Nootropil
Nootropil: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Nootropil
ATX code: N06BX03
Active ingredient: piracetam (piracetam)
Producer: UCB Pharma SA (Belgium), Aesica Pharmaceuticals Srl (Italy)
Description and photo update: 2018-21-11
Prices in pharmacies: from 185 rubles.
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Nootropil is a nootropic drug; a neurometabolic stimulant that activates metabolism in nerve cells and improves thinking processes.
Release form and composition
Dosage forms of Nootropil:
- solution for intravenous (i / v) and intramuscular (i / m) administration: clear, colorless liquid (in 15 ml ampoules, 4 ampoules in plastic trays, 4 pallets in a cardboard box; in 5 ml ampoules, 6 ampoules in plastic pallet, in a cardboard box 2 pallets);
- oral solution 33%: colorless liquid of thick consistency (125 ml in glass vials of dark color, in a cardboard box 1 bottle complete with a measuring cup);
- coated tablets: oblong, almost white or white, on both sides there is a dividing transverse line, on one side there is an engraving "N" to the right and left of the line (dosage 1.2 g: 10 pcs. in blisters, in cardboard a pack of 2 blisters; dosage 0.8 g: 15 pcs. in blisters, in a cardboard box 2 blisters);
- oral solution: clear, colorless liquid (125 ml each in dark glass vials, 1 vial in a cardboard box complete with a measuring cup);
- capsules: gelatinous, white cap and body, marked "ucb" and "N", capsule contents - white powder (15 pieces in blisters, 4 blisters in a cardboard box).
1 ml of solution for intravenous and intramuscular administration contains:
- active substance: piracetam - 0.2 g;
- auxiliary components: glacial acetic acid, sodium acetate trihydrate, water for injection.
1 ml of oral solution 33% contains:
- active substance: piracetam - 0.33 g;
- auxiliary components: sodium saccharin, glycerol, propyl hydroxybenzoate, methyl parahydroxybenzoate, caramel flavor, apricot flavor, sodium acetate, glacial acetic acid, water.
1 tablet contains:
- active substance: piracetam - 0.8 g or 1.2 g;
- auxiliary components: macrogol 6000, silicon dioxide, croscarmellose sodium, magnesium stearate;
- casing: opadry OY-S-29019 [hypromellose 2910 50cP, macrogol 6000]; opadry Y-1-7000 [titanium dioxide (E171), hypromellose 2910 5cP (E464), macrogol 400].
1 ml of oral solution contains:
- active substance: piracetam - 0.2 g;
- auxiliary components: propyl parahydroxybenzoate, glycerol 85%, methyl parahydroxybenzoate, sodium saccharinate, glacial acetic acid, apricot flavor, sodium acetate, caramel flavor, purified water.
1 capsule contains:
- active substance: piracetam - 0.4 g;
- auxiliary components: lactose monohydrate, colloidal silicon dioxide, macrogol 6000, magnesium stearate;
- capsule shell: titanium dioxide (E171), gelatin.
Pharmacological properties
Pharmacodynamics
The active ingredient of Nootropil, piracetam, is a cyclic derivative of gamma-aminobutyric acid (GABA). It does not possess organ-specific or cell-specific properties, the main mechanism of its action is due to the binding of phospholipids to the polar heads and the formation of mobile piracetam-phospholipid complexes. This contributes to the restoration of the two-layer structure of the cell membrane and its stability, the three-dimensional structure of membrane and transmembrane proteins and their functional properties.
Piracetam predominantly affects postsynaptic receptor density and activity, facilitating various types of synaptic transmission at the neuronal level. Without showing sedative and psychostimulating effects, it improves the function of memory, attention, learning and consciousness.
Influencing erythrocytes, platelets and vascular walls contributes to the positive dynamics of hemorheological parameters. In sickle cell anemia, it increases the ability of erythrocytes to deform, lowers blood viscosity and prevents the formation of "coin columns". In addition, without significantly affecting the number of platelets, it reduces their aggregation. Piracetam is able to prevent vasospasm and counteract vasospastic substances. It causes a decrease in the adhesion of erythrocytes to the vascular endothelium and stimulates the production of prostacyclins by healthy endothelium.
Pharmacokinetics
There is no information on the pharmacokinetics of the solution for injection.
