Active substancePyracetamPyracetam
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  • Dosage form: & nbsp

    Solution for intravenous and intramuscular injection.

    Composition:1 ampoule (5 ml) contains as active substance piracetam 1000 mg; auxiliary substances: sodium dihydrogen phosphate dihydrate 4.00 mg, potassium hydrophosphate trihydrate 0.25 mg, water for injection - up to 5.0 ml.
    Description:

    Transparent colorless or slightly brownish shade solution.

    Pharmacotherapeutic group:Nootropic agent.
    ATX: & nbsp

    N.06.B.X.03   Pyracetam

    Pharmacodynamics:

    Nootropic agent. Pyracetam is a cyclic derivative of gamma-aminobutyric acid (GABA), directly affecting the brain. Improves cognitive (cognitive) processes (ability to learn, memory, attention), mental performance.

    Pyracetam has an effect on the central nervous system in various ways: it changes the rate of spread of excitation in the brain, improves microcirculation and metabolic processes in nerve cells, affects the rheological characteristics of the blood and does not cause vasodilating action.

    Improves communication between the cerebral hemispheres and synaptic conductivity in neocortical structures, increases mental capacity, improves cerebral blood flow. Reduces the severity and duration of the vestibular nystagmus.

    Pharmacokinetics:

    The half-life (T1/2) from the blood plasma is 4-5 h and 8.5 h from the cerebrospinal fluid. T1/2 lengthened with renal failure. The pharmacokinetics of pyracetam do not change in patients with hepatic insufficiency.

    Penetrates through blood-brain, placental barriers and membranes used in hemodialysis. Selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, as well as in the cerebellum and basal ganglia. It does not bind to blood plasma proteins and is not metabolized in the body.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 (including elderly patients with memory loss, reduced concentration of attention and general activity, mood changes, behavioral disorder, gait disorders, as well as patients with Alzheimer's disease and senile dementia of the Alzheimer's type);
    • treatment of the consequences of ischemic stroke, such as speech disorders, emotional disorders, to enhance motor and mental activity;
    • for the treatment of withdrawal syndrome and psycho-organic syndrome in chronic alcoholism;
    • comatose conditions (and during the recovery period), including after trauma and intoxication of the brain;
    • for the treatment of vertigo and related disorders of equilibrium (with the exception of cases of dizziness of vasomotor and psychogenic origin);
    • treatment of cortical myoclonus (both in the form of monotherapy, and in combination therapy);
    • sickle-cell anemia (as part of combination therapy);
    • treatment of dyslexia in children (in combination with other methods).

    Contraindications:

    • hypersensitivity to piracetam, pyrrolidone derivatives and other components of the drug;
    • acute phase of hemorrhagic stroke;
    • severe renal dysfunction (with creatinine clearance less than 20 ml / min);
    • psychomotor agitation at the time of prescribing;
    • Huntington's chorea;
    • children under 3 years.

    Carefully:
    • violation of hemostasis;
    • extensive surgical interventions;
    • heavy bleeding.

    Pregnancy and lactation:
    Controlled studies on the use of the drug piracetam in 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 blood of the mother.

    Except in special circumstances piracetam should not be administered during pregnancy. It should be refrained from breastfeeding while prescribing the drug during lactation.
    Dosing and Administration:

    Intravenous or intramuscular.

    Intravenous infusion of a daily dose is performed through a catheter at a constant rate for 24 hours a day (for example, coma or at the initial stage of treatment with severe myoclonia).Preliminary preparation is diluted in one of the compatible infusion solutions: dextrose 5%, 10% or 20%, fructose 5%, 10% or 20%, sodium chloride 0.9%, dextran (average molecular weight 35000-45000) (10% in solution of sodium chloride 0.9%), Ringer, mannitol 20 %. The total volume of solution intended for administration is determined taking into account the clinical indications and the patient's condition.

