Isoprinosin, tablets 500 mg 30 pcs.

Isoprinosine is a synthetic complex derivative of purine with immunostimulatory activity and nonspecific antiviral action.

It restores functions of lymphocytes under immunosuppression, increases blastogenesis in monocytic cell population, stimulates expression of membrane receptors on T-helper surface, prevents decrease of lymphocytic cell activity under influence of glucocorticosteroids, normalizes thymidine inclusion in them.

. Isoprinosin has a stimulating effect on the activity of cytotoxic T-lymphocytes and natural killer cells, T-suppressor and T-helper functions, increases production of immunoglobulin (lg) G, interferon-gamma, interleukins (IL)-1 and IL-2, reduces formation of pro-inflammatory cytokines – IL-4 and IL-10, potentiates chemotaxis of neutrophils, monocytes and macrophages.

The drug shows antiviral activity in vivo against viruses:

• Herpes simplex.
• Cytomegalovirus.
• Coris virus.
• Human T-cell lymphoma virus type III.
• Polioviruses.
• Hypnea A and B.
• ESNO virus (human enterocytopathogenic virus).
• Encephalomyocarditis.
• Cone encephalitis.

. The mechanism of antiviral action of Izoprinosin is associated with inhibition of viral RNA and dihydropteroate synthetase enzyme which participates in replication of some viruses; it increases suppression of viral mRNA synthesis in lymphocytes accompanied by inhibition of viral RNA biosynthesis and translation of viral proteins and increases production of interferon-alpha and gamma which have antiviral properties.

In combined treatment it increases the effect of interferon-alpha, antiviral agents acyclovir and zidovudine.

Pharmacokinetics

The drug is well absorbed from the gastrointestinal tract after oral administration. The maximum concentration of the ingredients in the blood plasma is determined after 1-2 hours.

It is quickly metabolized and excreted through the kidneys. It is metabolized similarly to endogenous purine nucleotides with formation of uric acid. 1M-dimethylamino-2-propranolone is metabolized to N-oxide, and para-acetamidobenzoate to o-acylglucuronide.

No cumulation of the drug in the body has been 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, varicella, Epstein-Barr virus-induced mononucleosis;

Active ingredient

Inosyn Pranobex

Composition

One tablet contains:

The active ingredient:

Inosin Pranobex (Isoprinosin) – 500 mg

Associates:

Mannitol,

Wheat starch,

povidone,

Magnesium stearate.

How to take, the dosage

The recommended dose for adults and children from 3 years old (body weight of 15-20 kg) is 50 mg/kg/day divided into 3-4 intakes. Adults take 6-8 tablets a day, children – ½ tablet per 5 kg/body weight/day. In severe forms of infectious diseases the dose may be increased individually up to 100 mg/kg body weight per day divided into 4-6 doses.

Maximum daily dose for adults 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. The treatment should be continued until the disappearance of clinical symptoms and for another 2 days if there are no symptoms. If necessary the therapy duration may be increased individually under the control of a physician.

In chronic relapsing diseases in adults and children the treatment should be continued by several courses of 5-10 days with a break in therapy of 8 days.
For maintenance therapy the dose can be reduced to 500-1000 mg per day (1-2 tablets) for 30 days.

In herpes infections in adults and children it is prescribed for 5-10 days until 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 prescribed for adults 2 tablets 3 times a day, for children – ½ tablet per 5 kg/body weight per day in 3-4 times during 14-28 days as monotherapy. In case of recurrent acute condyloma the preparation is prescribed for adults 2 tablets 3 times, for children – ½ tablet per 5 kg/body weight per day in 3-4 times daily either as monotherapy or in combination with surgical treatment during 14-28 days and then with triple repeating of the given course with 1 month intervals.
In cervical dysplasia associated with human papilloma virus it is prescribed 2 tablets 3 times a day for 10 days and then there are 2-3 similar courses with 10-14-day intervals.

Interaction

Immunosuppressants may decrease the effectiveness of the drug. Xanthine oxidase inhibitors and uricosuric agents (including diuretics) may contribute to the risk of elevated serum uric acid levels in patients taking Isoprinosin.

Special Instructions

The drug should be used with caution with xanthine oxidase inhibitors, diuretics, zidovudine, in acute renal failure.

Inosin pranobex, like other antiviral agents, is most effective in acute viral infections if treatment is started early in the disease (better from the first day).

Because inosine is excreted from the body in the form of uric acid, with long-term use it is recommended to monitor the uric acid concentration in the blood serum and urine periodically. Patients with significantly elevated uric acid concentrations in the body can concomitantly take medications to lower these concentrations.

The serum uric acid concentration should be monitored when using Pranobex Inosin concomitantly with drugs that increase uric acid concentration or drugs that impair renal function.

Elderly patients are more likely to have increased concentrations of uric acid in serum and urine than middle-aged patients.

With caution, use in patients with acute hepatic impairment because the drug is metabolized in the liver. In patients with hepatic insufficiency serum and urine uric acid content should be monitored every 2 weeks. Control of liver enzymes activity is recommended every 4 weeks during long-term treatment with the drug.

Impact on driving and operating machinery

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

Contraindications

• High sensitivity to the ingredients.
• Penal ulcer.
• Arrhythmias.
• Chronic renal insufficiency.
• Children under 3 years of age (body weight up to 15-20 kg).

.

Side effects

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

Gastrointestinal system disorders: often – decreased appetite, nausea, vomiting, epigastric pain; rarely – diarrhea, constipation.

Hepatobiliary system disorders: often – increase of liver enzymes activity, alkaline phosphatase.

Skin and subcutaneous fatty tissue: often – itching, rash.

Renal and urinary tract: infrequent – polyuria.

Allergic reactions: infrequent – macropapular rash, urticaria, angioedema.

Muscular system disorders: often – joint pain, exacerbation of gout.

Others: often – increase in blood urea nitrogen concentration.

Overdose

Isoprinosine overdose has not been described.

Pregnancy use

The use is contraindicated in pregnancy and during lactation (breastfeeding).

Similarities

Groprinosin, Normomed