After taking piracetam inside, there is a rapid and almost complete absorption from the gastrointestinal tract. The maximum concentration (Cmax) in blood plasma is 0.000084 g / ml with a single dose of 3.2 g. When using Nootropil at a dose of 3.2 g 3 times a day, Cmax in blood plasma reaches 0.000115 g / ml after 1 an hour and after 5 hours in the cerebrospinal fluid. Simultaneous food intake lowers Cmax by 17% and increases the time to reach maximum concentration up to 1.5 hours. While taking a dose of 2.4 g, Cmax in women is 30% higher than in men.
Piracetam does not bind to blood plasma proteins. The volume of distribution is approximately 0.6 l / kg. Selective accumulation of piracetam was established in the tissues of the cerebral cortex, mainly in the cerebellum and basal ganglia, parietal, frontal and occipital lobes.
The substance penetrates the blood-brain and placental barriers, overcomes the filtering membranes of hemodialysis machines. Not metabolized in the body.
It is excreted unchanged through the kidneys by renal filtration up to 80-100% of the accepted dose of piracetam. The total clearance is 80–90 ml / min. The half-life (T 1/2) does not depend on the route of administration and is 4–5 hours from blood plasma and 8.5 hours from cerebrospinal fluid.
With renal failure, T 1/2 is lengthened, with chronic renal failure in the terminal stage, it can be 59 hours.
In hepatic insufficiency, the pharmacokinetics of piracetam does not change.
Indications for use
For adult patients:
- psychoorganic syndrome (in elderly patients inclusive), accompanied by dizziness, memory loss, poor concentration, decreased activity, behavioral disorder, mood changes, gait disturbance (these symptoms refer to early signs of age-related diseases such as Alzheimer's disease, senile dementia of Alzheimer's type) - as symptomatic therapy;
- dizziness and associated imbalance (except for psychogenic and vasomotor dizziness) - for treatment;
- cortical myoclonus - as monotherapy or as part of complex therapy;
- sickle cell vaso-occlusive crisis: tablets, oral solution, capsules - as a prophylaxis, solution for intravenous and intramuscular administration - for treatment.
For kids:
- dyslexia: tablets, oral solution, capsules - as part of complex therapy;
- sickle cell vaso-occlusive crisis: tablets, oral solution, capsules - as a prophylaxis, solution for intravenous and intramuscular administration - for treatment.
Contraindications
- hemorrhagic stroke (acute disturbance of cerebral circulation);
- chorea of Huntington;
- period of psychomotor agitation;
- chronic renal failure with creatinine clearance (CC) less than 20 ml / min (end stage);
- period of pregnancy;
- breast-feeding;
- hypersensitivity to pyrrolidone derivatives;
- individual intolerance to the components of Nootropil.
Age restrictions:
- oral solution: not used in children under 1 year old;
- tablets, solution for intravenous and intramuscular administration, capsules: contraindicated in children under 3 years of age.
According to the instructions, Nootropil should be prescribed with caution to patients with chronic renal failure (CC 20-80 ml / min), impaired hemostasis, severe bleeding and major surgical interventions.
Instructions for the use of Nootropil: method and dosage
Film-coated tablets, capsules, oral solution
Nootropil in the form of a solution for oral administration, tablets and capsules is taken orally, on an empty stomach or during meals, with a sufficient amount of liquid.
Recommended dosage:
- psychoorganic syndrome (symptomatic therapy): 2.4-4.8 g per day, divided into 2-3 doses;
- dizziness and associated imbalance: 2.4-4.8 g per day, divided into 2-3 doses;
- cortical myoclonus: initial daily dose - 7.2 g; every 3-4 days it is increased by 4.8 g until the maximum daily dose of 24 g is reached, which is divided into 2-3 doses. Treatment should be continued for the entire period of the disease, attempting to reduce the dose or cancel Nootropil every 180 days. The dose should be reduced by a gradual (1 time in 2 days) decrease in the daily dose by 1.2 g;
- prevention of sickle cell vaso-occlusive crisis: daily dose - at the rate of 0.16 g per 1 kg of the patient's body weight, divided into 4 doses in equal shares;
- dyslexia (as part of complex therapy): the daily dose for children over 8 years old is 3.2 g, divided into 2 doses.
In case of impaired renal function, the dose is adjusted taking into account the QC indicator.
