Nootropil solution for intravenous and intramuscular injection of ampoules 5 ml 12 pcs

Piracetam

Solution

1 ml of 20% solution for injections contains: Piracetam 200 mg. Excipients: sodium acetate, glacial acetic acid, water d / and.

Nootropic drug, cyclic derivative of gamma-aminobutyric acid (GABA). Available data indicate that the main mechanism of action of piracetam is not cell-specific or organ-specific. Piracetam binds to the polar heads of phospholipids and forms mobile complexes piracetam-phospholipid. As a result, the bilayer 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 in animal studies). Piracetam improves functions such as learning, memory, attention and consciousness, without having a sedative or psychostimulant effects. The hemorheological effects of piracetam are associated with its effect on red blood cells, platelets, and vascular wall. In patients with sickle cell anemia, piracetam increases the ability of erythrocytes to deform, reduces blood viscosity and prevents the formation of coin columns. In addition, it reduces platelet aggregation, without significantly affecting their number. Animal studies have shown that piracetam prevents vasospasm and counteracts various vasospastic substances. In studies in healthy volunteers, piracetam reduced erythrocyte adhesion to the vascular endothelium and stimulated the production of prostacyclin healthy endothelium.

Data on the pharmacokinetics of the drug Nootropil not provided.

Impact treatment of psychoorganic syndrome, in particular in elderly patients with decreased memory, dizziness, decreased concentration and general activity, mood changes, behavioral disorders, gait disturbances, as well as Alzheimer's patients with senile dementia of Alzheimer's type. Treatment of the consequences of ischemic stroke ,such as speech disorders, disorders of the emotional sphere, to increase the motor and mental activity. Chronic alcoholism - for the treatment of psychoorganic and withdrawal syndromes. Automatous conditions (and during the recovery period), including after injuries and intoxications of the brain. Treatment of vertigo of vascular genesis. As part of complex therapy of low learning in children with psychoorganic syndrome. For the treatment of cortical myoclonia as a mono or complex therapy. Cellular anemia (as part of complex therapy).

Acute violation of cerebral circulation (hemorrhagic stroke). The terminal stage of renal failure (with creatinine clearance (kk) is less than 20 ml / min). Children age up to 1 year (for oral solution). Children age up to 3 years (for pills and capsules). Hypersensitivity to the drug.

Nervous system disorders: 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 the course of epilepsy, insomnia, confusion, agitation, anxiety, hallucinations, increased sexuality. The following side effects were observed in post-marketing practice, the frequency of which has not been established (due to insufficient data): headache, insomnia, agitation, imbalance, ataxia, exacerbation of the course of epilepsy, anxiety, hallucinations, confusion. On the part of the digestive system: nausea, vomiting, diarrhea, abdominal pain (including gastralgia). On the part of metabolism: an increase in body weight (1.29%). On the part of the hearing: vertigo. For the skin: dermatitis, pruritus, urticaria.

Adequate and strictly controlled studies of the safety of Nootropil during pregnancy was not conducted. Controlled studies of the drug during pregnancy has not been conducted. Piracetam penetrates the placental barrier. The concentration of the drug in newborns reaches 70-90% of its concentration in the blood of the mother. Nootropil should not be prescribed during pregnancy. Piracetam is excreted in breast milk.In appointing the drug during lactation should refrain from breastfeeding.

