Piracetam таб. п / lake of 200 mg, No. 60 Comte. cell. (in a pack)

General characteristics. Structure:

Active agent: piracetam of 200 mg; Excipients: povidone (polyvinylpirrolidone low-molecular medical), potato starch, magnesium hydroxycarbonate (magnesium carbonate the main), stearate calcium monohydrate, sucrose (sugar), silicon dioxide colloid (aerosil), talc, titanium dioxide, beeswax, liquid paraffin (liquid paraffin medical), dye quinolinic yellow E-104.

Pharmacological properties:

Exerts positive impact on exchange processes of a brain, increases concentration of adenosinetriphosphate in brain fabric, strengthens biosynthesis of RNA and phospholipids, stimulates glycoclastic processes, strengthens glucose utilization. Improves integrative activity of a brain, promotes memory consolidation, facilitates training process. Changes the speed of spread of activation in a brain, improves microcirculation, without having at the same time vasodilating effect, inhibits aggregation of the activated thrombocytes. Has protective action at the injuries of a brain caused by a hypoxia, intoxications, an electroshock strengthens alpha and beta activity, reduces delta activity on the electroencephalogram, reduces expressiveness of a vestibular nystagmus. Has no sedative, psychogogic influence. Drug improves bonds between cerebral hemispheres and synaptic conduction in neocortical structures, recovers and stabilizes cerebral functions, especially consciousness, memory and the speech, increases intellectual working capacity, improves a brain blood stream. After intake it is well soaked up and gets into various bodies and fabrics. Bioavailability, irrespective of a dosage form, makes about 95%. Time necessary for achievement of the maximum concentration – 0,5 - 1 h. Gets through hematoencephalic and placental barriers, collects in brain fabric in 1 - 4 h after intake. Out of cerebrospinal fluid it is brought much more slowly, than out of other fabrics. Practically it is not metabolized. An elimination half-life – 4,5 h (7,7 h - from a brain). It is removed by kidneys - 2/3 in not changed look during 30 h.

Indications to use:

Symptomatic treatment of a psychoorganic syndrome, in particular at the elderly patients suffering from decrease in the memory, dizziness lowered by concentration of attention and the general activity, lability of mood, disorder of behavior, gait disturbance and also at patients with Alzheimer's disease and senile dementia like Alzheimer. Effects of an ischemic stroke, such as disturbances of the speech, disturbances of the emotional sphere, for increase in motor and mental performance. An alcoholism - for treatment of psychoorganic and abstinent syndromes. The recovery period after craniocereberal injuries and intoxications of a brain. Dizzinesses and related disorders of balance. As a part of complex therapy of low learnability at children with a psychoorganic syndrome. In complex therapy of drepanocytic anemia.

Route of administration and doses:

Inside, during meal or on an empty stomach. Attention: to accept the last single dose no later than 17:00 for prevention of sleep disorders. A daily dose - 30-160 mg/kg of body weight, frequency rate of reception - 2 times/days, if necessary - 3-4 times/days. A course of treatment from 2-3 weeks to 2-6 months. If necessary the course of treatment is repeated. At therapy of a psychoorganic syndrome at elderly drug is appointed on 1,2-2,4 g/days; a load dose within the first weeks of therapy - to 4,8 g/days. Treatment by piracetam if necessary can be combined using psychotropic, heart vascular and other medicines. At treatment of effects of a stroke appoint 4,8 g/days. At treatment of effects of intoxications, in the posttraumatic period an initial dose - 9-12 g/days, supporting - 2,4 g, a course of treatment - not less than 3 weeks. This dosage form is recommended for children of 3 years - on 1 tablet 3 times a day. Maximum daily dose of-1,8 g. A course of treatment from 2 weeks to 2-6 months. At alcoholism - 12 g/days in the period of alcohol withdrawal manifestation; a maintenance dose - 2,4 g. At dizziness and the related disorders of balance of 2,4-4,8 g/days. At drepanocytic anemia a daily dose - 160 mg/kg of body weight, divided into 4 equal portions. Dosing by the patient with a renal failure As Piracetam is brought out of an organism by kidneys, it is necessary to be careful at treatment of patients with a renal failure in compliance with this scheme of dosing. The renal failure Clearance of creatinine (ml/min.) Dosing Norma > 80 Usual dose Easy 50 - 79 2/3 usual doses in 2 – 3 receptions Average  30 - 49 1/3 usual doses in 2 receptions Heavy <30 1/6 usual doses, once Final stage - contraindicated Elderly patient a dose korrigirutsya in the presence of a renal failure and at long therapy control of a functional condition of kidneys is necessary. Dosing by the patient with an abnormal liver function Patients with an abnormal liver function do not need dose adjustment. The patient with disturbance of functions and kidneys and a liver, dosing is carried out according to the scheme.

