Isoprinosine (Tablets, Syrup) Instructions for Use

Instructions
Dosage forms

ATC Code

J05AX05 (Inosine pranobex)

Active Substance

Inosine pranobex

Clinical-Pharmacological Group

Antiviral and immunostimulating drug

Pharmacotherapeutic Group

Systemic antiviral agents; direct-acting antiviral agents; other antiviral agents

Pharmacological Action

Inosine pranobex is a synthetic purine derivative, a complex containing inosine and the salt of para-acetamidobenzoic acid with N,N-dimethylamino-2-propanol in a molar ratio of 1:3.

It has immunostimulating activity and a nonspecific antiviral effect. The efficacy of the complex is determined by the presence of inosine, the second component increases its availability for lymphocytes.

It restores lymphocyte function under immunosuppression conditions, increases blastogenesis in the monocyte population, stimulates the expression of membrane receptors on the surface of T-helpers, prevents a decrease in lymphocyte activity under the influence of glucocorticosteroids, and normalizes thymidine incorporation into them. Inosine pranobex stimulates the activity of T-lymphocytes and natural killer cells, the functions of T-suppressors and T-helpers, increases the production of immunoglobulin G (IgG), interferon gamma, interleukins IL-1 and IL-2, reduces the formation of anti-inflammatory cytokines – IL-4 and IL-10, and potentiates the chemotaxis of neutrophils, monocytes, and macrophages.

The drug exhibits antiviral activity in vivo against herpes simplex virus, cytomegalovirus, measles virus, human T-cell lymphotropic virus (type III), polioviruses, influenza A and B viruses, ECHO virus (human enterocytopathic virus), encephalomyocarditis virus, and equine encephalitis virus. The mechanism of the antiviral action of inosine pranobex is associated with the inhibition of viral RNA and dihydropteroate synthase, which is involved in the replication of some viruses, enhances the virus-suppressed synthesis of lymphocyte mRNA, which is accompanied by a reduction in viral RNA synthesis and translation of viral proteins, and increases the production of alpha and gamma interferons by lymphocytes, which have antiviral properties. When prescribed in combination, it enhances the effect of interferon-alpha, acyclovir, and zidovudine.

Pharmacokinetics

Absorption

After oral administration, the drug is well absorbed from the gastrointestinal tract. C_max of the ingredients in the blood plasma is reached within 1-2 hours.

Distribution

No accumulation of the drug in the body has been detected.

Metabolism

It is rapidly metabolized and excreted by the kidneys.

It is metabolized similarly to endogenous purine nucleotides with the formation of uric acid. N,N-dimethylamino-2-propanol is metabolized to N-oxide, and 4-acetamidobenzoate is metabolized to o-acylglucuronide.

Excretion

T_1/2 is 3.5 hours for N,N-dimethylamino-2-propanol and 50 minutes for 4-acetamidobenzoate. The drug and its metabolites are excreted from the body by the kidneys within 24-48 hours.

Indications

For adults and children over 3 years of age (body weight over 15-20 kg)

Treatment of influenza and other acute respiratory viral infections as part of complex therapy;
Treatment of labial herpes (Herpes simplex) as part of complex therapy.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
B00	Herpesviral [herpes simplex] infections
J06.9	Acute upper respiratory infection, unspecified
J10	Influenza due to identified seasonal influenza virus
J11	Influenza, virus not identified

ICD-11 code	Indication
1E30	Influenza due to identified seasonal influenza virus
1E32	Influenza, virus not identified
1F00.Z	Infections due to herpes simplex virus, unspecified
CA07.0	Acute upper respiratory tract infection of unspecified site

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

Tablets should be taken after meals with a small amount of water.

The recommended daily dose for adults and children aged 3 years and older (with a body weight of 15-20 kg) is 50 mg/kg of body weight in 3-4 divided doses (for adults – 6-8 tablets/day, for children – 1/2 tablet per 5 kg of body weight/day).

In severe forms of infectious diseases, the dose may be individually increased to 100 mg/kg of body weight/day, divided into 4-6 doses. The maximum daily dose 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 be continued until clinical symptoms disappear and for another 2 days after the symptoms have subsided. If necessary, the duration of treatment can be individually extended under medical supervision.

For chronic recurrent diseases in adults and children, treatment should be continued in several courses of 5-10 days with an 8-day break between courses.

For maintenance therapy, the dose may be reduced to 500-1000 mg/day (1-2 tablets) for 30 days.

For herpetic infection in adults and children, the drug is prescribed for 5-10 days until the symptoms of the disease disappear; during the asymptomatic period – 1 tablet 2 times/day for 30 days to reduce the number of recurrences.

For papillomavirus infection in adults, the drug is prescribed as 2 tablets 3 times/day, for children – 1/2 tablet per 5 kg/body weight/day in 3-4 divided doses for 14-28 days as monotherapy.

For recurrent anogenital warts in adults, the drug is prescribed as 2 tablets 3 times/day, for children – 1/2 tablet per 5 kg/body weight/day in 3-4 divided doses, either as monotherapy or in combination with surgical treatment for 14-28 days, followed by three repetitions of the specified course with intervals of 1 month.

For cervical dysplasia associated with human papillomavirus, 2 tablets 3 times/day are prescribed for 10 days, followed by 2-3 similar courses with an interval of 10-14 days.

Syrup

Orally, after meals, with a small amount of water, at regular intervals (8 or 6 hours) 3-4 times a day. A measuring spoon included in the cardboard package is provided for correct dosing of the drug.

Adults

20 ml of syrup 3-4 times/day. Maximum daily dose is 80 ml.

For influenza and other acute respiratory viral infections, treatment continues for 5 to 14 days. After the symptoms disappear, treatment should be continued for 1-2 days.

