GROPRINOSIN PILL 500MG

Immunostimulant

Mechanism of action

Immunostimulating drug with antiviral action. It is a complex containing inosine and a salt of 4-acetamido-benzoic 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 multiplication of viral particles by damaging the genetic apparatus, stimulates the activity of macrophages, the proliferation of lymphocytes and the formation of cytokines.

Reduces the clinical manifestations of viral diseases, accelerates recovery, increases the body's resistance.

When Groprinosin is prescribed as an auxiliary drug in case of infection of the mucous membranes and skin caused by the Herpes simplex virus, healing of the affected surface is faster than with the traditional method. Less frequently, new vesicles, edema, erosion, and relapse of the disease occur. With the timely use of the drug reduces the incidence of viral infections, reduced the duration and severity of the disease.

Pharmacokinetics

Suction

After ingestion, the drug is rapidly and almost completely (> 90%) absorbed and has good bioavailability. When taken orally at a dose of 1500 mg Cmax inosine pranobex is reached after 1 h and is 600 μg / ml. Not detected in the blood 2 hours 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. Almost 100% of metabolites are found in the urine in the range of 8 to 24 hours from the time of admission. Inosine is metabolized according to a cycle typical of 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. Increasing the concentration of uric acid is non-linear in nature and may change by &№177; 10% within 1-3 hours after ingestion.As a result of the metabolism of p-acetamido-benzoic acid, o-acyl glucuronide is formed; N, N-dimethylamino-2-propanol is metabolized to N-oxide. AUC of p-acetamidobenzoic acid> 88%, AUC N, N - dimethylamino-2-propanol> 77%. Cumulation of the drug in the body is not detected.

Removal

Inosine and its metabolites are excreted in the urine. When an equilibrium concentration is reached when taking a daily dose of 4 g, the daily urinary excretion of p-acetamido benzoic 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.

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

Indications

- immunodeficiency states caused by viral infections in patients with normal and weakened immune systems, including Herpes simplex type 1 and 2 diseases (including genital herpes and other herpes);

- Subacute sclerosing panencephalitis.

Dosage and administration

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

Tablets are taken with a small amount of water.

For adults designate from 6 to 8 tab. / day in 3-4 doses.

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

Like u adults and childrenat severe infectious diseases the dose can be increased individually to 100 mg / kg of body weight / day, divided into 4-6 doses. Maximum Daily Dose adults makes 3-4 g, the maximum daily dose at children - 50 mg / kg.

At acute diseases treatment usually lasts from 5 to 14 days. After the symptoms disappear, treatment should be continued for 1-2 days or more, depending on the indication.

At chronic recurrent diseases treatment adults and children conducted by 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 herpesvirus infections, in adults and children: should take several courses, lasting 5-10 days until the symptoms disappear. To reduce the number of relapses, it is recommended to carry out maintenance treatment on 1 tab. 2 times / day for 30 days.

The need for dose adjustment in elderly patients No, the drug is applied in the same way as in middle-aged patients. Older patients are more likely to have an increase in the concentration of uric acid in the serum and in the urine than in middle-aged patients.

The drug is used in children over 3 years old.

On the background of treatment with the drug Groprinosin® at patients with liver failure should be every 2 weeks to monitor the content of uric acid in the serum and urine. Monitoring the activity of liver enzymes is recommended every 4 weeks for long courses of drug treatment.

Side effect

Side effects are defined as frequent (> 1/100 and <1/10) and infrequent (> 1/1000 and <1/1000).

From the nervous system: often - headache, dizziness, fatigue, feeling unwell; infrequently - nervousness, drowsiness, sleeplessness.

From the digestive tract: often - loss of appetite, nausea, vomiting, epigastric pain; infrequently - diarrhea, constipation.

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

On the part of the skin and subcutaneous fat: often - itching, rash.

From the kidneys and urinary tract: infrequently - polyuria.

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

From the musculoskeletal system: often - pain in the joints, aggravation of gout.

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

Contraindications

- gout;

- urolithiasis disease;

- arrhythmia;

- chronic renal failure;

- children's age up to 3 years (body weight up to 15-20 kg);

- pregnancy;

- lactation period (breastfeeding);

- hypersensitivity to the drug.

WITH caution It should be prescribed a drug with xanthine oxidase inhibitors, diuretics, zidovudine, with acute liver failure.

Use during pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding), because its safety in this category of patients has not been established.

Application for violations of the liver

Patients with acute liver failure require a reduction in the dose of the drug, because Inosine pranobex metabolism process occurs in the liver.

Application for violations of kidney function

The drug is contraindicated in urolithiasis.

Special notes

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 excreted in the form of uric acid, with long-term 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 control the concentration of uric acid in the blood serum when administering Groprinosin simultaneously with drugs that increase the concentration of uric acid, or drugs that affect kidney function.

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

Influence on ability to drive motor transport and control mechanisms

Effect of Groprinosin® the psychomotor functions of the body and the ability to drive vehicles and moving mechanisms have not been studied. When using the drug should take into account the possibility of dizziness and drowsiness.

Overdose

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

Drug interaction

Immunosuppressants weaken the immunostimulating effect of Groprinosin®.

Groprinosin® should be used with caution in patients taking both xanthine oxidase inhibitors (allopurinol) or “loopback” diuretics (furosemide, Torsemide , ethacrynic acid), because this can lead to an increase in serum uric acid concentration.

The combined use of the drug Groprinosin® with zidovudine leads to an increase in the concentration of zidovudine in the blood plasma and prolongs its half-life. Thus, with the joint use of the drug Groprinosin® zidovudine may require a dose adjustment of zidovudine.

Terms and conditions of storage

The drug should be stored out of reach of children at a temperature not exceeding 25 ° C. Shelf life - 3 years.

Pharmacy sales terms

The drug is available on prescription.