ЛУЦЕТАМ® tablets

General characteristics. Structure:

Active ingredient: 1 tablet coated, contains 400 mg, 800 mg or 1200 mg of active agent of piracetam, and also excipients: magnesium stearate, K-30 povidone, macrogoal 6000, дибутилсебакат, titanium dioxide (E171), talc, ethyl cellulose, gipromelloza.  

Description: White or almost white, biconvex tablets of an oval form, coated, inodorous. Tablets on 400 mg - with a facet, with an engraving E 241 on one party of a tablet. Tablets on 800 mg - with a facet, with risky on both sides, and with an engraving E 242 on one party of a tablet. Tablets on 1200 mg - with an engraving E 243 on one party of a tablet. A type of tablets on a break: outside ring of a cover, and also kernel of a tablet of white or almost white color.

Pharmacological properties:

Pharmacodynamics. Active component of Lutsetam is piracetam, cyclic derivative piperidic acid (GABA). Lutsetam is nootropic drug which directly influences a brain. Lutsetam improves cognitive (cognitive) processes, such as ability to training, memory, attention, ability to storing, and also increases intellectual working capacity, without development of sedative and psychogogic effect. Exerts impact on the central nervous system in various ways: changes the speed of spread of activation in a brain, improves neyronalny plasticity and metabolic processes in nervous cells. Improves interaction between cerebral hemispheres and synaptic conduction in neocortical structures, increases intellectual working capacity, improves a brain blood stream. Lutsetam improves microcirculation in a brain, influencing rheological characteristics of blood and does not cause vasodilating action. Lutsetam inhibits aggregation of thrombocytes and recovers elasticity of a membrane of erythrocytes, and also ability of the last to a passage through a microcirculator bed. Reduces adhesion of erythrocytes. In a dose of 9.6 g reduces the level of fibrinogen and Villibrand's factor by 30% - 40% and extends a bleeding time. Lutsetam has the tire-tread and recovering effect at dysfunction of a brain owing to a hypoxia, intoxication or an injury. Lutsetam reduces expressiveness and duration of a vestibular nystagmus.

Pharmacokinetics. At administration of drug inside piracetam is quickly and almost completely soaked up from a GIT, peak concentration is reached in 1 hour after reception. Bioavailability of drug makes about 100%. After intake of a single dose of 2 g the maximum concentration (Cmax) makes 40-60 mkg/ml which is reached in blood in 30 minutes and in 5 hours in cerebrospinal fluid. 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. Piracetam gets through the blood-brain and placental barrier and membranes used at a hemodialysis. Piracetam selectively collects in tissues of a cerebral cortex, is preferential in frontal, parietal and occipital lobes, in a cerebellum and basal gangliya. Does not contact proteins of a blood plasma, it is not metabolized in an organism and allocated with kidneys in not changed look. 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 Altsgeymerovsky type. Treatment of effects of an ischemic stroke, such as disturbances of the speech, disturbance of the emotional sphere, motor and mental performance. An alcoholism - for treatment of psychoorganic and abstinent syndromes. During recovery after injuries and intoxications of a brain. Treatment of dizziness and the related disorders of balance, except for dizzinesses of a mental origin. As a part of complex therapy of low learnability at children, especially in cases of acquisition of specific skills of reading, the letter, account which cannot be explained with mental retardation, inadequate training or feature of domestic surroundings. For treatment of a cortical myoclonia as mono - or complex therapy.

Route of administration and doses:

It is inside appointed during meal or on an empty stomach, washing down with liquid (water, juice). Daily dose - 30-160 mg/kg, frequency rate of reception – 2-4 times a day. At a symptomatic treatment of a chronic psychoorganic syndrome, depending on expressiveness of symptoms appoint 1.2-2.4 g, and within the first week - 4.8 g a day. At treatment of effects of a stroke appoint 4.8 g/days. At an alcoholic abstinence syndrome - 12 g/days. Maintenance dose 2.4g/days. Treatment of dizziness 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 3.2 g/days. Treatment continues during all academic year. At a cortical myoclonia treatment begins with 7.2 g/days, each 3-4 days the dose increases 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. Dosing by the patient with a renal failure. As Lutsetam is brought from an organism by kidneys, it is necessary to be careful at treatment of patients with a renal failure in compliance with 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 dose adjustment. 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:

Due to the influence of piracetam on aggregation of thrombocytes, care at purpose of drug is recommended to patients 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:

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 and in a stomach; a nervous system - dizziness, headaches, an ataxy, balance disturbance, an aggravation of a 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 extract of a thyroid gland (TZ+T4) the acrimony, disorientations and sleep disorders is possible. Interaction with clonazepam, Phenytoinum, phenobarbital, sodium Valproatum is noted. 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, Villibrandt'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 not changed view with urine. In vitro piracetam does not oppress P450 cytochrome of the CYP1A2, 2V6, 2S8, 2S9, 2S19, 2D6, 2E1 and 4A9/11 isoform in concentration of 142, 426 and 1422 mkg/ml. At concentration of 1422 mkg/ml, small oppression of CYP2A6 (21%) and 3A4/5 is noted (11%). However the Ki level of these two CYP isomers sufficient at exceeding of 1422 mkg/ml. Therefore metabolic interaction with other drugs is a little probable. Reception of piracetam in a dose of 20 mg/days did not change peak and a curve of level of concentration of antiepileptic drugs in blood serum (carbamazepine, Phenytoinum, phenobarbital, Valproatum) at the patients with epilepsy receiving a constant dosage. Joint reception with alcohol did not influence the level of concentration of piracetam in serum and concentration of alcohol in blood serum did not change at reception of 1,6 g of piracetam.

Contraindications:

Individual intolerance of piracetam or derivatives of a pirrolidon, and also other components of drug. Hemorrhagic stroke. A final stage of a renal failure (at clearance of creatinine less than 20 ml/min.). Children's age till 1 year.

Overdose:

Treatment. Right after the considerable peroral overdose can wash out a stomach or to cause artificial vomiting. A symptomatic treatment which can include a hemodialysis. There is no specific antidote. Efficiency of a hemodialysis makes 50% - 60% for piracetam.

Storage conditions:

List B. To store at a temperature of 15-30 °C. To store in the place, unavailable to children. Period of validity: 5 years. Not to use drug after the expiry date specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Tablets coated 400 mg, 800 mg 1200 mg are packed respectively on 60 tablets, 30 tablets and on 20 tablets into a jar from brown glass with PE a stopper with control of the first opening. The jar with the application instruction is placed in a cardboard pack. Or tablets on 400,800 and 1200 mg in the blister from PVH/PVDH/al.folga respectively on 15, 15, or 10 tablets, and respectively on 4, 2 or 2 blisters are packed together with the instruction on a medical use into a cardboard pack.