Active substancePyracetamPyracetam
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  • Dosage form: & nbspSolution for intravenous and intramuscular injection.
    Composition:

    Active substance: piracetam - 200 mg. Excipients: sodium acetate trihydrate (sodium acetate 3-water) - 1 mg, acetic acid diluted 30% - to pH 5.8, 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 remedy that directly affects the brain, improving cognitive (cognitive), such as learning ability, memory, attention, and mental performance. Pyracetam has an effect on the central nervous system in various ways: it changes the rate of propagation of excitation in the brain, improves metabolic processes in nerve cells, improves microcirculation, affects the rheological characteristics of the blood without providing a vasodilating effect.

    Improves the connection between the cerebral hemispheres and synaptic conductivity in neocortical structures, improves cerebral blood flow.

    Piracetam inhibits platelet aggregation and restores the configuration properties of the outer membrane of rigid red blood cells; and the ability of the latter to pass through the vessels of the microcirculatory bed. At a dose of 9.6 g reduces the concentration of fibrinogen and von Willebrand factor by 30-40% and prolongs bleeding time.

    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 piracetam from blood plasma is 4-5 h and 8.5 h from cerebrospinal fluid, prolonged in chronic renal failure (with terminal chronic renal failure - up to 59 h).

    Hepatic insufficiency does not affect the pharmacokinetics of piracetam.

    Penetrates through blood-brain and placental barriers, is removed during hemodialysis. In animal experiments, it selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal nuclei. It does not bind to blood plasma proteins, is not metabolized in the body and is excreted by the kidneys unchanged by glomerular filtration. The total clearance of piracetam is 80-90 ml / min.

    Indications:

    In adults:

    • symptomatic treatment of psycho-organic syndrome, accompanied by memory loss, decreased concentration and activity, mood changes, behavioral disorder, gait disturbance;
    • treatment of dizziness (vertigo) and associated disorders of equilibrium (with the exception of vertigo of the vasomotor and psychogenic origin;
    • cortical myoclonus (monotherapy or as part of complex therapy);
    • sickle-cell vaso-occlusive crisis.

    Children:

    • treatment of dyslexia from the age of 8 in combination with other methods, including speech therapy;
    • sickle-cell vaso-occlusive crisis.

    Contraindications:

    • hypersensitivity;
    • Huntington's chorea;
    • hemorrhagic stroke;
    • severe chronic renal failure (creatinine clearance less than 20 ml / min);
    • psychomotor agitation at the time of prescribing;
    • pregnancy, the period of breastfeeding.

    Carefully:

    • violation of hemostasis;
    • extensive surgical interventions;
    • heavy bleeding;
    • chronic renal failure (creatinine clearance 20-80 ml / min).

    Pregnancy and lactation:

    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. During pregnancy, the drug is contraindicated.

    During the treatment should be abolished breastfeeding.

    Dosing and Administration:

    Intravenous or intramuscular.

    Parenteral administration of piracetam is given if oral administration of the drug is not possible (tablets, capsules, oral solution), for example, if swallowing is difficult or when the patient is unconscious, with intravenous administration being preferred.

    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%, hydroxyethyl starch 6% or 10%, Ringer, mannitol 20%. The total volume of solution intended for administration is determined taking into account the clinical indications and the patient's condition.

    Intravenous administration (for example, urgent treatment sickle-cell vaso-occlusive crisis) is performed for at least 2 min, the daily dose is then distributed into several injections at uniform intervals.

    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 a reduced body weight. In addition, the administration of the drug intramuscularly can be painful due to 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 or oral administration.

    If there is an opportunity, they switch to oral administration of the drug (see instructions for the medical use of the appropriate forms of release of the drug).

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

    Symptomatic treatment of psycho-organic syndrome - 4.8 g / day during the first week, then go to a maintenance dose of 1.2-2.4 g / day.

    Treatment of dizziness and related imbalances - 2.4-4.8 g / day.

