Lucetam tablets p / o 800mg, No. 30

• symptomatic treatment of intellectual-mnestic disorders in the absence of an established diagnosis of dementia;

• in order to reduce the manifestations of cortical myoclonus in patients sensitive to piracetam, both as monotherapy and as part of complex therapy (to determine sensitivity to piracetam in a particular case, a trial course of treatment can be carried out).

The drug is taken orally, during meals or on an empty stomach, with some liquid. The daily dose is divided into 2-4 doses. The last dose should be taken no later than 17 hours (to prevent sleep disturbances).

For symptomatic treatment of intellectual-mnestic disorders , depending on the severity of symptoms, 2.4-4.8 g / day are prescribed, distributing the dose for 2-3 doses.

With cortical myoclonus, treatment begins with a dose of 7.2 g / day, every 3-4 days the dose is increased by 4.8 g / day until a maximum dose of 24 g / day is reached. Treatment continues throughout the entire period of the disease. To prevent the deterioration of the patient's condition, the use of the drug should not be abruptly stopped. It is necessary to gradually reduce the dose of the drug - by 1.2 g / day every 2 days. In the absence of effect or the presence of a slight therapeutic effect, treatment is discontinued.

Because piracetam is excreted by the kidneys, care should be taken when treating patients with renal impairment .

The calculation of the dose should be based on the assessment of QC in the patient, which is calculated by the formula:

CC = [140 - age (years)]? body weight (kg) / 72 - serum creatinine (mg%)

For women, the resulting figure is multiplied by 0.85.

Elderly patients, the dose should be adjusted in the presence of renal failure. With prolonged therapy, it is necessary to monitor kidney function.

No dose adjustment is required in patients with impaired liver function .

For patients with impaired renal and liver function, dosing is carried out according to the scheme described for patients with impaired renal function.

Active substance:

piracetam - 800 mg

Excipients : stearate - 6 mg, povidone K-30 - 50 mg.

Shell composition: dibutylsebacate - 1.4 mg, ethylcellulose (in the form of an aqueous suspension) - 7 mg, white opadry (macrogol 6000 - 0.5 mg, titanium dioxide - 1.5 mg, talc - 2 mg, hypromellose - 7.6 mg).

• chorea of ??Huntington;

• hemorrhagic stroke;

• severe chronic renal failure (with CC less than 20 ml / min);

• pregnancy;

• lactation period;

• hypersensitivity to piracetam or pyrrolidone derivatives, as well as other components of the drug.

The drug should be prescribed with caution in case of hemostasis disorders, major surgical interventions, severe bleeding, chronic renal failure (CC 20-80 ml / min).

Clinical and pharmacological group: Nootropic drug

Pharmaco-therapeutic group: Nootropic agent

pharmachologic effect

Nootropic drug. It has an effect on the central nervous system in various ways: it modifies neurotransmission in the brain, improves conditions conducive to neuronal plasticity, improves microcirculation, affecting the rheological characteristics of blood and not causing vasodilation.

The use of piracetam in patients with cerebral dysfunction increases concentration of attention and improves cognitive functions, which is manifested by significant changes in the EEG (increase in? And? Activity, decrease? In activity).

Promotes the restoration of cognitive functions due to various disorders, such as hypoxia, intoxication or electroconvulsive therapy. Reduces the duration of vestibular neuronitis.

Piracetam inhibits the increased aggregation of activated platelets and, in the case of pathological rigidity of erythrocytes, improves their deformability and filtration capacity.

Pharmacokinetics

Suction

After taking the drug inside, piracetam is rapidly and almost completely absorbed from the gastrointestinal tract. The bioavailability of the drug is about 100%. After a single dose of 2 g, Cmax is reached in blood plasma after 30 minutes and is 40-60 ?g / ml, after 2-8 hours - in the cerebrospinal fluid.

Distribution and metabolism

Vd is about 0.6 l / kg. Piracetam selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal nuclei.

Does not bind to blood plasma proteins.

Piracetam crosses the BBB and the placental barrier. It is not metabolized in the body.

Withdrawal

T1 / 2 from blood plasma is 4-5 hours, T1 / 2 from cerebrospinal fluid is 8.5 hours.

It is excreted by the kidneys unchanged. Excretion by the kidneys is almost complete (> 95%) within 30 hours. The total clearance of piracetam in healthy volunteers is 86 ml / min.

Pharmacokinetics in special clinical situations

In renal failure, T1 / 2 increases.

Indications

• symptomatic treatment of intellectual-mnestic disorders in the absence of an established diagnosis of dementia;

• in order to reduce the manifestations of cortical myoclonus in patients sensitive to piracetam, both as monotherapy and as part of complex therapy (to determine sensitivity to piracetam in a particular case, a trial course of treatment can be carried out).

Dosage regimen

The drug is taken orally, during meals or on an empty stomach, with some liquid. The daily dose is divided into 2-4 doses. The last dose should be taken no later than 17 hours (to prevent sleep disturbances).

For symptomatic treatment of intellectual-mnestic disorders , depending on the severity of symptoms, 2.4-4.8 g / day are prescribed, distributing the dose for 2-3 doses.

