Pharmacodynamics. The active ingredient of the preparation is piracetam, a cyclic derivative of gamk. piracetam is a nootropic agent that acts on the brain to improve cognitive (cognitive) functions such as learning ability, memory, attention, and mental performance. the mechanisms of the preparations influence on the central nervous system are probably several: a change in the rate of propagation of excitation in the brain; strengthening of metabolic processes in nerve cells; improvement of microcirculation by influencing the rheological characteristics of blood, without causing a vasodilator effect. improves connections between the cerebral hemispheres and synaptic conduction in neocortical structures. after prolonged use of the preparation in patients with a decrease in brain function, an improvement in cognitive functions, an improvement in attention are noted. these changes are objectively recorded on the EEG (strengthening of the α- and β-rhythms of the brain and weakening of the δ-rhythms). piracetam inhibits platelet aggregation and restores the elasticity of the erythrocyte membrane, reduces the adhesion of erythrocytes. at a dose of 9.6 g reduces the level of fibrinogen and von Willebrand factor by 30-40% and lengthens the bleeding time. piracetam has a protective and restorative effect in case of dysfunction of the brain due to hypoxia, intoxication, and electrical impulse therapy. piracetam reduces the severity and duration of vestibular nystagmus, as monotherapy is effective in the treatment of cortical myoclonus.
Pharmacokinetics. Cmax after intravenous administration is reached in the blood after 30 minutes, and in the CSF - after 5 hours and is 40-60 μg / ml. The volume of distribution of piracetam is almost 0.6 l / kg of body weight. T1 / 2 of the preparation from blood plasma is 4–5 hours and, accordingly, 8.5 hours - from CSF. This period can be lengthened with renal failure. Does not bind to blood plasma proteins, is not metabolized in the body. 80-100% of piracetam is excreted unchanged by the kidneys by glomerular filtration. The renal clearance of piracetam in healthy volunteers is 86 ml / min. The pharmacokinetics of piracetam does not change in patients with hepatic insufficiency. Piracetam crosses the BBB and the placental barrier and membranes that are used in hemodialysis. In a study on animals, it was found that piracetam selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital zones, cerebellum and basal ganglia.
Adults:
Children:
The preparation in the form of an injection solution is used in acute cases or when it is impossible to use oral forms of piracetam. for adults, the daily dose is 30–160 mg / kg of body weight (the frequency of use is 2–3 times a day).
The preparation is used intravenously (injected slowly, over several minutes), starting from 2-4 g and quickly adjusting the dose to 4-6 g / day. After improvement of the condition, they switch to oral administration. In the form of tablets, capsules and oral solution, the preparation is taken orally. The duration of treatment and the choice of an individual dose depends on the severity of the patient's condition and the rate of reverse dynamics of the clinical picture of the disease.
The recommended daily dose is 2.4-4.8 g. Usually the dose is divided into 2-3 doses.
Treatment of cortical myoclonus
The initial daily dose is usually 7.2 g, which is increased to 24 g / day over 3-4 days. The daily dose is divided into 3-4 doses (2-3 injections for an injection solution). If the therapeutic effect is weak or absent, continue to use the preparation in the same dose for up to 7 days. If during this period the desired therapeutic effect is not obtained, treatment with piracetam should be discontinued and other anti-myoclonic agents should be prescribed. When the required therapeutic effect is achieved, therapy is continued until the symptoms of the disease disappear. To prevent the deterioration of the patient's condition, the use of the preparation should not be abruptly stopped. It is necessary to gradually reduce the dose by 1-2 g every 2 days (every 3-4 days in the case of Lanz-Adams syndrome).
| The degree of renal failure | Creatinine clearance, ml / min | Dosage |
| - | 80 | The usual dose |
| Easy | 50-79 | ⅔ the usual dose for 2-3 injections |
| Moderate | 30–49 | 1/3 of the usual dose in 2 administrations |
| Heavy | 30 | 1/6 of the usual dose once |
| Terminal stage | - | Contraindicated |
For patients with impaired liver function, there is no need to adjust the dose. In the case of diagnosed violations of liver and kidney function, dose adjustment is carried out as indicated in the section
Dosing in patients with impaired renal function
Use in elderly patients. Dose adjustment is recommended for elderly patients with diagnosed renal impairment (see Dosing in patients with renal impairment). With long-term treatment, it is necessary to control creatinine clearance in order to adequately adjust the dose of the preparation to such patients.
Hypersensitivity to piracetam or pyrrolidone derivatives, as well as other components of the preparation.
Acute violation of cerebral circulation (hemorrhagic stroke).
Terminal stage of renal failure (with creatinine clearance 20 ml / min). Chorea of Huntington. For solution - the period of pregnancy and lactation. Children under 8 years old.
From the nervous system: often - hyperkinesia; sometimes - ataxia, headache, insomnia, increased frequency of epileptic seizures, imbalance, drowsiness, tremor.
From the immune system: hypersensitivity, including anaphylaxis.
From the digestive system: abdominal pain, pain in the upper abdomen, nausea, diarrhea, vomiting.
From the vestibular system: vertigo.
Skin and subcutaneous tissue disorders: angioedema, dermatitis, itching, rash, urticaria.
Mental disorders: often - hyperexcitability, drowsiness, depression; sometimes - anxiety, confusion, hallucinations.
Others: often - an increase in body weight; sometimes asthenia; very rarely - hypertension, sexual arousal, thrombophlebitis, hyperthermia.
Due to the fact that piracetam reduces platelet aggregation, it is necessary to prescribe the preparation with caution to patients with impaired hemostasis, during major surgical operations or to patients with symptoms of severe bleeding. when treating patients with cortical myoclonus, abrupt interruption of treatment should be avoided, as this can cause a resumption of seizures. with prolonged therapy in the elderly, it is recommended to regularly monitor the indicators of renal function, if necessary, adjust the dose depending on the results of the study of creatinine clearance.
Penetrates through the filter membranes of hemodialysis machines.
The preparation in the form of capsules contains lactose. Therefore, patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use this preparation.
Elderly patients. With long-term therapy in elderly patients, regular monitoring of renal function indicators is recommended, if necessary, the dose is adjusted depending on the results of the study of creatinine clearance.
Warnings related to the content of excipients in the preparation: the preparation contains 2 mmol (46 mg) sodium per 24 g of piracetam.
Use during pregnancy and lactation. Do not use the preparation during pregnancy.
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