Isoprinosine® Instruction

International Non-Proprietary Name (INN): inosinum pranobexum
Dosage form: pills
Structure
In 1 pill:
Active ingredient: inosine pranobex (Isoprinosine®) 500 mg;
Excipients: mannitol, wheat starch, povidone, magnesium stearate.
Description
Oblong biconvex tablets of white or almost white color with a slight amine odor, and a break line on one side.
ATC code: J05AX05
Pharmacological action: immunostimulating, antiviral


Pharmacodynamics

After an 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. N-N-dimethylamino-2-propranolone is metabolized to N-oxide, and para-acetamidobenzoate – to o-acyl glucuronide. Cumulation of the drug in the body is not detected. The 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.

Intended uses

  • treatment of influenza and other acute respiratory viral infections;
  • infections caused by Herpes simplex virus of the 1st, 2nd, 3rd and 4th types: genital and labial herpes, herpetic keratitis, herpes zoster, chickenpox, infectious mononucleosis caused by the Epstein-Barr virus;
  • cytomegalovirus infection;
  • severe measles;
  • papillomavirus infection: papilloma of the larynx / vocal cords (fibrous type), papillomavirus infection of the genitals in men and women, warts;
  • molluscum contagiosum.


Contraindications

  • hypersensitivity to the drug components;
  • gout;
  • kidney stone disease;
  • arrhythmia;
  • chronic renal failure;
  • children under 3 years old (body weight up to 15–20 kg).


Precaution

After 2 weeks of using Isoprinosine®, a concentration of uric acid in the blood serum and urine should be monitored. It is advisable to monitor liver and kidney functions (plasma transaminase activity, creatinine, uric acid) every month after a 4-week use, in case of the long-term application. It is necessary to control the level of uric acid in the blood serum when using Isoprinosine® in combination with drugs that increase the level of uric acid or drugs that impair renal function.

Dosage and administration

The tablets are taken orally after a meal with some water.
The recommended dose for adults and children from 3 years old (body weight over 15–20 kg) is 50 mg / kg per day, divided into 3–4 intakes. For adults: 6–8 tablets per day; for children: ½ of the tablet per 5 kg / body weight per day. In severe forms of infectious diseases, the dose can be individually increased up to 100 mg / kg body weight per day, divided into 4–6 intakes. The maximum daily dose for adults is 3-4 g / day, for children – 50 mg / kg body weight per day.

Acute diseases
The duration of treatment in adults and children usually lasts from 5 to 14 days. The treatment should be continued until the disappearance of clinical symptoms and for another 2 days in the absence of the 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, the treatment should be continued with several courses of 5–10 days with a break in the admission of 8 days. In the maintenance therapy, the dose can be reduced to 500–1000 mg per day (1-2 tablets) for 30 days.

In case of a herpetic infection
The drug is prescribed for adults and children for 5–10 days until the symptoms disappear; in the asymptomatic period, 1 tablet 2 times a day for 30 days is prescribed to reduce the number of relapses.

In human papillomavirus infection
Adults are prescribed 2 tablets 3 times a day, children – ½ of a tablet per 5 kg / body weight per day in 3-4 intakes for 14–28 days as a monotherapy.

In relapsing genital condylomata acuminata
Adults are prescribed 2 tablets 3 times a day, and children – ½ tablet per 5 kg / body weight per day divided into 3-4 intakes per day, either as a monotherapy or in a combination with surgical treatment for 14–28 days, then the course is repeated three times with 1-month intervals.

In cervical intraepithelial neoplasia associated with the human papillomavirus
2 tablets are prescribed 3 times a day for 10 days, and then the course is repeated 2-3 times with an interval of 10–14 days.

Side effects

The incidence of side effects after using the drug is classified according to WHO recommendations. Often: ≥1% and <10%. Sometimes: ≥0.1% and <1%.

On the part of the gastrointestinal tract
Often: Nausea, vomiting, epigastric pain;
Sometimes: Diarrhea, constipation.

On the part of the liver and biliary tract
Often: A temporary increase in the activity of transaminases and alkaline phosphatase in blood plasma, an increase in the concentration of urea in blood plasma.

On the part of the skin and subcutaneous fat
Often: Itching.

On the part of the nervous system
Often: Headache, dizziness, weakness;
Sometimes: Drowsiness, insomnia.

On the part of the urinary system
Sometimes: Polyuria.

On the part of the musculoskeletal system and connective tissue
Often: Joint pain, exacerbation of gout.

Overdose

Cases of drug overdose are not described.

Interaction with other drugs

Immunosuppressants may decrease the effectiveness of the drug action. Xanthine oxidase inhibitors and uricosuric agents (including diuretics) may enhance the risk of an increase of the serum uric acid level in patients taking Isoprinosine®.

Pregnancy and lactation

It is not recommended to use the drug during pregnancy and lactation, since the safety of use has not been studied.

Influence on the ability to drive vehicles and operate mechanisms

There are no special contraindications.

Storage conditions

Store at a temperature not exceeding +25°C (+77°F) in a dry, dark place. Keep out of the reach of children.

Shelf life

5 years. Do not use beyond the expiration date indicated on the package.

Manufacturer

TEVA Pharmaceutical Ltd, Israel. https://teva.ru/, https://www.tevapharm.com/

Instructions