Piracyzin - instructions for use, doses, side effects, contraindications

Composition of gelatin capsule shell: gelatin - 80,751 mg, glycerol - 0,121 mg. sodium lauryl sulfate - 0.055 mg, purified water - 13.92 mg, titanium dioxide - 1.153 mg.

The weight of the capsule is 556 mg ± 10%. The weight of the contents of the capsule is 460 mg ± 10%.

Description:

Capsules hard gelatinous № 0 cylindrical with hemispherical ends of white color. The contents of capsules are white or almost white powder.

Pharmacotherapeutic group:Nootropic agent.

ATX: & nbsp

N.06.B.X Other psychostimulants and nootropic drugs

Pharmacodynamics:

Piracesin ® is a combined medicinal product with a pronounced nootropic and vasodilating effect.

Pyracetam - cyclic derivative of GABA, nootropic agent; acts directly on the brain, improving cognitive (cognitive) processes, such as learning ability, memory, attention, and mental performance.It affects the central nervous system (CNS) in various ways: changes the velocity of propagation of the excitation in the brain, improves metabolic processes in nerve cells, improves acts on the rheological characteristics of the blood, without causing vasodilating action. Improves the connection between the cerebral hemispheres and synaptic conductivity in neocortical structures, improves cerebral blood flow. Inhibits the aggregation of platelets and restores the configuration properties of the outer membrane of rigid red blood cells, as well as the ability of the latter to pass through the vessels of the microcirculatory bed. At a dose of 9.6 g reduces the concentration of fibrinogen and von Willebrand factor by 30-40% and prolongs bleeding time. It has a protective and restoring effect when the brain function is impaired due to hypoxia and intoxication. Reduces the severity and duration of the vestibular nystagmus.

Cinnarizine - a selective blocker of "slow" calcium channels, inhibits the entry of calcium ions into cells and reduces their content in the depot of the plasmolemma, reduces the tone of the smooth muscles of arterioles,reduces their reaction to biogenic vasoconstrictors (epinephrine, norepinephrine, dopamine, angiotensin II, vasopressin). It has a vasodilating effect (especially with respect to cerebral vessels), without having a significant effect on blood pressure.

Pharmacokinetics:

Absorption of piracetam for oral administration is rapid and complete. Bioavailability is about 100%. After a single oral dose at a dose of 3.2 g, the maximum concentration is 84 μg / ml, after multiple (3.2 g 3 times daily) - 115 μg / ml, the therapeutic maximum plasma concentration is 1 hour, cerebrospinal fluid -5 h The intake of food reduces the maximum concentration by 17% and increases the therapeutic maximum concentration to 1.5 hours. In women, the maximum concentration and the degree of accessibility after taking 2.4 g is 30% higher than that of men. The volume of distribution is about 0.6 l / kg. Penetrates through the blood-brain barrier and placental barrier; is removed during hemodialysis. Does not bind to plasma proteins, it is not metabolized. The half-life is 4 to 5 hours from the blood plasma and 8.5 hours from the cerebrospinal fluid. 80 - 100% of piracetam is excreted by the kidneys unchanged by glomerular filtration. The total clearance is 80 - 90 ml / min.The half-life is prolonged in chronic renal failure. Hepatic insufficiency does not affect the pharmacokinetics of piracetam.

Cinnarizine is well absorbed. When administered, the maximum concentration is noted after 3-3 hours. Cinnarizine is actively metabolized. 1/3 metabolites are excreted in the urine, 2/3 - with feces.

The half-life of cinnarizine is about 4 hours.

Indications:

In the complex therapy of chronic cerebrovascular insufficiency, CNS diseases, accompanied by a decrease in intellectual-mnestic functions, psychoorganic syndrome with predominance of signs of asthenia and adynamia, asthenia of psychogenic origin, labyrinthopathy, Meniere syndrome, for the prevention of migraine and kinetosis.

Contraindications:

Hypersensitivity to the drug components, chronic renal failure (creatinine clearance less than 20 ml / min), Parkinsonism (including Parkinson's disease), hemorrhagic stroke, Huntington's chorea, psychomotor agitation, pregnancy, breastfeeding period, children's age (under 18 years) ).

Carefully:

violation of hemostasis;
extensive surgical interventions;
heavy bleeding;
chronic renal failure (creatinine clearance 20 - 80 ml / min).

Pregnancy and lactation:

The drug is contraindicated in pregnancy and during breastfeeding.

Dosing and Administration:

Inside, during or after a meal.

1-3 capsules 3 times a day. The course of treatment - 1-3 months.

In chronic renal failure (creatinine clearance less than 60 ml / min), a dose reduction or an increase in the interval between taking the drug is necessary.

Side effects:

From the side of the central nervous system: motor disinhibition, irritability, drowsiness, depression, asthenia, headache, insomnia, mental agitation, imbalance, ataxia, exacerbation of epilepsy, anxiety, hallucinations, confusion.

From the digestive system: nausea, vomiting, diarrhea, abdominal pain.

From the side of metabolism: increase in body weight.

From the senses: vertigo.

From the skin: dermatitis, itching, urticaria.

Allergic reactions: hypersensitivity, anaphylactic reactions, angioedema.

Overdose:

Symptoms: abdominal pain, diarrhea with an admixture of blood.

Treatment: induction of vomiting, gastric lavage, symptomatic therapy, hemodialysis (efficacy is 50-60%). There is no specific antidote.

Interaction:

Strengthens the effects of nootropic, hypotensive drugs, drugs that depress the central nervous system (including ethanol).

With the simultaneous use of vasodilators enhance the action of cinnarizine, and hypertensive drugs reduce it.

When used simultaneously with iodine-containing hormones of the thyroid gland, confusion, irritability and sleep disturbance may occur.

In high doses (9.6 r / day) in patients with venous thrombosis increases the anticoagulant effect of indirect anticoagulants (more pronounced decrease in platelet aggregation, fibrinogen content, Widgetbrand factor, viscosity of blood and plasma).

Special instructions:

Due to the influence of piracetam on platelet aggregation, caution is recommended when prescribing a drug to patients with hemostasis disorder, during major surgeries or patients with symptoms of severe bleeding.

With prolonged therapy of elderly patients, regular monitoring of renal function indicators is recommended,if necessary, dose adjustment is performed depending on the results of the study of creatinine clearance.

During the treatment it is necessary to monitor liver function.

During treatment, alcohol should be avoided.

Effect on the ability to drive transp. cf. and fur:

During the treatment period, care must be taken when driving a car and engaging in activities that require a high concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Capsules 400 mg + 25 mg.

Packaging:

10 capsules per contour cell package (blister) made of polyvinylchloride film and aluminum foil. For 1, 6 contour squares (blisters) together with the instruction for use are put in packs of cardboard.

Storage conditions:

In dry, dark place at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N016013 / 01

Date of registration:03.11.2009

The owner of the registration certificate:MINSKINTERKAPS, UP MINSKINTERKAPS, UP Republic of Belarus

Manufacturer: & nbsp

MINSKINTERKAPS, UP Republic of Belarus

Representation: & nbspMINSKINTERKAPS MINSKINTERKAPS Republic of Belarus

Information update date: & nbsp12.08.2015

Illustrated instructions

Instructions

Piracesine (Piracezine)