Piracetam
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Clinical Pharmacology
Piracetam activates associative processes in the central nervous system, improves mood, memory and mentality in sick and healthy people. Stimulates intellectual activity and integrative activity of the brain, facilitates learning processes, improves communication between the cerebral hemispheres and synaptic conduction in the cortex, improves mental performance, stabilizes and restores impaired brain functions (memory, consciousness, speech). Piracetam normalizes the ratio of ADP and ATP (inhibits nucleotide phosphatase and activates adenylate cyclase), increases the activity of phospholipase A, stimulates bioenergetic and plastic processes in nervous tissue, and accelerates the exchange of neurotransmitters.
Piracetam increases the resistance of the brain tissue to toxic effects and hypoxia, enhances the synthesis of phospholipids and nuclear RNA, enhances glycolytic processes and glucose utilization in the brain. Piracetam blocks platelet aggregation, improves microcirculation, optimizes the ability of red blood cells to pass through the microvessels and the conformational properties of the erythrocyte membrane, and increases regional blood flow in the ischemic brain regions. Piracetam enhances EEG beta and alpha activity and lowers delta activity. Reduces vestibular nystagmus. During hypoxia, intoxication, trauma, electroconvulsive effects has a neuroprotective effect.
Due to its antihypoxic effect, piracetam is effective in the complex treatment of myocardial infarction. Anxiolytic and sedative effects of piracetam are absent.
Almost completely and quickly piracetam absorbed after ingestion. Bioavailability is 100%. When ingestion of 2 g of the drug, the maximum plasma concentration is 40-60 μg / ml after 30 minutes. Piracetam does not bind to plasma proteins. After 2–8 hours, the maximum concentration in the liquor is created. Piracetam penetrates all tissues and organs, and penetrates through the placental barrier. Almost not metabolized. Selectively accumulates in the cerebral cortex, mainly in the parietal, frontal and occipital lobes, basal ganglia and cerebellum. The plasma half-life of piracetam is 4–5 hours; from liquor is 6-8 hours. More than 95% of the drug is excreted unchanged by the kidneys after 30 hours. In patients with renal failure, the elimination half-life increases.
Indications
- Chronic cerebrovascular insufficiency (hypertension, atherosclerosis, vascular parkinsonism), which is accompanied by a violation of attention, memory, speech, headache and dizziness;
- ischemic stroke and its consequences;
- psychoorganic disorders;
- dementia (senile dementia, Alzheimer's disease, vascular dementia);
- traumatic brain injury;
- acute viral neuroinfection;
- intoxication (recovery period, coma and subcomatal state);
- diseases of the nervous system, which are accompanied by a decrease in the level of wakefulness, intellectual-mnestic functions, violation of behavior and emotional-volitional sphere;
- dizziness;
- vestibular nystagmus;
- sluggish apathetic condition;
- aphasia;
- cortical myoclonia;
- epilepsy (as an adjunct);
- senile and atrophic processes;
- depressive conditions that are resistant to treatment with antidepressants;
- prevention or elimination of neurological, somatovegetative, mental complications of treatment with neuroleptics and other psychotropic drugs;
- neurotic depression with a prevalence of senesto-hypochondriac and asthenic disorders, adynamia, and ideomotor retardation in the clinical picture;
- psychoorganic syndrome in chronic alcoholism;
- relief of pre - and delirious, withdrawal states in drug addiction and alcoholism;
- acute intoxication with morphine, ethanol, amphetamine, barbiturates;
- in children - cerebral palsy, the effects of perinatal damage to the central nervous system, mental retardation, low learning in psychoorganic syndrome, speech disorder, oligophrenia, impaired memory, cerebrosis, intellectual failure;
- sickle cell anemia (as part of a comprehensive treatment).
