Normomed syrup 50mg/ml, 120ml

Composition

Composition per 100 ml of syrup Active ingredient: Inosine pranobex 5,00 g

Auxiliary substances: Sucrose 65.00 g Glycerol 5.00 g Methyl Parahydroxybenzoate 0.18 g Propyl parahydroxybenzoate 0.02 g Citrus flavor 0.50 g Water purified to 100 ml

Pharmacological action

Pharmacotherapy group. Immunostimulating agent.

ATX Code: J05AX05

Pharmacological properties

Pharmacodynamics

An immunostimulating agent that has an antiviral effect. It is a complex containing inosine and a salt of para-acetamidobenzoic acid with N, N-dimethylamino-2-propanol in a molar ratio of 1: 3.

The effectiveness of the complex is determined by the presence of inosine, the second component increases its availability for lymphocytes. Normomed® blocks the reproduction of viral particles by damaging the genetic apparatus, stimulates macrophage activity, lymphocyte proliferation and cytokine formation. The second component increases the availability of Normomed® for lymphocytes. Reduces the clinical manifestations of viral diseases, accelerates convalescence, increases the body’s resistance.

When Normomed® is prescribed as an auxiliary drug for infectious lesions of the mucous membranes and skin caused by the Herpes simplex virus, faster healing of the affected surface occurs than with traditional treatment. Less often, new blisters, edema, erosion, and relapses of the disease occur. Timely use of the drug reduces the frequency of viral infections, reduces the duration and severity of the disease.

Pharmacokinetics

After oral use, the drug is rapidly and almost completely absorbed (>90%) and has good bioavailability. When taken orally at a dose of 1500 mg, the Cmax of inosine pranobex is reached in 1 h and is 600 mcg / ml. It is not detected in the blood 2 hours after ingestion. Normomed® consists of inosine and a salt of para-acetamidobenzoic acid with N, N-dimethylamino-2-propanol. Each of the components of pranobex inosine is rapidly metabolized. Almost 100% of the metabolites are detected in the urine between 8 and 24 hours after ingestion. Inosine is metabolized in a cycle typical of purine nucleotides, with the formation of uric acid, the concentration of which in the blood serum can increase. As a result, uric acid crystals may form in the urinary tract. The increase in uric acid concentration is non-linear and can change by ±10% within 1-3 hours after oral use. As a result of the metabolism of para-acetamidobenzoic acid, ortho-acylglucuronide is formed; N, N-dimethylamino-2-propanol is metabolized to N-oxide. The AUC of para-acetamidobenzoic acid is >88%, and the AUC of N, N-dimethylamino-2-propanol is >77%. Accumulation of the drug in the body was not detected. Inosine and its metabolites are excreted in the urine. When Css is reached with a daily dose of 4 g, the daily urinary excretion of para-acetamidobenzoic acid and its metabolite is approximately 85% of the dose taken; T1/2 – 50 minutes, T1/2 N, N-dimethylamino-2-propanol – 3-5 hours. Complete elimination of inosine pranobex and its metabolites from the body occurs within 48 hours.

Indications

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

Use during pregnancy and lactation

It is contraindicated in pregnant and breast-feeding women, as the safety of the drug has not been studied.

Contraindications

-hypersensitivity to inosine pranobex and other components of the drug; – gout; – urolithiasis; – chronic renal failure; – arrhythmias; – pregnancy; – breast-feeding period; – children under 3 years of age (body weight up to 15-20 kg).

Use with caution

when administered concomitantly with xanthine oxidase inhibitors, diuretics, zidovudine; in acute hepatic insufficiency

Side effects

Side effects are defined as follows: often – >1/100 and ><1/10; and infrequently – >1/1000 and <1/10; and infrequently – ><1/100.

From the nervous system: 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.

From the skin and subcutaneous fat: often-itching, rash.

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

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

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

Laboratory and instrumental data: often-an increase in the concentration of blood urea nitrogen.

If you experience any of the side effects listed in the instructions, or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Immunosuppressants weaken the immunostimulating effect of the drug. The drug should be used with caution in patients taking concomitant xanthine oxidase inhibitors (allopurinol) or loop diuretics (furosemide, torasemide, etacric acid), as this may lead to an increase in the concentration of uric acid in the blood serum. Combined use of the drug with zidovudine leads to an increase in the concentration of zidovudine in blood plasma and lengthens its T 1/2. Thus, when the drug is co-administered with zidovudine, it may be necessary to adjust the dose of zidovudine. If you are taking the above medications or other medications (including over-the-counter medications), please consult your doctor before using Normomed®.

How to take, course of use and dosage

Inside, after eating, with a small amount of water, at regular intervals (8 or 6 hours) 3-4 times a day.

Adults and children over 12 years of age: 20 ml of syrup 3-4 times a day.

Children from 3 to 12 years old: 50 mg per 1 kg of body weight per day, divided into 3-4 doses.

For children over 3 years of age, the drug is prescribed in accordance with the table:

Body weight Single dose taken 3 times a 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 flu and other acute respiratory infections, treatment lasts from 5 to 14 days. After the symptoms disappear, treatment should be continued for 1-2 days.

With labial herpes, treatment lasts from 5 to 10 days until the symptoms of infection disappear.

Special patient groups

Use in elderly patients. There is no need to adjust the dose, the drug is used in the same way as in middle-aged patients.

The duration of treatment without consulting a doctor is not more than 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.

Use the drug only according to the indications, the method of use and in the doses indicated in the instructions.

Overdose

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

Description

Clear, slightly yellowish liquid with a characteristic odor.

Special instructions

Normomed®, 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, when prescribing the drug simultaneously with drugs that increase the concentration of uric acid or drugs that disrupt kidney function, it is necessary to monitor the concentration of uric acid in the blood serum.

Elderly patients are more likely than middle-aged patients to have increased uric acid concentrations 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.

Normomed® should be used with caution in patients with acute hepatic insufficiency, since the drug undergoes metabolism in the liver.

Save the instructions. You may need it again. If you have any questions, contact your doctor.

Influence on the ability to drive vehicles and mechanisms

The effect of the drug on the psychomotor functions of the body 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.

Form of production

Syrup 50 mg / ml. 120 ml,240 ml in dark glass vials (type III, Heb. Pharm. ), sealed with a screw-on lid made of polypropylene with the control of the first opening. 1 bottle with a polypropylene measuring cup and instructions for use is placed in a pack of cardboard.

Storage conditions

Store in the original packaging (bottle in a pack) at a temperature of 15 to 25 °C. Keep out of reach of children.

Shelf

life is 3 years.

Shelf life after the first opening of the bottle is 3 months.

Do not use after the expiration date indicated on the package.

Active ingredient

Inosine Pranobex

Dosage form

syrup

Purpose

For children over 3 years of age, For adults as prescribed by a doctor, For children as prescribed by a doctor

Indications

Cytomegalovirus infection, Herpes, Flu