctor, Children over 3 years of age, Adults as prescribed by a doctor

Indications

Inflammation of the female genital organs, Cytomegalovirus infection, Respiratory tract infections, Flu, Herpes

Weight

Weight: 50 gr.