Piracetam capsules 400mg, No. 60

In adults

- Symptomatic treatment of psychoorganic syndrome, in particular in elderly patients, accompanied by memory loss, dizziness, decreased concentration and decreased activity, mood changes, behavioral disorders, gait disturbances (these symptoms can be early signs of age-related diseases such as Alzheimer's disease and senile dementia of the Alzheimer's type);
- Treatment of vertigo and related imbalance, with the exception of vascular and psychogenic vertigo;
- Complex therapy and monotherapy of cortical myoclonus;
- Complex therapy of sickle cell anemia (for the prevention of sickle cell vaso-occlusive crisis).

In children

- Treatment of dyslexia (in combination with other methods);
- Complex therapy of sickle cell anemia (for the prevention of sickle cell vaso-occlusive crisis).

Inside.

During meals or on an empty stomach with a liquid.

Symptomatic treatment of psychoorganic syndrome: 2.4 - 4.8 g / day in 2-3 doses.

Treatment of dizziness and related imbalance: 2.4 - 4.8 g / day in 2-3 doses.

Treatment of cortical myoclonus: start 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 in 2-3 doses. Treatment continues throughout the entire period of the disease. Every 6 months, attempts should be made to reduce the dose or discontinue the drug, gradually reducing the dose by 1.2 g / day every 2 days.

Treatment of sickle cell anemia: The daily prophylactic dose is 160 mg / kg body weight, divided into 4 equal doses.

Treatment of dyslexia in children (in combination with other methods of treatment): the recommended daily dose for children from 8 years of age and adolescents is 3.2 g, divided into 2 doses.

Active ingredient: piracetam - 400 mg.

Excipients (core): croscarmellose sodium, pregelatinized starch, povidone (polyvinylpyrrolidone), magnesium stearate.

Excipients (shell): hypromellose, macrogol, titanium dioxide.

- Individual intolerance to piracetam or pyrrolidone derivatives, as well as other components of the drug;
- Psychomotor agitation at the time of prescribing the drug;
- Chorea of ??Huntington;
- Acute violation of cerebral circulation (hemorrhagic stroke);
- End stage renal failure (with creatinine clearance less than 20 ml / min);
- Children under 3 years old.

With care:
impaired hemostasis; extensive surgical interventions; heavy bleeding; chronic renal failure (with creatinine clearance 20-80 ml / min).

Tradename:

Piracetam

International non-proprietary name:

Piracetam

Dosage form:

film-coated tablets

Composition for one tablet:

Dosage 200 mg

Active ingredient: Piracetam - 200.0 mg.

Excipients: povidone-K25 - 5.0 mg, croscarmellose sodium - 3.0 mg, pregelatinized starch - 3.0 mg, magnesium stearate - 2.0 mg.

Dosage 400 mg

Active substance:

piracetam - 400 mg.

Excipients (core) :

croscarmellose sodium, pregelatinized starch, povidone (polyvinylpyrrolidone), magnesium stearate.

Excipients (shell):

hypromellose, macrogol, titanium dioxide.

Dosage 800 mg

Active substance:

piracetam - 800.0 mg.

Excipients (core):

croscarmellose sodium - 12.0 mg, pregelatinized starch - 12.0 mg, povidone (polyvinylpyrrolidone) - 20.0 mg, magnesium stearate - 8.0 mg.

Excipients (shell):

hypromellose - 15.2 mg, macrogol-4000 - 4.0 mg, titanium dioxide - 8.8 mg.

Dosage 1200 mg

Active substance:

piracetam -1200.0 mg.

Excipients (core):

croscarmellose sodium - 18.0 mg, pregelatinized starch - 18.0 mg, povidone (polyvinylpyrrolidone) - 30.0 mg, magnesium stearate - 12.0 mg.

Excipients (shell):

hypromellose - 22.8 mg, macrogol-4000 - 6.0 mg, titanium dioxide - 13.2 mg.

Description:

Dosage 800 mg
Biconvex capsule-shaped tablets, film-coated, white or almost white, with a line on one side. Slight surface roughness is allowed. At the fracture, two layers are visible - a white or almost white core and a film shell.

Dosage 1200 mg
Oval tablets of a biconvex shape, film-coated, white or almost white, with a scored on one side. Slight surface roughness is allowed. At the fracture, two layers are visible - a white or almost white core and a film shell.

Pharmacotherapeutic group:

Nootropic agent.

ATX code

N06BX03.

