Normomed, tablets 500 mg 20 pcs
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ATX code: J05AX05
Pharmacological properties
Pharmacodynamics
Inosin Pranobex is a synthetic purine derivative, is a complex containing inosin 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 inosin, the second component increases its availability to lymphocytes.
It restores lymphocyte functions under immunosuppression, increases blastogenesis in monocyte population, stimulates membrane receptor expression on the surface of T-helpers, prevents decrease in lymphocyte activity under glucocorticosteroids influence, normalizes thymidine induction into lymphocytes. Inosin Prepobex stimulates T-lymphocytes activity and natural killer cells, T-suppressor and T-helper functions, increases immunoglobulin G (Ig G), interferon-gamma production, IL-1 and IL-2, decreases anti-inflammatory cytokines formation -I J1-4 and IL-10, potentiates neutrophils, monocytes and macrophages chemotaxis.
The preparation 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 associated with inhibition of viral RNA and dihydropteroatetase involved in the replication of some viruses, it increases the suppressed viral mRNA synthesis of lymphocytes, which is accompanied by reduction of viral RNA synthesis and translation of viral proteins, increases production of alpha and gamma interferons having antiviral properties by lymphocytes. In combination treatment it increases the effect of interferon-alpha, acyclovir and zidovudine.
Pharmacokinetics
After oral administration the drug is well absorbed from the gastrointestinal tract (GIT). Maximum concentration of ingredients in blood plasma is determined after 1-2 hours. It is rapidly 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
Herpes, Influenza, Cytomegalovirus infection
- Treatment of influenza and other acute respiratory infections;
- infections caused by herpes virus types I and II: genital and labial herpes, herpetic keratitis, varicella, herpes zoster;
- infections with Epstein-Barr virus-induced mononucleosis;
- cytomegalovirus infection;
- severe measles;
- papillomavirus infection: laryngeal/vocal ligament papillomas (fibrous type), genital papillomavirus infection in men and women, warts;
- subacute sclerosing panencephalitis;
- contagious molluscum.
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Active ingredient
Inosyn Pranobex
Composition
1 tablet contains:
Active ingredient:
Inosin Pranobex 500.0 mg
Excipients:
Microcrystalline cellulose 33.5 mg
Perlitol flush (mannitol – 80% and corn starch – 20%) 33.5 mg
br> 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 daily for adults, 1/2 tablet per 5 kg of body weight 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. The maximum daily dose for adults 3-4 g/day, for children aged 3 years and older – 50 mg/kg/day.
Treatment duration:
In acute diseases the treatment duration 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 treatment duration can be increased individually under the doctor’s supervision.
In chronic relapsing diseases in adults and children the treatment is carried out in several courses of 5-10 days with 8-day intervals. During the maintenance therapy the dose may be reduced to 500-1000 mg/day (1-2 tablets) for 30 days.
In herpes infections in adults and children it is prescribed for 5-10 days until the disappearance of symptoms, in asymptomatic period – 1 tablet 2 times a day for 30 days to reduce the number of relapses.
In case of papillomavirus infection the drug is administered to adults for 2 tablets 3 times a day, for children – 1/2 tablet per 5 kg/body weight per day in 3-4 times during 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 10-14-day intervals.
In case of recurrent acute condyloma the preparation is administered to adults – 2 tablets 3 times a day, for children – 1/2 tablet per 5 kg/body weight per day in 3-4 times a day or as a mopotherapy or in combination with surgical treatment within 14-28 days and then the course is repeated 3 times with 1 month intervals.
Use in older patients. There is no need to adjust the dose, the drug is used in the same way as in middle-aged patients. It is necessary to take into account that elderly patients more often have increased uric acid concentration in blood serum and urine than the average age patients.
Administration in patients with renal and hepatic insufficiency.
During the treatment by Normomed it is necessary to monitor uric acid content in blood serum and urine every 2 weeks. Monitoring 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 taking simultaneously xacytinoxidase inhibitors (allopurinol) or drugs that can block cialic acid secretion, such as “loop” diuretics (furosemide, thorasemide, etacryic acid), since this may lead to increased serum uric acid concentration.
Co-administration of the drug with zidovudine increases the concentration of the latter in blood plasma and prolongs its T1/2 (if used together it may require correction of zidovudine dose).
Special Instructions
Normomed, like other antiviral agents, 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 the drug administration it is necessary to monitor uric acid concentration in blood serum and urine.
With long-term use after 4 weeks it is advisable to monitor the liver and kidney function (activity of “hepatic” transaminases in plasma, creatinine, uric acid) every month.
Patients with a significantly increased concentration of uric acid in the body may simultaneously take drugs that reduce its concentration. During the treatment it is necessary to monitor the concentration of uric acid in serum in case the drug is administered simultaneously with the drugs that increase the concentration of uric acid or the drugs that affect renal function.
Normomed should be used with caution in patients with acute hepatic failure, because the drug is metabolized in the liver.
Effect on the ability to drive or operate machinery
Effect of the drug on the speed of psychomotor reactions has not been studied. When using the drug the possibility of dizziness and somnolence should be taken into account.
Synopsis
Oblong biconvex white or almost white tablets with a faint characteristic odor, with a ridge on one side
Contraindications
- High sensitivity to inosine praiobex and other components of the drug;
- Podagra;
- Penal disease;
- Hypertensionchronic renal failure;
- arrhythmia;
- pregnancy and breastfeeding period;
- children under 3 years of age (body weight under 15-20 kg).
Cautions
Cautions should be taken when concomitantly prescribing with xaptinoxidase inhibitors, diuretics, zidovudine, acute hepatic failure.
Side effects
The frequency of side effects after using the drug is classified according to the WHO recommendations: frequent ->1% and < 10%; infrequent ->0.1% and < 1%.
Nervous system disorders: frequent – headache, dizziness, fatigue, malaise, weakness; infrequent – nervousness, drowsiness, insomnia.
Gastrointestinal disorders: frequent – decreased appetite, nausea, vomiting, epigastric pain; infrequent – diarrhea, constipation.
The liver and biliary tract: frequent – temporary increase in the activity of transaminases and alkaline phosphatase in blood plasma, increased concentration of urea in blood plasma.
Skin and subcutaneous tissue: frequent – itching, rash, infrequent – maculopapular rash, urticaria, angioedema.
Renal and urinary tract: infrequent – polyuria.
General disorders: frequent – pain in the joints, exacerbation of gout.
Laboratory and instrumental data: frequent – increase in blood urea nitrogen concentration.
Overdose
In case of overdose, gastric lavage and symptomatic therapy are indicated.
Pregnancy use
It is contraindicated for pregnant and breastfeeding women, since the safety of the drug has not been studied.
Similarities
Groprinosin, Isoprinosin
Weight | 0.100 kg |
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Shelf life | 3 years. |
Conditions of storage | In the dark place at a temperature no higher than 30 ° C. Keep out of reach of children. |
Manufacturer | Obninsk HFC, Russia |
Medication form | pills |
Brand | Obninsk HFC |
Other forms…
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