Normomed, tablets 500 mg 50 pcs

ATX code: J05AX05

Pharmacological properties

Pharmacodynamics

Inosine Pranobex is a synthetic purine derivative, a complex containing inosine and N,N-dimethylamino-2-propanol in a molar ratio of 1:3. It has immunostimulating activity and nonspecific antiviral action. The effectiveness of the complex is determined by the presence of inosine, the second component increases its availability to lymphocytes.

It restores functions of lymphocytes under immunosuppression, increases blastogenesis in monocyte population, stimulates expression of membrane receptors on the surface of T-helper cells, prevents decrease of lymphocyte activity caused by glucocorticosteroids and normalizes thymidine incorporation into lymphocytes.

. Inosin Prepobex stimulates the activity of T-lymphocytes and natural killer cells, T-suppressor and T-helper functions, increases production of immunoglobulin G (Ig G), interferon-gamma, IL-1 and IL-2, decreases formation of anti-inflammatory cytokines -I J1-4 and IL-10, potentiates chemotaxis of neutrophils, monocytes and macrophages.

The drug shows antiviral activity in vivo against herpes simplex virus, cytomegalovirus, measles virus, human T-cell lymphoma virus (Tin III), polioviruses, influenza A and B viruses, human EHV (EHV), encephalomyocarditis and horse encephalitis viruses.

The mechanism of antiviral action of Pranobex inosine is connected with inhibition of viral RNA and dihydropteroacetase, participating in replication of some viruses; it increases mRNA synthesis of lymphocytes suppressed by viruses, which is accompanied with decrease of viral RNA synthesis and translation of viral proteins, increases production of alpha and gamma interferons by lymphocytes having antiviral properties.

In combined administration it increases the effect of interferon-alpha, acyclovir and zidovudine.

Pharmacokinetics

The drug is well absorbed from the gastrointestinal tract (GIT) after oral administration. Maximum concentration of ingredients in blood plasma is determined after 1-2 hours. It is quickly metabolized and excreted through the kidneys.

It is metabolized similarly to endogenous puripose nucleotides with formation of uric acid. N,N-dimethylamino-2-propanol is metabolized to N-oxide, and 4-acetamidobenzoate to o-acylglucuropide. 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;
infections caused by herpes virus types I and II: genital and labial herpes, herpetic keratitis, chickenpox, herpes zoster;
infectious mononucleosis caused by the Epstein-Barr virus;
cytomegalovirus infection;
severe measles;
papillomavirus infection: papillomas of the larynx/vocal cords (fibrous type), papillomavirus infection of the genital organs in men and women, warts;
subacute sclerosing panencephalitis;
Molluscum contagiosum.

Pharmacological effect

ATX code: J05AX05

Pharmacological properties

Pharmacodynamics

Inosine Pranobex – a synthetic derivative of purine, is a complex containing inosine and N,N-dimethylamino-2-propanol in a molar ratio of 1:3. It has immunostimulating activity and nonspecific antiviral effect. The effectiveness of the complex is determined by the presence of inosine; the second component increases its availability to lymphocytes.

Restores the functions of lymphocytes in conditions of immunosuppression, increases blastogenesis in the monocyte population, stimulates the expression of membrane receptors on the surface of T-helper cells, prevents a decrease in the activity of lymphocytes under the influence of glucocorticosteroids, and normalizes the inclusion of thymidine in them.

Inosine Prapobex stimulates the activity of T-lymphocytes and natural killer cells, the functions of T-suppressors and T-helpers, increases the production of immunoglobulin G (Ig G), interferon-gamma, IL-1 and IL-2, reduces the formation of anti-inflammatory cytokines -I J1-4 and IL-10, potentiates the chemotaxis of neutrophils, monocytes and macrophages.

The drug exhibits antiviral activity in vivo against herpes simplex virus and cytomegalovirus. measles virus, human T-cell lymphoma virus (Tin III), polioviruses, influenza A and B viruses, ECHO virus (human etherocytopathogenic virus), encephalomyocarditis and equine encephalitis viruses.

