Piracetam-Eskom - instructions for use, dose, side effects, contraindications

Pyracetam is a nootropic agent. It directly affects the brain, improving cognitive (cognitive) processes, such as learning ability, memory, attention, and mental performance. Pyracetam affects the central nervous system (CNS) in various ways: it changes the rate of spread of excitation in the brain, improves metabolic processes in nerve cells, improves microcirculation, affects the rheological characteristics of the blood without causing vasodilating action.

The drug improves the connections between the cerebral hemispheres and synaptic conductivity in neocortical structures, improves cerebral blood flow.

Pyracetam-inhibits platelet aggregation and restores the elasticity of the erythrocyte membrane, reduces the adhesion of erythrocytes. In a dose of 9.6 g reduces the level of fibrinogen and von Willebrand factors by 30-40% and lengthens the time of bleeding.

Piracetam has a protective and restorative effect in the violation of brain function due to hypoxia and intoxication

Pyracetam reduces the severity and duration of the vestibular nystagmus.

Pharmacokinetics:

The half-life of the drug from the blood plasma is 4-5 hours, of cerebrospinal fluid - 8.5 hours. In patients with renal failure, the half-life is prolonged.The pharmacokinetics of pyracetam does not change in patients with hepatic insufficiency.

Penetrates through blood-brain and placental barriers. When tested on animals piracetam selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal ganglia. It does not bind to blood plasma proteins, is not metabolized in the body, and is secreted by the kidneys in an unchanged form (80-100%). The renal clearance of piracetam in healthy volunteers is 86 ml / min.

Indications:

Symptomatic treatment of psycho-organic syndrome, in particular in elderly patients suffering from memory loss, dizziness, reduced concentration of attention and general activity, mood changes, behavioral disorders, gait disorders, as well as patients with Alzheimer's disease and senile dementia of the Alzheimer type.

Treatment of the consequences of stroke (chronic stage of ischemic stroke), such as speech disorders, emotional disorders, to enhance motor and mental activity.

Chronic alcoholism - for the treatment of psycho-organic and abstinence syndromes.

Comatose conditions (and during the recovery period), including after traumas and intoxications of the brain.

Treatment of dizziness and related disorders of balance, except for psychogenic dizziness.

For the treatment of cortical myoclonia as a mono-and complex therapy.

In the complex therapy of sickle cell anemia.

In pediatric practice: correction of the effects of perinatal brain damage caused by intrauterine infections, hypoxia, birth trauma.

Contraindications:

Individual intolerance to piracetam or pyrrolidone derivatives, as well as other components of the drug.
Psychomotor agitation at the time of prescribing.
Horea Huntington.
Acute disturbance of cerebral circulation (hemorrhagic stroke).
Terminal stage of renal failure (with creatinine clearance less than 20 ml / min).

Carefully:

Violation of the hemostasis, extensive surgical interventions, heavy bleeding.

Pregnancy and lactation:

Studies in animals have not revealed the damaging effect of pyracetam on the embryo and its development, including in the postnatal period. There were no changes in the course of pregnancy and childbirth.

Studies on pregnant women were not conducted. Pyracetam penetrates the placental barrier and into breast milk. The concentration of the drug in newborns reaches 70-90% of its concentration in the mother's blood. Except in special circumstances piracetam should not be administered during pregnancy. It should be refrained from breastfeeding with the appointment of a woman piracetam.

Dosing and Administration:

Intravenous or intramuscular.

With symptomatic treatment of chronic psychoorganic syndrome, depending on the severity of symptoms, 2-4 g are prescribed, gradually increasing the dose to 4-6 g per day, the course of treatment is 10-15 days.

When treating the consequences of a stroke (chronic stage), 4.8 g / day is prescribed. The course of treatment is 10-15 days, if necessary, repeated courses in 6-8 weeks.

In the treatment of coma, as well as difficulties in perception in people with brain injuries, the initial dose is 9-12 g / day, supporting - 2 g / day. Treatment lasts no less than 3 weeks.

With alcohol withdrawal syndrome - 12 g / day. Supportive dose of 2.4 g / day.

Treatment of dizziness and associated disorders of equilibrium 2,4-4,8 g per day, course 10-15 days.

