Piracetam

Package leaflet (information for patients)

Tradename
Piracetam

Dosage form
Injection 200mg / ml.

Description
Transparent liquid of light yellow color with a weak odor.

Structure
1 ml of solution contains:
Active ingredient: Piracetam 200 mg.
Auxiliary components: ethyl oleate.

Pharmacotherapeutic group
Other psychostimulants and nootropics.

Pharmacological properties
Piracetam is a nootropic agent that improves cognitive functions. Improves microcirculation, affecting the rheological characteristics of blood and does not cause a vasodilator effect.
Piracetam helps to restore cognitive abilities after impaired brain function due to hypoxia, intoxication or trauma. Piracetam is used in the treatment of cortical myoclonus as monotherapy or in combination with antimyoclonic agents.

Indications for use
- symptomatic treatment of memory disorders, intellectual disorders in the absence of a diagnosis of dementia;
- piracetam can reduce the manifestations of cortical myoclonus. A trial course of treatment is necessary to determine the effect of piracetam in a patient with cortical myoclonus.

Method of administration and dosage
Parenteral administration of piracetam is prescribed if it is impossible to use oral forms of the drug. The drug is administered intravenously or intramuscularly. The total volume of the solution intended for administration is determined taking into account the clinical indications and the patient's condition.
Intravenous infusion of a daily dose may be administered through a catheter at a constant rate for 24 hours a day (eg, during the initial treatment of severe myoclonus). The drug is preliminarily diluted in a compatible infusion solution: 0.9% isotonic sodium chloride solution, 5% dextrose solution.
The drug can be administered as an intravenous bolus for at least 2 minutes, the daily dose is distributed over several injections (2-4) at regular intervals so that the dose per administration does not exceed 3 g.
The drug is administered intramuscularly if the introduction through a vein is difficult. The volume of the solution injected intramuscularly should not exceed 5 ml.
When the opportunity arises, they switch to oral administration of the drug (see instructions for medical use of the corresponding dosage forms).
The duration of treatment is determined by the doctor depending on the characteristics of the disease, the achieved effect and the tolerability of the drug.
When calculating the dose, it should be borne in mind that 1 ml of the drug contains 200 mg of piracetam.
Symptomatic treatment of memory disorders, intellectual disorders in the absence of a diagnosis of dementia: depending on the severity of symptoms, the daily dose is 2.4-4.8 g, divided into two or three injections.
Treatment of 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 until a maximum dose of 24 g / day is reached. Treatment is continued throughout the entire period of the disease. Every 6 months, an attempt should be made to reduce the dose or stop the drug, gradually reducing the dose by 1.2 g every 2 days in order to prevent an attack. In the absence of effect or with a slight therapeutic effect, treatment is stopped.
In patients with impaired renal function, correction of the dosage regimen is required depending on the creatinine clearance (CC).

Side effects
Adverse reactions are classified depending on the frequency of their occurrence: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1 / 10000, <1/1000), very rare (<1/10000), frequency unknown (due to insufficient data).
From the nervous system and psyche: often: nervousness, hyperkinesia; infrequently: depression, drowsiness; frequency unknown: dizziness, headache, ataxia, imbalance, exacerbation of epilepsy, insomnia, confusion, agitation, anxiety, hallucinations, tremors, confusion.
On the part of the blood and lymphatic system: frequency unknown: hemorrhagic disorders.
Immune system disorders: frequency unknown: anaphylactoid reactions, hypersensitivity.
From the digestive system: the frequency is unknown: abdominal pain, pain in the upper abdomen, diarrhea, vomiting, nausea.
From the side of the skin: the frequency is unknown: angioedema, dermatitis, itching, urticaria.
Metabolic and nutritional disorders: often: weight gain.
From the reproductive system: frequency unknown: sexual arousal.
On the part of the organ of hearing: frequency unknown: vertigo.
General disorders: infrequently: asthenia.
Vascular disorders: rarely: thrombophlebitis (for injectable form), arterial hypotension (for injectable form).
In the event of adverse reactions, including those not listed in this leaflet, consult a doctor.

Contraindication
- individual intolerance to piracetam or pyrrolidone derivatives, as well as other components of the drug;
- psychomotor agitation at the time of prescribing the drug;
- Huntington's chorea;
- Acute violation of cerebral circulation (hemorrhagic stroke);
- end-stage chronic renal failure (with creatinine clearance less than 20 ml / min);
- pregnancy and lactation.
Carefully
Use with caution in patients with hemostasis disorders, surgery (including dental), risk factors for bleeding (for example, gastric ulcer and duodenal ulcer), previous hemorrhagic stroke, or
intracerebral hemorrhage, in patients taking anticoagulants or antiplatelet agents, including low doses of acetylsalicylic acid.

