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Active ingredients
Inosine pranobex
Release form
Pills
Composition
In 1 tablet: Inosine pranobex 500 mg. Auxiliary substances: potato starch - 85 mg, povidone K25 - 45 mg, magnesium stearate - 10 mg.
Pharmacological effect
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 reproduction of viral particles by damaging the genetic apparatus, stimulates macrophage activity, lymphocyte proliferation and the formation of cytokines. Reduces the clinical manifestations of viral diseases, speeds up recovery, increases resistance of the body. virus Herpes simplex, there is a faster healing of the affected surface than in the treatment of tr -traditional way. 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
Absorption: After ingestion, the drug is rapidly and almost completely (more than 90%) absorbed and has good bioavailability. When taken orally at a dose of 1500 mg Cmax of inosine pranobex is reached after 1 hour and is 600 μg / ml. Not detected in the blood 2 hours after administration. Distribution and metabolism: Inosine pranobex consists of inosine and the salt of p-acetamido-benzoic 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 ± 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-acetamido-benzoic acid is more than 88%, AUC N, N - dimethylamino-2-propanol is more than 77%. Cumulation of the drug in the body is not detected. Excretion: 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. The 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.
Contraindications
Gout; - urolithiasis; - 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 components. It should be prescribed a drug with xanthine oxidase inhibitors, diuretics, zidovudine, with acute liver failure.
Precautionary measures
The drug is contraindicated in urolithiasis.
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.
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. Adults are prescribed from 6 to 8 pills / day in 3-4 doses. Children aged from 3 to 12 years prescribed in a dose of 50 mg / kg / day, divided into 3-4 doses. As in adults as in children, in severe infectious diseases, the dose can be increased individually to 100 mg / kg body weight / day, divided into 4-6 receptions. The maximum daily dose in adults is 3-4 g, the maximum daily dose in children is 50 mg / kg. In 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 indications. In chronic recurrent diseases, treatment in adults and children is conducted in courses of 5-10 days at intervals of 8 days. Maintenance treatment can last up to 30 days, at the same time the dose can be reduced to 0.5-1 g / day. Treatment of infections,caused by the herpes virus in adults and children: you should spend several courses, lasting 5-10 days before 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. There is no need for dose adjustment in elderly patients, the drug is used 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. Against the background of treatment with Groprinosin, patients with hepatic insufficiency should be monitored every 2 weeks serum and urine. Monitoring the activity of liver enzymes is recommended every 4 weeks for long courses of drug treatment.
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). On the side of the nervous system: often - headache, dizziness, fatigue, feeling unwell; infrequently - nervousness, drowsiness, sleeplessness. On the side of the gastrointestinal tract: often - loss of appetite, nausea, vomiting, epigastric pain; infrequently - diarrhea, constipation. On the side of the hepatobiliary system: often - increased activity of liver enzymes, alkaline phosphates. On the side of the skin and subcutaneous fat: often - itching, rash. On the part of the kidneys and urinary tract: rare - polyuria. - maculopapular rash, urticaria, angioedema. From the musculoskeletal system: often - joint pain, exacerbation of gout. Others: often - an increase in blood urea nitrogen concentration.
Overdose
In case of overdose, gastric lavage and symptomatic therapy are indicated.
Interaction with other drugs
Immunosuppressants weaken the immunostimulating effect of the drug Groprinosin. Groprinosin should be used with caution in patients taking both xanthine oxidase inhibitors (allopurinol) or loop 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 with zidovudine, it may be necessary to adjust the dose of zidovudine.
special instructions
Groprinosin, like other antivirals, is most effective for acute viral infections if treatment is started at an early stage of the disease (preferably from the first day). Since inosine is excreted from the body in the form of uric acid, it is recommended to periodically monitor the concentration of serum uric acid in case of prolonged use blood 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. The effect on the ability to drive vehicles and management mechanisms: Influence of drug Groprinosin on psychomotor functions of the body and the ability to drive vehicles and moving machinery has not been studied. When using the drug should take into account the possibility of dizziness and drowsiness.