Universal reference book for medicines
Product name: LUCETAM ® (LUCETAM)

Active substance: piracetam

Type: Nootropic preparation

Manufacturer: EGIS Pharmaceuticals (Hungary)
Composition, form of production and packaging
Tablets covered with a film shell of
white or almost white color, oval, biconcave, chamfered, engraved "E 241" on one side, odorless.

1 tab.

piracetam 400 mg

Excipients: magnesium stearate - 3 mg, povidone K-30 - 25 mg.

Sheath composition: dibutyl sebacate 0.7 mg, ethyl cellulose (in the form of an aqueous suspension) 3.5 mg, opadrai white (macrogol 6000 0.25 mg, titanium dioxide 0.75 mg, talc 1 mg, hypromellose 3.8 mg).

15 pcs.
- blisters (4) - packs of cardboard.
60 pcs.
- banks of dark glass (1) - packs of cardboard.
The tablets covered with a film shell of white or almost white color, oval, biconcave, with a facet, with a risk on both sides, with engraving "E 242" on one side, odorless.

1 tab.

piracetam 800 mg

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

Sheath composition: dibutyl sebacate 1.4 mg, ethyl cellulose (in the form of an aqueous suspension) 7 mg, opadrai white (macrogol 6000 0.5 mg, titanium dioxide 1.5 mg, talc 2 mg, hypromellose 7.6 mg).

15 pcs.
- blisters (2) - packs of cardboard.
30 pcs.
- banks of dark glass (1) - packs of cardboard.
The tablets covered with a film shell of white or almost white color, oval, biconcave, with a facet, with engraving "E 243" on one side, without a smell.

1 tab.

piracetam 1200 mg

Excipients: magnesium stearate - 9 mg, povidone K-30 - 75 mg.

Sheath composition: dibutyl sebacate - 1.82 mg, ethyl cellulose (in the form of an aqueous suspension) - 9.1 mg, opadrai white (macrogol 6000 - 0.65 mg, titanium dioxide - 1.95 mg, talc - 2.6 mg, hypromellose - 9.88 mg).


10 pieces.
- blisters (2) - packs of cardboard.
20 pcs.
- banks of dark glass (1) - packs of cardboard.
60 pcs.
- banks of dark glass (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

Nootropic preparation.
It acts on the central nervous system in various ways: it modifies neurotransmission in the brain, improves the conditions that promote neuronal plasticity, improves microcirculation, influencing the rheological characteristics of the blood and not causing vasodilation.
The use of piracetam in patients with cerebral dysfunction increases concentration and improves cognitive function, which is manifested by significant changes in the EEG (increased и and активности activity, decreased активности activity).

Promotes restoration of cognitive functions due to various disorders, such as hypoxia, intoxication or electroconvulsive therapy.
Reduces the duration of the vestibular neuronitis.
Piracetam inhibits increased aggregation of activated platelets and, in the case of abnormal rigidity of erythrocytes, improves their deformability and ability to filter.

PHARMACOKINETICS

Suction

After taking the drug inside piracetam quickly and almost completely absorbed from the digestive tract.
Bioavailability of the drug is about 100%. After a single dose of 2 grams of C max is achieved in the blood plasma after 30 minutes and is 40-60 μg / ml, after 2-8 hours - in the cerebrospinal fluid.
Distribution and Metabolism

V d 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.

Pyracetam penetrates the GEB and the placental barrier.
It is not metabolized in the body.
Excretion

T 1/2 from the blood plasma is 4-5 h, T 1/2 of the cerebrospinal fluid is 8.5 h.

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

With renal failure, T 1/2 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 myoclonias in piracetam sensitive patients, both as monotherapy and as part of complex therapy (a trial course of treatment can be performed to determine sensitivity to pyracetam in a specific case).

DOSING MODE

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

In cortical myoclonia, treatment starts at 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 period of the disease.
To prevent worsening of patients, do not abruptly stop using the drug. 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.
Since pyracetam is excreted from the body by the kidneys, caution should be exercised in the treatment of patients with renal insufficiency .

Calculation of the dose should be based on the assessment of CC in the patient, which is calculated by the formula:

CC = [140 - age (years)]?
body weight (kg) / 72 - serum creatinine (mg%)
For women, the result is multiplied by 0.85.

