Groprinosin® (Groprinosin®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceInosin pranobeksInosin pranobeks
Dosage form: & nbsppills
Composition:

1 tablet contains:

active substance: inosine pranobex 500.00 mg;

Excipients: potato starch 85.00 mg, povidone-K 25 45.00 mg, magnesium stearate 10.00 mg.

Description:

White or almost white oblong biconvex tablets with a risk on one side.

Pharmacotherapeutic group:Immunostimulating agent
ATX: & nbsp

J.05.A.X.05   Inosin pranobeks

Pharmacodynamics:

Immunostimulating agent with antiviral effect. It is a complex containing inosine and a salt of 4-acetamidobenzoic acid with N,Ndimethylamino-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. Groprinsin® blocks the multiplication of viral particles by damaging the genetic apparatus, stimulates macrophage activity, proliferation of lymphocytes, and the formation of cytokines. The second component increases the availability of the drug Groprinosin® for lymphocytes.Reduces the clinical manifestations of viral diseases, accelerates convalescence, increases the resistance of the body.

When the drug Groprinosin® is administered as an auxiliary drug for infectious damage to the mucous membranes and skin caused by the virus Herpes simplex, there is a faster healing of the affected surface than with traditional treatment. Rarely are new vesicles, edema, erosion and relapse of the disease. With the timely use of the drug, the incidence of viral infections decreases, the duration and severity of the disease decreases.

Pharmacokinetics:

After ingestion, the drug quickly and almost completely (≥ 90%) is absorbed and has good bioavailability. When ingested at a dose of 1500 mg, the maximum concentration (CmOh) inosine pranobeksa achieved after 1 h and is 600 mcg / ml. Not detected in the blood after 2 hours after taking.

Inosine pranobex consists of inosine and p-acetamidobenzoic acid salt with N,Ndimethylamino-2-propanol. Each of the components of inosine pranobex is rapidly metabolized.Virtually 100% of metabolites are found in the urine in the range of 8 to 24 hours from the time of admission. Inosine is metabolized by a cycle typical of purine nucleotides, with the formation of uric acid, the concentration of which in the blood serum can be increased. As a result, it is possible to form crystals of uric acid in the urinary tract. The increase in the concentration of uric acid is non-linear in nature and can vary by ± 10% within 1-3 hours after ingestion. As a result of the metabolism of β-acetamidobenzoic acid, o-acylglucuronide forms; N,N - Dimethylamino-2-propanol is metabolized to Noxide. The area under the concentration-time curve (AUC) β-acetamidobenzoic acid ≥88%, AUC N,N -dimethylamino-2-propanol ≥77%. Cumulation drug in the body is not found.

Inosine and its metabolites are excreted in the urine. When the equilibrium concentration is reached by taking a daily dose of 4 g, the daily urinary excretion of p-acetamidobenzoic acid and its metabolite is approximately 85% the accepted dose; half-life (T1/2) - 50 min. T1/2 N,Ndimethylamino-2-propanol is 3-5 hours.

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

Indications:

- Immunodeficiency conditions caused by viral infections in patients with a normal and weakened immune system, including diseases caused by a virus Herpes simplex (type I and type II, genital herpes and herpes of other localization);

- subacute sclerosing panencephalitis.

Contraindications:

- Hypersensitivity to inosine pranobex and other components of the drug;

- gout;

- urolithiasis disease;

- chronic renal failure;

- children under 3 years old (body weight up to 15-20 kg);

- arrhythmias;

- Pregnancy and the period of breastfeeding.

Carefully:- With simultaneous administration with inhibitors of xanthine oxidase, diuretics, zidovudine;
- with acute hepatic insufficiency.
Pregnancy and lactation:

Contraindicated in pregnant women and women breastfeeding, since the safety of the drug has not been investigated.

