Пирацетам-Ферейн®

General characteristics. Structure:

Active ingredient: 200 mg of piracetam in 1 l of solution.

Excipients: sodium acetate, acetic acid divorced, water for injections.

Pharmacological properties:

Pharmacodynamics. 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.

Pharmacokinetics. The drug elimination half-life from a blood plasma makes 4-5 hour and 8,5 hours of medullispinal liquid 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:

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, change of mood, disorder of behavior, gait disturbance and also at patients with Alzheimer's disease and senile dementia like Alzheimer.

Treatment of effects of a stroke (chronic stage of an ischemic stroke), such as disturbances of the speech, disturbances of the emotional sphere, for increase in motor and mental performance.
 
Alcoholism - for treatment of psychoorganic and abstinent syndromes. Comas (and during recovery) including after injuries and intoxications of a brain.

Treatment of dizziness of vascular genesis.

For treatment of a cortical myoclonia as mono - or complex therapy. In complex therapy серповидноклеточнрй anemias.

Route of administration and doses:

Intravenously or intramusculary. At a symptomatic treatment of a chronic psychoorganic syndrome, depending on expressiveness of symptoms appoint 2-4 g, gradually raising a dose to 4-6 g a day, a course of treatment of 10-15 days.

At treatment of effects of a stroke (a chronic stage) appoint 4,8 g/days, a course of treatment of 10-15 days, if necessary repeated courses in 6-8 weeks.

At treatment of comas, and also difficulties of perception at persons with brain injuries the initial dose makes 9-12 g/days, supporting - 2 g/days. Treatment continues not less than 3 weeks.

At an alcoholic abstinence syndrome - 12 g/days. Maintenance dose of 2,4 g/days. Treatment of dizziness and the related disorders of balance of 2,4 - 4,8 in day, a course of treatment of 10-15 days.

To children appoint at the rate of 30 - 50 mg/kg.

At drepanocytic anemia the daily preventive dose for adults and children since 1 makes 160 mg/kg of body weight, divided into four equal doses. During crisis - 300 mg/kg intravenously.

Dosing by the patient with a renal failure. As Piracetam is removed from 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.

• Norm: KK > 80 - a usual dose;
• Easy degree of a renal failure: KK 50-79 - 2/3 usual doses in 2 - 3 receptions;
• Average degree of a renal failure: KK 30-49 - 1/3 usual doses in 2 receptions;
• Heavy degree of a renal failure: KK < 30 - 1/6 usual doses, once;
• Final stage of a renal failure - it is contraindicated.

The dose is adjusted by the elderly patient in the presence of a renal failure, 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.

Dosing by the patient with a renal failure and a liver. Dosing is carried out according to the scheme "Dosing by the Patient with a Renal Failure". 

Features of use:

Pregnancy and lactation. Researches on animals did not reveal the damaging action on an embryo and its development, including in the post-natal period, and also did not change the course of pregnancy and childbirth. Researches on pregnant women were not conducted. Пирацетам-Ферейн®проникает through a placental barrier and in breast milk. Concentration of drug at newborns reaches 70-90% of concentration it in blood at mother. Except for special circumstances it should not be appointed during pregnancy. It is necessary to refrain from breastfeeding at appointment to the woman of Piratsetama-Fereyn®.

Due to the influence of Piratsetama-Fereyn® 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:

There are single messages on side effects from the alimentary system - nausea, vomiting, diarrhea, a gastralgia.

From cardiovascular system - change of arterial pressure, deterioration in a course of stenocardia;

from a nervous system - dizziness, a headache, an ataxy, balance disturbance, an aggravation of a course of epilepsy, motive disinhibition, sleeplessness or drowsiness, irritability, disbalance, extrapyramidal disturbances (including a hyperkinesia), spasms, a tremor;

from mentality - confusion, nervousness, excitement, uneasiness, hallucinations, decrease in concentration of attention, a depression;

allergic reactions - dermatitis, an itch, rashes, hypostasis;

others - increase in sexual activity, increase in body weight, an adynamy.

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.

Interaction with other medicines:

Interaction with clonazepam, Phenytoinum, phenobarbital, sodium Valproatum is noted.

High doses (9,6 g/days) Piratsetama-Fereyn® increased efficiency of an atsenokumarol at patients with venous thrombosis: bigger decrease in level of aggregation of thrombocytes, level of fibrinogen, Villibrand'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 Piratsetama-Fereyn® under the influence of other medicines is low as 90% of drug are removed in not changed view with urine.

Joint reception with alcohol does not influence the level of concentration of piracetam in blood serum, concentration of alcohol in blood serum does not change at reception of 1,6 g of Piratsetama-Fereyn®.

Contraindications:

Individual intolerance of piracetam or derivatives of a pirrolidon, and also other components of drug. Acute stage of a hemorrhagic stroke.

Final stage of a renal failure (at clearance of creatinine less than 20 ml/min.). Psychomotor excitement. Children's age till 1 year.

With care. Disturbance of a hemostasis, extensive surgical interventions, heavy bleeding.

Storage conditions:

List B. In the place protected from light, at a temperature not above 25 °C. To store in the place, unavailable to children. A period of validity - 5 years. Not to apply after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Solution for intravenous and intramuscular administration of 200 mg/ml. On 5 ml in ampoules of neutral glass. On 5 ampoules place in a blister strip packaging from a film polyvinyl chloride. On 5 ampoules place in a blister strip packaging from a film of the polyvinyl chloride and printing aluminum foil varnished or a packing material. 1, 2 blister strip packagings together with the application instruction and a knife ampoule or the scarificator ampoule place in a pack from a cardboard. On 6 ampoules place in a blister strip packaging from polyethylene of high pressure. 2 blister strip packagings but 6 ampoules together with the application instruction and a knife ampoule or the scarificator ampoule place in a pack from a cardboard. On 5, 6, 10 or 12 ampoules together with the application instruction and a knife ampoule or the scarificator ampoule place in a pack with an insert with cells for ampoules in 1 or 2 rows from a cardboard. When using ampoules with a point or a ring of a break the knife ampoule or the scarificator ampoule is not put.