Composition
1 solution contains:
active substance: Piracetam - 200.0 g
Excipients: sodium acetate, dilute acetic acid - to pH 5.0-5.8, water for injection
Piracetam is marketed under different brands and generic names, and comes in different dosage forms:
Brand name | Manufacturer | Country | Dosage form |
---|---|---|---|
Piracetam | Pharmstandard Ufavita | Russia | solution |
Piracetam-SOLOpharm | Grotex Ltd | Russia | solution |
Piracetam | V-MIN LLC | Russia | pills |
Piracetam | Biochemist | Russia | solution |
Piracetam | PFK Obnovlenie | Russia | solution |
Piracetam | Ozon | Russia | pills |
Piracetam | Obolensky OP | Russia | pills |
Lucetam | Egis | Hungary | solution |
Lucetam | Egis | Hungary | pills |
Nootropil | UCB Pharma | Belgium | ampoules |
Nootropil | UCB Pharma | Belgium | pills |
Nootropil | UCB Pharma | Belgium | vials |
Piracetam | Synthesis AKOMP | Russia | capsules |
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Dosage and Administration
the drug is prescribed in a daily dose of 30-160 mg / kg (peroral), split in multiple doses - 2-4 times / day.
Lutsetam pills are taken during a meal or on an empty stomach, washed down with a liquid (water, juice).
When symptomatic treatment of chronic psychoorganic syndrome, depending on the severity of symptoms, 1.2-2.4 g / day is prescribed, and during the first week - 4.8 g / day.
In the treatment of the effects of stroke prescribed 4.8 g / day.
With alcohol withdrawal syndrome - 12 g / day. Maintenance dose - 2.4 g / day.
For the treatment of dizziness and related balance disorders, 2.4-4.8 g / day is prescribed.
With cortical myoclonus, treatment begins with a dose of 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 entire period of the disease. Every 6 months, an attempt should be made to reduce the dose or discontinue the drug, gradually reducing the dose by 1.2 g every 2 days in order to prevent an attack. If there is no effect or a slight therapeutic effect, treatment is stopped.
Children for the correction of reduced learning are prescribed by mouth at a dose of 3.2 g / day. Treatment continues throughout the school year.
In patients with impaired liver function, dosing regimen adjustment is not required.
In patients with impaired renal function, correction of the dosage regimen is required depending on creatinine clearance (CK). The degree of renal failure QC (ml / min) Dose Norma> 80 Normal dose Light 50-79 2/3 usual dose in 2 - 3 doses Average 30-49 1/3 usual dose in 2 doses Heavy
In elderly patients, the dose is corrected in the presence of renal failure, and with prolonged therapy, monitoring of the functional state of the kidneys is necessary.
Adverse reactions
Nervous system disorders: hyperkinesis, irritability, drowsiness, depression, asthenia: these symptoms occur more often in elderly patients receiving doses exceeding 2.4 g / day, in most cases it is possible to regress these symptoms by reducing the dose of the drug. Headache, dizziness, insomnia, mental agitation, anxiety, imbalance, tremor, ataxia, exacerbation of the course of epilepsy, anxiety, hallucinations, confusion, increased libido.
Blood and lymph disorders: bleeding
Immune system disorders: hypersensitivity, including anaphylaxis
Disturbances from an organ of hearing and a labyrinth: vertigo
Violations of the cardiovascular system: decrease or increase in blood pressure.
Disorders of the digestive system: nausea, vomiting, diarrhea, abdominal pain, epigastric pain.
Metabolic and nutritional disorders: weight gain.
Violations of the skin: dermatitis, pruritus, urticaria.
Allergic reactions: angioedema.
General disorders and disorders at the site of administration: pain at the injection site, thrombophlebitis, hyperthermia.
Contraindications
- Hemorrhagic stroke.
- End-stage renal failure (with creatinine clearance less than 20 ml / min).
- Children's age up to 1 year.
- Pregnancy.
- Lactation.
- Hypersensitivity to piracetam or a derivative of pyrrolidone, as well as other components of the drug.
Drug interactions
If applied simultaneously with an extract of the thyroid gland, irritability, disorientation and sleep disturbance are possible.
No interactions with clonazepam, phenytoin, phenobarbital, sodium valproate.
High-dose piracetam (9.6 g / day) increases the effectiveness of acenocoumarol in patients with venous thrombosis (there was a more pronounced decrease in the level of platelet aggregation, fibrinogen levels, von Willebrand factors, blood and plasma viscosity).
The possibility of changing the pharmacodynamics of piracetam under the influence of other drugs is low, because90% of the drug is excreted unchanged in the urine.
In vitro, piracetam does not inhibit CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 4A9 / 11 isoenzymes at 142, 426, and 1422 mcg / ml. At a concentration of piracetam of 1422 mcg / ml, slight inhibition of CYP2A6 (21%) and 3A4 / 5 (11%) was observed. However, the level Ki of these two isoenzymes is sufficient when exceeding 1422 μg / ml. Therefore, metabolic interaction with other drugs is unlikely.
