Piratsetam-Darnitsa, tab. of 0.4 g No. 30

General characteristics. Structure:

Active ingredient: piracetam;

1 tablet contains 200 mg of piracetam;

excipients: magnesium carbonate light, potato starch, povidone, calcium stearate, gipromelloz, macrogoal 4000, titanium dioxide (Е 171), quinolinic yellow (Е 104).

Pharmacological properties:

Piracetam is nootropic means which has effect on a brain, improving cognitive (cognitive) processes, such as ability to training, memory, attention, and also intellectual working capacity. Piracetam exerts impact on TsNS in various ways: change of speed of spread of activation in a brain, improvement of metabolic processes in nervous cells, microcirculation improvement, influencing rheological characteristics of blood and not having vasodilating effect. Improves communication between cerebral hemispheres and synaptic conduction in not cortical structures. Piracetam inhibits aggregation of thrombocytes and recovers elasticity of membranes of erythrocytes, reduces adhesion of erythrocytes. In a dose of 9,6 g reduces the level of fibrinogen and Villibrand's factors by 30-40% and extends a bleeding time. Piracetam reduces expressiveness and duration of a vestibular nystagmus.

After administration of drug inside piracetam is quickly and almost completely soaked up, peak concentration is reached in 1 hour after reception. Bioavailability of drug makes about 100% after reception of a single dose of 2 g. Piracetam distribution volume – about 0,6 l/kg. The drug elimination half-life from a blood plasma makes 4-5 hours and 8,5 hours – of cerebrospinal fluid which is extended at a renal failure. Does not contact proteins of a blood plasma, it is not metabolized in an organism. 80-100% of piracetam are removed by kidneys in not changed look by renal filtering. The renal clearance of piracetam at healthy volunteers makes 86ml/min. The pharmacokinetics of piracetam does not change at patients with a liver failure. Piracetam gets through hematoencephalic and placental barriers and membranes which are used at a hemodialysis. At a research on animals piracetam selectively collects in tissues of a cerebral cortex, is preferential in frontal, temporal and occipital lobes, in a cerebellum and basal gangliya.

Indications to use:

Adults:

- a symptomatic treatment of the psychoorganic syndrome which is followed by decrease in memory, dizzinesses, decrease in concentration of attention;

- treatment of dizziness and the related disorders of balance, except for dizzinesses of a vasculomotor and mental origin;

- treatment of a cortical myoclonia as monodrug or as a part of complex therapy;

- treatment of an alcoholism and alcoholic abstinence.

Children:

- treatment of a dizleksiya at children aged from 8 years in combination with other appropriate methods, including logopedics.

Route of administration and doses:

Drug is used in inside to or during food. Tablets should be washed down with liquid (water or juice).

Treatment of a psychoorganic syndrome.

The daily dose of 2,4 - 4,8 is recommended. Usually the dose is divided into 2-3 receptions. A maintenance dose – 2,4 g a day. Treatment continues not less than 3 weeks.

Treatment of a cortical myoclonia.

The initial dose usually makes 24 g a day within 3 days. The daily dose is distributed on 2 - 3 receptions. If the therapeutic effect weak or at all is absent - continue use of drug in the same dose up to 7 days. If for this term the desirable therapeutic effect is not gained, treatment piracetam it is necessary to stop and appoint other anti-myoclonic means. In case of obtaining necessary therapeutic effect treatment is continued before disappearance of symptoms of a disease. For the prevention of an aggravation of symptoms of patients it is impossible to stop administration of drug sharply. It is necessary to lower gradually a dose by 1-2 g each 2-3 days (each 3-4 days in case of Lantsa-Adams's syndrome). At use during treatment of other antimioklonichny means the dose of piracetam does not decrease, but, depending on a clinical picture, dosages of other drugs can decrease if it is possible. Patients with bad spontaneous attacks need to appoint each 6 months repeated courses of treatment drug, adjusting at the same time a dose depending on a condition of the patient, disappearance or reduction of displays of a disease.

Treatment of dizziness and related disorders of balance.

The recommended daily dose makes 2,4-4,8 g. Usually the dose is distributed on 2-3 receptions.

Treatment of alcoholism, including chronic.

Appoint during the acute period 12 g a day. After obtaining therapeutic effect the maintenance dose makes 2,4 g a day.

Use for children.

As a part of complex therapy of a dizleksiya.

Apply to children 8 years are more senior. The daily dose makes usually 3,2 g, divided into 2 receptions.

