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Piracetam

Piracetam

Registration number: PN 000377/01

Trade name: Piracetam

Chemical name: 2-oxo-1-pyrrolidinylacetamide

International nonproprietary name: piracetam

Dosage form: film-coated tablets

Compound:

active substance: piracetam 200 mg;

excipients: povidone (low molecular weight medical polyvinylpyrrolidone), potato starch, magnesium hydroxycarbonate (basic magnesium carbonate), calcium stearate monohydrate, sucrose (sugar), colloidal silicon dioxide (Aerosil), talc, titanium dioxide, beeswax, liquid paraffin (vaseline oil medical), quinoline yellow dye E-104.

Description

Round tablets, biconvex, yellow film-coated.

Pharmacotherapeutic group: nootropic agent.

ATX code : [N06BX03]

Pharmacological properties

Pharmacodynamics

Read also: Rifampicin

It has a positive effect on the metabolic processes of the brain, increases the concentration of adenosine triphosphate in brain tissue, enhances the biosynthesis of ribonucleic acid and phospholipids, stimulates glycolytic processes, and enhances glucose utilization. Improves the integrative activity of the brain, promotes memory consolidation, and facilitates the learning process. Changes the speed of propagation of excitation in the brain, improves microcirculation without having a vasodilating effect, and inhibits the aggregation of activated platelets. It has a protective effect against brain damage caused by hypoxia, intoxication, electric shock, enhances alpha and beta activity, reduces delta activity on the electroencephalogram, and reduces the severity of vestibular nystagmus. Does not have a sedative or psychostimulating effect. The drug improves connections between the cerebral hemispheres and synaptic conduction in neocortical structures, restores and stabilizes cerebral functions, especially consciousness, memory and speech, increases mental performance, and improves cerebral blood flow.

Pharmacokinetics

After oral administration, it is well absorbed and penetrates into various organs and tissues. Bioavailability, regardless of the dosage form, is about 95%. The time required to achieve maximum concentration is 0.5 - 1 hour.

Penetrates through the blood-brain and placental barriers, accumulates in the brain tissue 1-4 hours after ingestion. It is excreted from the cerebrospinal fluid much more slowly than from other tissues. Practically not metabolized. The half-life is 4.5 hours (7.7 hours from the brain). Excreted by the kidneys - 2/3 unchanged within 30 hours.

Indications for use

Symptomatic treatment of psychoorganic syndrome, in particular in elderly patients suffering from memory loss, dizziness, decreased concentration and general activity, mood lability, behavioral disorder, gait disturbance, as well as in patients with Alzheimer's disease and senile dementia of the Alzheimer's type.
Consequences of ischemic stroke, such as speech disorders, emotional disturbances, to increase motor and mental activity. Chronic alcoholism - for the treatment of psychoorganic and withdrawal syndromes.
The recovery period after traumatic brain injury and brain intoxication.
Dizziness and related balance disorders.
As part of complex therapy for learning disabilities in children with psychoorganic syndrome.
In the complex therapy of sickle cell anemia.

Contraindications

Hypersensitivity, renal failure (creatinine clearance less than 20 ml/min), pregnancy, lactation, childhood (up to 3 years), hemorrhagic stroke, depression with anxiety (agitated depression), Huntington's chorea.

Carefully

Impaired hemostasis, extensive surgical interventions, severe bleeding, pregnancy and lactation.

Directions for use and doses

Inside, during meals or on an empty stomach.

Attention: take the last single dose no later than 17.00 to prevent sleep disturbances.

Daily dose - 30-160 mg/kg body weight, frequency of administration - 2 times/day, if necessary - 3-4 times/day. The course of treatment is from 2-3 weeks to 2-6 months. If necessary, the course of treatment is repeated.

When treating psychoorganic syndrome in the elderly, the drug is prescribed at 1.2-2.4 g/day; loading dose during the first weeks of therapy - up to 4.8 g/day. Treatment with piracetam, if necessary, can be combined with the use of psychotropic, cardiovascular and other drugs.

When treating the consequences of a stroke, 4.8 g/day is prescribed.

When treating the consequences of intoxication, in the post-traumatic period, the initial dose is 9-12 g/day, the maintenance dose is 2.4 g, the course of treatment is at least 3 weeks.

This dosage form is recommended for children over 3 years old - 1 tablet 3 times a day.

The maximum daily dose is 1.8 g. The course of treatment is from 2 weeks to 2-6 months.

For alcoholism - 12 g/day during the period of manifestation of alcohol withdrawal syndrome; maintenance dose - 2.4 g.

For dizziness and related balance disorders, 2.4-4.8 g/day.

For sickle cell anemia, the daily dose is 160 mg/kg body weight, divided into 4 equal portions.

Dosing in patients with impaired renal function

Since Piracetam is excreted from the body by the kidneys, caution should be exercised when treating patients with renal failure in accordance with this dosage regimen.

