Normomed syrup 50mg/ml 240ml

Normomed syrup user manual

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Composition per 100 ml of syrup

Active substance:
Inosine pranobex 5.00 g
Excipients :
Sucrose 65.00 g
Glycerol 5.00 g
Mossilparahydroxybenzoate 0.18 g
Propyl parahydroxybenzoate 0.02 g
Citrus Flavor 0.50 g
Purified water to 100 ml
Description:
Transparent, slightly yellowish liquid with a characteristic odor.
Pharmacotherapeutic group:
Immunostimulating agent.

Pharmacodynamics

Immunostimulant with antiviral effect. It is a complex containing inosine and a salt of para-acetamido-benzoic acid with L, L-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 the activity of macrophages, the proliferation of lymphocytes and the formation of cytokines. The second component increases the availability of Normed® for lymphocytes. Reduces the clinical manifestations of viral diseases, accelerates recovery, increases the body's resistance.
When prescribing the drug Normomed Syrup as an adjunct drug in case of infection of the mucous membranes and skin caused by the Herpes simplex virus, the affected surface heals faster than the traditional treatment. Less frequently, new bubbles, edema, erosion, and relapse of the disease occur. With timely use of Normomed Syrup, the frequency of viral infections is reduced, the duration and severity of the fever are reduced.

Pharmacokinetics

After ingestion, Normomed Syrup is rapidly and almost completely (> 90%) absorbed and has good bioavailability. When administered orally in a dose of 1500 mg Stax inosine pranobex is reached after 1 h and is 600 μg / ml. Not detected in the blood 2 hours after administration. Normed® consists of inosine and a salt of para-acetamido-benzoic acid with M, 1 ^ -dimethylamino-2-propanol. Each of the components of inosine pranobex rapidly metabolizes. Almost 100% of metabolites are found in the urine in the range of 8 to 24 hours from the time of admission. Inosine is metabolized according to a cycle typical of 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. The increase in the concentration of uric acid is non-linear in nature and may change by ± 10% within 1-3 hours after ingestion. As a result of para-acetamido-benzoic acid metabolism, ortho-acyl glucuridide is formed; M, N-dimethylamino-2-propanol is metabolized to N-oxide. AUG para-acetamidobenzoic acid> 88%, AUC N, N-dimethylamino-2-propanol -> 77%. Cumulation of Normomed Syrup in the body is not detected. Inosine and its metabolites are excreted in the urine. When Css is reached, when a daily dose of 4 g is taken, the daily urinary excretion of para-acetamidobenzoic acid and its metabolite is approximately 85% of the dose taken; T1 / 2 - 50 min., Tl / 2 N, N-dimethylamino-2-propanol - - 3-5 h. Complete elimination of inosine pranobex and its metabolites from the body occurs within 48 h.

Indications for use

- Treatment of flu and other acute respiratory viral infections
- Immunodeficiency states caused by viral infections in patients with normal and weakened immune systems, including diseases caused by Herpes simplex (type I and type II, genital herpes and herpes other localization)
- Subacute sclerosing panencephalitis

Contraindications

- hypersensitivity to inosine pranobex and other components of Normomed Syrup;
- gout;
- urolithiasis disease;
- chronic renal failure;
- arrhythmias;
- pregnancy;
- breastfeeding period;
- children's age up to 3 years (body weight up to 15-20 kg).

Carefully

with simultaneous appointment with xanthine oxidase inhibitors, diuretics, zidovudine; with acute liver failure

Use during pregnancy and during breastfeeding

Contraindicated in pregnant women and women who are breastfeeding, because the safety of Normomed Syrup has not been investigated.