Pharmacological properties

Pharmacodynamics
The active ingredient is piracetam, a cyclic derivative of gamma-aminobutyric acid (GABA).

Available evidence suggests that the primary mechanism of action of piracetam is not cell-specific or organ-specific.

Piracetam binds to the polar heads of phospholipids and forms mobile drug-phospholipid complexes. As a result, the two-layer structure of the cell membrane and its stability are restored, which in turn leads to the restoration of the three-dimensional structure of membrane and transmembrane proteins and the restoration of their function.

At the neuronal level, piracetam facilitates various types of synaptic transmission, with a predominant effect on the density and activity of postsynaptic receptors (data obtained from animal studies). Piracetam improves functions such as learning, memory, attention and consciousness without sedation or psychostimulatory effects.

The hemorheological effects of piracetam are associated with its effect on red blood cells, platelets and the vascular wall.

In patients with sickle cell disease, piracetam increases the ability of red blood cells to deform, reduces blood viscosity, and prevents the formation of 'coins'. In addition, it reduces platelet aggregation without significantly affecting platelet count.

Animal studies have shown that piracetam inhibits vasospasm and counteracts various vasospastic substances.

In studies on healthy volunteers, piracetam reduced the adhesion of red blood cells to the vascular endothelium and stimulated the production of prostacyclins by healthy endothelium.

Pharmacokinetics
Absorption.
After oral administration, piracetam is rapidly and almost completely absorbed from the gastrointestinal tract. The bioavailability of piracetam is close to 100%. After a single dose of the drug at a dose of 3.2 g, the maximum concentration (Cmax) is 84 ?g / ml, after repeated administration of 3.2 mg 3 times a day - 115 ?g / ml and is reached after 1 hour in blood plasma and after 5 hours in cerebrospinal fluid. Food intake reduces Cmax by 17% and increases the time to reach it (Tmax) up to 1.5 hours. In women, when taking piracetam at a dose of 2.4 g Cmax and the area under the concentration-time curve (AUC) is 30% higher than in men.

Distribution.
The volume of distribution (Vd) is about 0.6 l / kg. Piracetam crosses the blood-brain and placental barriers. In a study on animals, it was found that piracetam selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal nuclei.

Metabolism.
Does not bind to blood plasma proteins, is not metabolized in the body.

Excretion.
The half-life (T1 / 2) is 4-5 hours from blood plasma and 8.5 hours from cerebrospinal fluid. The half-life does not depend on the route of administration. 80-100% of piracetam is excreted unchanged by the kidneys by glomerular filtration. The total clearance of piracetam in healthy volunteers is 80-90 ml / min. T1 / 2 is lengthened in renal failure (in end-stage chronic renal failure - up to 59 hours). The pharmacokinetics of
piracetam does not change in patients with hepatic insufficiency.

Indications for use:

In adults

- Symptomatic treatment of psychoorganic syndrome, in particular in elderly patients, accompanied by memory loss, dizziness, decreased concentration and decreased activity, mood changes, behavioral disorders, gait disturbances (these symptoms can be early signs of age-related diseases such as Alzheimer's disease and senile dementia of the Alzheimer's type);
- Treatment of vertigo and related imbalance, with the exception of vascular and psychogenic vertigo;
- Complex therapy and monotherapy of cortical myoclonus;
- Complex therapy of sickle cell anemia (for the prevention of sickle cell vaso-occlusive crisis).

In children

- Treatment of dyslexia (in combination with other methods);
- Complex therapy of sickle cell anemia (for the prevention of sickle cell vaso-occlusive crisis).

Contraindications:

- Individual intolerance to piracetam or pyrrolidone derivatives, as well as other components of the drug;
- Psychomotor agitation at the time of prescribing the drug;
- Chorea of ??Huntington;
- Acute violation of cerebral circulation (hemorrhagic stroke);
- End stage renal failure (with creatinine clearance less than 20 ml / min);
- Children under 3 years old.

With care:
impaired hemostasis; extensive surgical interventions; heavy bleeding; chronic renal failure (with creatinine clearance 20-80 ml / min).

Application during pregnancy and lactation

There have been no controlled studies of the use of the drug during pregnancy. Piracetam crosses the placental barrier and into breast milk. The concentration of the drug in newborns reaches 70-90% of the concentration in the blood of the mother. Piracetam should not be prescribed during pregnancy. During lactation, the issue of stopping breastfeeding should be resolved.

