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

Excipients: silicon dioxide colloid (aerosil) - 0.025 g, microcrystalline cellulose - 0.005 g to obtain the contents of the capsule 0.43 g capsules hard gelatinous (capsules opaque, white, No. 0)

Capsule composition: titanium dioxide - 2.88 mg, gelatin medical - up to 96 mg.

Description:

The contents of capsules are crystalline powder of white or almost white color. Capsules of white color № 0.

Pharmacotherapeutic group:Nootropic agent.

ATX: & nbsp

N.06.B.X.03 Pyracetam

Pharmacodynamics:

Pyracetam - a cyclic derivative of gamma-aminobutyric acid, is a nootropic agent that directly affects the brain, improves cognitive processes (learning ability, memory, attention, 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, and does not cause vasodilating action. 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, increases the bleeding time by 30-40%.

Improves interhemispheric connections in the brain and synaptic conductivity in neocortical structures.

Piracetam has a protective and restoring effect when 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 intake at a dose of 3.2 g, the maximum concentration in the blood (C_max) - 84 mcg / ml, after multiple (3.2 g 3 times a day) - 115 mcg / ml, the time to reach the maximum concentration (TC_max) in plasma - 1 h, in cerebrospinal fluid -5 h. The intake of food reduces the maximum concentration in the blood (C_max) by 17% and increases the time to reach the maximum concentration (TC_max) to 1.5 hours. In women, the maximum concentration in the blood (C_max) and the indicator on bioavailability (AUC) after taking 2.4 g is 30% higher than in men.

The volume of distribution (Vd) is about 0.6 l / kg. Penetrates through the blood-brain barrier 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 (T_1/2) - 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. half-life (T_1/2) is prolonged in chronic renal failure (with terminal chronic renal failure - up to 59 hours). Hepatic insufficiency does not affect the pharmacokinetics of piracetam.

Indications:

In adults:

symptomatic treatment of psychoorganic syndrome, accompanied by a decrease in memory, a decrease in concentration and activity, a change in mood,disorder of behavior, violation of gait;
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. 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:

Contraindicated in pregnancy, at the time of treatment should stop breastfeeding.

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 go to the maintenance dose - 1.2 - 2.4 g / day.

Treatment of dizziness and related imbalances: 2.4-4.8 g / day. Treatment of cortical myoclonia: begin with a dose of 7.2 g / day, every 3-4 days the dose is increased by 4.8 g / day until the maximum dose of 24 g / day is reached. 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 reception 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.

For chronic renal failure of mild degree (creatinine clearance 50-79 ml / min) - 2/3 dose divided into 2-3 doses; average (creatine clearance 30-49 ml / min) - 1/3 dose divided into 2 doses; heavy (creatine 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.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

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 creatine clearance.

It penetrates the hemodialysis apparatus through the filter membranes.

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 concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Capsules 400 mg.

Packaging:

10 capsules per contour cell packaging made of polyvinylchloride film and foil printed lacquered.

For 10, 20, 30, 40, 50, 60 capsules in a can of polymer.

Each jar or 1, 2, 3, 4, 5, 6 contour mesh packages together with the instruction for use are placed in a bundle.

Storage conditions:

In dry, 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 the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N003881 / 01

Date of registration:06.05.2010

The owner of the registration certificate:URALBIOFARM, OJSC URALBIOFARM, OJSC Russia

Manufacturer: & nbsp

URALBIOFARM, OJSC Russia

Information update date: & nbsp22.09.2015

Illustrated instructions

Instructions

Pyracetam (Piracetam)