Instruction for use: Groprinosin

Dosage form: tablets

Active substance: Inosinum pranobexum

ATX

J05AX05 Inosin pranobex

Pharmacological groups:

Immunostimulating agent [Other immunomodulators]

Immunostimulating agent [Antiviral (excluding HIV) means]

The nosological classification (ICD-10)

A60 Anogenital herpetic viral infection [herpes simplex]: Herpes simplex genitalis; Banal recurrent genital herpes; Secondary genital herpes; Genital herpesvirus infection; Genital herpetic infections; Genital herpes; Herpes genitalia; Genital herpes; Herpes simplex organs; Herpetic lesions of the mucocutaneous urinary organs; Herpetic lesions of the genitals; Primary genital herpes; Primary herpes simplex; Simple herpes extragenital and genital localization; Recurrent genital herpes; Recurrent herpes of genital organs; Herpes of the lips and genitals

A81.1 Subacute sclerosing panencephalitis: Progressive rubella panencephalitis

B00 Infections caused by the herpes simplex virus [herpes simplex]: Herpes simplex; Herpes virus; Herpes simplex virus; Herpes simplex virus type I and II; HSV; Herpes; Herpes simplex / herpes simplex /; Herpes lips; Herpes simplex; Herpes in patients with immunodeficiency; Labial herpes; Acute herpetic disease of the mucous membranes; Herpes simplex; Herpes simplex skin and mucous membranes; Herpes simplex with skin and mucous membrane damage; Recurrent herpes; Urogenital herpetic infection; Chronic recurrent herpesvirus infection; Herpes-viral infections of various localizations

B00.9 Herpetic infection, unspecified: Herpes face; Herpes mucous membranes; Herpes-viral infections; Herpes-viral infections of various localizations; Herpetic infection; Herpetic infections; Herpetic lesions; Latent herpetic infection; Neonatal herpes; Recurrent herpetic infection; Chronic recurrent herpesvirus infection; Chronic recurrent herpetic infection; Acute herpetic disease of the mucous membranes; Recurrent herpes

B34 Viral infection of unspecified site: Viral respiratory tract infections; Infections viral; Viral infection; Viral infections

D84.9 Unspecified Immunodeficiency: Pneumonia in immunodeficient states; Autoimmune disease; Autoimmune diseases; Severe immunodeficiency; immune deficiency; Immunodeficiency; immunodeficiency diseases; Immunodeficiency states due to surgery; Immunotherapy for cancer; Immunomodulation; Infections in patients with weakened immune systems; Correction of immune deficiency; Correction of immunodeficiencies; Correction of a weakened immune system; Correction of a weakened immunity in immunodeficient states; Violation of immunity; Violation of the immune status; Immune System Disorders; Primary immunodeficiency; Maintaining immunity; Lowering the body's defenses; Lowering the immunity; Lowering the immunity of colds and infectious diseases; The decrease of the immune status; Lowered resistance to infections; Lowered resistance to infections and colds; Lowered resistance; Immunosuppression; Predisposition to colds; acquired immune deficiencies; Radiation immunodeficiency; The development of immunodeficiency; Immune dysfunction syndrome; immunodeficiency syndrome; primary immunodeficiency syndrome; Reducing the body's defenses; Immunosuppression; Reduced immune defense; Reducing local immunity; Reducing the total body resistance; The decrease in cell-mediated immunity; Reduced resistance to infections in children; Reducing the body's resistance; Reduced resistance; reduced immunity; Status immunodeficiency; Stimulation of the processes of nonspecific immunity; Heavy selective secondary immunodeficiency; immunity Oppression; Primary immunodeficiency

Composition

Tablets - 1 table.

active substance: Inosine pranobex 500 mg

Auxiliary substances: potato starch - 85 mg; Povidone K25 - 45 mg; Magnesium stearate - 10 mg

Description of dosage form

Tablets: white or almost white oblong, biconvex, with a risk on one side.

Pharmachologic effect

Mode of action - antiviral, immunostimulating.

Pharmacodynamics

Immunostimulating agent with antiviral effect. It is a complex containing inosine and a salt of para-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. Groprinoin® 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.