Method of administration and dosage

Inside.

During meals or on an empty stomach with a liquid.

Symptomatic treatment of psychoorganic syndrome: 2.4 - 4.8 g / day in 2-3 doses.

Treatment of dizziness and related imbalance: 2.4 - 4.8 g / day in 2-3 doses.

Treatment of cortical myoclonus: start 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 in 2-3 doses. Treatment continues throughout the entire period of the disease. Every 6 months, attempts should be made to reduce the dose or discontinue the drug, gradually reducing the dose by 1.2 g / day every 2 days.

Treatment of sickle cell anemia: The daily prophylactic dose is 160 mg / kg body weight, divided into 4 equal doses.

Treatment of dyslexia in children (in combination with other methods of treatment): the recommended daily dose for children from 8 years of age and adolescents is 3.2 g, divided into 2 doses.

Side effect

From the nervous system: motor disinhibition, irritability, drowsiness, depression, asthenia, headache, insomnia, agitation, imbalance, ataxia, exacerbation of epilepsy, anxiety, hallucinations, confusion.

From the digestive system: nausea, vomiting, diarrhea, abdominal pain (including gastralgia).

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

On the part of the hearing organs: vertigo.

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

Allergic reactions: angioedema, hypersensitivity, anaphylactic reactions.

Overdose

Symptoms: bloody diarrhea, abdominal pain.

Treatment: in case of a significant overdose, the stomach should be flushed or vomited. Symptomatic therapy is recommended, which may include hemodialysis. There is no specific antidote. The effectiveness of hemodialysis for piracetam is 50-60%.

Interaction with other medicinal products

The possibility of changing the pharmacokinetics of piracetam under the influence of other drugs is low, because 90% of piracetam is excreted unchanged by the kidneys.

With simultaneous use with thyroid hormones, there have been reports of confusion, irritability and sleep disturbance.

According to a published study in patients with recurrent venous thrombosis, piracetam at a dose of 9.6 g / day increases the effectiveness of indirect anticoagulants (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 indirect anticoagulants).

In vitro, piracetam does not inhibit cytochrome P450 isoenzymes, such as CYP1A2, 2B6, 2C8, 2C9, 2C19, 2B6, 2E1 and 4A9 / 11 at a concentration of 142, 426 and 1422 ?g / ml. At a concentration of 1422 ?g / ml, a slight inhibition of CYP2A6 (21%) and 3A4 / 5 (11%) was noted, however, the Ki level of these two isoenzymes is sufficient when exceeding 1422 ?g / ml, and therefore metabolic interaction with other drugs is unlikely.

Taking piracetam at a dose of 20 g / day for 4 weeks did not change the maximum serum concentration and the area under the concentration-time curve of antiepileptic drugs (carbamazepine, phenytoin, phenobarbital, valproic acid).

Coadministration with alcohol did not affect the serum concentration of piracetam; the concentration of ethanol in the blood serum did not change with the intake of 1.6 g of piracetam.

special instructions

When treating cortical myoclonus, abrupt interruptions of treatment should be avoided, as this may cause recurrence of seizures.
In the treatment of sickle cell anemia, a dose of less than 160 mg / kg or irregular administration of the drug may exacerbate the disease.
Penetrates through the filter membranes of hemodialysis machines.

Influence on the ability to drive vehicles and work with mechanisms

¬ период лечени¤ следует соблюдать осторожность при вождении автотранспорта и зан¤тии другими потенциально опасными видами де¤тельности, требующими повышенной концентрации внимани¤ и быстроты психомоторных реакций.

‘орма выпуска:

“аблетки, покрытые пленочной оболочкой 800 мг и 1200 мг.
ѕо 10, 20, 30 таблеток в контурную ¤чейковую упаковку из пленки поливинилхлоридной и фольги алюминиевой печатной лакированной.
ѕо 10, 20, 30, 40, 50, 60, 80, 90, 100 или 120 таблеток в банки полимерные дл¤ лекарственных средств.
ќдну банку или 1, 2, 3, 4, 5, 6, 8, 9, 10 или 12 контурных ¤чейковых упаковок вместе с инструкцией по применению помещают в картонную упаковку (пачку).

”слови¤ хранени¤:

¬ защищенном от света месте при температуре не выше 25 ?—.
’ранить в недоступном дл¤ детей месте.

—рок годности:

3 years.
Do not use after the expiration date.

Terms of dispensing from pharmacies:

On prescription.