With cortical myoclonus, treatment begins with a dose of 7.2 g / day, every 3-4 days the dose is increased by 4.8 g / day until a maximum dose of 24 g / day is reached. Treatment continues throughout the entire period of the disease. To prevent the deterioration of the patient's condition, the use of the drug should not be abruptly stopped. It is necessary to gradually reduce the dose of the drug - by 1.2 g / day every 2 days. In the absence of effect or the presence of a slight therapeutic effect, treatment is discontinued.

Because piracetam is excreted by the kidneys, care should be taken when treating patients with renal impairment .

The calculation of the dose should be based on the assessment of QC in the patient, which is calculated by the formula:

CC = [140 - age (years)]? body weight (kg) / 72 - serum creatinine (mg%)

For women, the resulting figure is multiplied by 0.85.

Elderly patients, the dose should be adjusted in the presence of renal failure. With prolonged therapy, it is necessary to monitor kidney function.

No dose adjustment is required in patients with impaired liver function .

For patients with impaired renal and liver function, dosing is carried out according to the scheme described for patients with impaired renal function.

Side effect

From the side of the central nervous system: hyperkinesis, irritability, drowsiness, depression, asthenia, headache, dizziness, insomnia, mental agitation, anxiety, imbalance, tremor, ataxia, exacerbation of epilepsy, anxiety, hallucinations, confusion, increased libido.

From the senses: dizziness (vertigo).

From the side of the cardiovascular system: decrease or increase in blood pressure.

From the digestive system: nausea, vomiting, diarrhea, abdominal pain, epigastric pain.

From the side of metabolism and nutrition: an increase in body weight.

On the part of the skin: dermatitis, itching, urticaria.

From the immune system: hypersensitivity, anaphylactic reactions, angioedema.

Contraindications for use

• chorea of ??Huntington;

• hemorrhagic stroke;

• severe chronic renal failure (with CC less than 20 ml / min);

• pregnancy;

• lactation period;

• hypersensitivity to piracetam or pyrrolidone derivatives, as well as other components of the drug.

The drug should be prescribed with caution in case of hemostasis disorders, major surgical interventions, severe bleeding, chronic renal failure (CC 20-80 ml / min).

Application during pregnancy and lactation

Adequate and strictly controlled clinical studies on the safety of the drug during pregnancy have not been carried out, therefore LucetamЃ should not be used during pregnancy.

Piracetam crosses the placental barrier, excreted in breast milk. If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Use in elderly patients

In elderly patients, the dose is adjusted in the presence of renal failure. With prolonged therapy, it is necessary to monitor the functional state of the kidneys.

special instructions

In connection with the effect of piracetam on platelet aggregation, the drug should be prescribed with caution to patients with hemorrhagic disorders, the risk of bleeding (for example, with gastric ulcer), hemostasis disorder, in patients taking anticoagulants and antiplatelet agents, incl. acetylsalicylic acid in low doses.

When treating cortical myoclonus, abrupt interruption of treatment should be avoided. this can cause seizures to recur.

With long-term therapy, elderly patients are recommended to regularly monitor the indicators of renal function, if necessary, adjust the dose depending on the results of the QC study.

Penetrates through the filter membranes of hemodialysis machines.

Influence on the ability to drive vehicles and work with mechanisms

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

Overdose

Piracetam is non-toxic even at high doses. A single case of the development of dyspeptic phenomena in the form of diarrhea with blood and pain in the lower abdomen was recorded when taking the drug in a dosage form, a solution for oral administration in a daily dose of 75 g.

Treatment: induction of vomiting, gastric lavage, symptomatic therapy, hemodialysis (50-60% efficiency). There is no specific antidote.

Drug interactions

With simultaneous use with an extract of the thyroid gland (T3 + T4), increased irritability, disorientation and sleep disturbances are possible.

There was no interaction with clonazepam, phenytoin, phenobarbital, valproic acid.

Piracetam in high doses (9.6 g / day) increases the effectiveness of acenocoumarol in patients with venous thrombosis (there was a more pronounced decrease in the level of platelet aggregation, fibrinogen, von Willebrand factors, blood and plasma viscosity compared with the use of only acenocoumarol).

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

In vitro piracetam does not inhibit isoenzymes CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 4A9 / 11 at a concentration of 142, 426 and 1422 ?g / ml. At a piracetam concentration of 1422 ?g / ml, there was a slight inhibition of CYP2A6 (21%) and 3A4 / 5 (11%). However, the Ki level probably goes well beyond the concentration of 1422 ?g / ml. Therefore, metabolic interactions with other drugs are unlikely.

Taking piracetam at a dose of 20 mg / day did not affect the Cmax and AUC of antiepileptic drugs in the blood serum (carbamazepine, phenytoin, phenobarbital, valproate) in epileptic patients receiving the drug at a constant dose.

Coadministration with ethanol did not affect the serum concentration of piracetam, the concentration of ethanol in the blood serum did not change when taking piracetam at a dose of 1.6 g.

Storage conditions

The drug should be stored out of the reach of children at a temperature of 15 ? to 30 ? C.

Shelf life

The shelf life is 5 years.

Terms of sale

The drug is available with a prescription.