In the absence of renal failure in elderly patients, dose adjustment is not required.
If the liver function is impaired, the dose of Nootropil is not adjusted.
Solution for i / v and i / m administration
Parenterally Nootropil is prescribed in the absence of the possibility of taking the drug inside - difficulty in swallowing, unconsciousness of the patient.
The solution is used by intravenous (drip and jet) and intramuscular injection.
For the preparation of the infusion solution, you can use one of the following compatible with the preparation of physiological solutions for infusion: 5%, 10% or 20% dextrose or fructose; 0.9% sodium chloride; 10% dextran 40 in 0.9% sodium chloride solution; 20% mannitol; Ringer.
The volume of the drug for administration is prescribed individually, taking into account the patient's condition and clinical indications.
IV administration is preferred. The intravenous infusion of Nootropil is carried out through a catheter at a constant rate for 24 hours. Bolus intravenous administration is used for emergency treatment of a crisis; it is performed for at least 2 minutes in a single dose of no more than 15 ml. The daily dose is usually divided into 2-4 injections in equal shares. IM administration is used if IV administration is difficult. A single volume of the drug for intramuscular injection is no more than 5 ml, the daily dose is divided proportionally into 2–4 procedures. The transition to oral administration of the drug is made immediately when the opportunity arises.
The duration of treatment is determined by the doctor individually, taking into account the clinical indications and the dynamics of symptoms.
Recommended dosage of Nootropil:
- chronic psychoorganic syndrome (symptomatic therapy): 12-24 ml per day;
- dizziness and associated imbalance: 12-24 ml per day;
- cortical myoclonus: the initial daily dose is 36 ml, every 3-4 days it is increased by 24 ml until the maximum dose of 120 ml per day is reached. The use of Nootropil should be continued throughout the entire period of the illness, attempting to lower the dose or discontinue the drug every 180 days. The dose is reduced by gradually reducing it by 6 ml every 2 days;
- the period of the crisis of sickle cell anemia: IV - at the rate of 1.5 ml per 1 kg of the patient's weight per day, divided into 4 procedures in equal shares.
In case of impaired renal function, the dose of Nootropil is adjusted taking into account the CC indicator.
If liver function is impaired and in elderly patients, dose adjustment is not required.
Side effects
- from the nervous system: drowsiness, motor disinhibition, irritability, depression, asthenia; in isolated cases - headache, dizziness, imbalance, ataxia, insomnia, agitation, confusion, confusion, anxiety, hallucinations; all dosage forms except capsules - increase sexuality; in patients with epilepsy - exacerbation of the course of the disease;
- from the digestive system: nausea, vomiting, abdominal pain, diarrhea, gastralgia;
- from the side of metabolism: increased body weight;
- on the part of the organ of hearing and balance: vertigo;
- allergic reactions: hypersensitivity, angioedema, anaphylactic reactions;
- dermatological reactions: itching, dermatitis, urticaria;
- other: in rare cases - hyperthermia, pain at the injection site, thrombophlebitis, arterial hypotension (against the background of intravenous injection).
Overdose
An overdose of the drug is unlikely, its symptoms have not been established.
Treatment: since piracetam does not have a specific antidote, immediately after ingestion of a significant dose of Nootropil, it is necessary to induce artificial vomiting or rinse the stomach. It is possible to use hemodialysis, its effectiveness is 50-60%.
special instructions
To relieve the symptoms of side effects, in most cases, it is sufficient to reduce the dose of the drug.
The effect of Nootropil on platelet aggregation should be taken into account when prescribing the drug to patients with impaired hemostasis, symptoms of severe bleeding, or during major surgical operations.
Abrupt discontinuation of treatment for cortical myoclonus may cause recurrence of seizures.
In the treatment of sickle cell anemia, a daily dose of less than 0.16 g per 1 kg of body weight and irregular use of Nootropil can cause an exacerbation of the disease.
If a hyponatrium diet is observed, the content of 0.0805 g of sodium in 24 g of solution for oral administration in a dose of 0.2 g per 1 ml should be taken into account.
Influence on the ability to drive vehicles and complex mechanisms
During the period of treatment, patients are advised to be careful when driving vehicles and complex mechanisms.
Application during pregnancy and lactation
The safety of using Nootropil during gestation has not been established.
