Piracetam

General characteristics. Structure:

Active ingredient: 400 mg of piracetam.

Excipients: calcium stearate, potato starch. The mass of contents of a kapsuyola - 0,43 g. Capsules (white No. 0) capsule cover excipients: titanium dioxide of E 171 - 2,0%. gelatin - to 100%.

The nootropic drug having direct influence on a brain.

Pharmacological properties:

Pharmacodynamics. Cyclic derivative din-aminomaslyannoy of acid (GAMK), nootropic means; influences directly a brain, improving cognitive (cognitive) processes, such as ability to training, memory, vnimayony, and also intellectual working capacity. Exerts impact on the central nervous system (CNS) in various ways: changes the speed of spread of activation in a brain, improves metabolic processes in neyorvny cells, improves microcirculation, influences rheological characteristics of blood, without having at the same time vazodilatiruyushchy effect. Improves communication between cerebral hemispheres and synaptic conduction in neocortical structures, improves a brain blood stream.

Inhibits aggregation of thrombocytes and recovers configuration properties of an outer membrane of rigid erythrocytes, and also ability of the last to a passage through vessels of a microcirculator bed. In a dose of 9,6 g reduces concentration of fibrinogen and Villebrand's factor by 30-40% and extends a bleeding time.

Has the tire-tread and recovering effect at dysfunction of a brain owing to a gipokyosiya and intoxication. Reduces expressiveness and duration of a vestibular nystagmus.

Pharmacokinetics. Absorption at intake bystry and full. Bioavailability - about 100%. After a single dose inside in a dose of 3,2 g the maximum concentration (Smakh) - 84 mkg/ml, after repeated (3,2 g 3 times a day)-115 mkg/ml, time of achievement of the maximum concentration (Tsmakh) in plasma - 1 h, cerebrospinal fluid (SMZh) - 5 h.

Meal is lowered by Smakh by 17% and Tsmakh to 1.5 h increases. Women have Smakh and AUC after reception of 2.4 g is 30% higher, than at men. Vd - about 0.6 l/kg. Gets through a blood-brain barrier (GEB) and a placental barrier: is removed at a hemodialysis. In experiments on animals selectively collects in tissues of a cerebral cortex, preimushcheyostvenno in frontal, parietal and occipital lobes, in a cerebellum and basal kernels.

Does not contact proteins of plasma, it is not metabolized. An elimination half-life (Т½) - 4-5 h from a blood plasma and 8,5 h - from SMZh. 80-100% of piracetam are removed by kidneys in not changed look by glomerular filtering. The general clearance - 80-90 ml/min. Т½ is extended at the chronic renal failure (CRF) (at terminal HPN - to 59 h). The liver failure does not influence piracetam pharmacokinetics.

Indications to use:

At adults: a symptomatic treatment of the psychoorganic syndrome which is followed by decrease in memory, a sniyozheniye of concentration of attention and activity, change of mood, disorder of behavior, disturbance of a pokhodyoka; 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 a complex terayopiya); prevention of drepanocytic vazookklyuzionny crisis.

At children: a dyslexia at children since 8 years in a complex with other methods. Prevention of drepanocytic vazookyoklyuzionny crisis.

Route of administration and doses:

Inside (during meal or on an empty stomach, washing down with liquid). 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 a neznachiyotelny therapeutic effrekt or its absence treatment is stopped. Prevention of drepanocytic vazookklyuzionny crisis (at adults and children) - inside on 160 mg/kg/days, razdeyolenny on 4 equal doses.

The dose less than 160 mg/kg/days or irregular administration of drug can cause a zaboyolevaniye aggravation. 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 the forthcoming extensive surgical interventions 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 a vozobyonovleniye 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.

During treatment it is necessary to be careful at control of vehicles and occupation of a drugiyoma potentially dangerous types of activity demanding the increased concentration of attention and speed of psikhoyomotorny reactions.

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.

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 antiyokoagulyant (more expressed decrease in aggregation of thrombocytes, contents of fibrinogen, Villebrand's factor, a vyazyokost of blood and plasma).

Contraindications:

Hypersensitivity, heavy HPN (KK less than 20 ml/min.), hemorrhagic stroke, psychomotor excitement, chorea of Gentington, pregnancy, lactation period.

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:

In the dry, protected from light place at a temperature not above 25 °C. In the place, unavailable to children, the Period of validity 3 years. Not to use after the expiry date specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Capsules of 400 mg. On 10 capsules in a blister strip packaging. 6 planimetric packagings together with the application instruction place in a pack from a cardboard.