Normomed tab 500mg 30 pieces

Description

Composition
Active substance:
1 tablet contains: inosine pranobex 500.0 mg.
Excipients:
Microcrystalline cellulose 33.5 mg perlitol flash (mannitol – 80% and the corn starch – 20%) 33.5 mg Sodium carboxymethyl starch 67.0 mg Povidone K-17 10.0 mg Magnesium stearate 6.0 mg.
Description:
Oblong biconcave tablets of white or almost white color with a faint characteristic odor, c line on one side.
Product form:
Tablets of 500 mg. 10 tablets in blisters. 2, 3 or 5 the contour of cellular packaging together with instructions for use placed in a pile of cardboard.
Contraindications
Hypersensitivity to inosine pranobex and other ingredients; gout; urolithiasis disease; chronic renal insufficiency; arrhythmia; pregnancy and lactation; Children under 3 years old (weight 15-20 kg).
Carefully.
Caution should be exercised with concomitant administration with xanthine oxidase inhibitors, diuretics, zidovudine, in acute liver failure.
Dosage
500 mg
Indications
Treatment of influenza and other acute respiratory viral infections; infections caused by herpes simplex virus type I and II: genital and labial herpes, herpetic keratitis, chicken pox, shingles; infectious mononucleosis caused by the Epstein-Barr virus; cytomegalovirus infection; measles, severe; human papillomavirus infection: laryngeal papilloma / vocal cords (the fibrous type), genital human papillomavirus infection in men and women, the warts; subacute sclerosing panencephalitis; molluscum contagiosum.
Interaction with other drugs
Immunosuppressants weaken the immune stimulatory effect of the drug.
The drug should be used with caution in patients receiving both inhibitors of xanthine oxidase (allopurinol) or drugs capable of blocking the tubular secretion of uric acid, such as “loop” diuretics (furosemide, torasemide, ethacrynic acid), as this may lead to increased concentration of uric acid in serum.
The combined use of the drug with zidovudine leads to an increase in the concentration of the latter in the blood plasma and lengthens its TL (a joint application may require a dosage adjustment zidovudine).
Overdose
In overdose shown gastric lavage and symptomatic therapy.
pharmachologic effect
Pharmacological group:
Immunostimulatory agent.
Pharmacodynamics:
Inosine pranobex – synthetic purine derivative, it is a complex containing inosine and AND, AND-dimethylamino-2-propanol in a molar ratio of 1: 3. It has immunopotentiating activity and non-specific antiviral effect. The effectiveness of the complex is determined by the presence of inosine, the second component increases its availability for lymphocytes.
Restores lymphocyte function in a immunosuppression increases blastogenesis in a population of monocytes and stimulates the expression of membrane receptors on the surface of T-helper lymphocytes prevents reduction activity under the influence of glucocorticoids, normalizes the inclusion of thymidine. Inosine pranobex stimulates the activity of T-lymphocytes and natural killer cells, of T-suppressor and T-helper cells increases the production of immunoglobulin G (Ig G), interferon-gamma, interleukins IL-1 and IL-2, reduces the formation of anti-inflammatory cytokines – IL-4 and IL-10, potentiates the chemotaxis of neutrophils, monocytes and macrophages.
The drug shows antiviral activity in vivo against herpes simplex virus, cytomegalovirus, measles virus, T cell lymphoma (type III), polioviruses, influenza viruses A and B, echovirus (enterotsitopatogennogo human virus), encephalomyocarditis virus and equine encephalitis . The mechanism of antiviral action inosine pranobex associated with inhibition of viral RNA and digidropteroatsintetazy involved in the replication of some viruses, virus enhances depressed lymphocyte mRNA synthesis, accompanied by a decrease in viral RNA synthesis, and translation of viral proteins, production increases lymphocytes possess antiviral properties of alpha and gamma interferons. When combined appointment 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 determined after 1-2 hours. Quickly metabolized and excreted through the kidneys. It metabolized analogous endogenous purine nucleotide to form uric acid. K, K-dimethylamino-2-propanol is metabolized to N-oxide and 4-atsetamidobenzoat – to O-atsilglyukuronida. Not revealed accumulation of the drug in the body. The half-life (T`A) is 3.5 hours for N, N-dimethylamino-2-propanol and 50 minutes – 4-atsetamidobenzoata. The drug and its metabolites are excreted in the kidneys for 24-48 hours.
