Composition, form of production and packaging
Tablets white or almost white, oblong, biconvex, with a slight amine odor, with a risk on one side.
inosine pranobex 500 mg
Excipients: mannitol, wheat starch, povidone, magnesium stearate.
10 pieces. - blisters (2) - packs of cardboard.
10 pieces. - blisters (3) - packs of cardboard.
10 pieces. - blisters (5) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
Isoprinosine is a synthetic complex derivative of purine, which possesses immunostimulating activity and nonspecific antiviral action. It restores the functions of lymphocytes under conditions of immunodepression, increases blastogenesis in a population of monocytic cells, stimulates the expression of membrane receptors on the surface of T-helpers, prevents the decrease in activity of lymphocyte cells under the influence of glucocorticosteroids, normalizes the incorporation of thymidine into them. Isoprinosine exerts a stimulating effect on the activity of cytotoxic T-lymphocytes and natural killers, the function of T-suppressors and T-helpers, increases the production of IgG, interferon gamma, interleukins (IL-1) and IL-2, reduces the formation of pro-inflammatory cytokines-IL-4 and IL-10, potentiates the chemotaxis of neutrophils, monocytes and macrophages.
The drug exhibits antiviral activity in vivo against the viruses Herpes simplex, cytomegalovirus and measles virus, human T-cell lymphoma virus type III, polioviruses, influenza A and B, ECHO virus (enterocytopathogenic human virus), encephalomyocarditis and equine encephalitis. The mechanism of antiviral action of Isoprinosin is associated with the inhibition of viral RNA and the enzyme dihydropteroate synthetase involved in the replication of certain viruses. Strengthens the virus-suppressed synthesis of mRNA lymphocytes, which is accompanied by suppression of the biosynthesis of viral RNA and translation of viral proteins, increases the production of lymphocytes with alpha and gamma interferons possessing antiviral properties.
When combined, increases the effect of interferon alfa, antiviral agents of acyclovir and zidovudine.
After oral administration, it is well absorbed from the digestive tract. C max of the active substance in the blood plasma is determined after 1-2 hours.
Rapidly exposed to metabolism. Metabolized similarly to endogenous purine nucleotides with the formation of uric acid, NN-dimethylamino-2-propranololone is metabolized to the N-oxide, and para-acetamidobenzoate to o-acylglucuronide. No cumulation of the drug in the body.
T 1/2 is 3.5 hours for NN-dimethylamino-2-propranololone and 50 minutes for para-acetamidobenzoate. It is excreted by the kidneys. Elimination of the drug and its metabolites from the body occurs within 24-48 hours.
- treatment of influenza and other ARVI;
- infections caused by the Herpes simplex virus types 1, 2, 3 and 4: genital and labial herpes, herpetic keratitis;
- shingles, chicken pox;
- infectious mononucleosis caused by the Epstein-Barr virus;
- cytomegalovirus infection;
- Measles heavy current;
- papillomavirus infection: laryngeal papillomas / vocal cords (fibrous type), papillomavirus infection of genitalia in men and women, warts;
Tablets are taken after meals, washed down with a small amount of water.
The recommended daily intake for adults and children aged 3 years and over (with a body weight of 15-20 kg) is 50 mg / kg body weight in 3-4 doses (for adults- 6-8 tablets / day, for children - 1/2 tablespoons per 5 kg of body weight / day).
In severe forms of infectious diseases, the dose can be increased individually to 100 mg / kg of body weight / day, divided into 4-6 receptions. The maximum daily intake for adults is 3-4 g / day, for children - 50 mg / kg / day.
The duration of treatment for acute diseases in adults and children is usually from 5 to 14 days. Treatment should continue until the disappearance of clinical symptoms and for another 2 days already in the absence of symptoms. If necessary, the duration of treatment can be increased individually under the supervision of a doctor.
With chronic relapsing diseases in adults and children, treatment should be continued with several courses for 5-10 days with a break in admission in 8 days.
For maintenance therapy, the dose can be reduced to 500-1000 mg / day (1-2 tablets) for 30 days.
In herpetic infection, adults and children are prescribed a drug for 5-10 days before the symptoms disappear, in the asymptomatic period - 1 tab. 2 times / day for 30 days to reduce the number of relapses.
With papillomavirus infection, adults are prescribed 2 tab. 3 times / day, children - 1/2 tab. at 5 kg / body weight / day in 3-4 doses for 14-28 days in the form of monotherapy.
With recurrent genital warts, adults are prescribed 2 tab. 3 times / day, children - 1/2 tab. at 5 kg / body weight / day in 3-4 doses, either as monotherapy or in combination with surgical treatment for 14-28 days, then with a three-fold repetition of this course at intervals of 1 month.
When dysplasia of the cervix, associated with the human papillomavirus, appoint 2 tab. 3 times / day for 10 days, then 2-3 similar courses are conducted with an interval of 10-14 days.
The incidence of side effects after the use of the drug is classified according to WHO recommendations: often (? 1%, <10%), sometimes (? 0.1%, <1%).
From the gastrointestinal tract: often - nausea, vomiting, pain in epigastrium; sometimes diarrhea, constipation.
From the liver and biliary tract: often - a temporary increase in the activity of transaminases and alkaline phosphatase in the blood plasma, an increase in the concentration of urea in the blood plasma.
Dermatological reactions: often - itching.
From the nervous system: often - headache, dizziness, weakness; sometimes drowsiness, insomnia.
From the urinary system: sometimes - polyuria.
From the musculoskeletal system and connective tissue: often - joint pain, exacerbation of gout.
- urolithiasis disease;
- chronic renal failure;
- Children under 3 years old (body weight up to 15-20 kg);
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
Safety of the use of Isoprinosine during pregnancy and lactation is not established, therefore, the use of the drug is not recommended.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in chronic renal failure, urolithiasis.
After 4 weeks of use, it is advisable to monitor kidney function every month (level of creatinine, uric acid).
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
After 4 weeks of use, it is advisable to monitor liver function every month (transaminase activity).
APPLICATION FOR CHILDREN
Contraindication: children under 3 years old (body weight up to 15-20 kg).
After 2 weeks of using Isoprinosine, it is recommended to monitor the content of uric acid in the serum and urine.
With prolonged admission after 4 weeks of use, it is advisable to monitor liver and kidney function every month (transaminase activity in blood plasma, creatinine, uric acid level).
It is necessary to monitor the level of uric acid in the blood serum when prescribing Isoprinosine in combination with drugs that increase the level of uric acid or drugs that disrupt kidney function.
Impact on the ability to drive vehicles and manage mechanisms
There are no special contraindications.
Cases of overdose of isoprinosine are not described.
With simultaneous use of immunosuppressants can reduce the effectiveness of Iprinosin.
Inhibitors of xanthine oxidase and uricosuric agents (including diuretics) may contribute to the risk of increasing the level of uric acid in the serum of patients taking Isoprinosine.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 В° C. Shelf life - 5 years.