Nootropil pills 1200 mg 20 pcs
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Active ingredients
Piracetam
Release form
Pills
Composition
Active ingredient: Piracetam Auxiliary substances: silicon dioxide, magnesium stearate, Macrogol 6000, croscarmellose sodium. Concentration of active ingredient (mg): 1200 mg
Pharmacological effect
Nootropic drug, cyclic derivative of gamma-aminobutyric acid (GABA). The available data indicate that the main mechanism of action of piracetam is not cell-specific or organ-specific. Pyracetam binds to the polar heads of phospholipids and forms mobile complexes piracetam-phospholipid. As a result, the bilayer structure of the cell membrane and its stability are restored, which in turn leads to the restoration of the three-dimensional structure of membrane and transmembrane proteins and their function. At the neuronal level, piracetam facilitates various types of synaptic transmission, having a predominant 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 rendering a sedo ivnogo or psychostimulant effects vozdeystviya.Gemoreologicheskie piracetam connected with its effect on red blood cells, platelets, and the wall sosudov.U patients with sickle cell anemia piracetam increases the capacity of erythrocytes to deformation, reduces the viscosity of the blood and prevents the formation of rouleaux. In addition, it reduces platelet aggregation without significantly affecting their number. In animal studies, it was shown that piracetam prevents vascular spasm and counteracts various vasospastic substances. In studies in healthy volunteers, piracetam reduced erythrocyte adhesion to vascular endothelium and stimulated prostate stimulation endothelium.
Pharmacokinetics
AbsorptionAfter taking the drug inside piracetam quickly and almost completely absorbed from the gastrointestinal tract. After a single dose of the drug in a dose of 3.2 g, Cmax is 84 μg / ml, after repeated administration in a dose of 3.2 mg 3 times / day, it amounts to 115 μg / ml and is achieved after 1 h in plasma and after 5 h in cerebrospinal fluid. Eating reduces Cmax by 17% and increases Tmax to 1.5 h.In women, when taking piracetam at a dose of 2.4 g Cmax and AUC, 30% more than men. Distribution and metabolism Does not bind to plasma proteins. Vd piracetam is about 0.6 l / kg. During a study on animals, piracetam was found to selectively accumulate in the cerebral cortex, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal ganglia. It is not metabolized in the body. It penetrates the BBB and the placental barrier. The T1 / 2 output from plasma is 4-5 h, from the cerebrospinal fluid - 8.5 h T1 / 2 does not depend on path vvedeniya.80-100% piracetam excreted by the kidneys in unchanged form by renal filtration. The total clearance of piracetam in healthy volunteers is 80-90 ml / min. The pharmacokinetics in special clinical situations T1 / 2 is prolonged in renal failure; in end-stage chronic renal failure - up to 59 hours. The pharmacokinetics of piracetam do not change in patients with hepatic insufficiency. It penetrates through the filtering membranes of hemodialysis machines.
Indications
- Symptomatic treatment of psychoorganic syndrome, in particular in elderly patients suffering from memory loss, dizziness, low concentration of attention and general activity, mood changes, behavior disorder, gait disturbance, as well as Alzheimer's patients with senile dementia of Alzheimer's type. - Treatment of the effects of stroke, such as speech disorders, disturbances of the emotional sphere, to increase motor and mental activity. - Chronic alcoholism - for the treatment of psychoorganic and withdrawal syndromes. - The recovery period after coma, including after injuries and intoxication of the brain. - Treatment of vertigo and related balance disorders, with the exception of vertigo of vascular and mental origin. - As part of the complex therapy of low learning in children with psychoorganic syndrome. - For the treatment of cortical myoclonus as a mono-or complex therapy. - In the complex therapy of sickle cell anemia.
Contraindications
- Individual intolerance to piracetam or pyrrolidone derivatives, as well as other components of the drug. - Acute violation of cerebral circulation (hemorrhagic stroke).- The final stage of renal failure (with creatinine clearance less than 20 ml / min). - Children's age up to 1 year (for oral solution, 200 mg / ml) and up to 3 years (for capsules and pills).
Precautionary measures
Do not exceed the recommended dose. With caution, you should use the drug in violation of hemostasis, extensive surgery, severe bleeding, in chronic renal failure (CC 20-80 ml / min).
Use during pregnancy and lactation
Adequate and strictly controlled studies of the safety of Nootropil during pregnancy was not conducted. Controlled studies of the use of the drug during pregnancy have not been carried out. Piracetam crosses the placental barrier. The concentration of the drug in newborns reaches 70-90% of its concentration in the blood of the mother. Nootropil should not be prescribed during pregnancy. Piracetam is excreted in breast milk. In appointing the drug during lactation should refrain from breastfeeding.
