Nootropil (Piracetam) tablets, oral solution - Instructions for Use, Dosage, Side Effects, Reviews

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Active substance: Piracetam.

ATC - N06BX03 Piracetam.

Pharmacological group – Nootropics.

Piracetam (sold under many brand names) is a nootropic drug in the racetams group, with chemical name 2-oxo-1-pyrrolidine acetamide. It shares the same 2-oxo-pyrrolidone base structure with pyroglutamic acid. Piracetam is a cyclic derivative of GABA (gamma-Aminobutyric acid).

Piracetam's mechanism of action, as with racetams in general, is not fully understood. The drug influences neuronal and vascular functions and influences cognitive function without acting as a sedative or stimulant.[6] Piracetam is a positive allosteric modulator of the AMPA receptor. It is hypothesized to act on ion channels or ion carriers, thus leading to increased neuron excitability. GABA brain metabolism and GABA receptors are not affected by piracetam.

It has been found to increase blood flow and oxygen consumption in parts of the brain, but this may be a side effect of increased brain activity rather than a primary effect or mechanism of action for the drug.

Piracetam improves the function of the neurotransmitter acetylcholine via muscarinic cholinergic (ACh) receptors, which are implicated in memory processes. Furthermore, piracetam may have an effect on NMDA glutamate receptors, which are involved with learning and memory processes. Piracetam is thought to increase cell membrane permeability. Piracetam may exert its global effect on brain neurotransmission via modulation of ion channels (i.e., Na+, K+). It has been found to increase oxygen consumption in the brain, apparently in connection to ATP metabolism, and increases the activity of adenylate kinase in rat brains. Piracetam, while in the brain, appears to increase the synthesis of cytochrome b5, which is a part of the electron transport mechanism in mitochondria. But in the brain, it also increases the permeability of the mitochondria of some intermediaries of the Krebs cycle. You can buy Nootropil.

Nosological classification (ICD–10)

D57.1 Sickle-cell disease without crisis;

F00 Dementia in Alzheimer’s disease (G30 +)

F01 Vascular dementia;

F03 Dementia, unspecified;

F06.3 Organic mood disorder [affective ];

F07 Disorders of personality and behavior due to illness, injury or brain dysfunction;

F07.0 Personality disorder of organic etiology;

F07.1 Post-encephalitic syndrome;

F07.2 Postcontusion syndrome;

F07.8 Other organic personality disorder and behavior due to illness, injury and brain dysfunction;

F10.2 Alcohol dependence syndrome;

F10.3 abstinence;

F81 Specific developmental disorders of learning skills;

G25.3 Myoclonus;

G30 Alzheimer’s disease;

G92 Toxic encephalopathy;

G93.4 Encephalopathy, unspecified;

H81 Disorders of vestibular function;

H81.4 Vertigo of central origin;

I63 Cerebral infarction;

I69 Effects of cerebrovascular diseases;

R41.3.0 * Reduced memory;

R41.8.0 * Disorders Intellectual mnestic;

R47 speech disorders, not elsewhere classified;

T90.5 Effects of intracranial injury.

Nootropil (Piracetam) Composition, structure and packing

Film-coated tablets are white or nearly white, oblong, with transverse separation scored on both sides, on one side of the tablet on the right and left of the risks engraved “N”;

Other ingredients: silicon dioxide, magnesium stearate, macrogol 6000, croscarmellose sodium; Opadry Y–1–7000 (titanium dioxide (E171), macrogol 400, hypromellose 2910 5sR (E464)), Opadry OY-S–29019 (hypromellose 2910 50sR, macrogol 6000).

Oral solution is colorless and transparent.

Vials of dark glass complete with measuring glass.

Excipients: 27 g of glycerol 85%, 300 mg of Sodium saccharin, 200 mg of sodium acetate, 135 mg of methyl parahydroxybenzoate, 15 mg of propyl parahydroxybenzoate, 30 mg Apricot flavor, 15 mg caramel flavor, glacial acetic acid 16 mg ± 5%, Purified water 62.1 g ± 5%.

