Memotropil

General characteristics. Structure:

Active agent: piracetam of 800 mg or 1200 mg.

Excipients: cellulose microcrystallic, arboksimetilkrakhmat sodium, potato starch, silicon dioxide colloid, magnesium stearate.

Cover: a gipromelloza, a macrogoal 6000, talc, titanium dioxide, propylene glycol, dye a sunset yellow (Е ON) (tablets of 1200 mg), dye quinolinic yellow (Е 104) (tablets of 800 mg).

Pharmacological properties:

Pharmacodynamics. Active  component  is  piracetam,  cyclic  derivative gamma aminobutyric acid (GAMK).

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 (CNS) in various ways: changing the speed of spread of activation in a brain, improving microcirculation and metabolic processes in nervous cells, influencing rheological characteristics of blood, not having vasodilating effect.

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. Piracetam has tire-tread effect at dysfunction of a brain owing to a hypoxia and intoxication. Piracetam reduces expressiveness and duration of a vestibular nystagmus.

Pharmacokinetics. After intake piracetam is quickly and almost completely absorbed from digestive tract. Well gets into various bodies and fabrics. Bioavailability makes about 95%. After a single dose of drug in a dose of 2 g the maximum concentration in a blood plasma (Cmax) making 40-60 mkg/l is reached during 0,5 h and in cerebrospinal fluid - approximately in 5 h. Gets through hematoencephalic and placental barriers, and also through the membranes used at a hemodialysis. Does not communicate proteins of a blood plasma, it is not metabolized in an organism and allocated with kidneys in an invariable look by renal filtering. The drug elimination half-life (T Ѕ) from a blood plasma makes 4-5 hours and 8,5 hours of cerebrospinal fluid, is extended at a renal failure. The renal clearance of piracetam at healthy volunteers makes 86 ml/min. The pharmacokinetics of piracetam does not change at patients with a liver failure.

Indications to use:

- a symptomatic treatment of the psychoorganic syndrome, in particular, at elderly patients which is followed by decrease in the memory, dizziness lowered by concentration of attention, change of mood, disorder of behavior, gait disturbance and also at patients with Alzheimer's disease and dementia of altsgeymerovsky type;

- treatment of dizziness (вертиго) and the related disorders of balance, except for dizziness of vascular genesis and psychogenic dizziness;

- for treatment of a cortical myoclonia as mono - or complex therapy;

- as a part of complex therapy of a sickemia;

- treatment of a dyslexia at children in a complex with other methods.

Route of administration and doses:

Inside, during meal or on an empty stomach, washing down with liquid.

Attention! To accept the last single dose no later than 17 hours.

Daily dose - 0,03-0,16 g/kg, frequency rate of reception - 2-4 times a day. Duration of treatment is defined by the doctor depending on a disease and with dynamics of symptoms. The course of treatment makes of 2-3 weeks up to 2-6 months. In need of it it is possible to repeat in 6-8 weeks.

At treatment of a psychoorganic syndrome - the load dose within the first weeks of therapy makes up to 4,8 g/days, further pass to a maintenance dose - 1,2-2,4 g/days.

At a cortical myoclonia treatment 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 divided into 2-3 receptions. Each 6 months it is necessary to reduce a dose by 1,2 g each 2 days.

At treatment of dizziness and the related disorders of balance a dose - 2,4-4,8 g/days in 2-3 receptions.

At a sickemia a daily dose - 0,16 g/kg, divided into 4 receptions. During crisis - to 0,3 g/kg.

Use in pediatric practice. To children from 3 years appoint 0,03-0,05 g/kg/days in a dose. For children of 8 years and teenagers the recommended daily dose makes 3,2 g, divided into 2 receptions.

Dosing to patients 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 and to appoint drug according to this scheme of dosing:

Renal failure	KK (ml/min.)	Dosing mode
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	20-30	1/6 usual doses once
End-stage	<20	contraindicated

Features of use:

At treatment of patients with a cortical myoclonia it is necessary to avoid sharp interruption of treatment as it can cause resuming of attacks.

At prolonged treatment of elderly patients regular control of indicators of function of kidneys is recommended.

Side effects:

From TsNS and peripheral nervous system: motive disinhibition, irritability, drowsiness, depression, adynamy. These side effects arise at the patients of advanced age receiving drug in a dose more than 2,4 g/days more often. In most cases it is possible to achieve regress of similar symptoms, having lowered a drug dose. In isolated cases - dizziness, a headache, an ataxy, an aggravation of a course of epilepsy, extrapyramidal disturbances, a tremor, emotional lability, decline in the ability to concentration of attention, sleeplessness, excitement, alarm, hallucinations, increase in a libido.

 From cardiovascular system: seldom – decrease or  increase in arterial pressure.

From the alimentary system: in isolated cases - nausea, vomiting, diarrhea,  abdominal pains (including a gastralgia).

From a metabolism: increase in body weight -  arises at the patients of advanced age receiving drug in a dose more than 2,4 g/days more often.

From integuments - dermatitis, an itch, rashes. Allergic reactions: Quincke's disease.

Interaction with other medicines:

Piracetam increases efficiency of hormones of a thyroid gland and antipsychotic drugs (neuroleptics). At co-administration with neuroleptics piracetam reduces danger of emergence of extrapyramidal disturbances.

At simultaneous  use  with    the medicines exerting the stimulating impact on TsNS strengthening of the stimulating influence on TsNS is possible.

Interaction with clonazepam, Phenytoinum, phenobarbital, valproic acid is noted.

High doses (9,6 g/days) of piracetam increase efficiency of indirect anticoagulants at patients with venous thrombosis (bigger decrease in aggregation of thrombocytes, level of fibrinogen, Villebrand's factor, viscosity of blood and plasma in comparison with use only of indirect anticoagulants was noted).

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.

Piracetam does not oppress P450 cytochrome isoenzymes. Metabolic interaction with other drugs is improbable.

Reception of piracetam in a dose of 20 mg/days did not change the maximum concentration and the area under a curve "concentration time" of the antiepileptic drugs (carbamazepine, Phenytoinum, phenobarbital, valproic acid) in blood serum at the patient 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.

Contraindications:

- and ndividualny intolerance of piracetam or derivatives of a pirrolidon, and also other components of drug;

- psychomotor excitement at the time of purpose of drug;

- chorea of Gentington;

- acute disorder of cerebral circulation (hemorrhagic stroke);

- an end-stage of a renal failure (at clearance of creatinine less than 20 ml/min.);

- children's age up to 3 years.

With care:

- disturbance of a hemostasis;

- extensive surgical interventions;

- heavy bleeding.

Overdose:

Symptoms: the isolated case of development of the dispeptic phenomena in the form of diarrhea with blood and pains in a stomach at administration of drug is registered inside in a daily dose of 75 g.

Treatment: in case of overdose performing symptomatic therapy which can include a hemodialysis is recommended. There is no specific antidote. Efficiency of a hemodialysis for piracetam makes 50-60%.

Storage conditions:

In the dry, protected from light place, at a temperature not above 25 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated 800 mg, 1200 mg.

On 5 or 10 tablets in the blister from a foil PVC Is scarlet/.

2 or 6 blisters on 10 tablets or, together with the application instruction place 4 or 12 blisters on 5 tablets (20 or 60 tablets respectively) in a cardboard pack.