Groprinosine-Richter syrup 50 mg/ml, 150 ml

Composition

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1 ml contains:

Active ingredient: Inosine Pranobex – 50.00 mg.

Excipients: methyl parahydroxybenzoate, propyl parahydroxybenzoate, sucrose, sodium hydroxide, citric acid, water.

Pharmacological action

Pharmacotherapeutic group: immunostimulating agent.

ATX Code: J05AX05

Pharmacological properties

Pharmacodynamics

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 an immunostimulating activity and a non-specific antiviral effect. The effectiveness of the complex is determined by the presence of inosine, the second component increases its availability for lymphocytes.

It 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-helper cells, prevents a decrease in the activity of lymphocytes under the influence of glucocorticosteroids, normalizes the inclusion of thymidine in them. Inosine pranobex stimulates the activity of T-lymphocytes and natural killers, the functions of T-suppressors and T-helpers, increases the production of immunoglobulin G (Ig G), 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, ESNO virus (human enterocytopathogenic virus), encephalomyocarditis and equine encephalitis viruses. The mechanism of antiviral action of inosine pranobex is associated with the inhibition of viral RNA and dihydropteroate synthetase, which is involved in the replication of some viruses, enhances the synthesis of lymphocyte mRNA suppressed by viruses, which is accompanied by a decrease in viral RNA synthesis and translation of viral proteins, and increases the production of alpha and gamma interferons with antiviral properties by lymphocytes. When combined, it enhances the effect of interferon-alpha, acyclovir and zidovudine.

Pharmacokinetics

After oral administration, the drug is well absorbed from the gastrointestinal tract (GIT). The maximum concentration of ingredients in the blood plasma is determined after 1-2 hours. It is rapidly metabolized and excreted through the kidneys. It is metabolized similarly to endogenous purine nucleotides to form uric acid. N, N-dimethylamino-2-propanol is metabolized to N-oxide, and 4-acetamidobenzoate is metabolized to o-acylglucuronide. No accumulation of the drug in the body was detected. The elimination half-life (T 1/2) is 3.5 h for N, N-dimethylamino-2-propanol and 50 min for 4-acetamidobenzoate. The drug and its metabolites are excreted by the kidneys within 24-48 hours.

Indications

• Influenza and acute respiratory viral infections.
• Infections caused by herpes simplex virus types 1,2,3 and 4: genital and labial herpes, herpetic keratitis, shingles, chickenpox, infectious mononucleosis caused by Epstein-Barr virus.
• Cytomegalovirus infection.
• Severe measles.
• Papillomavirus infection: laryngeal and vocal cord papillomas (fibrotic type), genital papillomavirus infections in men and women, warts.
• Subacute sclerosing panencephalitis.
• Molluscum contagiosum.

Use during pregnancy and lactation

The use of Groprinosin®-Richter during pregnancy and lactation is contraindicated, as the safety of use has not been established.

Contraindications

• Hypersensitivity to inosine pranobex and other components of the drug.
• Gout.
• Urolithiasis.
• Arrhythmias.
• Chronic renal failure.
• Children under 3 years of age (body weight up to 15-20 kg).
• Pregnancy and breast-feeding period.
• Sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

With caution

Caution should be exercised when prescribing concomitantly with xanthine oxidase inhibitors, diuretics, zidovudine, in acute hepatic insufficiency.

Side effects

The frequency of side effects after the use of the drug is classified according to WHO recommendations: frequent – >1% and ><10%; infrequent – >0.1% and <10%; infrequent – >

From the nervous system: frequent-headache, dizziness, fatigue, poor health, weakness; infrequent-nervousness, drowsiness, insomnia.

From the gastrointestinal tract: frequent-loss of appetite, nausea, vomiting, epigastric pain; infrequent-diarrhea, constipation.

From the liver and biliary tract: frequent-temporary increase in the activity of transaminases and alkaline phosphatase in blood plasma, increased urea concentration in blood plasma.

Skin and subcutaneous tissue disorders: frequent-pruritus, rash; infrequent-maculopapular rash, urticaria, angioedema.

From the side of the kidneys and urinary tract: infrequent – polyuria.

General disorders and disorders at the injectionsite: common-joint pain, exacerbation of gout.

Laboratory and instrumental data: frequent-increased concentration of blood urea nitrogen.

