Active substancePyracetamPyracetam
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  • Dosage form: & nbsp

    Solution for infusion.

    Composition:

    Active substance: piracetam - 200 mg

    Excipients: sodium acetate, acetic acid diluted, water for injection - up to 1.0 ml. Theoretical osmolarity is 1465 mOsm / l.

    Description:

    Transparent colorless liquid.

    Pharmacotherapeutic group:Nootropic agent.
    ATX: & nbsp

    N.06.B.X.03   Pyracetam

    Pharmacodynamics:

    The active component is piracetam cyclic derivative of gamma-aminobutyric acid.

    Pyracetam is a nootropic agent. It directly affects the brain, improving cognitive (cognitive) processes, such as learning ability, memory, attention, and mental performance. Pyracetam affects the central nervous system (CNS) in various ways: by changing the rate of spread of excitation in the brain, improving metabolic processes in nerve cells, improving microcirculation, affecting the rheological characteristics of the blood and not causing vasodilating action.

    The drug improves the connections between the cerebral hemispheres and synaptic conductivity in neocortical structures, increases mental capacity, improves cerebral blood flow.

    Pyracetam inhibits platelet aggregation and restores the elasticity of the erythrocyte membrane, reduces the adhesion of erythrocytes. In a dose of 9.6 g reduces the level of fibrinogen and von Willebrand factors by 30-40% and lengthens the time of bleeding.

    Pyracetam reduces the severity and duration of the vestibular nystagmus.
    Pharmacokinetics:

    The half-life of the drug from the blood plasma is 4-5 hours, of the cerebrospinal fluid - 7.7 hours. In patients with renal failure, the half-life is prolonged. The pharmacokinetics of pyracetam does not change in patients with hepatic insufficiency.

    Penetrates through blood-brain and placental barriers.When tested on animals piracetam selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal ganglia. It does not bind to blood plasma proteins, is not metabolized in the body and is excreted by the kidneys - 2/3 unchanged for 30 hours. The kidney clearance of piracetam in healthy volunteers is 86 ml / min.

    Indications:

    Symptomatic treatment of psycho-organic syndrome, in particular in elderly patients, accompanied by a decrease in memory, reduced concentration of attention and a decrease in overall activity, mood changes, behavioral disorders, gait disorders, as well as patients with Alzheimer's disease and Alzheimer's dementia.

    Treatment of the consequences of acute cerebrovascular accident (ischemic stroke), such as speech impairment, emotional disorders, decreased motor and mental activity.

    Chronic alcoholism - for the treatment of psycho-organic and abstinence syndromes. Comatose conditions (and during the recovery period), including after traumas and intoxications of the brain.

    Treatment of dizziness and related disorders of balance, with the exception of dizziness of vascular genesis and psychogenic dizziness.

    Treatment of cortical myoclonus as a mono- and complex therapy.

    In the complex therapy of sickle cell anemia.

    In pediatric practice: dyslexia in children older than 8 years (as part of complex therapy).

    Contraindications:

    • Individual intolerance to piracetam or pyrrolidone derivatives, as well as other components of the drug.
    • Psychomotor agitation at the time of prescribing.
    • Horea Huntington.
    • Acute disturbance of cerebral circulation (hemorrhagic stroke).
    • The final stage of renal failure (with creatinine clearance less than 20 ml / min).
    • Contraindicated for children, except for dyslexia in children older than 8 years (as part of complex therapy).

    Carefully:

    Violation of the hemostasis, extensive surgical interventions, heavy bleeding.

    Pregnancy and lactation:

    Studies in animals have not revealed the damaging effect of pyracetam on the embryo and its development, including in the postnatal period. There were no changes in the course of pregnancy and childbirth.

    Studies on pregnant women were not conducted. Pyracetam penetrates the placental barrier and into breast milk. The concentration of the drug in newborns reaches 70-90% of its concentration in the mother's blood. If you need to prescribe the drug during pregnancy, you should evaluate the potential benefits to the mother and the risk to the fetus. If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

    Dosing and Administration:

    Enter slowly! Piracetam solutions are injected intravenously at a rate of 30-40 drops per minute.

    Bolus intravenous administration (for example, with the withdrawal of withdrawal syndrome with alcoholism, emergency treatment of sickle cell anemia, etc.) is performed for at least 2 minutes, the daily dose is then divided into several injections (2-4) at regular intervals so , so that the dose for one administration does not exceed 3 g. Parenteral administration of piracetam is prescribed when it is not possible to use oral medication (tablets, capsules, oral solution), for example, if swallowing is difficult or when the patient t is in a coma.

    When the opportunity arises, they switch to oral administration of piracetam. The duration of treatment is determined by the doctor depending on the disease and taking into account the dynamics of the symptoms.

    With the symptomatic treatment of chronic psychoorganic syndrome, depending on the severity of symptoms, appoint 2.4-4.8 g / day.

    In the treatment of cerebrovascular disorders (stroke) appoint 4.8 - 12 g / day.

    In the treatment of coma, as well as difficulties in perception in people with brain trauma the initial dose is 9-12 g / day, supporting - 2 g / day. Treatment continues for at least 3 weeks.

    With alcohol withdrawal syndrome - 12 g / day. Supportive dose of 2.4 g / day.

