Product Overview
Composition
Active substance:
Inosine Pranobex (Isoprinosine) - 500 mg
Excipients:
mannitol
wheat starch
povidone
magnesium stearate.
pharmachologic effect
Isoprinosine is a synthetic complex derivative of purine, which has immunostimulating activity and a non-specific antiviral effect.
It restores the functions of lymphocytes under conditions of immunosuppression, increases blastogenesis in the population of monocytic cells, stimulates the expression of membrane receptors on the surface of T-helpers, prevents the decrease in the activity of lymphocyte cells under the influence of glucocorticosteroids, and normalizes the incorporation of thymidine into them.
Isoprinosine has 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 immunoglobulin (lg) G, interferon-gamma, interleukins (IL) -1 and IL-2, reduces the formation of pro-inflammatory cytokines - IL-4 and IL-10, potentiates chemotaxis of neutrophils, monocytes and macrophages.
The drug exhibits antiviral activity in vivo against viruses:
- Herpes simplex.
- Cytomegalovirus.
- Measles virus.
- Human T-cell lymphoma virus type III.
- Polioviruses.
- Influenza A and B.
- ECHO virus (enterocytopathogenic human virus).
- Encephalomyocarditis.
- Equine encephalitis.
The antiviral mechanism of isoprinosine is associated with the inhibition of viral RNA and the enzyme dihydropteroate synthetase, which is involved in the replication of certain viruses, enhances virus-suppressed synthesis of mRNA of lymphocytes, which is accompanied by a suppression of the biosynthesis of viral RNA and the translation of viral proteins, increases the production of interferon-alpha and antiviral lymphocytes.
When combined, it enhances the effect of interferon-alpha, antiviral agents acyclovir and zidovudine.
Pharmacokinetics
After oral administration, the drug is well absorbed from the gastrointestinal tract. The 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 purine nucleotides with the formation of uric acid. 1M-M-dimethylamino-2-propranolone is metabolized to N-oxide, and para-acetamidobenzoate to o-acylglucuronide.
No cumulation of the drug in the body was detected.
The half-life is 3.5 hours for NN-dimethylamino-2-propranolone and 50 minutes for para-acetamidobenzoate. The elimination of the drug and its metabolites from the body occurs within 24-48 hours.
Indications
Pregnancy and lactation
Use during pregnancy and during lactation (breastfeeding) is contraindicated.
Contraindications
- Hypersensitivity to the components of the drug.
- Urolithiasis disease.
- Arrhythmias.
- Chronic renal failure.
- Children's age up to 3 years (body weight up to 15-20 kg).
Side effects
On the part of the nervous system: often - headache, dizziness, fatigue, poor health; infrequently - nervousness, drowsiness, insomnia.
From the gastrointestinal tract: often - loss of appetite, nausea, vomiting, epigastric pain; infrequently - diarrhea, constipation.
From the hepatobiliary system: often - increased activity of liver enzymes, alkaline phosphatase.
On the part of the skin and subcutaneous fat: often - itching, rash.
From the kidneys and urinary tract: infrequently - polyuria.
Allergic reactions: infrequently - maculopapular rash, urticaria, angioedema.
From the musculoskeletal system: often - joint pain, exacerbation of gout.
Other: often - increased blood urea nitrogen concentration.
Interaction
Immunosuppressants may decrease the effectiveness of the drug. Xanthine oxidase inhibitors and uricosuric agents (including diuretics) may contribute to the risk of increased serum uric acid levels in patients taking isoprinosine.
How to take, course of administration and dosage
The recommended dose for adults and children from 3 years of age (body weight from 15-20 kg) is 50 mg / kg per day, divided into 3-4 doses. Adults - 6-8 tablets per day, children - ½ tablets per 5 kg / body weight per day. In severe forms of infectious diseases, the dose can be individually increased to 100 mg / kg body weight per day, divided into 4-6 doses.
The maximum daily dose for adults is 3-4 g / day, for children - 50 mg / kg / day.
Treatment duration
Acute diseases: The duration of treatment in adults and children is usually from 5 to 14 days. Treatment should be continued 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 physician.
In case of chronic recurring diseases in adults and children, treatment should be continued with several courses of 5-10 days with a break in admission of 8 days.
For maintenance therapy, the dose can be reduced to 500-1000 mg per day (1-2 tablets) for 30 days.
With a herpetic infection, adults and children are prescribed for 5-10 days until the symptoms disappear, in the asymptomatic period, 1 tablet 2 times a day for 30 days to reduce the number of relapses.
In case of human papillomavirus infection, 2 tablets are prescribed 3 times a day for adults, for children ½ tablets per 5 kg / body weight per day in 3-4 doses for 14-28 days as monotherapy. For recurrent genital warts, adults are prescribed 2 tablets 3 times, for children ½ tablets per 5 kg / body weight per day in 3-4 doses per day, either as monotherapy or in combination with surgical treatment for 14-28 days, further with three repetitions of the specified course at intervals of 1 month.
With cervical dysplasia associated with the human papilloma virus, 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.
Overdose
Cases of an overdose of Isoprinosine are not described.
Special instructions
With caution, a drug with xanthine oxidase inhibitors, diuretics, zidovudine, in acute renal failure should be prescribed.
Inosine pranobex, like other antiviral agents, is most effective for acute viral infections if treatment is started at an early stage of the disease (preferably from the first day).
Since inosine is excreted in the form of uric acid, with prolonged use it is recommended to periodically monitor the concentration of uric acid in blood serum and urine. Patients with a significantly increased concentration of uric acid in the body can simultaneously take drugs that lower its concentration.
It is necessary to control the concentration of uric acid in the blood serum when using inosine pranobex simultaneously with drugs that increase the concentration of uric acid or drugs that impair renal function.
In elderly patients, an increase in the concentration of uric acid in blood serum and urine is more likely than in middle-aged patients.
Use with caution in patients with acute liver failure, since the drug is metabolized in the liver. In patients with hepatic insufficiency, serum and urine levels of uric acid should be monitored every 2 weeks. Monitoring the activity of liver enzymes is recommended every 4 weeks with long courses of treatment with the drug.
Influence on the ability to drive vehicles and control mechanisms
When used in patients involved in driving vehicles and other potentially hazardous activities, the possibility of dizziness and drowsiness should be considered.