For labial herpes, treatment continues for 5 to 10 days until the symptoms of the infection disappear. The duration of treatment without consulting a doctor should not exceed 5 days.

The decision to continue therapy with the drug for more than 5 days is made by the attending physician based on the clinical picture of the disease.

Children

Children from 12 to 18 years: 20 ml of syrup 3-4 times/day.

Children from 3 to 12 years (body weight over 15-20 kg): 50 mg per 1 kg of body weight per day, divided into 3-4 doses.

For children over 3 years, the drug is prescribed according to the table

Body weight	Single dose when taken 3 times/day	Maximum daily dose
15-20 kg	5-6.5 ml	15-20 ml/day
21-30 kg	7-10 ml	21-30 ml/day
31-40 kg	10-13 ml	31-40 ml/day
41-50 kg	13.5-16.5 ml	41-50 ml/day

For influenza and other acute respiratory viral infections, treatment continues for 5 to 14 days. After the symptoms disappear, treatment should be continued for 1-2 days.

For labial herpes, treatment continues for 5 to 10 days until the symptoms of the infection disappear.

The decision to continue therapy with the drug for more than 5 days is made by the attending physician based on the clinical picture of the disease.

The safety and efficacy of the drug in children aged 0 to 3 years (body weight less than 15-20 kg) have not been established. Data are not available.

Use in elderly patients.

No dose adjustment is necessary; the drug is used in the same way as in middle-aged patients.

Adverse Reactions

Classification of adverse reactions by frequency of development (number of reported cases/number of patients): very common (≥1/10), common (from ≥1/100 to <1/10), uncommon (from ≥1/1000 to <1/100), frequency not known (side effects from post-marketing experience; frequency cannot be estimated from the available data).

Nervous system disorders common – headache, dizziness, fatigue, malaise; uncommon – drowsiness, insomnia, nervousness.

Gastrointestinal disorders common – decreased appetite, nausea, vomiting, epigastric pain; uncommon – diarrhea, constipation.

Hepatobiliary disorders common – temporary increase in the activity of liver enzymes, alkaline phosphatase.

Skin and subcutaneous tissue disorders common – itching, rash; uncommon – maculopapular rash; frequency not known – erythema.

Renal and urinary disorders uncommon – polyuria.

Immune system disorders uncommon – angioedema, urticaria; frequency not known – hypersensitivity reactions, anaphylactic reactions, anaphylactic shock.

Musculoskeletal and connective tissue disorders common – joint pain, exacerbation of gout.

Laboratory and instrumental data common – temporary increase in the concentration of uric acid in blood plasma and urine, urea in blood plasma.

Contraindications

Hypersensitivity to inosine pranobex or to any of the excipients included in the drug;
Gout;
Urolithiasis, hyperuricemia;
Chronic renal failure;
Arrhythmias;
Pregnancy;
Breastfeeding period.

Use in Pregnancy and Lactation

Pregnancy

The drug is contraindicated during pregnancy.

Breastfeeding

It is not known whether inosine acedoben dimepranol is excreted in breast milk. The drug is contraindicated during breastfeeding.

Use in Hepatic Impairment

Use with caution in patients with acute hepatic failure, since the drug is metabolized in the liver.

Use in Renal Impairment

Contraindicated in chronic renal failure.

Pediatric Use

The safety and efficacy of the drug in children aged 0 to 3 years (body weight less than 15-20 kg) have not been established. Data are not available.

In children over 3 years of age, the drug is used according to the indications and in accordance with the dosage regimen.

Geriatric Use

No dose adjustment is necessary; the drug is used in the same way as in middle-aged patients.

Special Precautions

Isoprinosine syrup, 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 excreted from the body in the form of uric acid, when prescribing the drug simultaneously with drugs that increase the concentration of uric acid or drugs that impair kidney function, it is necessary to monitor the concentration of uric acid in the blood serum.

In elderly patients, an increase in the concentration of uric acid in the blood serum and urine occurs more often than in middle-aged patients.

Patients with a significantly increased concentration of uric acid in the body may simultaneously take drugs that lower its concentration.

Isoprinosine syrup should be used with caution in patients with acute hepatic failure, since the drug is metabolized in the liver.

Caution should also be exercised when co-administered with xanthine oxidase inhibitors, diuretics, zidovudine.

Patients with diabetes should take into account that a dose of the drug exceeding 10 ml contains ≥5 g of sucrose.

Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not take this drug.

The drug contains methylparahydroxybenzoate and propylparahydroxybenzoate, which may cause allergic reactions (including delayed ones).

The drug contains sodium. A dose of the drug exceeding 10 ml contains more than 24 mg of sodium, which is 1.2% of the recommended maximum daily dose of 2 g of sodium for an adult. This should be taken into account by patients on a controlled sodium diet.

Effect on ability to drive vehicles and machinery

The effect of the drug on psychomotor functions and the ability to drive vehicles and moving mechanisms has not been studied. When using the drug, the possibility of dizziness and drowsiness should be taken into account.

Overdose

In case of overdose, gastric lavage and symptomatic therapy are indicated.

Drug Interactions

Immunosuppressants weaken the immunostimulating effect of the drug.

The drug should be used with caution in patients simultaneously using xanthine oxidase inhibitors (allopurinol) or drugs that can block the tubular secretion of uric acid, for example, loop diuretics (furosemide, torasemide, ethacrynic acid), as this may lead to an increase in the concentration of uric acid in the blood plasma.

Concomitant use of the drug with zidovudine leads to an increase in the concentration of zidovudine in the blood plasma and prolongs its half-life. Thus, when the drug is used concomitantly with zidovudine, adjustment of the zidovudine dose may be required.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years.

After opening the bottle, the drug is suitable for use for 6 months.

Dispensing Status

The drug is dispensed without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer