Obolenskoye's piracetam

General characteristics. Structure:

Active ingredient: 200 mg, 400 mg and 800 mg of piracetam in 1 tablet.

Excipients: polyethyleneglycol 6000, sodium of a kroskarmeloz (primelloz), magnesium stearate, silicon dioxide colloid (aerosil), hydroxypropyl cellulose, (USP 24) of titanium dioxide, quinolinic yellow.

Nootropic means, exerts positive impact on exchange processes of a brain, microcirculation and a brain blood stream, recovers and stabilizes cerebral functions, especially consciousness, memory and the speech.

Pharmacological properties:

Pharmacodynamics. Piracetam - cyclic derivative piperidic GABA acid, is nootropic means which directly influences a brain, improving cognitive processes (ability to training, memory, attention, and also intellectual working capacity). Exerts impact on the central nervous system (CNS) in various ways: changes the speed of spread of activation in a brain, improves metabolic processes in nervous cells, improves microcirculation, influencing rheological characteristics of blood, not causing vasodilation.

Piracetam inhibits aggregation of thrombocytes and recovers elasticity of a membrane of erythrocytes, reduces adhesion of erythrocytes. In a dose of 9,6 g concentration of fibrinogen and Villebrand's factor lowers by 30-40% and extends a bleeding time. Improves communication between cerebral hemispheres and synoptic conductivity in neocortical structures. Piracetam has the tire-tread and recovering effect at dysfunction of a brain owing to a hypoxia and intoxication. Reduces expressiveness and duration of a vestibular nystagmus.

Pharmacokinetics. At administration of drug inside it is quickly and almost completely soaked up, peak concentration is reached in 1 hour after reception. Bioavailability of drug makes about 100%. After reception of a single dose of 2 g the maximum concentration making 40-60 mkg/ml which is reached in blood in 30 minutes and in 5 hours in cerebrospinal fluid after intravenous administration.

The seeming volume of distribution of piracetam makes about 0,6 l/kg. The drug elimination half-life from a blood plasma makes 4-5 hour and 8,5 hours of cerebrospinal fluid which is extended at a renal failure. The pharmacokinetics of piracetam does not change at patients with a liver failure.

Gets through the blood-brain and placental barrier and membranes used at a hemodialysis. At a research on animals piracetam selectively collects in tissues of a cerebral cortex, is preferential in frontal, parietal and occipital lobes, a cerebellum and basal gangliya.

Does not contact proteins of a blood plasma and it is not metabolized in an organism. 80-100% of piracetam are removed by kidneys in an invariable look by renal filtering. The renal clearance of piracetam at healthy volunteers makes 86 ml/min.

Indications to use:

Symptomatic treatment of a psychoorganic syndrome, in particular at the elderly patients suffering from decrease in the memory, dizziness lowered by concentration of attention and the general activity, change of mood, disorder of behavior, gait disturbance and also at patients with Alzheimer's disease and senile dementia of Alzheimer.

Effects of an ischemic stroke – disturbances of the speech, disturbance of the emotional sphere, decrease in motor and mental performance.

Alcoholism – for treatment of psychoorganic and abstinent syndromes.

The recovery period after injuries and intoxications of a brain.

Dizzinesses and the related disorders of balance, except for dizzinesses of a vasculomotor and mental origin.

As a part of complex therapy of low learnability at children with a psychoorganic syndrome.

For treatment of a cortical myoclonia as mono – or complex therapy.

In complex therapy of drepanocytic anemia.

Route of administration and doses:

Inside, it is appointed during meal or on an empty stomach, washing down with liquid (water, juice). A daily dose - 30-160 mg/kg, frequency rate of reception – 2-4 times a day.

At a symptomatic treatment of a psychoorganic syndrome, depending on expressiveness of symptoms appoint 1.2-2.4 g, and within the first week of 4.8 g

At treatment of effects of a stroke appoint 4.8 g/days.

At an alcoholic abstinence syndrome – 12 g/days. Maintenance dose of 2.4 g/days.

Treatment of dizzinesses and the related disorders of balance of 2.4-4.8 g a day.

To children for correction of the lowered learnability the dose makes 3.3 g/days. Treatment continues during the whole year of training.