Treatment for such patients is prescribed depending on the severity of renal failure, adhering to the following recommendations:

Renal failure Creatinine clearance (ml / min) Dosage

Norm> 80 Usual Dose

Light 50-79 2/3 of the usual dose in 2-3 doses

Average 30-49 1/3 of the usual dose in 2 doses

Severe <30 1/6 of the usual dose, once

Final stage - Contraindicated

Elderly patients should be adjusted for renal failure.
With prolonged therapy, monitoring of renal function is necessary.
Patients with a violation of liver function correction of the dose is not required.

Patients with impaired functions and kidney and liver, 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: hyperkinesia, irritability, drowsiness, depression, asthenia, headache, dizziness, insomnia, mental arousal, anxiety, imbalance, tremor, ataxia, exacerbation of epilepsy, anxiety, hallucinations, confusion, increased libido.

From the senses: dizziness (vertigo).

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

On the part of the digestive system: nausea, vomiting, diarrhea, abdominal pain, epigastric pain.

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

From the skin: dermatitis, itching, urticaria.

On the part of the immune system: hypersensitivity, anaphylactic reactions, angioedema.

CONTRAINDICATIONS

- Huntington's chorea;

- hemorrhagic stroke;

- chronic renal failure of severe degree (with CC less than 20 ml / min);

- Pregnancy;

- lactation period;

- hypersensitivity to pyracetam or pyrrolidone derivatives, as well as other components of the drug.

With caution should prescribe the drug for violations of hemostasis, extensive surgical interventions, severe bleeding, chronic renal failure (KK 20-80 ml / min).

PREGNANCY AND LACTATION

Adequate and strictly controlled clinical trials on the safety of the drug during pregnancy have not been carried out, so Lucetam ® should not be used during pregnancy.

Piracetam penetrates the placental barrier, excreted in breast milk.
If you need to use the drug during lactation, breastfeeding should be discontinued.
APPLICATION FOR FUNCTIONS OF THE LIVER

Patients with impaired renal function require a correction of the dosing regimen depending on the CK.

Degree of renal insufficiency KK (ml / min) Dose

Norm> 80 Usual Dose

Light 50-79 2/3 of the usual dose in 2 to 3 doses

Average 30-49 1/3 of the usual dose in 2 doses

Severe <30 1/6 of the usual dose, once

Terminal stage - contraindicated

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

In patients with impaired liver function, correction of the dosing regimen is not required.

APPLICATION IN ELDERLY PATIENTS

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

Due to the influence of piracetam on platelet aggregation, caution should be given to patients with hemorrhagic disorders, bleeding risk (eg, gastric ulcer disease), hemostasis disorder, in patients taking anticoagulants and antiplatelet agents, incl.
acetylsalicylic acid in low doses.
In the treatment of cortical myoclonus, a sharp interruption in treatment should be avoided.
this can cause a resumption of seizures.
With prolonged therapy, elderly patients are recommended regular monitoring of renal function, if necessary, dose adjustment is performed depending on the results of the QC study.

It penetrates the hemodialysis apparatus through the filter membranes.

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 requiring increased attention and speed of psychomotor reactions.

OVERDOSE

Pyracetam is not toxic even in high doses.
An isolated case of development of diarrhea in the form of diarrhea with blood and pain in the lower abdomen with the drug in the form of a drug for oral administration in a daily dose of 75 g.
Treatment: induction of vomiting, gastric lavage, symptomatic therapy, hemodialysis (efficacy 50-60%).
There is no specific antidote.
DRUG INTERACTION

When used simultaneously with the thyroid extract (T 3 + T 4 ), increased irritability, disorientation and sleep disturbances are possible.

No interaction with clonazepam, phenytoin, phenobarbital, valproic acid was observed.

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

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, pyracetam does not inhibit the isoenzymes CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 4A9 / 11 at a concentration of 142, 426 and 1422 μg / ml.
At a piracetam concentration of 1422 μg / ml, slight inhibition of CYP2A6 (21%) and 3A4 / 5 (11%) was noted. However, the Ki level probably goes well beyond the 1422 μg / ml concentration. Therefore, metabolic interaction with other drugs is unlikely.
Admission piracetam at a dose of 20 mg / day did not affect C max and AUC antiepileptic drugs in the blood serum (carbamazepine, phenytoin, phenobarbital, valproate) in epilepsy patients receiving the drug in a constant dose.

The combined administration with ethanol did not affect the level of serum piracetam concentration, the concentration of ethanol in the blood serum did not change with piracetam at a dose of 1.6 g.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of 15 ° to 30 ° C.
Shelf life - 5 years.
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