Dosing and Administration:

The drug is taken orally at regular intervals (8 or 6 hours) 3-4 times a day. Tablets are taken after meals, washed down with a small amount of water. Recommended doses and patterns of application:

Adults: from 6 to 8 tablets per day, divided into 3-4 doses;

Children from 3 to 12 years: 50 mg / kg body weight per day, divided into 3 to 4 admission;

As in adults, and in children, in severe infectious diseases the dose can be increased individually up to 100 mg / kg of body weight per day, divided into 4-6 receptions. The maximum daily intake in adults is 3-4 grams per day, the maximum daily dose in children is 50 mg / kg per day.

In acute diseases: treatment usually lasts from 5 to 14 days. After the disappearance of symptoms, treatment should be continued for 1-2 days or more, depending on the indications.

With chronic relapsing diseases: treatment in adults and children is conducted courses lasting 5-10 days at intervals of 8 days.

Duration supporting treatment can be up to 30 days, with the dose can be reduced to 500-1000 mg / day.

Treatment of infections caused by the herpes virus, in adults and children: several courses should be conducted, duration 5-10 days before the disappearance of symptoms. To reduce the number of relapses, it is recommended to hold maintenance treatment 1 tablet 2 times a day for 30 days.

Application in elderly patients

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

Use in children

It is used in children over 3 years old.

Use in patients with renal and hepatic impairment

Against the background of treatment with the drug Groprinosin® should be every 2 weeks to monitor the content of uric acid in blood serum and in urine. Control of the activity of "liver" enzymes is recommended to be carried out every 4 weeks with long courses of treatment with the drug.

Side effects:

Side effects are defined as frequent: more than 1/100 and less than 1/10; and infrequent more than 1/1000 and less than 1/1000.

Impaired nervous system:

Often: headache, dizziness, fatigue, poor health.

Infrequent: nervousness, drowsiness, insomnia.

Disorders from the gastrointestinal tract:

Often: decreased appetite, nausea, vomiting, epigastric pain.

Infrequent: diarrhea, constipation.

Disorders from the hepatobiliary system:

Often: increased activity of "liver" enzymes, alkaline phosphatase.

Disturbances from the skin and subcutaneous fat:

Often: itching, rash.

Disorders from the kidneys and urinary tract:

Infrequently: polyuria.

Allergic reactions:

Infrequent: patchy-papular rash, hives, angioedema.

General disorders:

Often: joint pain, exacerbation of gout.

Laboratory and instrumental data:

Often: increasing the concentration of blood urea nitrogen.

Overdose:

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

Interaction:

Immunosuppressants weaken the immunostimulating effect of the drug Groprinosin®.

Grogrinosin® should be used with caution in patients taking xanthine oxidase inhibitors simultaneously (allopurinol), or loop diuretics (furosemide, torasemide, ethacrynic acid), as this can lead to an increase in the concentration of uric acid in the blood serum.

Joint use of the drug Groprinosin® with zidovudine leads to an increase in the concentration of zidovudine in the blood plasma and lengthens its half-life.Thus, with the combined use of the drug Groprinosin® with zidovudine, a dose adjustment of zidovudine may be required.

Special instructions:

Before starting treatment, check with your doctor.

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

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

It is necessary to monitor the concentration of uric acid in the blood serum when the drug is prescribed concurrently with drugs that increase the concentration of uric acid or drugs that disrupt kidney function.

Grogrinosin® should be used with caution in patients with acute liver failure, because the drug is metabolized in the liver.

Effect on the ability to drive transp. cf. and fur:

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

Form release / dosage:

Tablets, 500 mg.

Packaging:

For 10 tablets in a blister of PVC / PVDC / PE - aluminum foil.

For 2, 3 or 5 blisters in a cardboard box together with instructions for use.
Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children!

Shelf life:

3 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription
Registration number:P N005951 / 01
Date of registration:14.03.2008 / 04.06.2013
Expiration Date:Unlimited
The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary
Manufacturer: & nbsp
Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary
Information update date: & nbsp10.05.2017
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