Kidney failure	Creatinine clearance (ml/min)	Dosing
Norm	> 80	Usual dose
Lightweight	50 – 79	2/3 of the usual dose in 2 – 3 doses
Average	30 – 49	1/3 of the usual dose in 2 divided doses
Heavy	< 30	1/6 of the usual dose, once
Final stage	—	contraindicated

In elderly patients, the dose is adjusted in the presence of renal failure and long-term therapy requires monitoring the functional state of the kidneys.

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”)

Side effect

Side effects are most often observed in elderly patients at doses above 2.4 g/day. In most cases, it is possible to achieve regression of such symptoms by reducing the dose of the drug. Nervousness, agitation, extrapyramidal disorders, weight gain, rarely - depression, drowsiness, asthenia. There are isolated reports of gastrointestinal side effects such as nausea, vomiting, diarrhea, abdominal and stomach pain; nervous system - dizziness, headaches, ataxia, imbalance, exacerbation of epilepsy, insomnia, decreased ability to concentrate, hyperkinesis, tremor; from the psyche - confusion, agitation, anxiety, hallucinations, increased sexual activity; on the part of the skin - dermatitis, itching, rashes, swelling; other: worsening of angina pectoris.

Overdose

Increased possible side effects. First aid is gastric lavage, taking activated charcoal.

Interaction with other drugs

There was no interaction with clonazepam, phenytoin, phenobarbital, or sodium valproate.

High doses (9.6 g/day) of piracetam increased the effectiveness of acenocoumarol in patients with venous thrombosis: there was a greater decrease in platelet aggregation, fibrinogen levels, von Willebrandt factors, blood and plasma viscosity than when acenocoumarol was prescribed alone. Increases the effectiveness of thyroid hormones, possible increased irritability, disorientation, sleep disturbance.

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

In vitro, piracetam does not inhibit cytochrome P450 isoforms CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 4A9/11 at concentrations of 142, 426 and 1422 μg/ml. At a concentration of 1422 μg/ml, a slight inhibition of CYP2A6 (21%) and 3A4/5 (11%) was noted. However, the Ki level of these two CYP isomers is sufficient when exceeding 1422 μg/ml. Therefore, metabolic interaction with other drugs is unlikely.

Taking piracetam at a dose of 20 mg/day did not change the peak and curve of the concentration of antiepileptic drugs in the blood serum (carbamazepine, phenytoin, phenobarbital, valproate) in patients with epilepsy receiving a constant dosage. Co-administration with alcohol did not affect the serum concentration of piracetam and the serum alcohol concentration did not change when taking 1.6 g of piracetam.

Increases the effectiveness of antipsychotic drugs (neuroleptics). When used concomitantly with drugs that stimulate the central nervous system, excessive stimulation of the central nervous system is possible.

When prescribed with antipsychotics, it reduces the risk of extrapyramidal disorders.

Special instructions.

Due to the effect of piracetam on platelet aggregation, caution is recommended when prescribing the drug to patients with impaired hemostasis, during major surgical operations, or to patients with symptoms of severe bleeding. When treating patients with cortical myoclonus, abrupt interruption of treatment should be avoided, which may cause resumption of attacks.

During long-term therapy in elderly patients, regular monitoring of renal function indicators is recommended; if necessary, dose adjustment is carried out depending on the results of a creatinine clearance study.

Taking into account possible side effects, caution should be exercised when operating machinery or driving a vehicle. Penetrates through the filter membranes of hemodialysis machines.

Release form: Film-coated tablets 200 mg. 10 tablets per blister pack. 60 tablets in jars made of polymeric materials or in jars made of glass melt. Each jar, 3 or 6 blister packs, along with instructions for use, are placed in a cardboard pack. The text of the instructions for use may be placed on the pack.

Conditions for dispensing from pharmacies: By prescription

Storage conditions:

In a dry place, protected from light, at a temperature not exceeding 25°C.

Best before date:

3 years. Do not use after expiration date.

Units:

pack

Piracetam Bufus, 200 mg/ml, solution for intravenous and intramuscular administration, 5 ml, 100 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. The total volume of solution intended for administration is determined taking into account the clinical indications and the patient's condition.

Bolus intravenous administration is carried out for at least 2 minutes, the daily dose is divided into 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 release 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 intellectual-mnestic disorders.

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 until a maximum dose of 24 g/day is reached (2 or 3 subdoses). 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.

Dosing in patients with impaired renal function.

The dose should be adjusted depending on the creatinine clearance (CC). Creatinine clearance for men can be calculated from serum creatinine concentration using the following formula:

Creatinine clearance for women can be calculated by multiplying the resulting value by a factor of 0.85.

Kidney failure	CC (ml/min)	Dosage regimen
Norm	> 80	usual dose
Lightweight	50–79	2/3 of the usual dose in 2–3 divided doses
Average	30–49	1/3 of the usual dose in 2 divided doses
Heavy	< 30	1/6 of the usual dose once
Final stage	—	contraindicated

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 “Dosing for patients with impaired renal function”).