The mechanism of the antiviral action of inosine pranobex is associated with the inhibition of viral RNA and dihydropteroate synthetase, which is involved in the replication of some viruses, enhances the synthesis of lymphocyte mRNA suppressed by viruses, which is accompanied by a decrease in the synthesis of viral RNA and translation of viral proteins, increases the production of alpha and gamma interferons by lymphocytes with antiviral properties.

When administered in combination, it enhances the effect of interferon-alpha, acyclovir and zidovudine.

Pharmacokinetics

After oral administration, the drug is well absorbed from the gastrointestinal tract (GIT). 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 puripid nucleotides with the formation of uric acid. N,N-dimethylamino-2-propanol is metabolized to N-oxide, and 4-acetamidobenzoate to o-acylglucuropide. 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

Before starting treatment, you should consult your doctor.

Normomed, like other antiviral drugs, is most effective for acute viral infections if treatment is started at an early stage of the disease (preferably from the first day).

After 2 weeks of using the drug, the concentration of uric acid in the blood serum and urine should be monitored.

With long-term use, after 4 weeks, it is advisable to monitor liver and kidney function every month (activity of “liver” transaminases in the blood plasma, creatinine, uric acid).

Patients with significantly increased concentrations of uric acid in the body can simultaneously take medications that lower their concentrations. At the treatment stage, it is necessary to monitor the concentration of uric acid in the blood serum when prescribing the drug simultaneously with drugs that increase the concentration of uric acid or drugs that impair renal function.

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

Impact on the ability to drive vehicles or operate machinery

The effect of the drug on the speed of psychomotor reactions 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 tablet contains:

Active ingredient:

Inosine Pranobex 500.0 mg

Excipients:

Microcrystalline cellulose 33.5 mg

Perlitol flash (mannitol – 80% and corn starch – 20%) 33.5 mg

Sodium carboxymethyl starch 67.0 mg

Povidone K-17 10.0 mg

Magnesium stearate 6.0 mg

Pregnancy

Contraindicated for pregnant women and breastfeeding women, because The safety of the drug has not been studied.

Contraindications

Hypersensitivity to inosine praiobex and other components of the drug;
gout;
urolithiasis;
chronic renal failure;
arrhythmias;
pregnancy and breastfeeding;
children under 3 years of age (body weight up to 15-20 kg).

With caution

Caution should be exercised when administered concomitantly with xaptin oxidase inhibitors, diuretics, zidovudine, and in acute liver failure.

Side Effects

The incidence of side effects after using the drug is classified according to WHO recommendations: frequent -> 1% and 0.1% and

From the nervous system: frequent – headache, dizziness, fatigue, poor health, weakness; infrequent – nervousness, drowsiness, insomnia.

From the gastrointestinal tract: frequent – loss of appetite, nausea, vomiting, epigastric pain; uncommon – diarrhea, constipation.

From the liver and biliary tract: frequent temporary increase in the activity of transaminases and alkaline phosphatase in the blood plasma, increase in the concentration of urea in the blood plasma.

From the skin and subcutaneous tissues: frequent – itching, rash; Uncommon: maculopapular rash, urticaria, angioedema.

From the kidneys and urinary tract: uncommon – polyuria.

General disorders: frequent – joint pain, exacerbation of gout.

Laboratory and instrumental data: frequent – increased blood urea nitrogen concentration.

Interaction

Immunosuppressants weaken the immunostimulating effect of the drug.

The drug should be used with caution in patients taking concomitantly xaitin oxidase inhibitors (allopurinol) or drugs that can block calcium secretion of uric acid, for example, loop diuretics (furosemide, torasemide, ethacryic acid), as this may lead to an increase in the concentration of uric acid in the blood serum.

The combined use of the drug with zidovudine leads to an increase in the concentration of the latter in the blood plasma and prolongs its T1/2 (when used together, a dose adjustment of zidovudine may be required).

Overdose

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

Storage conditions

In a place protected from light at a temperature not exceeding 30 ° C.

Keep out of the reach of children.

Shelf life

3 years.

Manufacturer

Obninsk HFC, Russia