With the appointment of Groprinosin® as an auxiliary drug for infectious damage to the mucous membranes and skin caused by the Herpes simplex virus, faster healing of the affected surface occurs than with conventional treatment. Less often new vesicles, swelling, 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 administered orally at a dose of 1500 mg Cmax, inosine pranobex is achieved after 1 hour and is 600 μg / ml. Not detected in the blood 2 hours after ingestion. Inosine pranobex consists of inosine and para-acetamidobenzoic acid salt with N, N-dimethylamino-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 increase. 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 and can vary by ± 10% within 1-3 hours after ingestion. As a result of the metabolism of para-acetamidobenzoic acid, ortho-acylglucuronide is formed; N, N-dimethylamino-2-propanol is metabolized to the N-oxide. AUC of para-acetamidobenzoic acid ≥88%, AUC N, N-dimethylamino-2-propanol - ≥77%. Cumulation of the drug in the body is not detected. Inosine and its metabolites are excreted in the urine. When Css is reached with a daily dose of 4 g, the daily urinary excretion of para-acetamidobenzoic acid and its metabolite is approximately 85% of the dose taken; T1 / 2 - 50 min, T1 / 2 N, N-dimethylamino-2-propanol - 3-5 hours. The complete elimination of inosine pranobeksa and its metabolites from the body occurs within 48 hours.

Indication of the Groprinosin

Immunodeficiency states caused by viral infections in patients with normal and weakened immune system, incl. Diseases caused by the Herpes simplex virus (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;

Arrhythmias;

pregnancy;

The period of breastfeeding;

Children's age to 3 years (body weight up to 15-20 kg).

With caution: with simultaneous administration with inhibitors of xanthine oxidase, diuretics, zidovudine; With acute hepatic insufficiency.

Application in pregnancy and breastfeeding

Contraindicated in pregnant women and breastfeeding women. The safety of the drug was not investigated.

Side effects

Side effects are defined as follows: often -> 1/100 and <1/10; And infrequently -> 1/1000 and <1/100.

From the nervous system: often - headache, dizziness, fatigue, poor health; Infrequently - nervousness, drowsiness, insomnia.

From the gastrointestinal tract: often - decreased appetite, nausea, vomiting, pain in epigastrium; Infrequently diarrhea, constipation.

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

From the skin and subcutaneous fat: often - itching, rash.

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

Allergic reactions: infrequent - patchy-papular rash, hives, angioedema.

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

Laboratory and instrumental data: often - increasing the concentration of blood urea nitrogen.

Interaction

Immunosuppressants weaken the immunostimulating effect of the drug Groprinosin®.

Groprinosin® should be used with caution in patients taking xanthine oxidase (allopurinol) inhibitors or loop diuretics (furosemide, torasemide, ethacrynic acid) at the same time. 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 T1 / 2. Thus, with the simultaneous use of the drug Groprinosin® with zidovudine, a dose adjustment of zidovudine may be required.

Dosing and Administration

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

Adults: 6 to 8 tablets. Per day, in 3-4 hours.

Children from 3 to 12 years: 50 mg / kg / day, in 3-4 hours.

Adults and children with severe infectious diseases: the dose can be increased to 100 mg / kg / day, in 4-6 receptions. The maximum daily dose in adults is 3-4 grams per day, in children - 50 mg / kg / 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. The duration of maintenance 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: should take several courses lasting 5-10 days before the symptoms disappear. To reduce the number of relapses, it is recommended to carry out maintenance treatment according to 1 table. 2 times a day for 30 days.

Special patient groups

The elderly. 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.

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

Renal and hepatic insufficiency. 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 urine. Control of hepatic enzyme activity is recommended to be performed every 4 weeks with long-term courses of treatment with the drug.

Overdose

Treatment: gastric lavage and symptomatic therapy.

Special instructions

Before starting treatment, consult a doctor.

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

Since 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 administered concurrently with drugs that increase the concentration of uric acid or drugs that disrupt kidney function.

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

Effect of the drug on the ability to drive vehicles and work with mechanisms. 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.

Release form

Tablets, 500 mg. In the blister of PVC / PVDC / PE-aluminum foil of 10 pcs. 2, 3 or 5 blisters in a cardboard bundle.

Manufacturer

OOO Gedeon Richter Poland. 05-825, Grodzisk Mazowiecki Str. Book. J. Poniatowski, 5, Poland.

The owner of the RU: JSC "Gedeon Richter", Budapest, Hungary.

Complaints of consumers should be sent to the address: Moscow Representative Office of OJSC "Gedeon Richter". Moscow.

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Groprinosin

At a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Groprinosin

3 years.

Do not use after the expiry date printed on the package.