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

Auxiliary substances of the kernel: potato starch, povidone low molecular weight, magnesium hydroxycarbonate hydrate (magnesium carbonate basic water), calcium stearate.

Shell accessories: sucrose, povidone low molecular weight, magnesium hydroxycarbonate hydrate (magnesium carbonate basic water), silicon dioxide colloid (aerosil), titanium dioxide, beeswax, sunflower oil (sunflower oil).

Description:

Tablets are white or white with a yellowish hue of color, round in shape with biconvex surfaces.

Pharmacotherapeutic group:Nootropic agent.

ATX: & nbsp

N.06.B.X.03 Pyracetam

Pharmacodynamics:

It has a positive effect on brain metabolic processes, increases the concentration of ATP in the brain tissue, enhances the biosynthesis of ribonucleic acid and phospholipids, stimulates glycolytic processes, and 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 in brain damage caused by hypoxia, intoxication, electroshock, increases 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:

After ingestion, it is well absorbed and penetrates into various organs and tissues. Bioavailability, regardless of the dosage form, is about 95%. TS_max - 0.5-1 h Penetrates through blood-brain and placental barriers, accumulates in the brain tissue 1-4 h after ingestion. From the cerebrospinal fluid is derived much slower than from other tissues. Virtually not metabolized. T_1/2- 4.5 hours (7.7 hours - from the brain). It is excreted by the kidneys - 2/3 unchanged for 30 hours.

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 lability, behavioral disorder, gait disorder, as well as in patients with Alzheimer's disease and senile dementia of Alzheimer's 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.
In the complex therapy of low learning in children with psycho-organic syndrome.
In the complex therapy of sickle-cell anemia.

Contraindications:

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

Dosing and Administration:

Inside, during meals or on an empty stomach. Attention, the latest single dose should be taken no later than 5 pm to prevent sleep disturbances.

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

In the treatment of psycho-organic syndrome in the elderly, the drug is prescribed at 1.2-2.4 g / day; The loading dose for the first weeks of therapy is up to 4.8 g / day. Treatment with pyracetamol, 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 after-effects of intoxication, in the post-traumatic period the initial dose is 9-12 g / day. Supporting - 2.4 g. course of treatment - at least 3 weeks.

This dosage form is recommended for children from 3 years - 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.

With alcoholism, a maintenance dose of 2.4 g.

With dizziness and associated disorders of equilibrium, 2.4-4.8 g / day.

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

Dosing to patients with impaired renal function.

Because the Pyracetam 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	Clearance creatinine (ml / min)	Dosing
Norm	>80	Usual Dose
Lightweight	50-79	2/3 of the usual dose in 2 to 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 Section "Dosing to patients with impaired renal function").

Side effects:

Side effects are most often observed in elderly patients at doses above 2.4 g / day. In most cases, it is possible to regress such symptoms by lowering the dose of the drug. Nervousness, agitation, extrapyramidal disorders, weight gain, rarely - depression, drowsiness, asthenia. 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, exacerbation of epilepsy, insomnia: confusion on the part of the psyche - confusion, agitation, anxiety, hallucinations, increased sexual activity: from the skin - dermatitis, itching, rashes, swelling, worsening of the course of angina pectoris.

Overdose:

Strengthening of possible side effects.

First aid - washing the stomach, taking activated carbon.

Interaction:

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

High doses (9.6 g / day) Piracetam increased efficiency acenocoumarol patients venous thrombosis: observed greater decrease in the level of platelet aggregation, fibrinogen, von Willebrand factor, blood viscosity and plasma than when assigning only acenocoumarol. Increases the effectiveness of thyroid hormones, there may be 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 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.

When used simultaneously with drugs that stimulate the central nervous system, excessive stimulation of the central nervous system is possible.

When administered with neuroleptics reduces the risk of extrapyramidal disorders.

The joint reception with alcohol did not affect the level of serum Piracetam concentration and the serum alcohol concentration 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 major surgeries 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:

The tablets covered with a cover, 200 mg.

Packaging:

For 30 or 60 tablets in a jar of glass with a triangular corolla type BDS, with a tight lid or a can of polymer type BP.

For 120 tablets per can of polymer type BP.

For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil, or paper with polyethylene coating.

Each jar or 1, 2, 3, 4, 5, 6 contour squares, together with instructions for use, are placed in a pack of cardboard.

Storage conditions:

In a dry place, protected from light and out of reach of children, at a temperature not exceeding 25 ° C.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N000767 / 01

Date of registration:22.12.2011

The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia

Manufacturer: & nbsp

BIOSINTEZ, PAO Russia

Information update date: & nbsp16.09.2015

Illustrated instructions

Instructions

Pyracetam (Piracetam)