Overdose
In case of an overdose, the severity of side effects may increase, the appearance of abdominal pain, diarrhea mixed with blood.
In case of symptoms of an overdose, you should consult a doctor. Treatment: symptomatic therapy, hemodialysis (efficiency 50-60%). There is no specific antidote.

Precautions
Due to the effect of piracetam on platelet aggregation, caution should be exercised when prescribing the drug to patients with hemostatic disorders, surgery (including dental), risk factors for bleeding (for example, gastric ulcer and duodenal ulcer), previous hemorrhagic stroke or intracerebral hemorrhage, patients taking anticoagulants or antiplatelet agents, including low doses of acetylsalicylic acid.
When treating cortical myoclonus, abrupt interruptions of treatment should be avoided, which may cause recurrence of seizures.
With long-term therapy, elderly patients are recommended to regularly monitor the indicators of renal function, if necessary, adjust the dose depending on the results of the study of creatinine clearance.
Piracetam penetrates the filter membranes of hemodialysis machines.
Application in children. The use of the drug in children under 18 years of age is not recommended.

Interaction with other medicinal products
With simultaneous use with thyroid hormones of the thyroid gland, increased irritability, disorientation and sleep disturbances are possible.
According to the results of a study of patients with recurrent venous thrombosis, piracetam at a dose of 9.6 g / day does not change the dose of acenocoumarol required to achieve an INR (international normalized ratio) of 2.5-3.5, but compared with the effects of acenocoumarol alone, the addition of piracetam to dose of 9.6 g / day significantly reduces
platelet aggregation, β-thromboglobin release, fibrinogen and von Willebrand factor concentration (VIII: C; VIII: vW: Ag; VIII: Vw: RCo), as well as blood and serum viscosity.
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.
In vitro, piracetam does not inhibit isoenzymes CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 4A9 / 11 at concentrations 142, 426 and 1422 μg / ml. At a piracetam concentration of 1422 μg / ml, a slight inhibition of CYP2A6 (21%) and 3A4 / 5 (11%) was noted. However, normal inhibition constant (Ki) values can probably be achieved at higher concentrations. Thus, metabolic interactions of piracetam with other drugs are unlikely.
Taking piracetam at a dose of 20 g / day for 4 weeks in patients with epilepsy who received stable doses of antiepileptic drugs did not change the maximum serum concentration and AUC (area under the curve) of antiepileptic drugs (carbamazepine, phenytoin, phenobarbital, valproate).
Coadministration with ethanol did not affect the serum concentration of piracetam, the concentration of ethanol in the blood serum did not change when 1.6 g of piracetam was taken.

Special instructions
Due to the antiplatelet effect of piracetam, it should be prescribed with caution to patients with severe hemorrhagic disorders, risk of bleeding (for example, with stomach ulcers), hemostasis disorders, in patients with surgical interventions, including dental interventions, in patients taking anticoagulants and antiplatelet agents, including... low doses of acetylsalicylic acid.
Since piracetam is excreted by the kidneys, care should be taken when prescribing it to patients with renal insufficiency.
With long-term treatment of elderly patients, regular monitoring of CC indicators is necessary, dose adjustment may be required.
Piracetam penetrates the filter membranes of hemodialysis machines.
When treating cortical myoclonus, abrupt interruption of treatment should be avoided, as this may result in a relapse of seizures.
In the event of sleep disturbances, it is recommended that the evening intake of piracetam be canceled by adding this dose to the daily intake.
Influence on the ability to drive vehicles and mechanisms
During the period of using piracetam, patients should be careful when driving vehicles and mechanisms, as well as when engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Pregnancy and elbowing
During pregnancy, it should be used only as directed by a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus.
If necessary, use during lactation should decide on the termination of breastfeeding.

Influence on the ability to drive vehicles and work with mechanisms
Does not affect.

Storage conditions
Store in a dry, dark place at a temperature not exceeding 25 ° C, out of the reach of children.

Shelf life
3 years. Do not use after the expiration date printed on the package.

Vacation conditions
On prescription.

Packaging
The solution is in 2 ml glass ampoules. Each ampoule is fixed in a plastic clip for 5 ampoules. 5 ampoules are packed in a cardboard box in a fixer together with an enclosed leaflet.