    Treatment of cortical myoclonia - start 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, you should try to reduce the dose or cancel the drug, gradually reducing the dose by 1.2 g / day every 2 days. With little or no therapeutic effect, treatment is discontinued.

    Sickle-cell vaso-occlusive crisis (in adults and children). The daily preventive dose is 160 mg / kg body weight divided into 4 equal doses.During the crisis, 300 mg / kg / day intravenously, divided into 4 equal doses.

    Treatment of dyslexia in children older than 8 years (in combination with other methods of treatment). The recommended daily dose is 3.2 g divided into 2 equal doses.

    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

    CK (ml / min)

    Dosing regimen

    Norm

    >80

    the usual dose of 2-4 admission

    Lightweight

    50-79

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

    Average

    30-19

    1/3 of the usual dose in 2 divided doses

    Heavy

    <30

    1/6 of the usual dose once

    The final stage

    -

    contraindicated

    Side effects:

    From the central nervous system: 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: increase in body weight.

    From the sense organs: Vertigo.

    From the skin: dermatitis, itching, urticaria.

    Allergic reactions: hypersensitivity, angioedema, anaphylactic reactions.

    Local reactions: pain in the injection site, thrombophlebitis.

    Other: fever, lowering blood pressure.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:

    Symptoms: abdominal pain, diarrhea with an admixture of blood.

    Treatment: symptomatic therapy, which may include hemodialysis (efficacy 50-60%). There is no specific antidote.

    Interaction:

    When used simultaneously with iodine-containing hormones of the thyroid gland, confusion, irritability and sleep disturbance may occur.

    Pyracetam in high doses (9.6 g / day) increases the anticoagulant effect of indirect anticoagulants in patients with venous thrombosis (more pronounced decrease in platelet aggregation, fibrinogen content, von Willebrand factor, viscosity of blood and plasma).

    The possibility of changing the pharmacodynamics of piracetam under the influence of other drugs is low, because 90% of piracetam is excreted unchanged by the kidneys.

    Pyracetam does not inhibit cytochrome P450 isoenzymes. Metabolic interaction with other drugs is unlikely.

    Receiving piracetam at a dose of 20 g / day did not change the maximum concentration and area under the concentration-time curve of antiepileptic drugs (carbamazepine, phenytoin, phenobarbital, valproic acid) in the serum of patients with epilepsy who receive the drug in a constant dose.

    Joint reception with alcohol does not affect the concentration of piracetam in the serum; the concentration of ethanol in the serum did not change with the intake of 1.6 g of piracetam.

    When used simultaneously with drugs that stimulate the central nervous system, excessive stimulation of the central nervous system is possible.

    With simultaneous use with neuroleptics reduces the risk of extrapyramidal disorders.

    Special instructions:

    Piracetam should be administered with caution to patients with hemostasis disorder, during extensive surgery, or to patients with symptoms of severe bleeding.

    In the treatment of cortical myoclonia, sudden interruption in treatment should be avoided, as this may cause the resumption of seizures.

    When managing a veno-occlusive crisis with sickle-cell anemia, a dose of less than 160 mg / kg or an irregular intake of the drug may cause a recurrence of the crisis.

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

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

    During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

    Form release / dosage:

    Solution for intravenous and intramuscular injection 200 mg / ml.

    Packaging:

    5 ml into neutral glass ampoules.

    10 ampoules are placed in a box of cardboard

    5 ampoules are placed in a contour mesh box made of a polyvinylchloride film and foil of aluminum printed lacquered or without foil.

    1 or 2 contour squares are placed in a pack of cardboard.

    In each box, the package is enclosed with instructions for medical use and a scarifier ampoule.In the case of using ampoules with a kink ring or with a notch and a point, the ampoule scaper is not inserted.

    Storage conditions:

    In the dark place at a temperature of 10 to 25 ° C. Freezing is unacceptable. 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-001599
    Date of registration:17.02.2011
    The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp17.09.2015
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