Active substancePyracetamPyracetam
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  • Dosage form: & nbsp

    solution for intravenous and intramuscular administration

    Composition:

    Active substance - piracetam 200 mg / ml (1000 mg or 3000 mg in an ampoule of 5 ml or 15 ml respectively), Excipients: sodium acetate trihydrate (5 mg / 15 mg), acetic acid ice (to pH 5.8), water for injection (up to 5 ml / 15 ml).

    Description:

    Transparent colorless solution or with a light greenish tint, odorless.

    Pharmacotherapeutic group:Nootropic remedy
    ATX: & nbsp

    N.06.B.X.03   Pyracetam

    Pharmacodynamics:

    The active component of Luccam is piracetam, a cyclic derivative of gamma-aminobutyric acid (GABA), a nootropic agent. It directly affects the brain, improves cognitive (cognitive) processes, such as learning ability, memory, attention, memory ability,as well as increases mental performance, without the development of sedative and psycho-stimulating effect. Influences the central nervous system in various ways: it changes the rate of spread of excitation in the brain, improves neuronal plasticity and metabolic processes in nerve cells. Improves the interaction between the cerebral hemispheres and synaptic conductivity in neocortical structures, increases mental performance, improves cerebral blood flow.

    Lucetam improves microcirculation in the brain, affecting the rheological characteristics of the blood and does not cause vasodilating action.

    Lucetam inhibits platelet aggregation and restores the elasticity of the erythrocyte membrane, as well as the ability of the latter to pass through the microcirculatory bed. Reduces the adhesion of red blood cells. In a dose of 9.6 g reduces the level of fibrinogen and factor Willebrand by 30% - 40% and lengthens the time of bleeding. Lucetam has a protective and restorative effect when brain function is impaired due to hypoxia, intoxication or trauma.

    Lucetam reduces the severity and duration of the vestibular nystagmus.

    Pharmacokinetics:

    The half-life of piracetam from plasma is 4-5 hours and 8.5 hours from cerebrospinal fluid. Half-life is prolonged with renal failure. The pharmacokinetics of pyracetam does not change in patients with hepatic insufficiency.

    Pyracetam penetrates the blood-brain and placental barrier and membranes used in hemodialysis. Pyracetam selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal nuclei. Pyracetam does not bind to blood plasma proteins, is not metabolized in the body and 80-100% of pyracetam is excreted by the kidneys unchanged, by renal filtration. The renal clearance of piracetam in healthy volunteers is 86 ml / min.

    Indications:

    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 related disorders of equilibrium (with the exception of vertigo of the vasomotor and psychogenic origin.

    Cortical myoclonia (monotherapy or as part of complex therapy).

    Closing (parenteral) sickle cell vaso-occlusive crisis.

    Children and teens

    As part of the complex therapy of dyslexia in children aged 8 years in combination with other methods, including speech therapy.

    Prophylaxis (oral) and arresting (parenteral) sickle cell vaso-occlusive crisis.

    Contraindications:
    • Individual intolerance to piracetam or pyrrolidone derivatives, as well as other components of the drug
    • Psychomotor agitation at the time of prescribing
    • Houteon Huntington
    • Hemorrhagic stroke
    • Severe chronic renal failure (with creatinine clearance (CC) less than 20 mL / min).
    • Children under 3 years old
    • Pregnancy and lactation period (see Section "Application during pregnancy and during lactation").
    Carefully:

    Violation of hemostasis, extensive surgical interventions, severe bleeding, chronic renal failure (with creatinine clearance (CC) less than 20-80 ml / min).

    Pregnancy and lactation:

    Studies on pregnant women have not been conducted, therefore piracetam should not be administered during pregnancy.

    Piracetam penetrates the placental barrier and into breast milk. If you need to use the drug, you should stop breastfeeding.

    Dosing and Administration:

    Intravenously. The daily dose is 30-160 mg / kg (3-12 g / day), the frequency of administration is 2-4 times a day. Parenteral administration of piracetam is given if oral administration of the drug is not possible, for example, with difficulty swallowing, or when the patient is in a coma.

    The solution of Lutzamam is compatible with the following infusion solutions:

    Glucose

    5%, 10%, 20%

    Fructose

    5%, 10%, 20%

    Levulose

    5%

    Sodium chloride

    0,9 %

    Dextran 40

    10% in a 0.9% solution of sodium chloride

    Dextran 100

    6% in a 0.9% solution of sodium chloride

    Ringer's solution
    Mannitol-Dextran
    Hydroxyethyl starch

    6%

    Infusion solutions with the addition of pyracetam are stable for at least 24 hours.

    Dosage regimen

    Adults

    Symptomatic treatment of psycho-organic syndrome:

    With symptomatic treatment of chronic psychoorganic syndrome, depending on the severity of the symptoms, 2.4-4.8 g per day are prescribed, spreading over 2-3 injections.

    Treatment of dizziness and related disorders of equilibrium:

    2.4 - 4.8 g per day, divided into 2-3 injections.

    Cortical myoclonia:

    Treatment begins with 7.2 g / day, every 3-4 days the dose increases by 4.8 g / day until the maximum dose of 24 g / day. Later on they switch to the oral form of Lucetam. Treatment continues throughout the period of the disease. To prevent the deterioration of patients, the drug should not be discontinued drastically. It is necessary to gradually reduce the dose of the drug. In the absence of effect or the presence of a slight therapeutic effect, treatment is discontinued.

