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

1 ml of the preparation contains: active substance - Piracetam 200 mg; Excipients - sodium acetate trihydrate 1 mg; acetic acid to pH 5.8; water for injection up to 1 ml.

Description:

Transparent colorless or slightly colored liquid.

Pharmacotherapeutic group:Nootropic agent.

ATX: & nbsp

N.06.B.X.03 Pyracetam

Pharmacodynamics:

The cyclic derivative of gamma-aminobutyric acid (GABA), a nootropic agent, acts directly on the brain, improving cognitive (cognitive) processes, such as learning ability, memory, attention, and mental performance. It 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, while not 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:

The volume of distribution is about 0.6 l / kg. Penetrates through blood-brain and placental barriers; 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. T_1/2 prolonged with chronic renal failure (CRF), with terminal CRF - up to 59 hours. Hepatic insufficiency does not affect the pharmacokinetics of pyracetam.

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); sickle-cell vaso-occlusive crisis.

Children: dyslexia in children from the age of 8 in conjunction with other methods, including speech therapy;

sickle-cell vaso-occlusive crisis.

Contraindications:

Hypersensitivity to the components of the drug, severe CRF (creatinine clearance (CC) - less than 20 ml / min), hemorrhagic stroke, psychomotor agitation, Huntington's chorea, pregnancy, lactation.

Carefully:

Violation of hemostasis, extensive surgical interventions, severe bleeding, CRF (KK 20-80 ml / min).

Pregnancy and lactation:

Application during pregnancy and during lactation is contraindicated (there is no information on efficacy and safety).

Dosing and Administration:

Intravenously struino or drip, intramuscularly (in case of difficulty swallowing or in the unconscious state).

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

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

Treatment of dizziness and related imbalances: on 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 a 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.

With sickle-cell vaso-occlusive crisis (in adults and children): intravenously at 300 mg / kg / day, divided into 4 equal doses.

Treatment of dyslexia in children older than 8 years (in combination with other methods of treatment) - 3.2 grams, divided into 2 equal doses.

With CRF of mild degree (KK 50-79 ml / min) - 2/3 dose divided into 2-3 injections; mean (KK 30-49 ml / min) - 1/3 dose divided into 2 injections; severe (KK 20-30 ml / min) -1/6 dose once.

Side effects:

From the side of 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.

Co skin: dermatitis, itching, urticaria.

Allergic reactions: hypersensitivity, anaphylactic reactions, angioedema.

Local reactions: pain in the injection site, thrombophlebitis.

Other (for parenteral administration): fever, lowering blood pressure.

Overdose:

Overdose Symptoms

Abdominal pain, diarrhea with an admixture of blood.

Measures to help with overdose

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). Pharmaceutically compatible with dextrose solutions (5%, 10%, 20%), fructose (5%, 10%, 20%), 0.9% sodium chloride solution, Ringer's solution, 20% mannitol solution, hydroxyethyl starch solution (6% 10%).

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, this can cause a 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 renal function is recommended, if necessary, dose adjustment is performed depending on the results of the QC study.

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:

A solution for intravenous and intramuscular injection of 200 mg / ml to 5 ml in an ampoule.

Packaging:

5 ampoules per contour cell pack of polyvinyl chloride film.

1 or 2 contour packs together with instructions for use and a scarifier in a cardboard box.

10 ampoules together with instructions for use and ampoule scarifier in a cardboard box with a corrugated liner.

When using ampoules with a dot or a ring of fracture, the ampoule scaper is not inserted.

Storage conditions:

Store in a dry, protected from light at a temperature not exceeding 20 ° C. Keep out of the reach of children.

Shelf life:

5 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-001303

Date of registration:19.08.2011

The owner of the registration certificate:ELLARA, LTD. ELLARA, LTD. Russia

Manufacturer: & nbsp

MC ELLARA, LLC Russia

ELLARA, LTD. Russia

Information update date: & nbsp17.09.2015

Illustrated instructions

Instructions

Pyracetam (Piracetam)