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, acetic acid, 3-water) 1.0 mg, acetic acid diluted 30% to pH 5.0-5.8, 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:

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

    Pyracetam is a nootropic agent; which directly affects the brain, improving cognitive (cognitive) processes, such as learning ability, memory, attention, and mental performance.It affects the central nervous system (CNS) in various ways: changes the velocity of propagation of the excitation in the brain, improves metabolic processes in nerve cells, improves acts on the rheological characteristics of the blood, without causing vasodilating action. Improves the connection between the cerebral hemispheres and synaptic conductivity in neocortical structures, improves cerebral blood flow. Pyracetam It inhibits platelet aggregation and restores the configuration properties rigid outer membrane of erythrocytes and the ability of the latter to the passage through the vessels of the microvasculature. 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:

    Half-life: 4-5 hours from the blood plasma and 8.5 hours from the cerebrospinal fluid. 80-100% of pyracetam is excreted by the kidneys unchanged by glomerular filtration.Overall clearance: 80-90 ml / min. The half-life period is prolonged for chronic renal failure (CRF) (with terminal CRF - up to 59 hours). Hepatic insufficiency does not affect the pharmacokinetics of piracetam.

    Penetrates through the blood-brain and placental barrier; 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.

    Does not bind to plasma proteins, it is not metabolized.

    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 vasomotor and psychogenic origin). Treatment of cortical myoclonias (monotherapy or as part of complex therapy). Cupping sickle-cell vaso-occlusive crisis.

    Children: treatment of dyslexia in children from the age of 8 in conjunction with other methods. Cupping sickle-cell vaso-occlusive crisis.

    Contraindications:

    Hypersensitivity, severe renal failure (creatinine clearance (CC) less than 20 ml / min), hemorrhagic stroke, psychomotor agitation, Huntington's chorea, pregnancy, lactation.

    Carefully:

    Violation of hemostasis, extensive surgical interventions, severe bleeding, chronic renal failure (KK 20-80 ml / min).

    Pregnancy and lactation:Application during pregnancy and during breastfeeding is contraindicated.
    Dosing and Administration:

    Intravenously sprayed or drip, intramuscularly.

    The daily dose is divided into 2-4 admission.

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

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

    Treatment of cortical myoclonia: begin with a dose of 7.2 g / day, every 3-4 days the dose is increased by 4.8 g / day until a 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.

    With sickle cell vasooclusiic crisis (in adults and children): treatment intravenously at 300 mg / kg / day, divided into 4 equal doses. Treatment of dyslexia in children older than 8 years (in conjunction with other methods of treatment) - 3.2 grams, divided into 2 equal doses.

    With CRF of mild degree (KK 50-79 ml / min) - 2/3 of the dose divided into 2 to 3 doses; average (KK 30-49 ml / min) - 1/3 dose divided into 2 doses; severe (CC 20-30 ml / min) - 1/6 dose once.

    Side effects:

    From the side CNC: 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, hives.

    Allergic reactions: hypersensitivity, anaphylactic reactions, angioedema.

    Local Reactions: pain at the injection site, thrombophlebitis

    Other: fever, lowering blood pressure.

    Overdose:

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

    Treatment: induction of vomiting, gastric lavage, symptomatic therapy, 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.

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

    Pharmaceutically compatible with dextrose solutions (5%, 10%, 20%), fructose (5%, 10%, 20%), 0.9% NaCl solution, Ringer's solution, 20% mannitol solution, hydroxyethyl starch (6%, 10% ).

    Special instructions:

    Be wary appoint patients with hemostasis, before the forthcoming extensive surgical interventions or in patients with symptoms of severe bleeding.

    In the treatment of cortical myoclonia, sudden cessation of treatment should be avoided,this can cause a resumption of seizures.

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

    It penetrates the hemodialysis apparatus through the filter membranes.
    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.

    For 10 ampoules with instruction for use and a knife for opening ampoules or a scarifier ampullum is placed in a box of cardboard.

    5 or 10 ampoules are placed in a contoured cell pack of a polyvinyl chloride film or a polyethylene terephthalate tape and aluminum foil, or paper with a polyethylene coating, or without a foil, or without paper.

    For 1 or 2 contour squares with instructions for use and a knife for opening ampoules or a scarifier ampullum is placed in a pack of cardboard.

    When you pack the ampoules with a break ring or break point, the ampoule opener or ampoule scapper is not put in.

    Storage conditions:

    Store in a dark place at a temperature of 15 to 25 ° C. Keep out of the reach of children.

    Shelf life:

    5 years. Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N002433 / 01
    Date of registration:24.04.2008
    The owner of the registration certificate:NOVOSIBHIMFARM, OJSC NOVOSIBHIMFARM, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp17.09.2015
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