Composition, form of production and packaging
Solution for intravenous and / m introduction 1 ml of 1 amp.
piracetam 200 mg 1 g
5 ml - ampoules (10) - packings of cellular contour (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
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. Piracetam has an effect on the central nervous system in various ways: changing 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 providing a vasodilating effect. Improves the connection between the cerebral hemispheres and synaptic conductivity in neocortical structures, improves cerebral blood flow.
Pyracetam inhibits platelet aggregation 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 microcircular bed. At a dose of 9.6 g reduces the concentration of fibrinogen and von Willebrand factors by 30-40% and prolongs the time of bleeding. Piracetam has a protective and restorative effect in the violation of brain function due to hypoxia and intoxication.
Pyracetam reduces the severity and duration of the vestibular nystagmus.
PHARMACOKINETICS
T 1/2 pyracetam - 4-5 h from plasma and 8.5 h from 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 is prolonged in chronic renal failure (CRF) (with thermal CRF - up to 59 hours). Hepatic insufficiency does not affect the pharmacokinetics. 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.
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 (vertigo) and related disorders of equilibrium (with the exception of vertigo of the vasomotor and psychogenic origin);
- treatment of cortical myoclonus (monotherapy or as part of complex therapy);
- cupping sickle-cell vaso-occlusive crisis.
Children :
- treatment of dyslexia in children from the age of 8 in conjunction with other methods;
- cupping sickle-cell vaso-occlusive crisis.
DOSING MODE
In / in jet or drip, in / m. 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 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 ): IV 300 mg / kg / day, divided into 4 equal doses.
Treatment of dyslexia in children older than 8 years (in conjunction with other methods of treatment) - 3.2 g divided into 2 equal doses.
For chronic renal failure of mild degree (KK 50-79 ml / min) - 2/3 of the dose divided into 2-3 doses; medium degree (KK 30-49 ml / min) - 1/3 dose divided into 2 doses; severe (KK 20-30 ml / min) -1/6 dose once.
SIDE EFFECT
From the side of the central nervous system: motor disinhibition, irritability, drowsiness, depression, asthenia, headache, insomnia, mental arousal, 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 senses: vertigo.
From the skin: dermatitis, itching, rashes.
Allergic reactions: hypersensitivity, anaphylactic reactions, angioedema.
Local reactions: pain at the injection site, thrombophlebitis. Other: fever, lowering blood pressure.
CONTRAINDICATIONS
- severe chronic renal failure (creatinine clearance (KK) less than 20 ml / min);
- hemorrhagic stroke;
- psychomotor agitation;
- Huntington's chorea;
- Pregnancy;
lactation period.
With caution: hemostasis disorder; extensive surgical interventions; heavy bleeding; chronic renal failure (KK 20-80 ml / min).
PREGNANCY AND LACTATION
Contraindicated in pregnancy and lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
For chronic renal failure of mild degree (KK 50-79 ml / min) - 2/3 of the dose divided into 2-3 doses; medium degree (KK 30-49 ml / min) - 1/3 dose divided into 2 doses; severe (KK 20-30 ml / min) -1/6 dose once.
Contraindicated in CC less than 20 ml / min .
APPLICATION FOR CHILDREN
Children :
- treatment of dyslexia in children from the age of 8 in conjunction with other methods;
- cupping sickle-cell vaso-occlusive crisis.
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.
With prolonged therapy in elderly patients, regular monitoring of kidney function is recommended, if necessary, dose adjustment is performed depending on the QC.
It penetrates the hemodialysis apparatus through the filter membranes.
Impact on the ability to drive vehicles and manage mechanisms
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.
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.
DRUG 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 (6%, 10%) .
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
Store in a dark place at a temperature of no higher than 25 В° C. Keep out of the reach of children. Shelf life - 5 years.
Do not use after the expiration date printed on the package.
