Groprinosin, tablets 500 mg 50 pcs

The drug with immunostimulatory and antiviral action.

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

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

Limits clinical manifestations of viral diseases, accelerates recuperation, increases the body’s resistance.

When Groprinosin is administered as an adjunctive medicine for infectious lesions of the mucous membranes and skin caused by Herpes simplex virus, the affected surface heals more quickly than with traditional treatment. New blisters, edema, erosions, and recurrences of the disease are less common.

The timely use of the drug reduces the frequency of viral infections and 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 virus types 1 and 2 (including genital herpes and other localized herpes); subacute sclerosing panencephalitis.

Active ingredient

Composition

Active substance:

Inosine pranobex 500 mg;

Supplementary substances:

Potato starch – 85 mg,

Polyvinylpyrrolidone K25 – 45 mg,

Magnesium stearate – 10 mg.

How to take, the dosage

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

The tablets are taken with a small amount of water.

Adults take 6 to 8 tablets daily in 3 to 4 doses.

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

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

In acute cases treatment usually lasts from 5 to 14 days. After symptoms disappear, treatment should be continued for 1 to 2 days or longer, depending on the indication.

In chronic relapsing disease, treatment in adults and children is given in courses of 5-10 days at intervals of 8 days.

The duration of maintenance treatment can be up to 30 days, and the dose can be reduced to 0.5-1 g/day.

Treatment of infections caused by the herpes virus in adults and children: several courses of 5-10 days should be taken until symptoms disappear. In order to reduce the number of relapses, maintenance treatment of 1 tablet per day is recommended. Twice a day for 30 days.

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

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

When treating with the drug Groprinosin in patients with hepatic insufficiency the uric acid content in serum and urine should be monitored every 2 weeks. Control of liver enzymes activity is recommended every 4 weeks during long-term treatment with the drug.

Interaction

Immunosuppressants weaken the immunostimulatory effect of Groprinosin.

Groprinosine should be used with caution in patients taking simultaneously xanthine oxidase inhibitors (allopurinol), or “loop” diuretics (furosemide, thorazemide, etacrynic acid), because this may lead to increased serum uric acid concentration.

The co-administration of the drug Groprinosine with zidovudine leads to increased plasma concentration of zidovudine and prolongs its half-life. Thus, when co-administering Groprinosine with zidovudine it may be necessary to adjust the dose of zidovudine.

Special Instructions

Groprinosine, like other antiviral agents, is most effective in acute viral infections if treatment is started early in the disease (better from the first day).

Because inosin is excreted from the body in the form of uric acid, with long-term use it is recommended to monitor the uric acid concentration in the blood serum and urine periodically. Patients with significantly elevated uric acid concentrations in the body can concomitantly take medications to lower these concentrations.

The serum uric acid concentration must be monitored when prescribing Groprinosin concomitantly with drugs that increase uric acid concentration or drugs that impair renal function.

Groprinosine should be used with caution in patients with acute hepatic impairment because the drug is metabolized in the liver.

The effect of the drug on driving and operating machinery

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

The use in liver function disorders

Patients with acute hepatic failure require reduction of the dose of the drug, because the process of metabolism of Pranobex inosine occurs in the liver.

The use in patients with impaired renal function

The drug is contraindicated in urolithiasis.

Features

Intake

After oral administration the drug is quickly and almost completely (> 90%) absorbed and has good bioavailability. When administered orally at a dose of 1500 mg, Cmax inosine pranobex is reached after 1 h and is 600 µg/ml. It is not detectable in the blood 2 h after administration.

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 inosine pranobex is rapidly metabolized. Virtually 100% of the metabolites are detected in the urine between 8 and 24 hours after ingestion. Inosine undergoes metabolism according to the cycle typical for purine nucleotides with the formation of uric acid, the concentration of which in the blood serum may increase.

As a result, uric acid crystals may form in the urinary tract. Increase of uric acid concentration is non-linear and may vary by ± 10% during 1-3 hours after oral administration. Metabolism of p-acetamidobenzoic acid produces o-acyl glucuronide; N,N-dimethylamino-2-propanol is metabolized to N-oxide. AUC of p-acetamidobenzoic acid >88%, AUC of N, N – dimethylamino-2-propanol >77%. No cumulation of the drug in the body was detected.

Contraindications

The drug should be used with caution with xanthine oxidase inhibitors, diuretics, zidovudine, and in acute renal failure.

Side effects

Side effects are defined as frequent (>1/100 and1/1000 and

Nervous system disorders: frequent – headache, dizziness, fatigue, malaise; infrequent – nervousness, drowsiness, insomnia.

Gastrointestinal system disorders: often – decreased appetite, nausea, vomiting, epigastric pain; rarely – diarrhea, constipation.

Hepatobiliary system disorders: often – increase of liver enzymes activity, alkaline phosphatase.

Skin and subcutaneous fatty tissue: often – itching, rash.

Renal and urinary tract: infrequent – polyuria.

Allergic reactions: infrequent – macropapular rash, urticaria, angioedema.

Muscular system disorders: often – joint pain, exacerbation of gout.

Others: often – increase in blood urea nitrogen concentration.

Overdose

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

Similarities