Isoprinosine, pills 500 mg 50 pcs.

Composition

One tablet contains:

Active ingredient: 

Inosine Pranobex (Isoprinosinee) – 500 mg

Auxiliary substances: 

mannitol,

wheat starch,

povidone,

magnesium stearate.

Pharmacological action

Isoprinosinee is a synthetic complex purine derivative with immunostimulating activity and non-specific antiviral effect.

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-helper cells, prevents a decrease in the activity of lymphocytic cells under the influence of glucocorticosteroids, normalizes the inclusion of thymidine in them.

Isoprinosinee has a stimulating effect on the activity of cytotoxic T-lymphocytes and natural killers, the functions 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 the chemotaxis of neutrophils, monocytes and macrophages.

The drug exhibits antiviral activity in vivo against viruses:

• Herpes simplex.
• Cytomegalovirus.
• The measles virus.
• Human T-cell lymphoma virus type III.
• Polioviruses.
• Influenza A and B.
• ESNO virus (enterocytopathogenic human virus).
• Encephalomyocarditis.
• Equine encephalitis.

The mechanism of antiviral action of Isoprinosinee is associated with inhibition of viral RNA and the enzyme dihydropteroate synthetase, which is involved in the replication of some viruses, enhances the synthesis of lymphocyte mRNA suppressed by viruses, which is accompanied by suppression of viral RNA biosynthesis and translation of viral proteins, and increases the production of interferons with antiviral properties by lymphocytes-alpha and gamma.

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 the 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 to form uric acid.1 M-M-dimethylamino-2-propranolone is metabolized to N-oxide, and para-acetamidobenzoate is metabolized to o-acylglucuronide.

No accumulation of the drug in the body was detected.

The elimination half-life is 3.5 hours for N-N-dimethylamino-2-propranolone and 50 minutes for para-acetamidobenzoate. Elimination of the drug and its metabolites from the body occurs within 24-48 hours.

Indications

Treatment of influenza and other acute respiratory infections; infections caused by Herpes simplex virus types 1,2,3 and 4: genital and labial herpes, herpetic keratitis, shingles, chickenpox, infectious mononucleosis caused by Epstein-Barr virus;cytomegalovirus infection;severe measles;papillomavirus infection: laryngeal/vocal cord papillomas (fibrotic type papillomavirus infection of the genitals in men and women, warts;molluscum contagiosum.

Use during pregnancy and lactation

Contraindicated use during pregnancy and lactation (breastfeeding).

Contraindications

• Hypersensitivity to the components of the drug.
• Urolithiasis.
• Arrhythmias.
• Chronic renal failure.
• Children under 3 years of age (body weight up to 15-20 kg).

Side effects

Nervous system disorders: often – headache, dizziness, fatigue, poor health; infrequently-nervousness, drowsiness, insomnia.

From the gastrointestinal tract: often-decreased appetite, nausea, vomiting, epigastric pain; infrequently-diarrhea, constipation.

From the side of the hepatobiliary system: often-increased activity of liver enzymes, alkaline phosphatase.

Skin and subcutaneous fat disorders: often – itching, rash.

From the side of the kidneys and urinary tract: infrequently-polyuria.

Allergic reactions: infrequently – maculopapular rash, urticaria, angioedema.

Musculoskeletal disorders: often-joint pain, exacerbation of gout.

Other services: often-an increase in the concentration of blood urea nitrogen.

Interaction

Immunosuppressants may reduce 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 Isoprinosinee.

How to take, course of administration and dosage

Tablets are taken orally after a meal, washed down with a small amount of water. 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 tablet per 5 kg / body weight per day. In severe forms of infectious diseases, the dose can be increased individually to 100 mg / kg of 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. Duration of treatment Acute diseases: the duration of treatment in adults and children is usually 5 to 14 days. Treatment should be continued until the clinical symptoms disappear and for another 2 days in the absence of symptoms. If necessary, the duration of treatment can be increased individually under the supervision of a doctor. In case of chronic recurrent diseases in adults and children, treatment should be continued in several courses of 5-10 days with a break of 8 days. For maintenance therapy, the dose can be reduced to 500-1000 mg per day (1-2 tablets) for 30 days. In case of herpetic 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, adults are prescribed 2 tablets 3 times a day, children – ½ tablet 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, children – ½ tablet per 5 kg / body weight per day in 3-4 doses per day or as monotherapy or in combination with surgical treatment for 14-28 days, then with a three-time repetition of the specified course at intervals of 1 month. In case of cervical dysplasia associated with the human papillomavirus,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 overdose of Isoprinosinee are not described.

Special instructions

With caution, the drug should be prescribed with xanthine oxidase inhibitors, diuretics, zidovudine, in acute renal failure.

Inosine pranobex, 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).

Since inosine is eliminated from the body in the form of uric acid, with prolonged use, it is recommended to periodically monitor the concentration of uric acid in the blood serum and urine. Patients with significantly increased concentrations of uric acid in the body can simultaneously take medications that lower its concentration.

It is necessary to monitor 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 violate renal function.

Elderly patients are more likely to have an increase in the concentration of uric acid in the blood serum and urine than in middle-aged patients.

Use with caution in patients with acute hepatic insufficiency, since the drug is metabolized in the liver. In patients with hepatic insufficiency, uric acid levels in the blood serum and urine should be monitored every 2 weeks. Monitoring of the activity of liver enzymes is recommended to be carried out every 4 weeks with long-term courses of treatment with the drug.

Influence on the ability to drive motor vehicles and manage mechanisms

When used in patients engaged in driving vehicles and other potentially dangerous activities, the possibility of dizziness and drowsiness should be taken into account.

Tablet Form of production

Storage conditions

List B. The drug should be stored out of the reach of children, in a dry, protected from light place at a temperature not exceeding 25°C.

Shelf life

5 years

Active ingredient

Inosine Pranobex

Conditions of release from pharmacies

By prescription

Dosage form

of the tablet

Weight

Weight: 52 gr.