Normomed pills 500mg, 50pcs

Composition

1 tablet contains:

Active ingredient:

Inosine Pranobex 500.0 mg

Auxiliary substances:

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

Pharmacological action

ATX Code: J05AX05

Pharmacological Properties

Pharmacodynamics

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

It restores the functions of lymphocytes under 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, normalizes the inclusion of thymidine in them.

Inosine Prapobex stimulates the activity of T-lymphocytes and natural killers, the functions of T-suppressors and T-helpers, increases the production of immunoglobulin G (Ig G), interferon-gamma, ipterleukips IL-1 and IL-2, reduces the formation of anti-inflammatory cytokines-Ij1-4 and IL-10, potentiates the chemotaxis of neutrophils, monocytes and macrophages.

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

The mechanism of antiviral action of inosine pranobex is associated with the inhibition of viral RNA and dihydropteroate cytetase, 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 viral RNA synthesis and translation of viral proteins, and increases the production of alpha and gamma interferons with antiviral properties by lymphocytes.

When combined, it enhances the effect of interferon-alpha, acyclovir and zidovudine.

Pharmacokinetics

After oral use, 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 rapidly metabolized and excreted through the kidneys.

It is metabolized similarly to endogenous purip nucleotides to form uric acid. N, N-dimethylamino-2-propanol is metabolized to N-oxide, and 4-acetamidobenzoate is metabolized to o-acylglucuropide. No accumulation of the drug in the body was detected. The elimination half-life (T 1/2) is 3.5 h for N, N-dimethylamino-2-propanol and 50 min for 4-acetamidobenzoate. The drug and its metabolites are excreted by the kidneys within 24-48 hours.

Indications

• Treatment of influenza and other acute respiratory viral infections;
• infections caused by herpes simplex virus types I and II: genitally and labially herpes, herpetic keratitis, varicella, herpes zoster;
• infectious mononucleosis caused by the Epstein-Barr;
• citomegalovirus infection;
• measles severe course;
• human papillomavirus infection: a papilloma of the larynx/vocal cords (fibrous type) HPV infection of the genital organs in men and women, warts;
• subacute sclerosing panencephalitis;
• molluscum contagiosum.

Use during pregnancy and lactation

It is contraindicated in pregnant and breast-feeding women, as 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 lactation;
• children under 3 years of age (body weight up to 15-20 kg).

With caution

Caution should be exercised when prescribing concomitantly with xaptin oxidase inhibitors, diuretics, zidovudine, in acute hepatic insufficiency.

Side effects

The frequency of side effects after the use of 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; infrequent-diarrhea, constipation.

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

Skin and subcutaneous tissue disorders: common-itching, rash; infrequent: macular-papular rash, urticaria, angioedema.

From the side of the kidneys and urinary tract: infrequent-polyuria.

Common disorders: common-joint pain, exacerbation of gout.

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

Interaction

Immunosuppressants weaken the immunostimulating effect of the drug.

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

Concomitant use of the drug with zidovudine leads to an increase in the concentration of the latter in blood plasma and prolongs its T 1/2 (when used together, it may be necessary to adjust the dose of zidovudine).

How to take, course of use and dosage

Tablets are taken orally after a meal, washed down with a small amount of water. The 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 is an average of 6-8 tablets per day for adults, and 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 to 100 mg / kg of body weight per day, divided into 4-6 doses. The maximum daily dose for adults is 3-4 g / day, for children aged 3 years and older-50 mg / kg / day.

Duration of treatment:

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

For chronic recurrent diseases, treatment in adults and children is carried out in several courses lasting 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, adults and children are prescribed for 5-10 days until the symptoms of the disease disappear, in the asymptomatic period-1 tablet 2 times a day for 30 days to reduce the number of relapses.

For papillomavirus infection, adults are prescribed 2 tablets 3 times a day, 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 the human papillomavirus,2 tablets are prescribed 3 times a day for 10 days, then 2-3 similar courses are carried out with an interval of 10-14 days.

With recurrent genital warts, adults are prescribed 2 tablets 3 times a day, children-1/2 tablet per 5 kg / body weight per day in 3-4 doses per day or as mopotherapy or in combination with surgical treatment for 14-28 days, then with a three-time repetition of the specified course at intervals of 1 month.

Use in elderly patients. If there is no need to adjust the dose of pet, 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 an increase in the concentration of uric acid in the blood serum and urine than in middle-aged patients.

Use in patients with renal and hepatic insufficiency.

During treatment with Normomed, the uric acid content in the blood serum and urine should be monitored every 2 weeks. Monitoring of the activity of liver enzymes is recommended to be carried out every 4 weeks with long-term courses of treatment with the drug.

Overdose

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

Description

Oblong biconvex tablets of white or almost white color with a faint characteristic smell, with a risk on one side

Special instructions

You should consult your doctor before starting treatment.

Normomed, like other antiviral agents, is most effective in 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 prolonged use after 4 weeks, it is advisable to monitor liver and kidney function every month (activity of “hepatic” transaminases in blood plasma, creatinine, uric acid).

Patients with significantly increased concentrations of uric acid in the body can simultaneously take medications that lower its concentration.In the foyer of treatment, 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 violate kidney function.

Normomed should be used with caution in patients with acute hepatic insufficiency, since the drug undergoes metabolism in the liver.

Influence on the ability to drive vehicles or work with mechanisms

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.

Form of production

500 mg tablets. 10 tablets in a contour cell package. 2,3 or 5 contour cell packages together with the instructions for use are placed in a pack of cardboard.

Storage conditions

Store in a dark place at a temperature not exceeding 30 °C.

Keep out of the reach of children.

Shelf

life is 3 years.

Active ingredient

Inosine Pranobex

Conditions of release from pharmacies

By prescription

Dosage form

syrup

Purpose

For adults as directed by your doctor

Indications

Cytomegalovirus infection, Flu, Herpes