Pyracetam - instructions for use, dose, side effects, contraindications

1 ml of the solution contains the active substance: piracetam - 200 mg; excipients: sodium acetate - 1 mg, acetic acid, diluted 30% - to pH 5.8, water for injection - up to 1 ml.

Description:

Transparent colorless or slightly colored liquid.

Pharmacotherapeutic group:Nootropic agent.

ATX: & nbsp

N.06.B.X.03 Pyracetam

Pharmacodynamics:

Has a positive effect on brain metabolic processes, increases the concentration of adenosine triphosphate in the brain tissue, enhances the biosynthesis of ribonucleic acid and phospholipids, stimulates glycolytic processes, enhances the utilization of glucose.It improves the integrative activity of the brain, facilitates the consolidation of memory, facilitates the learning process. Changes the speed of propagation of excitation in the brain, improves microcirculation, without providing a vasodilating action, inhibits the aggregation of activated platelets. Has a protective effect on brain damage caused by hypoxia, intoxication, electric shock; enhances alpha and beta activity, reduces delta activity on the electroencephalogram, reduces the severity of the vestibular nystagmus. Has no sedative, psycho-stimulating effect. The drug improves the connections between the cerebral hemispheres and synaptic conductivity in neocortical structures, restores and stabilizes cerebral functions, especially consciousness, memory and speech, increases mental performance, improves cerebral blood flow.

Pharmacokinetics:

The half-life of the drug from the blood plasma is 4-5 hours and 8.5 hours from the cerebrospinal fluid, which is prolonged with renal failure.

The pharmacokinetics of pyracetam does not change in patients with hepatic insufficiency.Penetrates through blood-brain and placental barriers and membranes used in hemodialysis. 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 excreted by the kidneys unchanged. 80-100% of piracetam is excreted by the kidneys unchanged by renal filtration. 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, low concentration and general activity, mood changes, behavioral disorders, gait disorders, as well as patients with Alzheimer's disease and senile dementia of the Alzheimer type.
The consequences of an 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.
The recovery period after craniocerebral trauma and brain intoxication.
Dizziness and related disorders of balance, with the exception of dizziness of the vasomotor and psychic origin.
In the complex therapy of low learning in children with psycho-organic syndrome.
In the complex therapy of sickle-cell anemia.

Contraindications:

Individual intolerance to piracetam or pyrrolidone derivatives, as well as other components of the drug.
Psychomotor agitation.
Acute stage of hemorrhagic stroke.
The final stage of renal failure (with creatinine clearance less than 20 ml / min).
Children up to 1 year.

Carefully:

Due to the influence of piracetam on platelet aggregation, caution is recommended when prescribing a drug to patients with hemostasis disorder, during major surgeries or patients with symptoms of severe bleeding.

Pregnancy and lactation:

Studies in animals showed no damaging effects on the embryo and its development, including in the postnatal period, and also did not change 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, 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 per 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.

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 intravenously.

This dosage can be given to children from 1 year of age.

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
Heavy	<30	1/6 of the usual dose, once
The final stage	-	Contraindicated

Elderly, the dose is corrected in the presence of renal failure and with prolonged therapy requires monitoring of 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. Patients with impaired functions and kidneys and liver dosing is carried out according to the scheme (see the section "Dosing to patients with impaired renal function").

Side effects:

Side effect	Common (from 1% and less than 10%)	Rare (from 0.1% and less than 1%)
Disorders of the central and peripheral nervous system	Hyperkinesia 1.72%
Metabolic disorders	Weight gain of 1.29%
Mental disorders	Nervousness of 1.13%	Drowsiness 0.96% Depression 0.83%
General disorders		Asthenia 0.23%

They are more common in elderly patients receiving doses above 2.4 g / day. In most cases, it is possible to regress such symptoms by lowering the dose of the drug. There are isolated reports of side effects from the gastrointestinal tract, such as nausea, vomiting, diarrhea, abdominal and stomach pain; nervous system - dizziness, headaches, ataxia, imbalance, decreased ability to concentrate, insomnia, exacerbation of epilepsy, tremor; from the side of the psyche - confusion, agitation, anxiety, hallucinations, increased sexual activity; from the skin - dermatitis, itching, rashes, swelling; other: worsening of the course of angina pectoris.

Overdose:

Symptoms: abdominal pain, diarrhea with an admixture of blood.

Treatment: symptomatic therapy, which may include hemodialysis (efficacy 50-60%). There is no specific antidote.

Interaction:

No interaction with clonazepam, phenytoin, phenobarbital, sodium valproate has been observed.High doses (9.6 g / day) of piracetam increased the efficacy of acenocoumarol in patients with venous thrombosis: there was a greater decrease in platelet aggregation, fibrinogen, von Willebrand factors, viscosity of blood and plasma than in the administration of acenocoumarol alone. Increases the effectiveness of thyroid hormones, there may be increased irritability, disorientation, sleep disturbance.

Increases the effectiveness of antipsychotic drugs (neuroleptics).

With the simultaneous use of stimulant CNS with drugs, excessive stimulation of the central nervous system is possible.

When administered with neuroleptics reduces the risk of extrapyramidal disorders.

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

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, valproate) in patients with epilepsy receiving a constant dosage.

Joint intake with alcohol did not affect the level of serum piracetam concentration, and the serum concentration of alcohol did not change with the intake of 1.6 g of piracetam.

Special instructions:

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:

During the treatment period, care must be taken when driving vehicles, performing work with mechanisms, engaging in other potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Solution for intravenous and intramuscular injection 200 mg / ml in ampoules.

Packaging:10 ampoules of 5 ml together with instructions for use in a cardboard box.

Storage conditions:

In the dark place at a temperature of no higher than 30 ° 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-000133/08

Date of registration:22.01.2008

The owner of the registration certificate:ORGANICS, JSC ORGANICS, JSC Russia

Manufacturer: & nbsp

ORGANICS, JSC Russia

Information update date: & nbsp16.09.2015

Illustrated instructions

Instructions

Pyracetam (Piracetam)