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

active substance: piracetam in terms of 100% substance - 400 mg; Excipients: sodium carboxymethyl starch 16.29 mg, magnesium hydroxycarbonate (magnesium carbonate basic heavy) 11.56 mg, sodium lauryl sulfate 2.15 mg. Capsule shell composition: capsule hard gelatinous (titanium dioxide - 2%, gelatin - up to 100%) - 96 mg.

Description:

Capsules of white color number 0. Contents of capsules - powder white or almost white.

Pharmacotherapeutic group:Nootropic agent.

ATX: & nbsp

N.06.B.X.03 Pyracetam

Pharmacodynamics:

Cyclic derivative of gamma-aminobutyric acid (GABA), nootropic agent; acts directly on the brain, improving cognitive (cognitive) processes, such as learning ability, memory, attention, and mental performance.It influences the central nervous system in various ways: it changes the rate of spread of excitation in the brain, improves metabolic processes in nerve cells, improves microcirculation, influences the rheological characteristics of the blood without providing a vasodilating effect. Improves the connection between the cerebral hemispheres and synaptic conductivity in neocortical structures, improves cerebral blood flow.

Inhibits the aggregation of platelets and restores the configuration properties of the outer membrane of rigid red blood cells, as well as the ability of the latter to pass through the vessels of the microcirculatory bed. At a dose of 9.6 g reduces the concentration of fibrinogen and von Willebrand factor by 30-40% and prolongs bleeding time.

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

Reduces the severity and duration of the vestibular nystagmus.

Pharmacokinetics:

Absorption at ingestion is fast and complete. Bioavailability is about 100%. After a single oral dose of 3.2 g, the maximum concentration of the drug in the blood plasma is 84 μg / ml,after multiple (3.2 g 3 times a day) - 115 mcg / ml, the period of reaching the maximum concentration of the drug in the plasma - 1 h, cerebrospinal fluid -5 h. The intake of food reduces the maximum concentration of the drug in plasma by

17% and increases the period of reaching the maximum plasma concentration in the plasma to 1.5 hours. In women, the maximum concentration of the drug in the blood plasma and AUC (area under the pharmacokinetic curve "concentration-time") after taking 2.4 g is 30% higher than in men.

The volume of distribution of pyracetam (Vd) is about 0.6 l / kg. Penetrates through the blood-brain and placental barrier; is removed during hemodialysis. In animal experiments, it 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 plasma proteins, it is not metabolized.

The half-life of the drug is 4-5 hours from the blood plasma and 8.5 hours from the cerebrospinal fluid. 80-100% of pyracetam is excreted by the kidneys unchanged by glomerular filtration. The total clearance is 80-90 ml / min. The half-life of the drug is prolonged in chronic renal failure (in terminal chronic renal failure - up to 59 hours). Hepatic insufficiency does not affect the pharmacokinetics of piracetam.

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 dizziness (vertigo) and associated disorders of equilibrium (with the exception of vertigo of the vasomotor and psychogenic origin);
cortical myoclonus (monotherapy or as part of complex therapy);
prophylaxis of sickle-cell vaso-occlusive crisis.

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:

Hypersensitivity, severe chronic renal failure (creatinine clearance less than 20 ml / min), hemorrhagic stroke, psychomotor agitation, Huntington's chorea, pregnancy, lactation.

Carefully:

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

Pregnancy and lactation:

Piracetam crosses the placental barrier and into breast milk, therefore during pregnancy should only be used in cases where the benefit to the mother outweighs the potential risk to the fetus. During the period of breastfeeding, the use of the drug is contraindicated.

Dosing and Administration:

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

The last dose is taken no later than 17 hours (to prevent sleep disturbance). The daily dose is divided into 2-4 admission.

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

Treatment of dizziness and related imbalances: 2.4-4.8 g / day. Treatment of cortical myoclonus: I start with a dose of 7.2 g / day every 3-4 days, increase the dose of 4.8 g / day to a maximum dose of 24 g / day. Treatment continues throughout the period of the disease. Every 6 months, you should try to reduce the dose or cancel the drug, gradually reducing the dose by 1.2 g / day every 2 days. With little or no therapeutic effect, treatment is discontinued.

In the sickle-cell vaso-occlusive crisis (in adults and children): prophylaxis - inside at 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. Treatment of dyslexia in children older than 8 years (in conjunction with other methods of treatment) - 3.2 grams, divided into 2 equal doses.

In chronic renal failure of mild degree (creatinine clearance 50 - 79 ml / min) - 2/3 dose divided into 2-3 doses; average (creatinine clearance 30-49 ml / min) - 1/3 dose divided into 2 doses; severe (creatinine clearance 20-30 ml / min) - 1/6 dose once.

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 in platelet aggregation, fibrinogen content, von Willebrand factor, viscosity of blood and plasma).

Special instructions:

Be wary appoint patients with hemostasis, before the forthcoming extensive surgical interventions or in patients with symptoms of severe bleeding.

In the treatment of cortical myoclonia, sudden cessation of treatment should be avoided, as this may cause the resumption of seizures.

When treating a veno-occlusive crisis with sickle-cell anemia, a dose of less than 160 mg / kg or an irregular intake of the drug may cause a recurrence of the crisis.

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.

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

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.

Form release / dosage:

Capsules 400 mg.

Packaging:

10 capsules in a planar cell package. 2 or 6 contour squares 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:

5 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N002872 / 01

Date of registration:07.08.2008

The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia

Manufacturer: & nbsp

AKRIKHIN HFK, JSC Russia

Information update date: & nbsp22.09.2015

Illustrated instructions

Instructions

Pyracetam (Piracetam)