Pyracetam - instructions for use, dose, side effects, contraindications

Excipients: potato starch - 17.63 mg, low molecular weight polyvinylpyrrolidone (povidone) - 4.37 mg, magnesium hydroxycarbonate 25.5 mg; calcium stearate - 2.5 mg; composition of the shell: sugar (sucrose) - 87.047 mg, low molecular weight polyvinylpyrrolidone (povidone) 2.278 mg, magnesium hydroxycarbonate 38.03 mg, titanium dioxide 1.566 mg, sunflower oil 0.204 mg, silicon dioxide colloid (aerosil) 0.692 mg, dye tropeolin O - 0.02 mg, wax bee g 0.163 mg.

Description:

The tablets covered with a cover, from light yellow to orange-yellow color, round biconcave forms. Two layers are visible on the cross-section. The kernel is white or almost white.

Pharmacotherapeutic group:Nootropic agent.

ATX: & nbsp

N.06.B.X.03 Pyracetam

Pharmacodynamics:

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

Pyracetam is a nootropic drug that directly affects the brain, improving cognitive (cognitive) processes, such as learning ability, memory, attention, and mental performance. Pyracetam affects the central nervous system (CNS) in various ways: it changes the rate of spread of excitation in the brain, improves metabolic processes in nerve cells, improves microcirculation, affects the rheological characteristics of the blood without causing vasodilating action.

Improves communication between the cerebral hemispheres and synaptic conductivity in neocortical structures, increases mental capacity, improves cerebral blood flow.

Pyracetam inhibits platelet aggregation and restores the elasticity of the erythrocyte membrane, reduces the adhesion of erythrocytes. At a dose of 9.6 g reduces the level of fibrinogen and von Willebrand factor by 30-40% and lengthens the time of bleeding.

Piracetam has a protective and restoring effect when brain function is impaired due to hypoxia and intoxication.

Pyracetam reduces the severity and duration of the vestibular nystagmus.

Pharmacokinetics:

Suction. After oral administration piracetam quickly and almost completely absorbed from the gastrointestinal tract. Bioavailability is approximately 100%. After a single dose in a dose of 2 g, the maximum concentration (C_max), which is 40-60 μg / ml, is reached after 30 minutes in the blood plasma and after 5 hours in the cerebrospinal fluid.

Distribution. The apparent volume of distribution (Vd) is about 0.6 l / kg. It penetrates through the blood-brain and placental barriers, as well as through membranes used in hemodialysis. In animal studies, it was found that piracetam accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal ganglia.

Metabolism. It does not bind to blood plasma proteins, it is not metabolized in the body.

Excretion. The half-life (T1) is 4-5 hours from the blood plasma and 8.5 hours from the cerebrospinal fluid.80-100% of piracetam is excreted by the kidneys unchanged by renal filtration. The renal clearance of piracetam in healthy volunteers is 86 ml / min.

T1 is prolonged with renal failure. The pharmacokinetics of pyracetam does not change in patients with hepatic insufficiency.

Indications:

In adults: symptomatic treatment of psycho-organic syndrome, accompanied by memory loss, decreased concentration and activity, mood changes, behavioral disorder, gait disturbance, treatment of vertigo and associated disorders of balance (with the exception of vertigo of the vasomotor and psychogenic origin), sickle-cell prophylaxis cell vaso-occlusive crisis.

In children: dyslexia in children from the age of 8 in combination with other methods, including speech therapy; prophylaxis 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;
Horea Huntington;
Acute disorders of cerebral circulation (hemorrhagic stroke);
Severe renal insufficiency (creatinine clearance less than 20 ml / min);
Deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption;
Children under 3 years.

Carefully:

Violation of hemostasis, extensive surgical interventions, severe bleeding, chronic renal failure (creatinine clearance 20-80 ml / min).

Pregnancy and lactation:

Studies in animals do not indicate a direct or indirect adverse effect on the fetus during pregnancy, during childbirth, postnatal development.