Children are prescribed in a dose of 30-50 mg / kg / day.

In cortical myoclonia, treatment starts with a dose of 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 throughout the 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. In the absence of effect or a slight therapeutic effect, treatment is discontinued.

With sickle cell anemia, the daily prophylactic dose is 160 mg / kg body weight divided into four equal doses. During the crisis, 300 mg / kg.

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 this dosing regimen.

Renal insufficiency	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
T Jelozhaya	<30	1/6 of the usual dose, once
Terminal stage	-	contraindicated

Elderly, the dose is corrected in the presence of kidney failure.With prolonged therapy, it is necessary to monitor the functional state of the kidneys.

Dosing to patients with impaired liver function.

Patients with a dysfunction of the liver do not need a dose adjustment. If the renal and hepatic functions are impaired simultaneously, the dosing is performed according to the scheme given (see section "Dosing to patients with impaired renal function").

Side effects:

From the side of the central nervous system and the peripheral nervous system: motor disinhibition (1.72%), irritability (1.13%), drowsiness (0.96%), depression (0.83%), asthenia (23%).

These side effects often occur in elderly patients who received the drug at a dose of more than 2.4 g / day. In most cases, it is possible to regress such symptoms by lowering the dose of the drug. In isolated cases - dizziness, headache, ataxia, exacerbation of epilepsy, extrapyramidal disorders, tremor, imbalance, decreased ability to concentrate, insomnia, agitation, anxiety, hallucinations, increased sexuality.

From the cardiovascular system: rarely - a decrease or increase in blood pressure.

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

From the side of metabolism: an increase in body weight (1.29%) - more often occurs in elderly patients who received the drug at a dose of more than 2.4 g / day.

From the skin: dermatitis, itching, rashes, angioedema.

Overdose:

In case of an overdose, symptomatic therapy is recommended, which may include hemodialysis. There is no specific antidote. The efficacy of hemodialysis for piracetam is 50-60%.

Interaction:

Increases the effectiveness of thyroid hormones, antipsychotic drugs - neuroleptics. With simultaneous appointment with neuroleptics piracetam reduces the risk of extrapyramidal disorders.

With simultaneous use with drugs that have a stimulating effect on the central nervous system, it is possible to enhance CNS stimulation.

No interaction with clonazepam, phenytoin, phenobarbital, sodium valproate has been observed.

High doses of pyracetam (9.6 g / day) increase the effectiveness of indirect anticoagulants in patients with venous thrombosis (there was a significant decrease in the level of platelet aggregation,the level of fibrinogen, von Willebrand factors, viscosity of blood and plasma compared with the use of only indirect anticoagulants).

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

In vitro piracetam It does not inhibit cytochrome P450 isoenzymes such as 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, slight inhibition of CYP2A6 (21%) and SA4 / 5 (I%) was noted, however, the Ki level of these two isoenzymes is sufficient when 1422 μg / ml is exceeded, and therefore metabolic interaction with other drugs is unlikely.

The administration of piracetam at a dose of 20 mg / day did not change the peak and the concentration curve of antiepileptic drugs in serum (carbamazepine, phenytoin, phenobarbital, sodium valproate) in patients with epilepsy receiving a constant dosage.

Joint reception with alcohol did not affect the serum level of piracetam and the serum concentration of alcohol 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 large surgical operations,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.

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.

It penetrates the hemodialysis apparatus through the filter membranes.

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 of the drug in ampoules.

5 or 10 ampoules per contour cell pack of a polyvinyl chloride film.

For 10 ampoules together with instructions for use and scarifier ampullum in a cardboard bundle with cardboard partitions.

When using ampoules with a notch or a fracture ring, the scarifier is not inserted.

For 1 or 2 outline carton packs along with instructions for use in a cardboard pack.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

5 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-000794/09

Date of registration:06.02.2009

The owner of the registration certificate:ESKOM NPK, OAO ESKOM NPK, OAO Russia

Manufacturer: & nbsp

ESKOM NPK, OAO Russia

Information update date: & nbsp22.09.2015

Illustrated instructions

Instructions

Piracetam-Eskom (Piracetam-Eskom)