At a cortical myoclonia treatment begin 7.2 g/days with a dose, each 3-4 days increase a dose by 4.8 g/days before achievement of the maximum dose of 24 g/days. Treatment continues throughout the entire period of a disease. Each 6 months attempts of reduction of a dose or drug withdrawal are made, for prevention of an attack gradually reducing a dose by 1.2 g each 2 days. In the absence of effect or insignificant therapeutic effect treatment is stopped.

At drepanocytic anemia a daily dose - 160 mg/kg, divided into 4 equal doses.

Dosing by the patient with a renal failure. As piracetam is removed from an organism by kidneys it is necessary to be careful at treatment of patients with a renal failure according to this scheme of dosing.

The dose korrigirutsya by the elderly patient in the presence of a renal failure and at long therapy control of a functional condition of kidneys is necessary.

Dosing by the patient with an abnormal liver function. Patients with an abnormal liver function do not need a correcting of a dose. The patient with disturbance of functions and kidneys, and a liver, dosing is carried out according to the scheme. (see the section "Dosing by the Patient with a Renal Failure").

Features of use:

Piracetam gets through a placental barrier and into breast milk. Concentration of drug at newborns reaches 70-90% of concentration it in blood at mother. Except for special circumstances piracetam should not be appointed during pregnancy. It is necessary to refrain from breastfeeding at appointment to the woman of piracetam.

purpose of drug the patient with disturbance of a hemostasis, during big surgeries or the patient with symptoms of heavy bleeding. At treatment of patients with a cortical myoclonia it is necessary to avoid sharp interruption of treatment that can cause resuming of attacks.

At long therapy of elderly patients regular control of indicators of function of kidneys is recommended, if necessary carry out dose adjustment depending on results of a research of clearance of creatinine.

In view of possible side effects, it is necessary to be careful when performing work with mechanisms and driving of the car.

Gets through the filtering membranes of devices for a hemodialysis.

Side effects:

Hyperkinesias, increase in body weight, drowsiness, irritability, depression, adynamy.

Arise at the elderly patients receiving doses over 2,4 g/days more often. In most cases it is possible to achieve regress of similar symptoms, having lowered a drug dose.

There are single messages on side effects from digestive tract, such as nausea, vomiting, diarrhea, abdominal pains; a nervous system – dizziness, headaches, an ataxy, balance disturbance, an aggravation the course of epilepsy, sleeplessness; from mentality – confusion, excitement, alarm, hallucinations, increase in sexuality.; from integuments – dermatitis, an itch, rashes, hypostasis.

Interaction with other medicines:

At combined use with hormones of a thyroid gland (T3+T4) the acrimony, disorientations and a sleep disorder is possible.

High doses (9,6 g/days) of piracetam increased efficiency of an atsenokumarol at patients with venous thrombosis: bigger decrease in level of aggregation of thrombocytes, level of fibrinogen, Villebrand's factors, viscosity of blood and plasma was noted, than at appointment only an atsenokumarol.

The possibility of change of a pharmacodynamics of piracetam under the influence of other medicines is low as 90% of drug are removed in an invariable view with urine.

Joint reception with alcohol does not influence the level of concentration of piracetam in a blood plasma.

Contraindications:

Individual intolerance of piracetam or derivatives of a pirrolidon, and also other components of drug.

Acute disorder of cerebral circulation (hemorrhagic stroke).

Final stage of a renal failure (at clearance of creatinine less than 20 ml/min.).

Children's age till 1 year.

Pregnancy and lactation.

Overdose:

At reception of 75 g of piracetam the dispepsichesky phenomena, such as diarrhea with blood and abdominal pains are noted.

Treatment: a gastric lavage, symptomatic therapy (can include a hemodialysis). There is no specific antidote. Efficiency of a hemodialysis makes 50% - 60% for piracetam.

Storage conditions:

In the dry, protected from light place at a temperature not above 25 °C. To store in the place, unavailable to children. A period of validity - 2 years. Not to use after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

On 10, 15, 20, 30 tablets in a blister strip packaging from a film of the polyvinyl chloride and printing aluminum foil varnished. On 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 12 blister strip packagings together with the application instruction place in a pack from a cardboard.