    Closing (parenteral) sickle-cell vaso-occlusive crisis:

    The drug is used in a dose of 300 mg / kg of body weight, dividing into 4 doses

    Children and teens

    As part of the complex therapy of dyslexia in children aged 8 years:

    The daily dose is 3.2 g, divided into 2 injections

    Killing of sickle-cell vaso-occlusive crisis in children over 3 years of age:

    300 mg / kg body weight, divided into 4 receptions.

    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 in accordance with the above schemedosing.

    Calculation of the dose should be based on an assessment of the creatinine clearance in the patient. Which is calculated by the formula:

    TOcr= [140-year (in years) *m (in kg)] / [72 * with creatinine in plasma (mg / dL)]

    For women: Kcr*0,85.

    Prescribe treatment to such patients, depending on the severity of renal failure, adhering to the following recommendations:

    Renal

    failure

    Creatinine clearance (ml / min)

    Dosing

    Norm

    >80

    Usual Dose

    Lightweight

    50-79

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

    Average

    30-49

    1/3 of the usual dose in 2 divided doses

    Heavy

    <30

    1/6 of the usual dose, once

    The final stage

    <20

    contraindicated

    Dosing to elderly patients:

    Elderly, the dose is corrected in the presence of renal failure and with prolonged therapy requires monitoring of kidney function.

    Dosing to patients with impaired liver function:

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

    Side effects:

    Disturbances from the nervous system: hyperkinesis, irritability, drowsiness, depression,asthenia: these symptoms are more common in elderly patients who receive doses above 2.4 g / day, in most cases it is possible to regress such symptoms by lowering the dose of the drug. Headache, dizziness, insomnia, mental arousal, anxiety, imbalance, tremor, ataxia, exacerbation of epilepsy, anxiety, hallucinations, confusion, increased libido.

    Violations of blood and lymph: bleeding

    Immune system disorders: hypersensitivity, including anaphylaxis

    Violations from the organ of hearing and labyrinth: dizziness (vertigo)

    Disorders from the cardiovascular system: decrease or increase in blood pressure.

    Disorders from the digestive system: nausea, vomiting, diarrhea, abdominal pain, epigastric pain.

    Disorders from the metabolism and nutrition: weight gain.

    Diseases from the skin: dermatitis, itching, urticaria.

    Allergic reactions: angioedema.

    General disorders and disorders at the site of administration: pain at the injection site, thrombophlebitis, hyperthermia.

    Overdose:

    Pyracetam is not toxic even in high doses.

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

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

    Interaction:

    When combined with an extract of the thyroid gland (triiodothyronine / T3 / + tetraiodothyronine / T4 /) increased irritability, disorientation and sleep disturbances are possible. No interaction with clonazepam, phenytoin, phenobarbital, valproic acid was observed.

    High doses (9.6 g / day) Piracetam increased efficiency acenocoumarol patients venous thrombosis: observed greater decrease platelet aggregation, fibrinogen, Willebrandt factor, blood viscosity and plasma than when assigning only acenocoumarol.

    Changeable pharmacodynamics piracetam under the influence of other drugs is low, since 90% of the drug is excreted unchanged in the urine.

    In vitro piracetam It does not inhibit the isoenzymes of CYP1A2, 2B6, 2C8, 2C19, 2D6, 2E1, 4C4 / 5 and 4A9 / 11 cytochromes P450 at concentrations of 142, 426 and 1422 μg / ml. At a concentration of 1422 μg / ml, there was a slight inhibition of the isoenzyme CYP2A6 (21%) and isoenzyme ZA4 / 5 (11%). However, the value of the inhibition constant (Ki) necessary to inhibit these two CYP isoenzymes is significantly higher than 1422 μg / ml.Therefore, metabolic interaction with other drugs is unlikely. Admission piracetam at a dose of 20 g / day did not affect the maximum concentration and area under the concentration-time curve of antiepileptic drugs in the blood serum (carbamazepine, phenytoin, phenobarbital, valproate) in patients with epilepsy receiving a constant dose.

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

    Special instructions:

    Due to the influence of piracetam on platelet aggregation, caution is recommended when prescribing a 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.

    The use of a parenteral drug to stop the sickle cell vaso-occlusive crisis at doses below 160 mg / kg / day, as well as erratic, unsystematic use, can cause a second crisis.

    With prolonged therapy of 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.

    Taking into account possible side effects, care should be taken when working with mechanisms and driving a car.

    Penetrates the filtration membranes of hemodialysis machines

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

    Taking into account possible side effects, care should be taken when working with mechanisms and driving a car.

    Form release / dosage:

    Solution for intravenous and intramuscular injection 200 mg / ml.

    Packaging:

    5 ml into ampoules of colorless glass with a break point and two red rings. A label is affixed to each ampoule.

    5 ampoules are placed in a plastic cell pack, sealed with a transparent film. For 2 packs (10 ampoules), together with the instructions for use, put in a cardboard box.

    For 15 ml in ampoules of colorless glass with a break point. A label is affixed to each ampoule. Four ampoules are placed in a contour mesh package sealed with a transparent film.For 1 or 5 packs (4 or 20 ampoules), together with the instructions for use, put in a cardboard box.

    Storage conditions:

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

    Shelf life:

    3 years. Do not use the drug after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N013160 / 01
    Date of registration:18.11.2009
    The owner of the registration certificate:EGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary
    Manufacturer: & nbsp
    Representation: & nbspEGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary
    Information update date: & nbsp20.03.2018
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