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

Nootropic agent. The drug has a positive effect on the metabolism of neurons, improves the activity of the central nervous system. Pyracetam normalizes the intracellular content of adenosine triphosphate and adenosine diphosphate, improves the function of neurons in conditions of oxygen starvation. Improves the connections between the cerebral hemispheres and synaptic conductivity in neocortical structures. Helps improve the integrative function of the brain, memory, concentration and intellectual abilities in patients with functional and organic disorders of the central nervous system. The effect develops gradually.

It changes the speed of propagation of excitation in the brain, improves microcirculation, without exerting a vasodilating action. The drug reduces the aggregation of platelets, and when the elasticity of erythrocytes is impaired, improves their ability to change shape and passage through the vessels of the brain, shortens the duration of the vestibular nystagmus.

Does not have antihistamine, soothing, analgesic properties and does not cause undesirable changes in the cardiovascular and respiratory systems.

It is not cumulated in the body and does not lead to drug dependence.

It does not convert to gamma-aminobutyric acid and does not increase its content in the brain.

Pharmacokinetics:

After oral administration piracetam quickly and almost completely absorbed from the gastrointestinal tract (GIT). Bioavailability is about 95%. The maximum concentration in the blood plasma is reached after 45-90 min.

The volume of distribution is 0.7 l / kg. The maximum concentration in CSF is reached after 2-8 hours. Pyracetam penetrates through the blood-brain and placental barriers and through the filtering membranes of hemodialysis apparatus penetrates into breast milk.

From the body piracetam stands out unchanged. The half-life of plasma is 4-5 hours, of cerebrospinal fluid - 6-8 hours.

After 30 hours it is excreted by the kidneys. The clearance of piracetam, which is approximately 86 ml / min, depends on the creatinine clearance and decreases with renal failure.

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 the Alzheimer type;
the consequences of ischemic stroke, such as speech disorders, emotional disorders, to increase motor and mental activity;
chronic alcoholism - for the treatment of psycho-organic and abstinence syndromes;
recovery period after traumatic brain injuries and brain intoxication;
Dizziness and related disorders of balance, with the exception of vertigo of the vasomotor and psychic origin;
in the complex therapy of low learning in children with psycho-organic syndrome;
cortical myoclonus;
in the complex therapy of sickle-cell anemia.

Contraindications:

Increased individual sensitivity to one of the components of the drug or a pyrrolidone derivative; severe renal failure (creatinine clearance less than 20 ml / min); depression with anxiety (agitated depression), Huntington's chorea; children's age (up to 3 years); hemorrhagic stroke, pregnancy and lactation.

Carefully:

Violation of hemostasis, condition after extensive surgical interventions, severe bleeding, renal failure (creatinine clearance more than 20 ml / min).

Pregnancy and lactation:

Taking the drug is only possible if the expected benefit for the mother exceeds the risk of complications for the fetus.

You should refrain from breastfeeding.

Dosing and Administration:

Inside, during or before eating.

With symptomatic treatment of chronic psychoorganic syndrome, depending on the severity of symptoms, 1.2-2.4 g is prescribed, and during the first week - 4.8 g / day.

When treating the consequences of stroke - 4.8 g / day.

In the treatment of conditions after brain injuries, the initial dose is 9-12 g / day, supporting - 2.4 g / day. Treatment lasts no less than 3 weeks.

At an alcoholic abstinent syndrome - 12 g / day. The maintenance dose is 2.4 g / day.

Treatment of dizziness and related disorders of equilibrium - 2.4-4.8 g / day. For children, the dose is 3.0-5.0 g / day to correct the decreased learning capacity. Treatment continues throughout the school year.

In the treatment of speech disorders (dyslexia), the daily dose is 3-5 g / day, divided into three doses.

In cortical myoclonia, treatment starts at 7.2 g / day, every 3-4 days the dose increases by 4.8 g / day until a maximum dose of 24 g / day is reached. After 6 months of treatment, it is advisable to reduce the dose of the drug by 1.2 g / day every 2 days, until the minimum effective dose is reached. 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, it is necessary to switch to an intravenous form of drug administration.

Because the piracetam is excreted from the body by the kidneys, caution should be exercised in the treatment of patients with renal insufficiency, in accordance with this dosing regimen.

Renal failure	Clearance creatinine (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 kidney failure; with prolonged therapy, it is necessary to monitor the functional state of the kidneys.

In patients with impaired liver function, dose adjustment is not required.

Side effects:

Nervousness, agitation, irritability, anxiety, sleep disorders, insomnia, gastralgia, nausea, vomiting, diarrhea, constipation, anorexia, ataxia, dizziness, headache, extrapyramidal disorders, convulsions, tremor, increased sexual activity, worsening of angina, dermatitis, skin itching, skin rash, hyperkinesia, weight gain; rarely - drowsiness, depression, asthenia. The listed side effects are more often observed in elderly patients receiving doses above 2.4 g / day.

In children, especially with mental retardation: fussiness, anxiety, restlessness, motor disinhibition, decreased ability to concentrate, unbalanced, irritable, increased conflict.

Overdose:

These dosages are known to be well tolerated. Pyracetam is a low-toxic drug, therefore, it is not recommended to resort to any special measures for its overdose. If necessary - rinse the stomach, induce vomiting, it is possible to carry out forced diuresis. Treatment is symptomatic. There is no specific antidote.The efficacy of hemodialysis for piracetam is 50% -60%.

Interaction:

Increases the effectiveness of thyroid hormones, antipsychotic drugs (neuroleptics), indirect anticoagulants (high doses of piracetam), psychostimulants.

Joint reception with alcohol did not affect the level of piracetam concentration in the serum; the concentration of alcohol in the serum did not change with the intake of 1.6 g of piracetam.

Special instructions:

It is necessary to avoid the sharp abolition of pyracetam in patients with cortical myoclonia, because of the risk of resumption of seizures.

In case of occurrence of disturbances of a dream it is recommended to cancel an evening reception, having added this dose to a day reception.

It is recommended to monitor the kidney function continuously (especially in patients with chronic renal insufficiency) - residual nitrogen and creatinine, while in patients with liver diseases - the functional state of the liver.

It is necessary to correct the dosage regimen for the elderly, patients with renal insufficiency.

The drug penetrates the filtration membranes of hemodialysis apparatus.

Effect on the ability to drive transp. cf. and fur:

During the treatment period, care should be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Film-coated tablets, 400 mg and 800 mg.

Packaging:

For 10 tablets per contour cell package, 2 contour packs with instructions for use in the pack.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

2 years.

Do not use after the expiration date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N002012 / 01

Date of registration:03.12.2008

The owner of the registration certificate:GEDEON RICHTER-RUS, CJSC GEDEON RICHTER-RUS, CJSC Russia

Manufacturer: & nbsp

GEDEON RICHTER-RUS, CJSC Russia

Information update date: & nbsp23.09.2015

Illustrated instructions

Instructions

Piracetam-Richter (Pyracetam-Richter)