Active substance 1 tab. 1 tab. 1 ml

piracetam 800 mg 1200 mg 200 mg

Nootropil (Piracetam) Pharmacological action

Nootropic drug cyclic derivative of gamma-aminobutyric acid (GABA).

Available data indicate that the main mechanism of action of piracetam is not cell-specific or organ specific.

Piracetam is associated with the polar heads of phospholipids to form mobile complexes piracetam-phospholipid. As a result of recovering the cell structure of the membrane bilayer and its stability, which in turn leads to the reconstruction of three-dimensional structure of the membrane and transmembrane proteins and restoring their function.

At the neuronal level, piracetam facilitates various types of synaptic transmission, providing a preferential effect on the density and activity of postsynaptic receptors (data obtained in animal studies).

Piracetam improves functions such as learning, memory, attention and consciousness, without causing sedation or psychostimulant effects.

Hemorheological effects of piracetam associated with its effect on red blood cells, platelets and vascular wall.

In patients with sickle cell anemia piracetam increases in deformation ability of erythrocytes, and reduce the blood viscosity prevents formation of a “rouleaux”. Furthermore, it reduces platelet aggregation without causing significant influence on their amount.

Animal studies have shown that piracetam prevents vasospasm and counteracts various vasospastic substances.

In studies in healthy volunteers piracetam reduced adhesion of red blood cells to the vascular endothelium and stimulated production of prostacyclin healthy endothelium.

Pharmacokinetics

Absorption

After oral dose Piracetam is rapidly and almost completely absorbed from the gastrointestinal tract. After receiving a single dose of the drug in 3.2 g of C max was 84 mcg/mL after multiple administration at a dose 3.2 mg three times/day –115 ug/ml achieved after 1 h in the blood plasma after 5 hours in the cerebrospinal fluid. Food intake reduces C max by 17% and increases to 1.5 T max h Women piracetam when receiving a dose of 2.4 g of C max and AUC by 30% more than men.

Distribution and metabolism

Does not bind to plasma proteins.

Piracetam V d is about 0.6 liter/kg.

In animal studies revealed that piracetam is selectively accumulated in cortex tissues, mainly in the frontal, parietal, and occipital lobes in the basal ganglia and cerebellum.

Is not metabolized in the body.

Penetrate the BBB and placental barrier.

Breeding

T 1/2 of the plasma is 4.5 hours, from cerebrospinal fluid - 8.5 h T 1/2 is not dependent on the route of administration.

80–100% piracetam excreted by the kidneys unchanged by renal filtration. The total clearance of piracetam in healthy volunteers is 80–90 ml/min.

Pharmacokinetics in special clinical situations

T 1/2 is prolonged in renal failure, with end-stage renal failure - up to 59 hrs.

Pharmacokinetics of piracetam is not changed in patients with hepatic insufficiency.

Penetrates through the filter membrane devices for hemodialysis.

Nootropil (Piracetam) Dosage

The drug is administered by mouth, during meals or on an empty stomach, drinking liquid.

Symptomatic treatment of psycho-organic syndrome: 2.4–4.8 g/day in 2–3 divided doses.

Treatment of vertigo and associated imbalance: 2.4–4.8 g/day in 2–3 divided doses.

Treatment of cortical myoclonus begin with a dose of 7.2 g/day, every 3–4 days, increase the dose to 4.8 g/day to a maximum dose of 24 g/day in 2–3 divided doses. Treatment continued throughout the period of the disease. Every 6 months, to attempt to reduce the dose or discontinuation of the drug, gradually reducing the dose to 1.2 g/day every 2 days.

Prevention of sickle cell vaso-occlusive crisis: the daily dose is 160 mg/kg body weight, divided into 4 equal doses.

Treatment of dyslexia in children (in the complex therapy): The recommended daily dose for children 8 years and adolescents - 3.2 g, divided into 2 doses.