Reception of piracetam in a dose of 20 mg / day did not change the peak and the curve of the concentration level of antiepileptic drugs in serum (carbamazepine, phenytoin, phenobarbital, valproate) in epilepsy patients receiving the drug in a constant dose.
Co-administration with ethanol did not affect the level of serum pyracetam concentration, the concentration of ethanol in blood serum did not change when taking 1.6 g pyracetam.
Pregnancy and Lactation
Studies on animals did not reveal a damaging effect on the embryo and the development of offspring, including in the postnatal period, as well as the course of pregnancy and childbirth. Studies in pregnant women have not been conducted. Piracetam penetrates the placental barrier and into breast milk. The concentration of the drug in newborns reaches 70-90% of its concentration in the blood of the mother. Except in special circumstances, lucetam should not be administered during pregnancy. You should refrain from breastfeeding when prescribing a woman Lucetam.
Special instructions
In connection with the effect of piracetam on platelet aggregation, the drug should be prescribed with caution to patients with impaired hemostasis, during major surgical operations or patients with symptoms of severe bleeding.
When treating cortical myoclonus, abrupt interruption of treatment should be avoided, which may cause the resumption of seizures.
Gets through the filtering membranes of hemodialysis machines.
With long-term therapy in elderly patients, regular monitoring of renal function indicators is recommended, and if necessary, dose adjustment is carried out depending on the results of the QC study.
Taking into account possible side effects, the patient should be careful when driving a car and working with mechanisms.
Overdosage
Treatment: immediately after taking the drug inside, you can flush the stomach or induce artificial vomiting. Conduct symptomatic therapy that may include hemodialysis. There is no specific antidote. The effectiveness of hemodialysis for piracetam is 50-60%.
- Brand name: Nootropil
- Active ingredient: Piracetam
- Dosage form: Injections, capsules, pills
Studies and clinical trials of Piracetam (Click to expand)
- The influence of piracetam on actual driving behaviour of elderly subjects
- Determination of piracetam in rat plasma by LC–MS/MS and its application to pharmacokinetics
- Synthesis and Nootropic Activity of Some 2,3-Dihydro-1H-isoindol-1-one Derivatives Structurally Related with Piracetam
- The effects of oxiracetam (ISF 2522) in patients with organic brain syndrome (a double-blind controlled study with piracetam)
- Piracetam in the treatment of cognitive impairment in the elderly
- Electrophysiological profile of neurotropics (hydergine, piracetam, pyritinol) in organic brain disease in the aged
- Thermodynamic characterization of three polymorphic forms of piracetam
- High-dose piracetam is effective on cerebellar ataxia in patient with cerebellar cortical atrophy
- Suppression of myoclonus in SCA2 by piracetam
- A controlled trial of piracetam in intellectually impaired patients with Parkinson's disease
- Effectiveness of piracetam in cortical myoclonus
- Clinical trial of piracetam in patients with myoclonus: Nationwide multiinstitution study in Japan
- Phenomenology of Polymorphism, III:p,TDiagram and Stability of Piracetam Polymorphs
- Age-related influence of piracetam on mitotic index and number of silver-stained nucleolus organizer regions
- The structure and conformations of piracetam (2-oxo-1-pyrrolidineacetamide): Gas-phase electron diffraction and quantum chemical calculations
- Rapid method for the sensitive determination of Piracetam in plasma by high-performance liquid chromatography
- Rapid determination of piracetam in human plasma and cerebrospinal fluid by micellar electrokinetic chromatography with sample direct injection
- The investigation of the interaction between piracetam and bovine serum albumin by spectroscopic methods
- Determination of piracetam in serum by gas chromatography
- Determination of 2-oxo-pyrrolidine-1-acetamide (piracetam) in human plasma using high-performance liquid chromatography
- Determination of piracetam in human plasma by capillary electrophoresis
- Determination of piracetam and its impurities by TLC
- Determination of possible impurities in piracetam using FTIR spectroscopy
- GM1 and Piracetam Do Not Revert the Alcohol-Induced Depletion of Cholinergic Fibers in the Hippocampal Formation of the Rat