    Treatment of dizziness and related disorders of balance 2,4-4,8 g per day, the course is 10-15 days.

    With cortical myoclonia treatment starts 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 period of the disease. Every 6 months. attempts should be made to reduce the dose or discontinue the drug, gradually reducing the dose by 1.2 g / day every 2 days. In the absence of effect or a slight therapeutic effect, treatment is discontinued.

    With sickle-cell anemia The daily prophylactic dose is 160 mg / kg of body weight divided into four equal doses. During the crisis, 300 mg / kg.

    Children. The only indication is dyslexia in children older than 8 years (as part of complex therapy). The escatropyl is prescribed in a dose of 30-50 mg / kg / day.

    Dosing to patients with impaired renal function.

    Because the piracetam is excreted from the body by the kidneys, care should be taken when treating patients with renal insufficiency in accordance with this dosing regimen.

    Renal insufficiency

    Creatinine clearance (ml / min)

    Dosing

    Absent

    >80

    Usual Dose

    Lightweight

    50-79

    2/3 of the usual dose in 2-3 injections

    Average

    30-49

    1/3 of the usual dose in 2 injections

    Heavy

    20-30

    1/6 of the usual dose, once

    The final stage

    <20

    contraindicated

    Elderly, the dose is corrected in the presence of kidney failure. With prolonged therapy, it is necessary to monitor the functional state of the kidneys.

    Dosing to patients with impaired liver function.

    Patients with a dysfunction of the liver do not need a dose adjustment. If the renal and hepatic functions are impaired simultaneously, the dosing is performed according to the scheme given (see section "Dosing to patients with impaired renal function").

    Side effects:

    From the side of the central nervous system and the peripheral nervous system: motor disinhibition (1.72%), irritability (1.13%), drowsiness (0.96%), depression (0.83%), asthenia (0.23%).

    These side effects often occur in elderly patients who received the drug at a dose of more than 2.4 g / day. In most cases, it is possible to regress such symptoms by lowering the dose of the drug. In isolated cases - dizziness, headache, ataxia, exacerbation of epilepsy, extrapyramidal disorders, tremor, imbalance, decreased ability to concentrate, insomnia, agitation, anxiety, hallucinations, increased libido.

    From the cardiovascular system: rarely - a decrease or increase in blood pressure.

    From the digestive system: in isolated cases - nausea, vomiting, diarrhea, abdominal pain (including gastralgia).

    From the side of metabolism: an increase in body weight (1.29%) - more often occurs in elderly patients who received the drug at a dose of more than 2.4 g / day.

    From the skin: dermatitis, itching, rashes.

    Allergic reactions: angioedema.

    Overdose:

    In case of an overdose, symptomatic therapy is recommended, which may include hemodialysis. There is no specific antidote. The efficacy of hemodialysis for piracetam is 50-60%.

    Interaction:

    Increases the effectiveness of thyroid hormones, antipsychotic drugs (neuroleptics). With simultaneous appointment with neuroleptics piracetam reduces the risk of extrapyramidal disorders.

    With simultaneous use with drugs that have a stimulating effect on the central nervous system, it is possible to enhance CNS stimulation.

    No interaction with clonazepam, phenytoin, phenobarbital, valproic acid was observed.

    High doses of piracetam (9.6 g / day) increase the effectiveness of indirect anticoagulants in patients with venous thrombosis (significant inhibition of platelet aggregation, fibrinogen concentration, vWF, plasma and blood viscosity compared with the use of only indirect anticoagulants).

    The possibility of changing the pharmacodynamics of piracetam under the influence of other drugs is low, because90% of piracetam is excreted unchanged in the urine. Receiving piracetam at a dose of 20 mg / day did not change the maximum concentration and area under the concentration-time curve of antiepileptic drugs in serum (carbamazepine, phenytoin, phenobarbital, valproic acid) in patients with epilepsy, taking a constant dose.

    Joint intake with alcohol did not affect the concentration of piracetam in the serum and the concentration of alcohol in the blood serum did not change with the intake of 1.6 g of piracetam.

    Special instructions:

    Due to the influence of piracetam on platelet aggregation, caution is recommended when prescribing the drug to patients with hemostasis disorder, during major surgical operations, or to patients with symptoms of severe bleeding. In the treatment of patients with cortical myoclonia, sudden interruption in treatment should be avoided, which can lead to the resumption of seizures.

    With prolonged therapy of elderly patients, regular monitoring of renal function parameters is recommended, if necessary, dose adjustment is performed depending on the results of the study of creatinine clearance.

    It penetrates the hemodialysis apparatus through the filter membranes.

    Effect on the ability to drive transp. cf. and fur:

    During the treatment period, care should be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Solution for infusion 200 mg / ml.

    Packaging:

    For 50 or 100 ml in glass bottles of MTO brand for blood, transfusion and infusion preparations with a capacity of 50 ml and 100 ml respectively.

    One bottle with instructions for medical use is placed in a pack of cardboard. For 28 bottles with an equal number of instructions for medical use are placed in boxes of corrugated cardboard with gaskets and nest boxes made from corrugated cardboard (for hospitals).

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:

    2 years. Do not use after the expiration date indicated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N002945 / 01
    Date of registration:12.09.2008
    The owner of the registration certificate:ESKOM NPK, OAO ESKOM NPK, OAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp15.10.2015
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