For patients with impaired renal function the dose should be adjusted depending on the magnitude of spacecraft.

RC can be calculated from the serum creatinine concentration by the following formula:

Men CC (ml/min) = [140 - age (years)] x weight (kg)/72 x serum creatinine (mg/dl);

QC for women is calculated by multiplying the resulting value by a factor of 0.85.

Patients with kidney failure require correction of the dose according to the following scheme.

Renal failure QC (ml/min) The dose and frequency of administration

Rate > 80 The usual dose

Mild 50 - 79 2/3 of the usual dose of 2 - 3 admission

The average degree 30 - 49 1/3 the normal dose in 2 hours

Severe <30 1/6 normal dose once

Final stage <20 Contraindicated

In elderly patients the dose is adjusted in the presence of renal failure, prolonged therapy is necessary to monitor renal function.

Patients with impaired hepatic function dose adjustment is required.

Patients with impaired renal function and liver, and the drug is prescribed as well as the patients only with impaired renal function.

Nootropil (Piracetam) Overdose

Symptoms: registered a single case dyspepsia development of diarrhea with blood and abdominal pain while taking the drug orally at a daily dose of ’75 Apparently, this was due to the use of a large total dose of sorbitol, formerly a member of the dosage form, the solution for ingestion.

Treatment: Immediately after a large overdose ingestion can cause stomach wash or artificial vomiting. No specific antidote. Effectiveness of hemodialysis is 50–60%.

Nootropil (Piracetam) Drug Interactions

The ability to change under the influence of piracetam pharmacokinetics of other drugs is low because 90% of the drug is excreted unchanged in the urine.

While the use of thyroid hormones marked reported confusion, irritability, and sleep disturbance.

According to a study of patients with recurrent venous thrombosis in a dose of piracetam 9.6 g/day increases the efficiency of indirect anticoagulants (noted a greater reduction of platelet aggregation, the concentration of fibrinogen, von Willebrand factor, the viscosity of blood and plasma as compared to using only indirect anticoagulants).

Piracetam does not inhibit cytochrome P450 isoenzymes. Metabolic interaction with other drugs is unlikely.

Reception piracetam in a dose of 20 g/day for 4 weeks did not alter the C max and AUC in serum antiepileptic drugs (carbamazepine, phenytoin, phenobarbital, valproate).

Co-administration with alcohol did not affect the concentration of piracetam in serum; ethanol concentration in serum did not change when receiving 1.6 g piracetam.

Nootropil (Piracetam) at Pregnancy and lactation

Adequate and well-controlled studies safety of Nootropilum during pregnancy was conducted. Controlled studies of the drug during pregnancy has not been conducted.

Piracetam crosses the placental barrier. The concentration of drug in the newborn reaches 70–90% of the concentration in the maternal blood. Nootropilum should not be administered during pregnancy.

Piracetam is excreted in breast milk. In appointing the drug during lactation should refrain from breastfeeding.

Nootropil (Piracetam) Side effects

The nervous system: motor disinhibition (1.72%), irritability (1.13%), somnolence (0.96%), depression (0.83%), asthenia (0.23%) and in rare cases - dizziness, headache, ataxia, impaired balance, exacerbation of epilepsy, insomnia, confusion, agitation, anxiety, hallucinations, increased sexuality. In post-marketing practices following side effects were observed, the frequency has not been established (due to insufficient data): headache, insomnia, agitation, impaired balance, ataxia, exacerbation of epilepsy, anxiety, hallucinations, confusion.

From the digestive system: nausea, vomiting, diarrhea, abdominal pain (including stomachalgia).

From a metabolism: weight gain (1.29%).

Part of the organ of hearing and balance: vertigo.

For the skin: dermatitis, pruritus, urticaria.

Allergic reactions: angioedema, hypersensitivity, anaphylactic reactions.

