Active substancePyracetamPyracetam
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  • Dosage form: & nbsp

    Solution for intravenous and intramuscular injection.

    Composition:

    1 ml of the drug contains 0.2 g of pyracetam as an active substance; auxiliary substances: sodium acetate, acetic acid, diluted, water for injection.

    Description:

    Transparent colorless or slightly colored liquid

    Pharmacotherapeutic group:Nootropic agent.
    ATX: & nbsp

    N.06.B.X.03   Pyracetam

    Pharmacodynamics:

    The active component is piracetam, a cyclic derivative of gamma-aminobutyric acid (GABA).

    Pyracetam is a nootropic drug that directly affects the brain by improving cognitive (cognitive) processes, such as learning ability, memory, attention, and mental performance. Pyracetam affects the central nervous system 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.

    Improves communication between the cerebral hemispheres and synaptic conductivity in neocortical structures, increases mental capacity, improves cerebral blood flow.

    Pyracetam inhibits platelet aggression 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 factors by 30% -40% and lengthens the time of bleeding.

    Piracetam has a protective and restoring effect when brain function is impaired due to hypoxia and intoxication.

    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 and 8.5 hours from the cerebrospinal fluid, which is prolonged with renal failure.The pharmacokinetics of pyracetam does not change in patients with hepatic insufficiency. Penetrates through the blood-brain and placental barrier and membranes used in hemodialysis. 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 secreted by the kidneys in an unchanged form. 80- 100% of piracetam is excreted by the kidneys unchanged by renal filtration. The renal clearance of piracetam in healthy volunteers is 86 ml / min.

    Indications:

    Symptomatic treatment of psycho-organic syndrome. In particular, elderly patients suffering from memory loss, dizziness, reduced concentration and general activity, mood changes, behavioral disorders, gait disorders, as well as patients with Alzheimer's disease and senile dementia such as Alzheimer's.

    Treatment of the consequences of stroke (chronic stage of ischemic stroke), such as speech disorders, emotional disorders,to enhance 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 of vascular genesis.

    For the treatment of cortical myoclonia 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 stage of hemorrhagic stroke.
    • The final stage of renal failure (with creatinine clearance less than 20ml / min).
    • Children up to 1 year.
    • Pregnancy and lactation.
    • Psychomotor agitation.

    Carefully:

    Violation of hemostasis, extensive surgical interventions.

    Dosing and Administration:

    Intravenous or intramuscular.

    With symptomatic treatment of chronic psychoorganic syndrome, depending on the severity of symptoms, 2-4 g are prescribed, gradually increasing the dose to 4-6 g / day, the course of treatment is 10-15 days.

    When treating the consequences of a stroke (chronic stage), 4.8 g / day is prescribed.

    The course of treatment is 10-15 days, if necessary, repeated courses in 6-8 weeks.

    In the treatment of coma, as well as difficulties in perception in people with brain injuries, the initial dose is 9-12 g / day, supporting - 2 g / day. Treatment lasts no less than 3 weeks.

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

    Treatment of dizziness and associated disorders of equilibrium 2,4-4,8 g per day, course 10-15 days.

    With sickle cell anemia, the daily prophylactic dose is 160 mg / kg body weight divided into four equal doses. In the period of clearance - 300 mg / kg intravenously. This dosage can be given to children from 1 year of age.

    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

    Norm

    >80

    Usual Dose

    Lightweight

    50-79

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

    Average

    30-49

    1/3 of the usual dose in 2 divided doses

    Heavy

    <30

    1/6 of the usual dose, once

    The final stage

    -

    contraindicated

    Elderly, the dose is corrected in the presence of renal failure and with prolonged therapy requires monitoring of the functional state of the kidneys.

    Dosing to patients with impaired liver function: patients with a dysfunction of the liver do not need correction of the dose. Patients with impaired functions and kidneys, and liver dosing is carried out according to the scheme given in the section "Dosing to patients with impaired renal function."

    Side effects:

    Hyperkinesis, weight gain, nervousness, drowsiness, depression, asthenia, which often occur in elderly patients receiving doses above 2.4 g / day. In most cases, it is possible to regress such symptoms by lowering the dose of the drug. There are isolated reports of side effects from the gastrointestinal tract (nausea, vomiting, diarrhea, abdominal and stomach pains), nervous system (dizziness, headaches, ataxia, imbalance, exacerbation of epilepsy, insomnia, motor disinhibition, decrease ability to concentrate, tremor), from the side of the psyche (confusion, agitation, anxiety, hallucinations,increased sexuality); from the skin (dermatitis, itching, rashes, edema), others (worsening of the course of angina pectoris, weight gain, asthenia).

    Interaction:

    No interaction with clonazepam, phenytoin, phenobarbital, sodium valproate has been observed. High doses of pyracetam (9.6 g / day) increased the efficacy of acenocoumarol in patients with venous thrombosis: there was a significant decrease in platelet aggregation, fibrinogen, von Willebrand factors, viscosity of blood and plasma than in the administration of acenocoumarol alone. The possibility of changing the pharmacodynamics of piracetam under the influence of other drugs is low, since 90% of the drug is excreted unchanged in urine. The administration of piracetam at a dose of 20 mg / day did not change the peak and the concentration curve of antiepileptic drugs in serum (carbamazepine, phenytoin, phenobarbital, valproate) in patients with epilepsy receiving a constant dosage. Joint intake with alcohol did not affect the level of serum piracetam concentration, and the serum alcohol concentration did not change with the intake of 1.6 g of piracetam.Increases the effectiveness of thyroid hormones, antipsychotic drugs (neuroleptics). When administered with neuroleptics reduces the risk of extrapyramidal disorders. When used simultaneously with drugs that stimulate the central nervous system, its excessive CNS is possible.

    Special instructions:

    Due to the influence of piracetam on platelet aggregation, caution is recommended when prescribing a drug to patients with hemostasis disorder, during major surgeries or patients with symptoms of severe bleeding. When treating patients with cortical myoclonia, sudden interruption in treatment should be avoided. What can cause a resumption of seizures.

    With prolonged therapy of elderly patients, regular monitoring of renal function indicators 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:Taking into account possible side effects, care should be taken when working with mechanisms and driving a car.
    Form release / dosage:

    Solution for intravenous and intramuscular injection 200 mg / ml.

    Packaging:

    5 ampoules in the outline of the cell. 2 contour cell packs of 5 ampoules together with instructions for use in a pack of cardboard with an attachment if necessary a knife ampoule. 10 ampoules per pack of cardboard.

    Storage conditions:

    In dry, dark place at a temperature of 18 to 20 ° C.

    Keep out of the reach of children.

    Shelf life:

    5 years. Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N000453 / 01
    Date of registration:06.11.2007
    The owner of the registration certificate:Armavir Biofactory, FKPArmavir Biofactory, FKP Russia
    Manufacturer: & nbsp
    Information update date: & nbsp16.09.2015
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