Assign inside and parenterally. The daily dose is 30-160 mg / kg. Parenteral prescribed in case of inability to take inside, in the same daily dose. Inside take during meals or on an empty stomach; pills and capsules should be taken with liquid (water, juice). The multiplicity of reception - 2-4 times / day. In symptomatic treatment of chronic psychoorganic syndrome Depending on the severity of symptoms, 1.2-2.4 g / day is prescribed, and during the first week - 4.8 g / day. In the treatment of the effects of stroke (chronic stage) Assign 4.8 g / day. In the treatment of comatose conditions, as well as the difficulties of perception in persons with brain injuries. The initial dose is 9-12 g / day, supporting - 2.4 g / day. The treatment lasts at least 3 weeks. When alcohol withdrawal syndrome 12 g / day. Maintenance dose of 2.4 g / day. Treatment of vertigo and related balance disorders 2.4-4.8 g / day. Children for the correction of reduced learning Assign 3.3 g / day - 8 ml of 20% solution for oral administration 2 times / day. Treatment continues throughout the school year. In case of cortical myoclonia, treatment begins with 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 for the duration of the illness. Every 6 months, attempts are made to reduce the dose or cancel the drug, gradually reducing the dose by 1.2 g every 2 days. If there is no effect or a slight therapeutic effect, treatment is stopped. When sickle cell anemia The daily prophylactic dose is 160 mg / kg body weight, divided into 4 equal doses. Taking the drug by patients with renal insufficiency. Patients with renal insufficiency require dose adjustment of the drug in accordance with the following scheme. Renal failure QC (ml / min) Dose and frequency of use Norm more than 80 Usual dose Mild 50 - 79 2/3 usual dose in 2 - 3 doses Medium degree 30 - 49 1/3 usual dose in 2 doses Heavy degree less 30 1 / 6 usual doses, one time End stage is less than 20 Contraindicated The drug is administered to elderly patients. In elderly patients, the dose is adjusted in the presence of renal failure; with long-term therapy, control of the functional state of the kidneys is necessary. Taking the drug by patients with impaired liver function Patients with impaired liver function dose adjustment is not required.Patients with impaired function and kidney and liver drug is prescribed as well as patients with only impaired renal function.

From the side of the central nervous system and peripheral nervous system 1.72% - hyperkinesia, 1.13% - nervousness, 0.96% - drowsiness, 0.83% - depression. in isolated cases - dizziness, headaches, ataxia, imbalance, exacerbation of epilepsy, insomnia, confusion, agitation, anxiety, hallucinations, increased sexuality. Metabolism 1.29% - weight gain (most often occurs in elderly patients who receive in doses of more than 2.4 g / day. In single cases - nausea, vomiting, diarrhea, abdominal pain. Dermatological reactions in isolated cases - dermatitis, itching, rash, edema. Other 0.23% - asthenia. In large nstve cases it is possible to achieve regression of these symptoms, lowering the dose of the drug.

Symptoms: when taking the drug in the form of a solution for oral administration in a daily dose of 75 g, dyspeptic phenomena, such as diarrhea with blood and abdominal pain, are noted. Apparently, this was due to the use of a large total dose of sorbitol, part of the dosage form solution for oral administration. Treatment: Immediately after a significant overdose, you can flush the stomach or induce artificial vomiting. Symptomatic therapy, which may include hemodialysis, is indicated. There is no specific antidote. The effectiveness of hemodialysis is 50-60%.

The possibility of changing the pharmacokinetics of piracetam under the influence of other drugs is low, because 90% of the drug is excreted unchanged in the urine. When applied simultaneously with thyroid hormones, there are reports of confusion, irritability and sleep disturbance. 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, Willebrand factors, blood and plasma viscosity compared with the use of only indirect anticoagulants). Piracetam does not inhibit the cytochrome P450 isoenzymes.Metabolic interaction with other drugs is unlikely. Reception of piracetam in a dose of 20 g / day for 4 weeks did not change Cmax in serum and AUC of antiepileptic drugs (carbamazepine, phenytoin, phenobarbital, valproate). Co-administration with alcohol did not affect the concentration of piracetam in serum; The concentration of ethanol in the serum did not change when taking 1.6 g of piracetam.

Due to the effect of piracetam on platelet aggregation, it is recommended to prescribe the drug with care to patients with impaired hemostasis, during major surgical operations, or patients with symptoms of severe bleeding. When treating patients with cortical myoclonia, abrupt interruption of treatment should be avoided, which may cause the resumption of seizures. With prolonged therapy in elderly patients, regular monitoring of renal function indicators is recommended, and if necessary, dose adjustment is carried out depending on the results of the creatinine clearance study. Impact on ability to drive motor vehicles and control mechanisms: Taking into account possible side effects, care should be taken when performing work with machinery and driving a car.