Dosage and administration
Inside Daily dose - 30-160 mg / kg, the multiplicity of reception - 2-4 times a day. The inside is prescribed during the meal or on an empty stomach; pills and capsules should be taken with liquid (water, juice). - When symptomatic treatment of chronic psychoorganic syndrome, depending on the severity of symptoms, 1.2-2.4 g is prescribed, and during the first week - 4.8 g / day. - In the treatment of the effects of stroke prescribed 4.8 g / day. - During the recovery period after coma, as well as the difficulties of perception in individuals with brain injuries, the initial dose is 9-12 g / day, supporting - 2.4 g / day. The treatment lasts at least 3 weeks. - When alcohol withdrawal syndrome during a crisis - 12 g / day in 2-3 doses. Maintenance dose - 2.4 g / day. - Treatment of dizziness and related balance disorders 2.4-4.8 g per day. - For children for the correction of reduced learning, the dose is 3.3 g / day (approximately 8 ml of oral solution, twice a day). Treatment continues throughout the school year. - With cortical myoclonus, treatment begins with 7.2 g / day, every 3-4 days the dose is increased by 4.8 g / day until the maximum dose of 24 g / day is reached. Treatment continues throughout the duration of the disease. Every 6 months, attempts are made to reduce the dose or cancel the drug, to prevent an attack, gradually reducing the dose by 1.2 g every 2 days. If there is no effect or a slight therapeutic effect, treatment is stopped.- With sickle cell anemia, the daily prophylactic dose is 160 mg / kg body weight, divided into four equal doses. During the crisis -300 mg / kg intravenously. Dosing for patients with impaired renal function. Since Nootropil is excreted by the kidneys, care should be taken when treating patients with renal insufficiency in accordance with this dosage regimen. Renal failure Creatinine clearance (ml / min) DosageNorma> 80 Usual doseEasy 50-79 2/3 usual dose in 2-3 doses Average 30-49 1/3 usual dose in 2 doses Severe <30 1/6 usual dose, once The final stage is contraindicated in the elderly Patients dose corrected in the presence of renal failure and with long-term therapy, the control of the functional state of the kidneys is necessary. Dosing for patients with impaired liver function. Patients with impaired liver function do not need dose adjustment. Patients with impaired function and kidney and liver dosing is carried out according to the scheme (see Section Dosing for patients with impaired renal function)
Side effects
From the side of the central nervous system: hyperkinesia (1. 72%), nervousness (1. 13%), drowsiness (0. 96%), depression (0. 83%), asthenia (0. 23%). These side effects often occur in elderly patients who received the drug in a dose of more than 2. 4 g / day. In some cases - dizziness, headache, ataxia, imbalance, exacerbation of the course of epilepsy, insomnia, confusion, agitation, anxiety, hallucinations, increased sexuality. On the part of metabolism: an increase in body weight (1. 29%). On the part of the digestive system: in some cases - nausea, vomiting, diarrhea, abdominal pain. Dermatological reactions: dermatitis, pruritus, rash, edema.
Overdose
Symptoms: a single case of development of dyspeptic phenomena was observed in the form of diarrhea with blood and pain in the abdomen when the drug was taken orally inside the daily dose of 75 g. Apparently, this was due to the use of a large total dose of sorbitol ingestion. Treatment: Immediately after a significant overdose, ingestion can flush the stomach or induce artificial vomiting. There is no specific antidote. The effectiveness of hemodialysis is 50-60%.
Interaction with other drugs
The possibility of changing the pharmacokinetics of piracetam under the influence of other drugs is low, because 90% of the drug is excreted unchanged in the urine. When used simultaneously with thyroid hormones, there are reports of confusion, irritability and sleep disturbance. According to a published study of patients with recurrent venous thrombosis, piracetam at a dose of 9.6 g / day increases the effectiveness of indirect anticoagulants (more pronounced decrease in platelet aggregation, fibrinogen concentration, von Willebrand factors, blood and plasma viscosity compared with the use of only indirect anticoagulant c) .Piratsetam not inhibit cytochrome P450 isozymes. Metabolic interaction with other drugs is unlikely. Taking piracetam at a dose of 20 g / day for 4 weeks did not change Cmax in serum and AUC antiepileptic drugs (carbamazepine, phenytoin, phenobarbital, valproate). Joint administration with alcohol did not affect the concentration of piracetam in serum; The concentration of ethanol in the serum did not change when taking 1.6 g of piracetam.
special instructions
Due to the effect of piracetam on platelet aggregation, the drug should be prescribed with caution to patients with impaired hemostasis, during extensive surgical interventions or patients with symptoms of severe bleeding. When treating cortical myoclonia, abrupt interruption of treatment should be avoided, because this may cause a resumption of seizures. When treating sickle cell anemia, a dose of less than 160 mg / kg or an irregular drug may cause an exacerbation of the disease. During prolonged therapy for elderly patients, regular monitoring of renal function indicators is recommended, and dose adjustment is necessary depending on the results of the study. When treating patients on a hyponatric diet, it is recommended to take into account that the oral solution of piracetam in a dose of 24 g contains 80.5 mg of sodium. Piraceta m penetrates through the filtration membranes of hemodialysis machines. Effect on the ability to drive vehicles and control mechanisms. During the period of treatment, care should be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and psychomotor speed.