Other: rarely - pain at the injection site, thrombophlebitis, pyrexia, hypotension (in/in the introduction).

In most cases it is possible to achieve regression of these symptoms by reducing the dose.

Nootropil (Piracetam) Indications

Adults

Symptomatic treatment of psycho-organic syndrome, particularly in elderly patients, accompanied by memory loss, dizziness, decreased concentration and decreased activity, mood changes, conduct disorder, impaired gait (these symptoms may be early signs of age-related diseases such as Alzheimer’s disease and senile dementia, Alzheimer’s type);

Treatment of vertigo and associated disequilibrium, except vasomotor and psychogenic dizziness;

Treatment of cortical myoclonus (as monotherapy or in combination therapy);

Prevention of sickle cell vaso-occlusive crisis.

Children

Treatment of dyslexia (in the complex therapy);

Prevention of sickle cell vaso-occlusive crisis.

Nootropil (Piracetam) Contraindications

Psychomotor agitation at the time of administration of the drug;

Huntington’s chorea;

Acute ischemic stroke (hemorrhagic stroke);

The final stage of chronic renal failure (with creatinine clearance <20 ml/min);

Children up to age 1 year (for oral solution);

Children up to age 3 years (for tablets);

Hypersensitivity to the drug;

Hypersensitivity to the pyrrolidinone derivatives.

With careful use in patients with disorders of hemostasis, extensive surgery, severe bleeding, chronic renal insufficiency (creatinine clearance 20–80 ml / min).

Nootropil (Piracetam) Cautions

Due to the influence of piracetam on platelet aggregation with caution should be prescribed to patients with impaired hemostasis during major surgery or in patients with symptoms of severe bleeding.

In the treatment of cortical myoclonus should avoid abrupt cessation of treatment, as this may cause the resumption of seizures.

In the treatment of sickle cell dose of less than 160 mg/kg or irregular taking the drug may aggravate the disease.

Long-term therapy in elderly patients is recommended regular monitoring of renal function, if necessary, shall adjust the dose depending on the results of research spacecraft.

When treating patients on Hyponatric diet is recommended to consider that the solution to piracetam oral dose of 24 g contains 80.5 mg sodium.

Piracetam penetrates through the filter membrane devices for hemodialysis.

Effects on ability to drive vehicles and management mechanisms

The treatment should be careful when driving and occupation of other potentially hazardous activities that require high concentration and speed of psychomotor reactions.

Nootropil (Piracetam) Reviews

Nataly, 45 years,Nootropil Piracetam - an excellent tool to improve brain function

Not really like the reviews on drugs, I believe that to solve a specialist should take the drug. But...
I thundered at the hospital. Like many women in our country until recently worked until quite bad gone.
Our ward was treating doctor-intern. Nothing bad to say I can not, but it turns out this time (I was educated grandmother several times lying in the hospital and very well experienced) need to ask the doctor to prescribe medications and complain, complain. Otherwise all the treatment will be at a minimum.
Something in my memory was bad, assign me something, from the hands of all falls, and the like.
A drug nootropil or piracetam excellent: improves brain activity, improves memory, concentration.
If you have the opportunity to talk to your doctor and may ask you to assign this excellent drug.

Eve, 19 years, Nootropil Piracetam - It is easy to prepare for exams
Advantages:
It helps to memorize large amounts of information

Effect of the drug is that it affects the memory of a man helping to restore it. As a student, before the session I need to memorize vast amounts of information, but by the end of the semester the brain and so loaded, so the material is very hard to remember. I go to the doctor to explain the situation and was advised to buy Nootropil Piracetam. Naturally, I followed the advice and began the same day reception. Though the drug and did not immediately effective, but the results are very good - I had only heard or read something a couple of times and information tightly fit into my head. But the drugs there and disadvantages - some have individual intolerance of drugs of this type, so before beginning a course of treatment, I suggest you consult with your doctor, make sure that your body is safely respond to the medicine, and then start taking the drug .