Interaction

Immunosuppressants weaken the immunostimulating effect of inosine pranobex.

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

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

How to take, course of administration and dosage

Method of application

Inside after eating. For proper dosing, a measuring syringe is attached to take the drug inside.

Doses

The dose of the drug depends on the patient’s body weight and the disease. The daily dose is divided into several parts (3-4), which should be taken at regular intervals throughout the day. The duration of treatment is usually 5-14 days. The drug should be continued for 1-2 days after the symptoms disappear.

The recommended daily dose for adults and elderly patients, as well as children 3 years and older (body weight more than 15-20 kg) is 50 mg/kg of body weight in 3-4 doses.1 ml of Groprinosin® – Richter contains 50 mg of inosine pranobex.

For the treatment of severe infections, the dose can be individually increased to 100 mg/kg of body weight 4-6 times a day. The maximum daily dose for adults is 3-4 g / day (60-80 ml / day).

For children over 3 years of age, the drug is prescribed in accordance with the table:

Body weight Single dose taken 3 times a day Maximum daily dose 15-20 kg 5-6.5 ml 15-20 ml/day 21-30 kg 7-10 ml 21-30 ml/day 31-40 kg 10-13 ml 31-40 ml/day 41-50 kg 13.5-16.5 ml 41-50 ml/day

The maximum daily dose for children 3 years and older is 50 mg / kg / day.

Duration of treatment

Acute infections: the duration of treatment in adults and children is usually from 5 to 14 days. Treatment should be continued until the clinical symptoms disappear and for another 1-2 days after the symptoms disappear. If necessary, the duration of treatment can be increased individually under the supervision of a doctor.

Chronic recurrent infections: in adults and children, treatment should be continued in several courses of 5-10 days with an interval of 8 days. During maintenance therapy, the dose can be reduced to 500-1000 mg per day (10-20 ml / day) for 30 days.

Herpes infections: treatment continues for 5-10 days until symptoms disappear. To reduce the number of relapses in the asymptomatic period, the drug is prescribed 500 mg 2 times a day (20 ml/day) for 30 days.

Papillomavirus infections: as monotherapy, the drug is prescribed for 14-28 days for adults at a dose of 1000 mg 3 times a day (60 ml/day), for children – 250 mg per 5 kg of body weight (1 ml/kg/day) 3-4 times a day.

Recurrent genital warts: as monotherapy or in combination with surgical treatment, the drug is prescribed for adults at a dose of 1000 mg 3 times a day (60 ml/day), for children – at a dose of 250 mg per 5 kg of body weight (1 ml/kg/day) in 3-4 doses. Conduct 3 courses of 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 (60 ml / day) for 10 days with an interval of 10-14 days.

Special patient groups

Use in elderly patients: there is no need to adjust the dose, the drug is used in the same way as in middle-aged patients. It should be taken into account that elderly patients are more likely to have an increase in the concentration of uric acid in the blood serum and urine than in middle-aged patients.

Patients with renal and hepatic insufficiency: during treatment with Groprinosin®-Richter, 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.

Description

Clear yellowish liquid.

Special instructions

Inosine pranobex, like other antiviral agents, is most effective in acute viral infections if treatment is started at an early stage of the disease (the first day). After 2 weeks of inosine pranobex administration, uric acid concentrations in the blood serum and urine should be monitored. Also, 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 the drug simultaneously with drugs that increase the concentration of uric acid or drugs that violate kidney function.

With prolonged use (after four weeks of use), it is advisable to monitor liver and kidney function every month (transaminase activity, creatinine level, uric acid in blood serum). Inosine pranobex 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 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, the possibility of dizziness and drowsiness should be taken into account.

Form of production

Syrup,50 mg / ml.

150 ml of syrup in a light-proof bottle made of hydrolytically resistant (Class III) glass with a capacity of 150 ml with a screw-on lid made of polyethylene with a protective device and a sealing plug.

1 bottle with a label, together with a plastic syringe graduated from 0.5 ml to 5 ml, and instructions for use in a cardboard pack.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 2 years. Shelf life after opening the bottle is 6 months. Do not use after the expiration date indicated on the package.

Active ingredient

Inosine Pranobex

Conditions of release from pharmacies

By prescription

Dosage form

syrup

Weight

Weight: 342 g.