Nootropil 200 mg-ml 125 ml oral solution


Nootropil tablet 800 mg No. 30

  • Piracetam penetrates through the filter membranes of hemodialysis machines.

    Description

    Nootropic drug.

    Dosage form

    Tablets, coated, white or almost white, oblong, with a dividing transverse score on both sides; on one side of the tablet to the right and left of the mark there is an engraving “N”.

    Use in children

    Contraindication: children under 3 years of age.

    Pharmacodynamics

    Nootropic drug, cyclic derivative of gamma-aminobutyric acid (GABA).

    Available evidence suggests that the primary mechanism of action of piracetam is not cell-specific or organ-specific.

    Piracetam binds to the polar heads of phospholipids and forms mobile piracetam-phospholipid complexes. As a result, the two-layer structure of the cell membrane and its stability are restored, which in turn leads to the restoration of the three-dimensional structure of membrane and transmembrane proteins and the restoration of their function.

    At the neuronal level, piracetam facilitates various types of synaptic transmission, having a predominant effect on the density and activity of postsynaptic receptors (data obtained from animal studies).

    Piracetam improves functions such as learning, memory, attention and consciousness without causing sedation or psychostimulant effects.

    The hemorheological effects of piracetam are associated with its effect on red blood cells, platelets and the vascular wall.

    In patients with sickle cell anemia, piracetam increases the ability of red blood cells to deform, reduces blood viscosity and prevents the formation of coin columns. In addition, it reduces platelet aggregation without significantly affecting platelet count.

    Animal studies have shown that piracetam prevents vasospasm and counteracts various vasospastic substances.

    In studies in healthy volunteers, piracetam reduced the adhesion of red blood cells to the vascular endothelium and stimulated the production of prostacyclins by healthy endothelium.

    Side effects

    From the nervous system: motor disinhibition (1.72%), irritability (1.13%), drowsiness (0.96%), depression (0.83%), asthenia (0.23%); in isolated cases - dizziness, headaches, ataxia, imbalance, exacerbation of epilepsy, insomnia, confusion, agitation, anxiety, hallucinations, increased sexuality. In post-marketing practice, the following side effects have been observed, the frequency of which has not been established (due to insufficient data): headache, insomnia, agitation, imbalance, ataxia, exacerbation of epilepsy, anxiety, hallucinations, confusion.

    From the digestive system: nausea, vomiting, diarrhea, abdominal pain (including gastralgia).

    From the metabolic side: increase in body weight (1.29%).

    On the part of the organ of hearing and balance: vertigo.

    From the skin: dermatitis, itching, urticaria.

    Allergic reactions: angioedema, hypersensitivity, anaphylactic reactions.

    Other: in rare cases - pain at the injection site, thrombophlebitis, hyperthermia, arterial hypotension (with intravenous administration).

    In most cases, it is possible to achieve regression of such symptoms by reducing the dose of the drug.

    Use during pregnancy and breastfeeding

    Adequate and strictly controlled studies of the safety of Nootropil during pregnancy have not been conducted. There have been no controlled studies of the use of the drug during pregnancy.

    Piracetam penetrates the placental barrier. The concentration of the drug in newborns reaches 70-90% of its concentration in the mother's blood. Nootropil® should not be prescribed during pregnancy.

    Piracetam is excreted in breast milk. When prescribing the drug during lactation, you should refrain from breastfeeding.

    Interaction

      The possibility of changes in the pharmacokinetics of piracetam under the influence of other drugs is low, because 90% of the drug is excreted unchanged in the urine.
  • When used concomitantly with thyroid hormones, there have been reports of confusion, irritability, and sleep disturbances.
  • According to a published study of patients with recurrent venous thrombosis, piracetam at a dose of 9.6 g/day increases the effectiveness of indirect anticoagulants (there was a more pronounced decrease in platelet aggregation, fibrinogen concentration, von Willebrand factors, blood and plasma viscosity compared with the use of indirect anticoagulants only).
  • Piracetam does not inhibit cytochrome P450 isoenzymes. Metabolic interaction with other drugs is unlikely.
  • Taking piracetam at a dose of 20 g/day for 4 weeks did not change the serum Cmax and AUC of antiepileptic drugs (carbamazepine, phenytoin, phenobarbital, valproate).
  • Co-administration with alcohol did not affect serum concentrations of piracetam; The concentration of ethanol in the blood serum did not change when taking 1.6 g of piracetam.
  • Overdose

    Symptoms: a single case of the development of dyspeptic symptoms in the form of diarrhea with blood and pain in the abdominal area was registered when taking the drug orally at a daily dose of 75 g. Apparently, this was associated with the use of a large total dose of sorbitol, previously included in the dosage form solution for ingestion.

    Treatment: immediately after a significant overdose when taken orally, you can rinse the stomach or induce artificial vomiting. There is no specific antidote. The effectiveness of hemodialysis is 50-60%.

    Impact on the ability to drive vehicles and operate machinery

    During the treatment period, care should be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Nootropil injection solution 200mg/ml 5ml amp 12 pcs

    Intravenously. Intramuscularly. Parenteral administration of piracetam is prescribed when it is impossible to use oral forms of the drug (unconsciousness, difficulty swallowing). Intravenous administration is preferred.

    Intravenous infusion of the daily dose is performed through a catheter at a constant rate for 24 hours a day (for example, in the initial stage of treatment of severe myoclonus).

    The drug is first diluted in one of the compatible infusion solutions: dextrose 5%, 10% or 20%; fructose 5%, 10%, 20%; sodium chloride 0.9%; dextran 40 10% (in sodium chloride solution 0.9%); Ringer's solution; mannitol solution 20%.

    The total volume of solution intended for administration is determined taking into account the clinical indications and the patient's condition.

    Bolus intravenous administration (for example, emergency treatment of a crisis in sickle cell disease) is carried out for at least 2 minutes, the daily dose is distributed over several injections (2-4) at regular intervals so that the dose per injection does not exceed 3 g .

    The drug is administered intramuscularly if administration through a vein is difficult. The volume of solution administered intramuscularly cannot exceed 5 ml. The frequency of administration of the drug is similar to that for intravenous or oral administration.

    When the opportunity arises, switch to oral administration of the drug (see instructions for medical use of the corresponding forms of the drug). The duration of treatment is determined by the doctor depending on the disease and taking into account the dynamics of symptoms.

    Symptomatic treatment of chronic psychoorganic syndrome. 2.4-4.8 g/day (2 or 3 subdoses) Treatment of dizziness and associated imbalance - 2.4-4.8 g/day (2 or 3 subdoses).

    Cortical myoclonus. Treatment begins with a dose of 7.2 g/day, every 3-4 days the dose is increased by 4.8 g/day (2 or 3 subdoses) until a maximum dose of 24 g/day is reached. Treatment is continued throughout the entire 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. Sickle cell anemia. During a crisis - 300 mg/kg intravenously, divided into 4 equal doses.

    Dosing in patients with impaired renal function. The dose should be adjusted depending on the creatinine clearance (CC):

    CC>80 ml/min is the usual dose;

    CC 50-79 ml/min-2/3 of the usual dose in 2-3 doses;

    CC 30-49 ml/min-1/3 of the usual dose in 2 divided doses;

    CC 20-30 ml/min-1/6 of the usual dose once;

    QC

    For elderly patients, the dose is adjusted in the presence of renal failure; with long-term therapy, monitoring of the functional state of the kidneys is necessary.

    Dosing in patients with impaired liver function.

    Patients with impaired liver function do not need dose adjustment. For patients with impaired renal and liver function, dosing is carried out according to the scheme (see section “Dosing for patients with impaired renal function”).

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