Active substanceInosin pranobeksInosin pranobeks
Dosage form: & nbsppills
Composition:

1 tablet contains:

active substance: Inosine Pranobeks (Isoprinosine) 500 mg;

Excipients: Mannitol, wheat starch, povidone, magnesium stearate.

Description:

The oblong biconvex tablets are white or almost white in color with a slight amine odor, with a risk on one side.

Pharmacotherapeutic group:Immunostimulating agent
ATX: & nbsp

J.05.A.X.05   Inosin pranobeks

Pharmacodynamics:

Isoprinosine is a synthetic complex derivative of purine, which possesses immunostimulating activity and nonspecific antiviral action.

It restores the function of lymphocytes under conditions of immunodepression, 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, 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 (Ig) 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 Herpes viruses simplex, cytomegalovirus and measles virus, human T-cell lymphoma virus type III, poliovirus, influenza A and B, ECHO virus (human enterocytopathogenic virus), encephalomyocarditis and equine encephalitis. The mechanism of the antiviral action of Isoprinosine is associated with the inhibition of viral RNA and the enzyme dihydropteroate synthetase involved in the replication of certain viruses, enhances the virus-suppressed synthesis of lymphocyte mRNA, which is accompanied by suppression of the biosynthesis of viral RNA and translation of viral proteins, and increases the production of lymphocytes possessing antiviral properties of interferons, alpha and gamma. When combined, increases the effect of interferon-alpha, antiviral agents of acyclovir and zidovudine.

Pharmacokinetics:

After ingestion, the drug is well absorbed from the gastrointestinal tract. The maximum concentration of ingredients in the blood plasma is determined after 1-2 hours. Rapidly exposed to metabolism and released through the kidneys. Metabolized similarly to endogenous purine nucleotides with the formation of uric acid. N-N-Dimethylamino-2-propranololone metabolized to the N-oxide, and para-acetamidobenzoate to o-acylglucuronide. No cumulation of the drug in the body. The half-life is 3.5 hours for N-N-dimethylamino-2-propranololone 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 SARS;

- infections caused by a virus Herpes simplex 1 st, 2 nd, 3 rd and 4 th types: 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;

molluscum contagiosum.

Contraindications:

- Pincreased sensitivity to the components of the drug;

- gout;

- urolithiasis disease;

- arrhythmias;

- chronic renal failure;

- Children under 3 years old (body weight up to 15-20 kg).

Carefully:

Pregnancy and lactation:It is not recommended to use the drug during pregnancy and during lactation, as safety of use has not been investigated.
Dosing and Administration:

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 (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 at 5 kg / body weight per day. In severe forms of infectious diseases, the dose can be increased individually up to 100 mg / kg of body weight per day, divided into 4-6 receptions. The maximum daily intake 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 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 continue 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 per day (1-2 tablets) for 30 days.

With herpetic infection adults and children are prescribed for 5-10 days before the symptoms disappear, in the asymptomatic period - 1 tablet 2 times a day for 30 days to reduce the number of relapses.

With papillomavirus infection adults, the drug is prescribed 2 tablets 3 times a day, children - ½ tablets at 5 kg / body weight per day in 3-4 doses for 14-28 days in the form of monotherapy.

With recurrent genital warts Adults are prescribed 2 tablets 3 times for children, 2 tablets for 5 kg / body weight per day for 3-4 children per day, either as monotherapy or in combination with surgical treatment for 14-28 days, then with a three-fold repetition specified course at intervals of 1 month.

With cervical dysplasia, associated with the human papillomavirus, 2 tablets 3 times a day for 10 days, followed by 2-3 similar courses with an interval of 10-14 days.

Side effects:

The incidence of adverse events following the use of the drug is classified according to WHO recommendations.

Often: 1% and <10%.

Sometimes: 0.1% and <1%.

From the gastrointestinal tract: often - nausea, vomiting, pain in the epigastrium, sometimes - diarrhea, constipation.

From the liver and bile ducts: 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.

From the skin and subcutaneous fat: often - itching.

From the nervous system: often - headache, dizziness, weakness; sometimes drowsiness, insomnia.

From the urinary system: sometimes polyuria.

From the side of the musculoskeletal system and connective tissue: often joint pain, exacerbation of gout.

Overdose:

Cases of drug overdose are not described.

Interaction:

Immunosuppressants can reduce the effectiveness of the drug. Xanthine oxidase inhibitors and uricosuric agents (including diuretics) may contribute to the risk of increasing serum levels of uric acid in patients taking Isoprinosine.

Special instructions:

After 2 weeks of using Isoprinosine, the concentration of uric acid in serum and urine should be monitored.

With long-term administration after 4 weeks of use, it is advisable to monitor liver and kidney functions every month (transaminase activity in blood plasma, creatinine, uric acid).

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.

Effect on the ability to drive transp. cf. and fur:

There are no special contraindications.

Form release / dosage:Tablets 500 mg.
Packaging:

10 tablets in a PVC / PVDC blister and aluminum foil.

2, 3 or 5 blisters in a pack of cardboard along with instructions for use.

Storage conditions:

List B. Store at a temperature of no higher than +25 ° C in a dry, the dark place.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription
Registration number:П N015167 / 01
Date of registration:18.09.2008
Expiration Date:Unlimited
The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
Manufacturer: & nbsp
Representation: & nbspTeva Teva Israel
Information update date: & nbsp23.10.2017
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