Normomed, 50 mg/ml syrup 240 ml

Pharmacotherapeutic group. Immunostimulant.

ATX code: J05AX05

Pharmacological properties

.Pharmacodynamics

The immunostimulant with antiviral action. It is a complex consisting of inosine and para-acetamidobenzoic acid salt with N,N-dimethylamino-2-propanol in the molar ratio of 1:3.

The effectiveness of the complex is determined by the presence of inosin, the second component increases its availability to lymphocytes. Normomed® blocks the multiplication of viral particles by damaging the genetic apparatus, and stimulates macrophage activity, lymphocyte proliferation and cytokine formation. The second component increases the availability of Normomed® for lymphocytes. It reduces clinical manifestations of viral diseases, accelerates recuperation, and increases resistance of the organism.

When applying Normomed® as an adjunctive medicine in infectious lesions of the mucous membranes and skin caused by Herpes simplex virus, the affected surface heals more quickly than if treated by the traditional method. New blisters, swellings, erosions and recurrences of the disease occur less frequently. With timely use of the drug, the frequency of viral infections is reduced, and the duration and severity of the disease is reduced.

Pharmacokinetics

After oral administration the drug is quickly and almost completely (>90%) absorbed and has good bioavailability. When administered orally at a dose of 1500 mg, the Cmax of Pranobex inosine is reached after 1 hour and is 600 µg/ml. It is not detected in the blood 2 h after the intake. Normomed® consists of inosine and para-acetamidobenzoic acid salt with N,N-dimethylamino-2-propanol. Each of the components of inosine pranobex is rapidly metabolized. Virtually 100% of the metabolites are detected in the urine between 8 and 24 hours after ingestion. Inosine undergoes metabolism according to the cycle typical for purine nucleotides with the formation of uric acid, the concentration of which in the blood serum may increase. As a result, uric acid crystals may form in the urinary tract. Increase of uric acid concentration is non-linear and may vary by ±10% during 1-3 hours after oral administration. The metabolism of para-acetamidobenzoic acid produces ortho-acyl glucuronide; N,N-dimethylamino-2-propanol is metabolized to N-oxide. AUC of para-acetamidobenzoic acid >88%, AUC of N,N-dimethylamino-2-propanol – >77%. Cumulation of the drug in the body was not detected. Inosine and its metabolites are excreted with the urine. Daily urinary excretion of para-acetamidobenzoic acid and its metabolite is approximately 85% of the accepted dose; T1/2 is 50 min, T1/2 of N,N-dimethylamino-2-propanol is 3-5 h when Css is reached at a daily dose of 4 g. Complete elimination of inosine pranobex and its metabolites from the body occurs within 48 hours.

Indications

Active ingredient

Composition

Composition per 100 ml of syrup
Active ingredient:
Inosin pranobex 5.00 g

Excipients:
Saccharose 65.00 g
Glycerol 5.00 g
Methyl parahydroxybenzoate 0.18 g
Propylparahydroxybenzoate 0,02 g
Citrus flavoring 0,50 g
Purified water up to 100 ml

How to take, the dosage

Overly, after meals, 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 daily.

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

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

Body weight Single dose when 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

In case of influenza and other acute respiratory infections the treatment lasts 5 to 14 days. After disappearance of symptoms, treatment should be continued for 1 to 2 days.

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

Special patient groups

Application in older patients. There is no need to adjust the dose, the drug is used the same as in middle-aged patients.

Duration of treatment without consulting a physician is not more than 5 days. Any decision to continue therapy for more than 5 days should be made by the physician based on the clinical picture of the disease.

Perform the drug only for the indications and in the doses and routes of administration listed in the instructions.

Interaction

Immunosuppressants weaken the immunostimulatory effect of the drug.

The drug should be used with caution in patients taking xanthine oxidase inhibitors (allopurinol) or loop diuretics (furosemide, thorasemide, etacrynic acid) simultaneously, since this may lead to increased serum uric acid concentrations.

The co-administration of the drug with zidovudine leads to increased plasma concentration of zidovudine and prolongs its T1/2. Thus, when co-administering the drug with zidovudine it may be necessary to adjust the dose of zidovudine.

If you are using the above medicines or other drugs (including over-the-counter drugs), talk to your doctor before using Normomed®.

Special Instructions

Normomed®, like other antiviral drugs, is most effective in acute viral infections if the 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, it is necessary to monitor serum uric acid concentrations when the drug is prescribed concomitantly with drugs that increase uric acid concentration or with drugs that impair renal function.

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

Patients with significantly elevated uric acid concentrations in the body may need to take lowering medications at the same time.

Normomed® should be used with caution in patients with acute hepatic impairment because the drug is metabolized in the liver.

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

Influence on the ability to drive vehicles, mechanisms

The effect of the drug on psychomotor functions of the body and the ability to operate vehicles and moving machinery has not been studied. When using the drug the possibility of dizziness and somnolence should be taken into account.

Synopsis

Contraindications

hypersensitivity to pranobex inosine and other components of the drug;

gout;

urinary stone disease;

Chronic renal failure;

arrhythmias;

pregnancy;

breastfeeding period;

children under 3 years of age (body weight under 15-20 kg).

With caution

with simultaneous administration with xanthine oxidase inhibitors, diuretics, zidovudine; in acute hepatic failure

Side effects

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

Nervous system disorders: frequent – headache, dizziness, fatigue, malaise; infrequent – nervousness, drowsiness, insomnia.

Gastrointestinal tract: frequent – decreased appetite, nausea, vomiting, epigastric pain; infrequent – diarrhea, constipation.

Hepatobiliary system disorders: frequently – increased activity of liver enzymes, alkaline phosphatase.

Skin and subcutaneous fat: often – itching, rash.

Kidney and urinary tract disorders: infrequent – polyuria.

Allergic reactions: infrequent – patchy-papular rash, urticaria, angioedema.

General disorders: often – joint pain, aggravation of gout.

Laboratory and instrumental findings: frequently – increased blood urea nitrogen concentration.

If you experience or worsen the side effects listed in the instructions, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Pregnancy use

Similarities