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 (ARVI) as part of complex therapy.
– Treatment of labial herpes (Herpes simplex) as part of complex therapy

Pharmacological effect

Pharmacotherapeutic group: immunostimulating agent.
ATX code: J05AX05

Pharmacodynamics

An immunostimulating agent with an 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 to lymphocytes. Inosine pranobex blocks the reproduction of viral particles by damaging the genetic apparatus, stimulates the activity of macrophages, the proliferation of lymphocytes and the formation of cytokines. The second component increases the availability of the drug Groprinosin®-Richter for lymphocytes. Reduces clinical manifestations of viral diseases, accelerates convalescence, increases the body’s resistance.

When prescribing inosine pranobex as an auxiliary drug for infectious lesions of the mucous membranes and skin caused by the Herpes simplex virus, faster healing of the affected surface occurs than with traditional treatment. New blisters, swelling, erosions and relapses of the disease occur less frequently. With timely use of the drug, the incidence of
is reduced.
viral infections, the duration and severity of the disease is reduced.

Pharmacokinetics

After oral administration, the drug is well absorbed from the gastrointestinal tract (GIT) and has good bioavailability. The maximum concentration of ingredients in the blood plasma is determined after 1–2 hours. It is quickly metabolized and excreted through the kidneys. Metabolized similarly to endogenous purine nucleotides with the formation of uric acid. N,N-dimethylamino-2-propanol is metabolized to N-oxide, and 4-
acetamidobenzoate – to o-acyl glucuronide. No accumulation of the drug in the body was detected. The half-life (T1/2) is 3.5 hours for N,N-dimethylamino-2-propanol and 50 minutes for 4-acetamidobenzoate. The drug and its metabolites are excreted from the body by the kidneys within 24–48 hours.

Special instructions

Inosine pranobex, like other antiviral agents, is most effective for acute viral infections if treatment is started at an early stage of the disease (the first day).

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

Elderly patients are more likely than middle-aged patients to experience increased concentrations of uric acid in serum and urine.
Patients with significantly increased concentrations of uric acid in the body can simultaneously take medications that lower their concentrations.

Inosine pranobex should be used with caution in patients with acute liver failure, since the drug is metabolized in the liver.

Groprinosin®-Richter contains 650 mg of sucrose per 1 ml of syrup, which must be taken into account 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 appear, you should stop taking Groprinosin®-Richter and consult a doctor.

Save the instructions. It may be needed again. If you have any questions, consult your doctor.

Impact on the ability to drive vehicles and machinery

The effect of inosine 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 drowsiness should be taken into account.

Active ingredient

Inosine Pranobex

Composition

1 ml of syrup contains:
Active ingredient: inosine pranobex – 50 mg.
Excipients: methyl parahydroxybenzoate, propyl parahydroxybenzoate, sucrose, sodium hydroxide, citric acid, water.

Pregnancy

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

Contraindications

– Hypersensitivity to inosine pranobex and other components of the drug.
– Gout.
– Urolithiasis.
– Arrhythmias.
– Chronic renal failure.
– Children under 3 years of age (body weight up to 15–20 kg).
– Pregnancy and breastfeeding.
– Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

With caution
Caution should be exercised when prescribed simultaneously with xanthine oxidase inhibitors, diuretics, zidovudine, in acute renal or liver failure, in diabetes mellitus and long-term use of Groprinosin®-Richter.
If you are taking any of the medications listed above or suffer from the conditions listed above, you should consult your doctor before using Groprinosin®-Richter.

Side Effects

The incidence of adverse reactions after using the drug is classified according to WHO recommendations: often – ≥1% and <10%; uncommon – ≥0.1% and <1%.Nervous system disorders
Common: headache, dizziness, fatigue, feeling unwell, weakness.
Uncommon: nervousness, drowsiness, insomnia.

Gastrointestinal disorders
Common: loss of appetite, nausea, vomiting, epigastric pain.
Uncommon: diarrhea, constipation.

Disorders of the liver and biliary tract
Often: increased activity of transaminases and alkaline phosphatase in the blood plasma.

Disorders of the skin and subcutaneous tissues
Common: itching, rash.

Renal and urinary tract disorders
Uncommon: polyuria.

Allergic reactions
Uncommon: maculopapular rash, urticaria, angioedema.

General disorders and disorders at the injection site
Common: joint pain, exacerbation of gout.

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

If you experience side effects listed in the instructions or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Immunosuppressants weaken the immunostimulating effect of inosine pranobex. Inosine pranobex should be used with caution in patients taking concomitant xanthine oxidase inhibitors (allopurinol) or drugs that can block tubular secretion of uric acid, for example, loop diuretics (furosemide, torasemide, ethacrynic acid), as this may lead to an increase in the concentration of uric acid in the blood serum.

The combined use of inosine pranobex with zidovudine leads to an increase in the concentration of zidovudine in the blood plasma and lengthens its half-life. Therefore, when inosine pranobex is co-administered with zidovudine, it may be necessary to adjust the dose of zidovudine prescribed by your doctor.

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

Overdose

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

Storage conditions

At a temperature not exceeding 25 °C.
Keep out of the reach of children.

Shelf life

2 years.
Shelf life after opening the bottle is 6 months.
Do not use after the expiration date indicated on the package.

Manufacturer

Gedeon Richter Romania A.O., Romania