Piracetam
Producer: LLC MTs Ellara Rossiya
Code of automatic telephone exchange: N06BX03
Release form: Liquid dosage forms. Solution for injections.
General characteristics. Structure:
Active ingredient: piracetam - 200 mg.
Excipients: sodium acetate, acetic acid divorced, water for injections.
Pharmacological properties:
Pharmacodynamics. Active component is piracetam, cyclic derivative piperidic acid (GABA).
Piracetam is nootropic means which directly influences a brain, improving cognitive (cognitive) processes, such as ability to training, memory, attention, and also intellectual working capacity. Piracetam exerts impact on the central nervous system in various ways: change of speed of spread of activation in a brain, improving metabolic processes in nervous cells, improving microcirculation, influencing rheological characteristics of blood and not causing vasodilating action.
Improves bonds between cerebral hemispheres and synaptic conduction in neocortical structures, increases intellectual working capacity, improves a brain blood stream.
Piracetam inhibits aggregation of thrombocytes and recovers elasticity of a membrane of erythrocytes, reduces adhesion of erythrocytes. In a dose of 9,6 g reduces the level of fibrinogen and Villibrand's factors, for 30% - 40% also are extended by a bleeding time.
Piracetam has the tire-tread and recovering effect at dysfunction of a brain owing to a hypoxia and intoxication. Piracetam reduces expressiveness and duration of a vestibular nystagmus.
Pharmacokinetics. The drug elimination half-life from a blood plasma makes 4-5 hour and 8,5 hours of cerebrospinal fluid which is extended at a renal failure. The pharmacokinetics of piracetam does not change at patients with a liver failure.
Gets through the blood-brain and placental barrier and membranes used at a hemodialysis. At a research on animals piracetam selectively collects in tissues of a cerebral cortex, is preferential in frontal, parietal and occipital lobes, in a cerebellum and basal gangliya. Does not contact proteins of a blood plasma, it is not metabolized in an organism and allocated with kidneys in not changed look. 80-100% of piracetam are removed by kidneys in an invariable look by renal filtering. The renal clearance of piracetam at healthy volunteers makes 86 ml/min.
Indications to use:
At adults:
- a symptomatic treatment of the psychoorganic syndrome which is followed by decrease in memory, decrease in concentration of attention and activity, change of mood, disorder of behavior, gait disturbance;
- treatment of dizziness (вертиго) and the related disorders of balance (except for dizzinesses of a vasculomotor and psychogenic origin);
- a cortical myoclonia (monotherapy or as a part of complex therapy);
- prevention (orally) and stopping (parenterally) drepanocytic vazookklyuzionny crisis.
At children:
- a dyslexia at children since 8 years in a complex with other methods, including logopedic treatment;
- prevention (orally) and stopping (parenterally) drepanocytic vazookklyuzionny crisis.
Route of administration and doses:
Inside (during meal or on an empty stomach, washing down with liquid); in/in struyno or kapelno, in oil (in case of difficulty of swallowing or in unconsciousness).
The last dose is accepted no later than 17 h (for prevention of a sleep disorder).
The daily dose is divided into 2-4 receptions.
Symptomatic treatment of a psychoorganic syndrome: on 4.8 g/days within the first week, then pass to a maintenance dose - 1.2-2.4 g/days.
Treatment of dizziness and related disturbances of balance: on 2.4-4.8 g/days.
Treatment of a cortical myoclonia: begin 7.2 g/days with a dose, each 3-4 days increase a dose by 4.8 g/days before achievement of the maximum dose of 24 g/days. Treatment is continued throughout the entire period of a disease. Each 6 months it is necessary to try to reduce a dose or to cancel drug, gradually lowering a dose by 1.2 g/days each 2 days. At insignificant therapeutic effect or its absence treatment is stopped.
At drepanocytic vazookklyuzionny crisis (at adults and children): prevention - inside on 160 mg/kg/days divided into 4 equal doses. The dose less than 160 mg/kg/days or irregular administration of drug can cause an exacerbation of a disease; treatment in/in on 300 mg/kg/days divided into 4 equal doses.
Treatment of a dyslexia at children is more senior than 8 years (in a complex with other methods of treatment) - on 3.2 g divided into 2 equal doses.
At HPN of easy degree (KK of 50-79 ml/min.) - 2/3 doses, divided into 2-3 receptions; average (KK of 30-49 ml/min.) - 1/3 doses, divided into 2 receptions; heavy (KK of 20-30 ml/min.) - 1/6 doses once.
Features of use:
With care appoint to patients with disturbance of a hemostasis, before forthcoming extensive surgical vmeshatelstvavb or at patients with symptoms of heavy bleeding.
At treatment of a cortical myoclonia it is necessary to avoid the sharp termination of treatment since it can cause resuming of attacks.
At treatment of venookklyuzionny crisis at a sickemia a dose less than 160 mg/kg or irregular administration of drug can cause a crisis recurrence.
At long therapy at patients of advanced age regular control of function of kidneys is recommended, if necessary carry out dose adjustment depending on KK.
Gets through the filtering membranes of devices for a hemodialysis.
Side effects:
From TsNS: motive disinhibition, irritability, drowsiness, depression, adynamy, headache, sleeplessness, hyperphrenia, balance disturbance, ataxy, aggravation of a course of epilepsy, alarm, hallucinations, confusion of consciousness.
From the alimentary system: nausea, vomiting, diarrhea, abdominal pain.
From a metabolism: increase in body weight.
From sense bodys: вертиго.
From integuments: dermatitis, itch, urticaria.
Allergic reactions: hypersensitivity, anaphylactic reactions, Quincke's disease.
Local reactions: pain in an injection site, thrombophlebitis
Other (at parenteral administration): fever, decrease in the ABP.
Interaction with other medicines:
At simultaneous use with iodinated hormones of a thyroid gland there can be a confusion of consciousness, irritability and a sleep disorder.
In high doses (9.6 g/days) at patients with venous thrombosis increases anticoagulating effect of indirect anticoagulants (more expressed decrease in aggregation of thrombocytes, contents of fibrinogen, Villebrand's factor, viscosity of blood and plasma).
Pharmaceutical we will combine with dextrose solutions (5%, 10%, 20%), fructose (5%, 10%, 20%), 0.9% NaCl solution, Ringer's solution, 20% Mannitolum solution, hydroxyethylstarch (6%, 10%).
Contraindications:
Hypersensitivity, heavy HPN (KK less than 20 ml/min.), hemorrhagic stroke, psychomotor excitement, chorea of Gentington, pregnancy, lactation period.
With care. Disturbance of a hemostasis, extensive surgical interventions, heavy bleeding, HPN (KK of 20-80 ml/min.).
Overdose:
Symptoms: abdominal pain, diarrhea with blood impurity.
Treatment: induction of vomiting, gastric lavage, symptomatic therapy, hemodialysis (efficiency of 50-60%). There is no specific antidote.
Storage conditions:
To store in the place protected from light at a temperature not above 20 °C. To store in the place, unavailable to children.
Issue conditions:
According to the recipe
Packaging:
Solution for intravenous and intramuscular administration of 200 mg/ml in ampoules from neutral glass of 5 ml. 5 ampoules in a blister strip packaging from a PVC film without foil polyvinyl chloride with the application instruction and the ampoule scarificator in a cardboard pack. One or two blister strip packagings with a knife ampoule and the application instruction in a cardboard pack.
10 ampoules with the application instruction, a knife ampoule in a cardboard pack with a corrugated insert from paper renal. When packaging import ampoules a knife ampoule or the scarificator does not invest in a pack.