Controlled studies of the use of the drug during pregnancy have not been conducted, the use of the drug in pregnancy is contraindicated. Pyracetam penetrates the placental barrier and into breast milk. The concentration of the drug in newborns reaches 70-90% of its concentration in the blood of the mother. It should be refrained from breastfeeding with the appointment of a woman piracetam.

Dosing and Administration:

Inside, during meals or on an empty stomach, squeezed with liquid.

Attention. The last single dose should be taken no later than 5 pm to prevent sleep disturbances.

The duration of treatment is determined by the doctor depending on the disease, taking into account the dynamics of the symptoms; the average course of treatment is from 2-3 weeks to 2-6 months. If necessary, repeat the treatment.

To adults. The daily dose is divided into 2-4 admission.

Symptomatic treatment of psycho-organic syndrome: 4.8 g / day for the first week, and then switch to a maintenance dose of 1.2-2.4 g / day.

Treatment of dizziness and related disorders of equilibrium: 2,4-4,8 g / day.

Children.

Treatment of dyslexia in children older than 8 years: the recommended daily intake for children and adolescents is 3.2 g divided into 2 doses.

In the sickle cell vasocclusive crisis, prophylaxis is 160 mg / kg / day, divided into 4 equal doses. Dose less than 160 mg / kg / day or irregular intake of the drug may cause an exacerbation of the disease.

Dosing to patients with impaired renal function:

because the Pyracetam is excreted from the body by the kidneys, care should be taken when treating patients with renal insufficiency and to select a dose in accordance with this dosing regimen:

Renal insufficiency	CK (ml / min)	Dosing regimen
Norm	>80	the usual dose of 2-4 admission
Lightweight	50-79	2/3 of the usual dose in 2-3 doses
Average	30-19	1/3 of the usual dose in 2 divided doses
Heavy	<30	1/6 of the usual dose once
The final stage	-	contraindicated

Elderly patients dose Correct in the presence of renal failure and with prolonged therapy requires monitoring of the functional state of the kidneys.

Dosing to patients with impaired liver function

Patients with a dysfunction of the liver do not need a dose adjustment. Patients with impaired functions and kidneys, and liver, dosing is carried out according to the scheme (see Section "Dosing to patients with impaired renal function").

Side effects:

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

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

From the side of metabolism: weight gain.

From the sense organs: Vertigo.

From the skin: dermatitis, itching, urticaria.

Allergic reactions: hypersensitivity, anaphylactic reactions, angioedema.

Overdose:

Symptoms: abdominal pain, diarrhea with an admixture of blood.

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

Interaction:

When used simultaneously with iodine-containing hormones of the thyroid gland, confusion, irritability and sleep disturbance may occur.

In high doses (9.6 g / day) in patients with venous thrombosis increases the anticoagulant effect of indirect anticoagulants (more pronounced decrease, platelet aggregation, fibrinogen content, von Willebrand factor, viscosity of blood and plasma).

Special instructions:

With prolonged therapy in elderly patients, regular monitoring of kidney function is recommended, if necessary, dose adjustment is performed depending on the creatinine clearance.

It penetrates the hemodialysis apparatus through the filter membranes.

Information for patients with diabetes: 1 tablet of the drug corresponds to 0.0105 bread units.

Effect on the ability to drive transp. cf. and fur:

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

Form release / dosage:

The tablets covered with a cover of 200 mg.

Packaging:

For 10 tablets in a contour mesh package or 60 tablets in cans of glass. 6 contour squares or a jar with instructions for use in a pack of cardboard.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:P N003484 / 01

Date of registration:21.05.2009

The owner of the registration certificate:TATHIMFARMPREPARATY, JSC TATHIMFARMPREPARATY, JSC Russia

Manufacturer: & nbsp

TATHIMFARMPREPARATY, JSC Russia

Information update date: & nbsp22.09.2015

Illustrated instructions

Instructions

Pyracetam (Piracetam)