Features of use:

Due to the influence of piracetam on aggregation of thrombocytes, care at purpose of drug is recommended to patients with disturbance of a hemostasis, during big surgeries or the patient with symptoms of heavy bleeding. At treatment of patients with a cortical myoclonia it is necessary to avoid sharp interruption of treatment that can cause resuming of attacks. At long therapy of elderly patients regular control of indicators of function of kidneys is recommended, if necessary carry out dose adjustment depending on results of a research of clearance of creatinine. In view of possible side effects, it is necessary to be careful when performing work with mechanisms and driving of the car. Gets through the filtering membranes of devices for a hemodialysis.

Side effects:

Side effects are most often noted at elderly patients at doses  over 2,4 g/days. In most cases it is possible to achieve regress of similar symptoms, having lowered a drug dose. Nervousness, excitement, extrapyramidal disturbances, increase in body weight, it is rare - a depression, drowsiness, an adynamy. There are single messages on side effects from digestive tract, such as nausea, vomiting, diarrhea, abdominal pains and in a stomach; a nervous system - dizziness, headaches, an ataxy, balance disturbance, an aggravation of a course of epilepsy, sleeplessness, decline in the ability to concentration of attention, a hyperkinesia, a tremor; from mentality - confusion, excitement, alarm, hallucinations, increase in sexual activity; from integuments - dermatitis, an itch, rashes, hypostasis; others: deterioration in a course of stenocardia.

Interaction with other medicines:

Interaction with clonazepam, Phenytoinum, phenobarbital, sodium Valproatum is noted. High doses (9,6 g/days) of piracetam increased efficiency of an atsenokumarol at patients with venous thrombosis: bigger decrease in level of aggregation of thrombocytes, level of fibrinogen, Villebrant's factors, viscosity of blood and plasma was noted, than at appointment only an atsenokumarol. Increases efficiency of hormones of a thyroid gland, the acrimony, a disorientation, a sleep disorder is possible. The possibility of change of a pharmacodynamics of piracetam under the influence of other medicines is low as 90% of drug are removed in not changed view with urine. In vitro piracetam does not oppress P450 cytochrome of the CYP1A2, 2V6, 2S8, 2S9, 2S19, 2D6, 2E1 and 4A9/11 isoform in concentration of 142, 426 and 1422 mkg/ml. At concentration    of 1422 mkg/ml, small oppression of CYP2A6 (21%) and ZA4/5 (11%) is noted. However the Ki level of these two CYP isomers sufficient at exceeding of 1422 mkg/ml. Therefore metabolic interaction with other drugs is a little probable. Reception of piracetam in a dose of 20 mg/days did not change peak and a curve of level of concentration of antiepileptic drugs in blood serum (carbamazepine, Phenytoinum, phenobarbital, Valproatum) at the patients with epilepsy receiving a constant dosage. Joint reception with alcohol did not influence the level of concentration of piracetam in serum and concentration of alcohol in blood serum did not change at reception of 1,6 g of piracetam. Increases efficiency of antipsychotic medicines (neuroleptics). At simultaneous use with the medicines stimulating the central nervous system excessive stimulation of the central nervous system is possible. At appointment with neuroleptics reduces danger of emergence of extrapyramidal disturbances.

Contraindications:

Hypersensitivity, renal failure (clearance of creatinine less than 20 ml/min.), pregnancy, a lactation, children's age (up to 3 years), a hemorrhagic stroke, a depression with concern (the agitated depressions), a chorea of Gentington.

Overdose:

Strengthening of possible side effects. First aid - a gastric lavage, reception of absorbent carbon.

Storage conditions:

List B. In dry, protected from light and the place, unavailable to children, at a temperature not above 25 °C.

Issue conditions:

According to the recipe

Packaging:

Tablets, coated 200 mg. On 10 tablets in a blister strip packaging. On 60 tablets in banks from polymeric materials or in banks from glass melt. Each can, 3 or 6 blister strip packagings together with the application instruction place in a pack from a cardboard. It is allowed to apply the text of the application instruction on a pack.