Pregnancy and breast-feeding
Contraindicated in pregnant and breastfeeding women, as safety of the drug has not been studied.
Conditions of supply of pharmacies
On prescription.
side effects
The incidence of side effects after treatment is classified according to the WHO guidelines: frequent -> 1%, and
special instructions
Before starting treatment should consult a doctor.
Normomed® as other antiviral agents, the most effective in acute viral infections if treatment is started at an early stage of disease (preferably with the first day).
After 2 weeks of preparation should be conducted to control the concentration of uric acid in blood serum and urine.
Chronic administration after 4 weeks of each month it is advisable to carry out monitoring of liver and kidney function (activity “liver” transaminases in plasma creatinine, uric acid).
Patients with significantly increased concentration of uric acid in the body can simultaneously receive drugs, lowering its concentration. The treatment is necessary to control the concentration of uric acid in blood serum when administering the drug in conjunction with drugs that increase the concentration of uric acid, drugs or violating kidney function.
Normomed® should be used with caution in patients with acute liver failure patients, because the drug is metabolized in the liver.
Effects on ability to drive vehicles or operate machinery.
Effect of the drug on the rate of psychomotor reactions were investigated. In applying the drug should be considered the possibility of dizziness and drowsiness.
Storage conditions
In the dark place at a temperature not higher than 30 ° C.
Keep out of the reach of children.
Dosing and Administration
The tablets are taken orally after meal with a little water.
The recommended daily dose for adults and children aged 3 years and older (body weight over 15-20 kg) is 50 mg / kg body weight in 3-4 divided doses, that is an average adult – 6-8 tablets a day, for children – 1/2 tablets per 5 kg of body weight per day. In severe infections the dose may be increased individually up to 100 mg / kg of body weight per day, divided into 4-6 doses. The maximum daily dose for adults 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 between 5 to 14 days. Treatment should be continued for two days after the disappearance of clinical symptoms. If necessary, the duration of treatment can be increased individually supervised by a doctor.
In chronic relapsing disease treatment in adults and children is held several courses lasting 5-10 days with intervals of 8 days. During maintenance therapy dose can be reduced to 500-1000 mg / day (1-2 tablets) for 30 days.
When herpes infection in adults and children is prescribed for 5-10 days prior to the disappearance of symptoms in asymptomatic period – 1 tablet 2 times a day for 30 days to reduce the number of relapses.
When papillomavirus infection adult drug administered 2 tablets 3 times a day for children – 1/2 tablet of 5 kg / body weight per day in 3-4 divided doses for 14-28 days as monotherapy.
In cervical dysplasia associated with human papilloma virus, administered 2 tablets 3 times a day for 10 days, followed by 2-3 similar course is performed at intervals of 10-14 days.
With recurrent genital warts adult drug administered 2 tablets 3 times a day for children – 1/2 tablet of 5 kg / body weight per day in 3-4 divided doses a day or as monotherapy or in combination with surgical treatment for 14 -28 days, then a three-fold repetition of this course at intervals of 1 month.
Use in elderly patients.
The need for dose adjustment of no drug use as well as in middle-aged patients. Keep in mind that older patients often is an increase in the concentration of uric acid in the blood serum and in the urine than in middle-aged patients.
Use in patients with renal or hepatic insufficiency.
Against the background of treatment with Normomed® should be every 2 weeks to carry out the control of uric acid in serum and urine. Monitoring of liver enzymes is recommended every 4 weeks during prolonged courses of drug treatment.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist