Groprinosin-Richter, 50 mg/ml syrup 150 ml

Pharmacotherapeutic group: immunostimulant.
ATX code: J05AX05

Pharmacodynamics

immunostimulant with antiviral effect. It is a complex containing inosine and para-acetamidobenzoic acid salt with N,N-dimethylamino-2-propanol in 1:3 molar ratio.

The effectiveness of the complex is determined by the presence of inosine, the second component increases its availability to lymphocytes. Inosin pranobex blocks the multiplication of viral particles by damaging the genetic apparatus, stimulates macrophage activity, lymphocyte proliferation and cytokine formation. The second component increases the availability of Groprinosin®-Richter to lymphocytes. It reduces clinical manifestations of viral diseases, accelerates recuperation, increases body resistance.

When administered as an adjunctive drug in infectious lesions of the mucous membranes and skin caused by Herpes simplex virus, the affected surface heals more quickly than with the traditional method of treatment. New blisters, swellings, erosions and recurrences of the disease occur less frequently. Timely use of the drug reduces the frequency of
viral infections, reduces the duration and severity of the disease.

Pharmacokinetics

After oral administration the drug is well absorbed from the gastrointestinal tract (GIT) and has good bioavailability. Maximum concentration of the ingredients in blood plasma is determined after 1-2 hours. It is rapidly metabolized and excreted through the kidneys. It is metabolized similarly to endogenous purine nucleotides with formation of uric acid. N,N-dimethylamino-2-propanol is metabolized to N-oxide, and 4-
acetamidobenzoate to o-acylglucuronide. No cumulation of the drug in the body has been detected. The elimination half-life (T1/2) is 3.5 h for N,N-dimethylamino-2-propanol and 50 min for 4-acetamidobenzoate. The drug and its metabolites are eliminated from the body by the kidneys within 24-48 hours.

Indications

– Treatment of influenza and other acute respiratory viral infections (ARI) as part of complex therapy.
– Treatment of labial herpes (Herpes simplex) as part of complex therapy

Active ingredient

Inosyn Pranobex

Composition

1 ml of syrup contains:
Active substance:inosine pranobex – 50 mg.
Auxiliary substances: methylparahydroxybenzoate, propylparahydroxybenzoate, sucrose, sodium hydroxide, citric acid, water.

How to take, the dosage

The drug dose depends on the body weight of the patient, the recommended daily dose is 50 mg/kg of body weight (1 ml of syrup per 1 kg of body weight per day). The daily dose is divided into several parts (3-4) to be taken at regular intervals during the day.

For proper dosing a measuring syringe for oral administration is enclosed.

Adults and children above 12 years

20 ml syrup 3-4 times a day. The maximum daily dose is 80 ml.

Children from 3 to 12 years

For children over 3 years old the drug is prescribed according to the table:

Body weight Single dose when taken 3 times per day Maximum daily dose

15-20 kg 5-6.5 ml 15-20 ml/day
21-30 kg 7-10 ml 21-30 ml/day
br> 31-40 kg 10-13 ml 31-40 ml/day
41-50 kg 13,5-16,5 ml 41-50 ml/day

The maximum daily dose for children 3 years and older is 50 mg/kg/day.

In case of influenza and other acute respiratory infections the treatment lasts from 5 to 14 days. The drug administration should be continued for 1-2 days after the disappearance of symptoms.
In case of labial herpes the treatment is continued from 5 to 10 days till the disappearance of infection symptoms.

Special patient groups

Patients of advanced age (over 65 years)

There is no need to adjust the dose, the drug is used the same as in middle-aged patients.
The duration of treatment without consulting a physician is not more than 5 days. The decision to continue therapy for more than 14 days is made by the attending physician on the basis of the clinical picture of the disease.
Use the drug only according to the indications, the method of administration and in the doses specified in the instructions.

Interaction

Immunosuppressants weaken the immunostimulatory effect of inosin pranobex. Inosin pranobex should be used with caution in patients taking simultaneously xanthine oxidase inhibitors (allopurinol) or drugs that can block the tubular secretion of uric acid, such as “loop” diuretics (furosemide, thorasemide, etacrynic acid), since this may lead to increased uric acid concentration in the blood serum.

Co-administration of inosine pranobex with zidovudine leads to an increase in plasma concentration of zidovudine and prolongs its elimination half-life. Thus, when co-administering inosin pranobex with zidovudine it may be necessary to adjust the dose of zidovudine prescribed by the physician.

If you are using the above medicinal products or other medicinal products (including over-the-counter medicinal products), consult your physician before using Groprinosin®-Richter.

Special Instructions

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

Since inosin is excreted from the body in the form of uric acid when prescribing Groprinosin®-Richter simultaneously with the drugs that increase uric acid concentration or with the drugs that impair kidney function it is necessary to monitor serum uric acid concentration.

Elderly patients are more likely than middle-aged patients to have increased concentrations of uric acid in serum and urine.
Patients with significantly elevated uric acid concentrations in the body may simultaneously take drugs that reduce its concentration.

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

Groprinosin®-Richter contains 650 mg of sucrose in 1 ml of syrup, which should be considered in patients with diabetes mellitus. The drug contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed). If any signs of allergy occur, discontinue the use of Groprinosin®-Richter and consult a physician.

Keep the instructions. You may need it again. If you have any questions, talk to your doctor.

Influence on ability to drive vehicles, machinery

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

Synopsis

A clear yellowish liquid.

Contraindications

– Hypersensitivity to pranobex inosine and other components of the drug.
– Gout.
– Urinary stone disease.
– Arrhythmias.
– Chronic renal insufficiency.
– Under 3 years of age (body weight less than 15-20 kg).
– Pregnancy and lactation.
– Sugars/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

With caution
Caution should be exercised when concomitantly prescribed with xanthine oxidase inhibitors, diuretics, zidovudine, acute renal or hepatic failure, diabetes and long-term use of Groprinosin®-Richter.
If you are taking any of the above medicinal products or if you are suffering from any of the conditions described above, you should consult your doctor before using Groprinosin®-Richter.

Side effects

The frequency of adverse reactions after using the drug is classified according to the WHO recommendations: frequently – ≥1% and < 10%; infrequently – ≥0.1% and < 1%.

Nervous system disorders
Often: headache, dizziness, fatigue, malaise, weakness.
Infrequent: nervousness, drowsiness, insomnia.

Gastrointestinal tract disorders
Often: decreased appetite, nausea, vomiting, epigastric pain.
Infrequent: diarrhea, constipation.

Liver and biliary tract disorders
Often: increased activity of transaminases and alkaline phosphatase in plasma.

Skin and subcutaneous tissue disorders
Often: itching, rash.

Renal and urinary tract disorders
Infrequent: polyuria.

Allergic reactions
Infrequent: macropapular rash, urticaria, angioedema.

General disorders and disorders at the site of administration
Often: pain in the joints, worsening of gout.

Laboratory and instrumental data
Often: increased blood urea nitrogen concentration.

If you have side effects mentioned in the instructions or they worsen, or if you notice any other side effects not mentioned in the instructions, inform your doctor.

Overdose

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

Pregnancy use

The use of Groprinosin®-Richter during pregnancy and breastfeeding is contraindicated, since the safety of its use has not been established.

Similarities

Isoprinosin, Normomed