Normomed tabs 500mg #50

Normomed instruction for use

You can buy Normomed here

Composition

1 tablet contains:
Active substance:
Inosine Pranobex 500.0 mg
Excipients:
Microcrystalline cellulose 33.5 mg
Perlitol Flush (mannitol - 80% and corn starch - 20%) 33.5 mg
Carboxymethyl starch sodium 67.0 mg
Povidone K-17 10.0 mg
Magnesium stearate 6.0 mg
Description:
Oblong biconvex tablets of white or almost white color with a faint characteristic odor, with a risk on one side
Pharmacotherapeutic group:
immunostimulating agent
ATX Code: J05AX05

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 non-specific antiviral action. The effectiveness of the complex is determined by the presence of inosine, the second component increases its availability for lymphocytes.
Restores the function of lymphocytes in immunodepression, 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. Inosine Prapobex stimulates the activity of T-lymphocytes and natural killer cells, functions of T-suppressors and T-helpers, increases the production of immunoglobulin G (Ig G), interferon-gamma, ipterleukipov 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.
Normomed exhibits antiviral activity in vivo against herpes simplex virus, cytomegalovirus. measles virus, human T-cell lymphoma virus (Tin III), polioviruses, influenza A and B viruses, the ECHO virus (human eitrocytopathogenic virus), encephalomyocarditis viruses and equine encephalitis. The mechanism of the antiviral effect of inosine pranobex is associated with inhibition of viral RNA and dihydropteroatsytetase involved in the replication of certain viruses, enhances viral mRNA synthesis of lymphocytes suppressed by viruses, which is accompanied by a decrease in viral RNA synthesis and translation of viral proteins, increases the production of lymphocytes with antiviral properties of alpha and gamma interferons. With a combined appointment enhances the action of interferon-alpha, acyclovir and zidovudine.

Pharmacokinetics

After ingestion, Normomed 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. Metabolized similarly to endogenous pupovyh nucleotides with the formation of uric acid. N, N-dimethylamino-2-propanol is metabolized to N-oxide, and 4-acetamido-benzoate to o-acylglucuronide. Not detected cumulation of Normomed in the body. The half-life (T1 / 2) is 3.5 hours for N, N-dimethylamino-2-propanol and 50 minutes for 4-acetamido benzoate. The drug and its metabolites are excreted by the kidneys within 24-48 hours.

Indications for use

    Treatment of influenza and other acute respiratory viral infections;
    infections caused by the herpes virus I and II types: genital and labial herpes, herpetic keratitis, chicken pox, shingles;
    infectious mononucleosis caused by Epstein-Barr virus;
    cytomegalovirus infection;
    severe measles;
    human papillomavirus infection: laryngeal / vocal cord papillomas (fibrous type), genital papillomavirus infection of the genital organs in men and women, warts;
    subacute sclerosing panencephalitis;
    molluscum contagiosum.

Contraindications

    hypersensitivity to inosine praiobex and other components of Normomed;
    gout;
    urolithiasis disease;
    chronic renal failure;
    arrhythmias;
    pregnancy and breastfeeding;
    children's age up to 3 years (body weight up to 15-20 kg).

Carefully

Caution must be exercised when administered concurrently with xaptin oxidase inhibitors, diuretics, zidovudine, and in acute liver failure. Use during pregnancy and the period of breastfeeding Contraindicated in pregnant women and women who are breastfeeding, because the safety of Normomed has not been investigated.

Dosage and administration

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 body weight in 3-4 doses, which is on average for adults 6-8 tablets per day, for children - 1/2 tablet per 5 kg of body weight per day. In severe forms of infectious diseases, the dose can be individually increased 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 from 5 to 14 days. Treatment should be continued for 2 days after the disappearance of the clinical symptoms. If necessary, the duration of treatment can be increased individually under the supervision of a physician.
In chronic recurrent diseases, treatment in adults and children is carried out in several courses lasting 5-10 days with 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 herpes 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 for adults, Normomed is prescribed 2 tablets 3 times a day, children - 1/2 tablets 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 papillomavirus, 2 tablets are prescribed 3 times a day for 10 days, followed by 2-3 courses with an interval of 10-14 days.
In case of recurrent genital warts for adults, Normomed is prescribed 2 tablets 3 times a day, children - 1/2 tablets per 5 kg / body weight per day in 3-4 doses per day, either as a therapy or in combination with surgical treatment for 14 -28 days, then with a threefold repetition of the specified course at intervals of 1 month.
Use in elderly patients. Need for dose adjustment pet, the drug is used in the same way as in patients of middle age. It should be borne in mind that elderly patients are more likely to have an increase in the concentration of uric acid in the serum and in the urine than in middle-aged patients.
Use in patients with renal and hepatic insufficiency.
Against the background of treatment with the drug Normomed, every 2 weeks should be monitored the content of uric acid in serum and urine. Monitoring the activity of liver enzymes is recommended every 4 weeks for long courses of drug treatment.

Side effect of Normomed

The frequency of side effects after using Normomed is classified according to WHO recommendations: frequent -> 1% and <10%; infrequent -> 0.1% and <1%.
On the part of the nervous system: frequent - headache, dizziness, fatigue, poor health, weakness; infrequent - nervousness, drowsiness, sleeplessness.
From the digestive tract: frequent - loss of appetite, nausea, vomiting, epigastric pain; infrequent - diarrhea, constipation.
On the part of the liver and biliary tract: frequent temporary increase in the activity of transaminases and alkaline phosphatase in the blood plasma, increasing the concentration of urea in the blood plasma.
On the part of the skin and subcutaneous tissues: frequent - itching, rash; infrequent: maculo-papular rash, urticaria, angioedema.
On the part of the kidneys and urinary tract: infrequent - polyuria.
Common disorders: frequent - pain in the joints, aggravation of gout.
Laboratory and instrumental data: frequent - increasing the concentration of blood urea nitrogen.

Overdose

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

Interaction with other drugs

Immune depressants weaken the immunostimulating effect of Normomed. The drug should be used with caution in patients taking both xytinoxidase inhibitors (allopurinol) or drugs that can block the kajaltza secretion of uric acid, for example, "loopback" diuretics (furosemide, torasemide, ethacrylic acid), as this may lead to an increase in uric acid concentration 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 T1 / 2 (if used together, it may be necessary to adjust the dose of zidovudine).

special instructions

Before starting treatment, you should consult with your doctor.
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 Normomed should be monitored the concentration of uric acid in the serum and urine.
With long-term administration after 4 weeks, it is advisable to monitor liver and kidney function every month (activity of liver transaminases in plasma, creatinine, uric acid).
Patients with a significantly increased concentration of uric acid in the body can simultaneously take drugs that lower its concentration. In the foyer of treatment, it is necessary to control 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 affect kidney function.
Normomed should be used with caution in patients with acute liver failure, since Normomed is metabolized in the liver.
Influence on ability to drive motor transport or work with mechanisms
The effect of the drug on the speed of psychomotor reactions has not been studied. When using Normomed should take into account the possibility of dizziness and drowsiness.

Release form

Tablets 500 mg. 10 tablets in a blister pack. On 2. 3 or 5 blister strip packagings together with the application instruction are placed in a pack from a cardboard.

Storage conditions

In the dark place at a temperature of no higher than 30 ° C.
Keep out of the reach of children.
Shelf life - 3 years. Do not use after the expiration date printed on the package.

Terms of sell

You can buy Normomed without a prescription.