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

Active ingredient

Composition

1 tablet contains:

The active ingredient:

Inosine Pranobex 500.0 mg

Excipients:

Microcrystalline cellulose 33.5 mg

Perlitol flash (mannitol 80% and cornstarch 20%) 33.5 mg

Perlitol./p>

Sodium carboxymethyl starch 67.0 mg

Povidone K-17 10.0 mg

Magnesium stearate 6.0 mg

How to take, the dosage

Tablets are taken orally after meals with a small amount of water. Recommended daily dose for adults and children aged 3 years and older (body weight over 15-20 kg) is 50 mg/kg of body weight in 3-4 doses, which averages 6-8 tablets per day for adults, 1/2 tablet per 5 kg of body weight per day for children. In severe forms of infectious diseases the dose can be increased individually up to 100 mg/kg body weight per day divided into 4-6 doses. Maximal daily dose for adults is 3-4 g/day, for children aged 3 years and older it is 50 mg/kg/day.

The duration of treatment:

In acute illness, the duration of treatment in adults and children is usually 5 to 14 days. Treatment should be continued for 2 days after the disappearance of clinical symptoms. If necessary, the duration of treatment may be increased individually under the supervision of a physician.

In chronic relapsing disease, treatment in adults and children is carried out in several courses of 5-10 days at intervals of 8 days. During maintenance therapy the dose can be reduced to 500-1000 mg/day (1-2 tablets) for 30 days.

In case of herpetic infection it is indicated for 5-10 days in adults and children until disappearance of symptoms, in asymptomatic period – 1 tablet 2 times a day for 30 days to decrease the number of relapses.

In case of papillomavirus infection the drug is indicated for adults 2 tablets 3 times a day, for children – 1/2 tablet per 5 kg/body weight per day in 3-4 doses for 14-28 days as monotherapy.

In case of cervical dysplasia associated with human papilloma virus the drug is prescribed 2 tablets 3 times a day for 10 days and then there are 2-3 similar courses with an interval of 10-14 days.

In case of recurrent acute condyloma the drug is prescribed for adults 2 tablets 3 times a day, for children – 1/2 tablet per 5 kg/body weight per day in 3-4 doses daily or as a mopotherapy or in combination with surgical treatment for 14-28 days, then the course is repeated 3 times with an interval of 1 month.

The use in elderly patients. There is no need to adjust the dose, the drug is used in the same way as in middle-aged patients. It should be taken into account that elderly patients are more likely to have increased uric acid concentrations in serum and urine than patients of middle age.

The use in patients with renal and hepatic impairment.

At the time of treatment with Normomed, the uric acid content in serum and urine should be monitored every 2 weeks. Control of liver enzymes activity is recommended every 4 weeks during long-term treatment with the drug.

Interaction

Immunosuppressants weaken the immunostimulatory effect of the drug.

. The drug should be used with caution in patients concomitantly taking xacytinoxidase inhibitors (allopurinol) or drugs that can block caiacal secretion of uric acid, such as “loop” diuretics (furosemide, thorasemide, etacryic acid), since this can lead to increased uric acid concentration in the blood serum.

Co-administration of the drug with zidovudine leads to increased plasma concentrations of the latter and prolongs its T1/2 (when used together zidovudine dosage adjustment may be required).

Special Instructions

Consult a doctor before starting treatment.

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

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

On long-term use after 4 weeks it is reasonable to monitor liver and renal function (plasma activity of “hepatic” transaminases, creatinine, uric acid) every month.

Patients with significantly elevated concentrations of uric acid in the body can simultaneously take drugs that reduce its concentration. Serum uric acid concentration should be monitored during treatment if the drug is concomitantly administered with drugs that increase uric acid concentration or with drugs that impair renal function.

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

The effect of the drug on the ability to drive 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 somnolence must be taken into account.

Synopsis

Contraindications

Cautions

Cautions should be taken when concomitantly prescribing with xaptinoxidase inhibitors, diuretics, zidovudine, acute hepatic failure.

Side effects

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

Nervous system disorders: frequent – headache, dizziness, fatigue, malaise, weakness; infrequent – nervousness, somnolence, insomnia.

Gastrointestinal disorders: frequent – decreased appetite, nausea, vomiting, epigastric pain; infrequent – diarrhea, constipation.

Hepatic and biliary tract disorders: frequent – temporary increase of transaminase and alkaline phosphatase activity in blood plasma, increased concentration of urea in blood plasma.

Skin and subcutaneous tissue disorders: frequent – itching, rash; infrequent:maculopapular rash, urticaria, angioedema.

Renal and urinary tract disorders: infrequent – polyuria.

General disorders: frequent – pain in the joints, exacerbation of gout.

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

Overdose

Pregnancy use

Similarities