Active substancePyracetamPyracetam
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  • Dosage form: & nbsp

    Solution for intravenous and intramuscular injection.

    Composition:

    Active substance:

    Piracetam - 200 mg

    Excipients:

    Sodium acetate trihydrate (sodium acetate acetic acid trihydrate) - 1 mg;

    Acetic acid diluted 30% to pH 5.8;

    Water for injection - up to 1 ml.

    Description:

    Transparent colorless or slightly yellowish liquid.

    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 affects 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 the connection between the cerebral hemispheres and synaptic conductivity in neocortical structures, 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:

    Application of the drug in adults:

    • symptomatic treatment of psycho-organic syndrome (including in elderly patients with memory loss, reduced concentration of attention and general activity, mood changes, behavioral disorder, gait disorder, as well as patients with Alzheimer's disease and senile dementia of the Alzheimer's type);
    • treatment of dizziness and related disorders of equilibrium, with the exception of vascular and psychogenic dizziness;
    • treatment of cortical myoclonia (both in the form of monotherapy, and as part of complex therapy);

    Application of the drug in children:

    • treatment of dyslexia (in conjunction 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;
    • chronic renal failure (creatinine clearance 20 - 80 ml / min).

    Pregnancy and lactation:

    Controlled studies on the use of piracetam in pregnant women have not been conducted. Pyracetam penetrates the placental barrier and into breast milk. The concentration of pyracetam 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:

    Method of administration: intravenously or intramuscularly.

    Intravenous infusion of the daily dose is performed through a catheter at a constant rate for 24 hours a day (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 a sodium chloride solution 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.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.

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

    In the treatment 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 dyslexia the recommended daily dose for children from 8 years and adolescents is 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)

    Dosing

    norm

    >80

    usual dose

    easy

    50-79

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

    mean

    30-49

    1/3 of the usual dose in 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, (with prolonged therapy, control of the functional state of the kidneys is necessary.

    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 specified in the section "Dosing to patients with impaired renal function."


    Side effects:

    From the central nervous system (CNS): motor disinhibition, irritability, drowsiness, depression, asthenia, headache, insomnia, mental agitation, imbalance, ataxia, exacerbation of epilepsy, anxiety, hallucinations, confusion.

    From the digestive system: nausea, vomiting, diarrhea, abdominal pain.

    From the side of metabolism: weight gain.

    From the sense organs: Vertigo.

    From the skin: dermatitis, itching, urticaria.

    Allergic reactions: hypersensitivity, anaphylactic reactions, angioedema.

    Local reactions: pain in the injection site, thrombophlebitis.

    Other (for parenteral administration): fever, lowering blood pressure.

    Overdose:

    Symptoms: increased severity of dose-dependent side effects.

    Treatment: Symptomatic, which may include hemodialysis. The efficiency 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. When used simultaneously with drugs that have 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 pyracetam increase the effectiveness of indirect anticoagulants in patients with venous thrombosis (there was a great inhibition of platelet aggregation, a decrease in the concentration of fibrinogen, von Willebrand factors, viscosity of blood and plasma 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 prolonged 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 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 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 into neutral glass ampoules.

    For 10 ampoules, together with the instruction for use and the ampoule opening opener or ampoule scarifier, is placed in a cardboard box.

    5 ampoules are placed in a contour mesh package made of a polyvinyl chloride film.

    2 contoured cell packs together with instructions for use and a knife for opening ampoules or a scarifier ampullum are placed in a pack of cardboard.

    When using ampoules with break points, incisions, rings, a knife for opening ampoules or an ampoule scarifier is allowed not to be put.

    Storage conditions:

    In the dark place at a temperature of 5 to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

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

    Terms of leave from pharmacies:On prescription
    Registration number:P N000382 / 02-2001
    Date of registration:28.04.2008
    The owner of the registration certificate:DALHIMFARM, OJSC DALHIMFARM, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp16.09.2015
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