Active substancePyracetamPyracetam
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  • Dosage form: & nbsp

    Solution for intravenous and intramuscular injection.

    Composition:

    In 1 ml of solution contains:

    Active substance: piracetam - 200 mg

    Excipients: sodium chloride - 100 mcg, water for injection - up to 1 ml.

    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, improving cognitive (cognitive) processes, such as learning ability, memory, attention, and mental performance. Pyracetam affects the central nervous system (CNS) in various ways: changing the speed of excitation in the brain, improves metabolic processes in nerve cells, improves microcirculation, affects the rheological characteristics of the blood, while not having a vasodilating effect.

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

    Pyracetam inhibits platelet aggregation and restores the configuration properties of the outer membrane of rigid red blood cells, as well as the ability of the latter to pass through the vessels of the microcircular bed. In a dose of 9.6 g reduces the concentration of fibrinogen and von Willebrand factors by 30-40% and prolongs 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 piracetam is 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.The total clearance is 80-90 ml / min. The half-life period is prolonged in chronic renal failure (CRF) (with thermal CRF - up to 59 hours). Hepatic insufficiency does not affect the pharmacokinetics. 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 a decrease in memory, a decrease in 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 myoclonus (monotherapy or as part of complex therapy). Cupping sickle-cell vaso-occlusive crisis.

    In children: treatment of dyslexia in children from 8 years in combination with other methods. Cupping sickle-cell vaso-occlusive crisis.

    Contraindications:

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

    Carefully:

    • violation of hemostasis;
    • extensive surgical interventions;
    • heavy bleeding;
    • CRF (KK 20-80 ml / min).

    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 of 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.

    In cases of mild-to-moderate mild CKD (KK 50-79 ml / min) - 2/3 of the dose divided into 2-3 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 of 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: weight gain.

    From the sense organs: vertigo.

    From the skin: dermatitis, itching, rashes.

    Allergic reactions: hypersensitivity, anaphylactic reactions, angioedema.

    Local reactions: pain in 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% sodium chloride 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, as this may cause the 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:

    For 5 ml of the drug in dark glass ampoules with a notch marked with a dot (paint).

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

    1 circuit cell pack together with instructions for use, a scarifier or an ampoule knife is placed in a cardboard box.

    Storage conditions:

    In the dark place 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:PL-000418
    Date of registration:28.02.2011
    Expiration Date:28.02.2016
    The owner of the registration certificate: Mapichem AG Mapichem AG Switzerland
    Manufacturer: & nbsp
    Representation: & nbspMapichem AGMapichem AG
    Information update date: & nbsp28.02.2016
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