The dose mode for patients with renal failures. As piracetam is removed from an organism by kidneys, it is necessary to show care at treatment of patients with a renal failure, adhering to such recommendations:

 

Degree renal     Clearance of creatinine (ml/min.)                Dosing
insufficiency
 Norm                                          > 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
End-stage                      -                                   it is contraindicated

It is not necessary to adjust doses for patients with a liver failure.

Features of use:

Necessary actions for safety at use.

Due to the influence of piracetam on aggregation of thrombocytes patients need care at purpose of drug with disturbances 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, it can cause resuming of attacks. At prolonged treatment of patients of advanced age carry out dose adjustment depending on results of a research of clearance of creatinine. Gets via membrane filters of devices for a hemodialysis.

Use during pregnancy or feeding by a breast.

Not to use drug during pregnancy. Drug gets into breast milk. It is necessary to abstain from feeding by a breast during treatment by drug.

Ability to influence speed of response at control of motor transport or work with other mechanisms.

It is necessary to be careful at control of motor transport or work with other mechanisms because of a possibility of development of side reactions from the central nervous system.

Children.

Use drug at children 8 years are more senior.

Side effects:

From a nervous system: often: hyperkinesia; sometimes: ataxy, nervousness, excitement, irritability, uneasiness, sleep disorder, dizziness, extrapyramidal disturbances, headache, depression, sleeplessness, increase in frequency of attacks of epilepsy, tremor, spasms, balance disturbance, drowsiness.
Mental disorders: hypererethism, drowsiness, depression, uneasiness, confusion of consciousness, hallucination. At children, especially mentally retarded: fussiness, uneasiness, restlessness, motive disinhibition, decline in the ability to concentration of attention, disbalance, irritability, the raised conflictness.
From the alimentary system: anorexia, an abdominal pain, pain in an upper part of a stomach, nausea, diarrhea, vomiting, a lock.
From immune system: hypersensitivity, including anaphylaxis.
From a reproductive system: increase in sexual activity.
From skin and hypodermic fabrics: Quincke's disease, dermatitis, itch, rash, urticaria.
Others: increase in body weight, adynamy, deterioration in a course of stenocardia, arterial hypertension, thrombophlebitis, hyperthermia.

Interaction with other medicines:

Treatment by piracetam if necessary can be combined using cardiovascular medicines. At treatment of psychiatric diseases - with the appropriate psychotropic drugs.

At simultaneous use with extract of a thyroid gland (T3 + T4) are possible: acrimony, disorientation and sleep disorder. Interaction with clonazepam, Phenytoinum, phenobarbital, sodium Valproatum is noted.

High doses (9,6 g/days) of piracetam can increase efficiency of an atsenokumarol at patients with venous thrombosis: bigger decrease in level of aggregation of thrombocytes, level of fibrinogen, Villebrandt's factor, viscosity of blood and plasma was noted, than at appointment only an atsenokumarol.

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 142, 426, 1422 mkg/ml. At concentration of 1422 mkg/ml small oppression of CYP2A6 (21%) and ZA4/5 (11%) is noted. However level Кі of these two CYP isomers sufficient at exceeding of 1422 mkg/ml. Therefore metabolic interaction with drugs which give in to biotransformation these enzymes is improbable.

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 patients with epilepsy.

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 a single dose 1,6g piracetam.

At elderly people strengthens action of anti-anginal means, increases efficiency of antidepressants.

Contraindications:

Individual hypersensitivity to piracetam or derivatives of a pirrolidon, and also other components of drug.

Acute disorder of cerebral circulation (hemorrhagic stroke).

End-stage of a renal failure (the clearance of creatinine is less than 20 ml/min.)

Huntington chorea.

Pregnancy and period of feeding by a breast.

Children's age up to 8 years. Not to apply to the children having diabetes and with existence in the past of data on the allergic reactions connected with the use of fruit juice.

Overdose:

Symptoms: strengthening of manifestations of side effect of drug (dispeptic phenomena, hemocolitis, abdominal pain and others).
Symptomatic treatment. There is no specific antidote, it is possible to apply a hemodialysis (a conclusion of 50 - 60% of piracetam).

Storage conditions:

Period of validity. 5 years. To store in original packaging at a temperature not higher than 25 ° C. To store in the place, unavailable to children.

Issue conditions:

Without recipe

Packaging:

Packaging. On 10 tablets in a blister strip packaging, on 6 blister strip packagings in a pack.