Since piracetam crosses the placental barrier and its blood content in newborns reaches 70–90% of the concentration in the mother, the use of the drug during pregnancy is contraindicated.
The drug is excreted in breast milk. If it is necessary to prescribe Nootropil during lactation, breastfeeding should be discontinued.
Pediatric use
Indications:
- dyslexia: tablets, oral solution, capsules - as part of complex therapy;
- sickle cell vaso-occlusive crisis: tablets, capsules, oral solution - as a prophylaxis, solution for intravenous and intramuscular administration - for treatment.
Age contraindications:
- oral solution: children under 1 year old;
- tablets, capsules, solution for i / v and i / m administration: children under 3 years old.
With impaired renal function
The use of Nootropil is contraindicated in the final stage of chronic renal failure (CC less than 20 ml / min).
The recommended dosage for patients with impaired renal function, taking into account the CC value:
- CC above 80 ml / min: usual dose;
- QC 50-79 mL / min: 2 / 3 normal dose 2-3 hours;
- QC 30-49 ml / m: 1 / 3 the usual dose in 2 hours;
- QC is less than 30 ml / min: single - 1 / 6 normal dose.
Calculation of the CC value can be made based on the concentration of serum creatinine. When calculating CC (ml / min) for men, it is necessary to subtract the age (years) of the patient from 140, multiply the result by body weight (kg), divide by 72 and multiply by the serum creatinine indicator (mg / dl). For women, the calculation of QC is performed in the same way, only the result obtained should be multiplied by a factor of 0.85.
With prolonged use of Nootropil, it is necessary to regularly monitor the functional state of the kidneys and, if necessary, adjust the dose.
For violations of liver function
In case of impaired liver function, nootropil dose adjustment is required.
Use in the elderly
Nootropil dose adjustment is required for elderly patients.
Drug interactions
- thyroid hormones: can cause confusion, irritability, sleep disturbance;
- indirect anticoagulants: piracetam increases their effectiveness, which contributes to a more pronounced (in comparison with the use of only indirect anticoagulants) decrease in blood and plasma viscosity, fibrinogen concentration, platelet aggregation, von Willebrand factor;
- phenobarbital, carbamazepine, phenytoin, valproate: their maximum concentration in the blood serum and the total concentration in the blood plasma do not change;
- ethanol: does not affect the pharmacokinetics of piracetam, the concentration of alcohol in the serum does not change while taking 1.6 g of piracetam.
Piracetam does not inhibit cytochrome P450 isozymes.
Analogs
Analogues of Nootropil are: Acefen, Bravinton, Karnicetin, Phezam, Piracesin, Piracetam, Biotropil, Lucetam.
Terms and conditions of storage
Keep out of the reach of children.
Store at a temperature: solution for intravenous and intramuscular administration - up to 30 ° C; tablets, capsules, oral solution - up to 25 ° C, protected from moisture.
Shelf life: solution for i / v and i / m administration - 5 years; tablets, capsules, oral solution - 4 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Nootropil
Reviews of Nootropil are mostly positive. They indicate the high efficacy of the drug during course use according to clinical indications. Patients warn that the action of Nootropil does not appear immediately. In addition, the use of the drug helps to improve brain activity, memory, and in children - the development of speech.
As disadvantages, the possible development of undesirable phenomena is indicated.
Price for Nootropil in pharmacies
The price of Nootropil per package: 20 tablets at a dose of 1200 mg - from 235 rubles; 30 tablets at a dose of 800 mg - from 283 rubles; 12 ampoules of 5 ml solution for injection - from 321 rubles; 1 bottle of oral solution (125 ml) - from 337 rubles.
Nootropil: prices in online pharmacies
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Drug name Price Pharmacy |
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Nootropil 800 mg film-coated tablets 30 pcs. RUB 185 Buy |
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Nootropil 1200 mg film-coated tablets 20 pcs. 215 RUB Buy |
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Nootropil tablets p.p. 800mg 30 pcs. 221 r Buy |
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Nootropil 200 mg / ml oral solution 125 ml 1 pc. 222 r Buy |
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Nootropil 200 mg / ml solution for intravenous and intramuscular administration 5 ml 12 pcs. 293 r Buy |
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Nootropil sol. for I / O int. 200 mg / ml amp. 5 ml 12 Pcs. 339 r Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