    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 is not exceeded 3 g. Intramuscularly the drug is administered if the introduction through the vein is difficult or the patient is overexcited. However, the amount of the drug that can be administered intramuscularly is limited, especially in children and patients with reduced body weight. In addition, the administration of the drug intramuscularly can be painful because of the large volume of fluid. The volume of the solution administered intramuscularly can not exceed 5 ml. The frequency of administration of the drug is similar to that of its intravenous application.

    The duration of treatment is determined by the doctor depending on the disease and taking into account the dynamics of the symptoms.

    When treatment of chronic psychoorganic syndrome prescribe the drug in a dose of 2.4-4.8 g / day.

    When treatment of the consequences of ischemic stroke piracetam should be prescribed in a dose of 4.8-12 g / day. .

    When 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 should be continued for at least 3 weeks.

    When treatment of alcohol withdrawal syndrome the dose of the drug reaches 12 g / day. The maintenance dose is 2.4 g / day.

    When treatment of dizziness and related imbalances the dose is 2.4-4.8 g / day.

    When treatment of 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. Later on they switch to the oral form of piracetam. Treatment with piracetam is continued 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.

    When treatment of sickle cell anemia during the crisis, the dose is up to 300 mg / kg intravenously divided into 4 equal doses. The daily preventive dose is 160 mg / kg body weight divided into 4 equal doses.

    When treatment of dyslexia the recommended daily dose for children from 8 years and adolescents - 3.2 g, divided into 2 injections.

    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 and to select a dose in accordance with this dosing regimen:

    Renal insufficiency

    Creatinine clearance (ml / min)

    Dosage:

    norm

    >80

    usual dose

    easy

    50-79

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

    mean

    30-49

    1/3 of the usual dose for 2 injections

    Heavy

    20-29

    1/6 of the usual dose once

    final stage

    <20

    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 impaired liver function do not need dose adjustment. Patients with impaired functions and kidneys and liver, dosing is carried out according to the scheme (see the section "Dosing to patients with impaired renal function").

    Side effects:

    From the central nervous system (CNS) and the peripheral nervous system: motor disinhibition, irritability, drowsiness, depression, asthenia. 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 some cases, there may be dizziness, headache, ataxia, exacerbation of epilepsy, extrapyramidal disorders, tremor, imbalance, decreased ability to concentrate, insomnia, agitation, anxiety, hallucinations, increased libido.

    From the cardiovascular system: in some cases, a decrease or increase in blood pressure.

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

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

    From the skin: dermatitis, itching, rash.

    Allergic reactions: angioedema.

    Overdose:

    Symptoms: increased severity of dose-dependent side effects.

    Treatment: Symptomatic, which may include hemodialysis. The efficacy of hemodialysis is 50-60 %. There is no specific antidote.

    Interaction:

    When combined with thyroid hormones and antipsychotic drugs (neuroleptics) increases their effectiveness. With simultaneous appointment with neuroleptics piracetam reduces the risk of extrapyramidal disorders. With simultaneous use with drugs that exert a stimulating effect on the central nervous system, it is possible to enhance the stimulating effect on the central nervous system.

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

    High doses (9.6 g / day) of piracetam increase the effectiveness of anticoagulants in patients with venous thrombosis (there was a great inhibition of platelet aggregation, a decrease in the concentration of fibrinogen, 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, since 90% of the drug is excreted unchanged in 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 receiving a constant dose.

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

    Special instructions:

    Due to the effect of piracetam on platelet aggregation, caution is recommended when administering the drug to patients with hemostasis disorder, during major surgeries or 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 long-term therapy in elderly patients, regular monitoring of renal function indicators is recommended, if necessary, dose adjustment is performed depending on the results of the study of creatine 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 must 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 intravenous and intramuscular injection 200 mg / ml.
    Packaging:

    5 ml per ampoule of colorless glass. 5 ampoules per contour cell pack. For 1 or 2 contour packs with instructions for use in a pack of cardboard.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

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

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000431
    Date of registration:12.05.2010
    The owner of the registration certificate:FarmSirma Soteks, ZAO FarmSirma Soteks, ZAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp16.09.2015
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