Dosage and administration

Inside, after eating, drinking down with a small amount of water at regular intervals (8 or 6 hours) 3-4 times a day.
The dosage regimen is set individually, depending on age, body weight, as well as the severity of the disease.
Adults and children over 12 years old: based on 50 mg per 1 kg of body weight, up to a maximum of 4 g per day. Usually, 20 ml of syrup is prescribed 3-4 times a day. Children from 3 to 12 years: 50 mg per 1 kg of body weight per day, divided into 3-4 doses. Adults and children with severe infectious diseases: the dose can be increased to 100 mg / kg / day, in 4-6 doses. The maximum daily dose in adults is 3-4 g per day, in children - 50 mg / kg / day.
In acute diseases: treatment usually lasts from 5 to 14 days. After the symptoms disappear, treatment should be continued for 1-2 days or more, depending on the indication.
In chronic recurrent diseases: treatment in adults and children is conducted in courses of 5-10 days with intervals of 8 days. The duration of maintenance treatment can be up to 30 days, while the dose can be reduced to 500-1000 mg / day.
Treatment of infections caused by the herpes virus in adults and children: you should spend several courses lasting 5-10 days before the symptoms disappear.

Special patient groups

Use in elderly patients. There is no need for dose adjustment, Normomed Syrup is used in the same way as in middle-aged patients. Older patients are more likely to have an increase in the concentration of uric acid in the serum and in the urine than in middle-aged patients.
Use in children. It is used in children over 3 years.
Use in patients with renal and hepatic insufficiency. Pa the background of treatment with Normed® should be monitored every 2 weeks to monitor the content of uric acid in serum and urine. Monitoring the activity of liver enzymes is recommended every 4 weeks for long courses of drug treatment.

Side effect

Side effects are defined as follows: often - -> 1/100 and <1/10; and infrequently -> 1/1000 and <1/100.
On the part of the nervous system: often - headache, dizziness, fatigue, feeling unwell; infrequently - nervousness, drowsiness, sleeplessness. On the part of the gastrointestinal tract: often - loss of appetite, nausea, vomiting, epigastric pain; infrequently - diarrhea, constipation.
On the part of the hepatobiliary system: often - increased activity of liver enzymes, alkaline phosphatase.
On the part of the skin and subcutaneous fat: often, pruritus, rash. On the part of the kidneys and urinary tract: infrequently - polyuria.
Allergic reactions: infrequently - maculopapular rash. urticaria, angioedema.
Common disorders: often - joint pain, aggravation of gout.
Laboratory and instrumental data: often - increasing the concentration of blood urea nitrogen.

Overdose

In case of overdose, gastric lavage, symptomatic therapy is indicated.

Interaction with other drugs

Immunosuppressants weaken the immunostimulating effect of Normomed Syrup. The drug should be used with caution in patients taking both xanthine oxidase inhibitors (allopurinol) or loop diuretics (furosemide, torasemide, ethacrynic acid), as this may lead to an increase in serum uric acid concentration.
The combined use of Normomed Syrup with zidovudine leads to an increase in the concentration of zidovudine in the blood plasma and lengthens its T1 / 2. Thus, in case of joint use of the drug with zidovudine, a dose adjustment of zidovudine may be required.

special instructions

Before starting treatment, you should consult with your doctor.
Syrup 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 excreted in the form of uric acid, with long-term use it is recommended to periodically monitor the concentration of uric acid in blood serum and urine. Patients with a significantly increased concentration of uric acid in the body can simultaneously take drugs that lower its concentration.
It is necessary to control the concentration of uric acid in the blood serum in the appointment of Normomed Syrup simultaneously with drugs that increase the concentration of uric acid or drugs that affect kidney function.
Normomed Syrup should be used with caution in patients with acute liver failure, since the drug is metabolized in the liver.

Influence on ability to steer vehicles, 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 should take into account the possibility of dizziness and drowsiness.

Release form

Syrup 50 mg / ml.
On 120 ml, 180 ml, 240 ml in bottles of dark glass (type III, Heb. Farm.), Corked by the screwed-on cover from polypropylene with control of the first opening. On 1 bottle with a polypropylene measuring cup and instructions for use are placed in a pack of cardboard.

Storage conditions

Store in a dark place at a temperature of from 15 to 25 ° C. Keep out of the reach of children.
Shelf life - 3 years. Shelf life after the first opening of the bottle - 3 months. Do not use after the expiration date printed on the package.

Terms of sell

You don't need a prescription to buy Normomed Syrup.