Pyracetam - instructions for use, dose, side effects, contraindications

The composition of the gelatin capsule shell: gelatin - 80,751 mg, glycerin - 0,121 mg, sodium lauryl sulfate - 0.055 mg, purified water - 13.92 mg, titanium dioxide - 1.153 mg.

Description:

Capsules hard gelatinous № 0 cylindrical with hemispherical ends of white flowers. The contents of capsules are white or almost white powder with a weak yellowish tinge.

Pharmacotherapeutic group:Nootropic agent.

ATX: & nbsp

N.06.B.X.03 Pyracetam

Pharmacodynamics:

The active component of the drug is piracetam, a cyclic derivative of gamma-aminobutyric acid.

Pyracetam is a nootropic remedy that directly affects the brain, improving cognitive (cognitive) processes, such as learning ability, memory, attention, and mental performance. Pyracetam affects the central nervous system in various ways: by changing the rate of spread of excitation in the brain, improving metabolic processes in nerve cells, improving microcirculation, affecting the rheological characteristics of the blood and not causing vasodilating action.

Improves communication between the cerebral hemispheres and synaptic conductivity in neocortical structures, increases mental capacity, improves cerebral blood flow.

Pyracetam inhibits platelet aggregation and restores the elasticity of the erythrocyte membrane, reduces the adhesion of erythrocytes. At a dose of 9.6 g reduces the level of fibrinogen and von Willebrand factors by 30-40% and prolongs bleeding time.

Piracetam has a protective and restoring effect when brain function is impaired due to hypoxia and intoxication.

Pyracetam reduces the severity and duration of the vestibular nystagmus.

Pharmacokinetics:

Absorption at ingestion is fast and complete. Bioavailability is about 100%. After a single oral intake at a dose of 3.2 g C_max - 84 μg / ml, after repeated (3.2 g 3 times daily) - 115 μg / ml, TS_max in plasma -1 h, cerebrospinal fluid -5 h. Food intake decreases Stach by 17% and increases TS_max up to 1.5 hours. For women C_max and AUC after taking 2.4 grams is 30% higher than in men.

Vd - about 0,6 l / kg. Penetrates through the blood-brain and placental barrier; is removed during hemodialysis.

Does not bind to plasma proteins, it is not metabolized.

The half-life of the drug from the blood plasma is 4 to 5 hours and 8.5 hours from the cerebrospinal fluid, which is prolonged in patients with chronic renal failure (in terminal chronic renal failure, up to 59 hours). 80- 100% of pyracetam is excreted by the kidneys unchanged by glomerular filtration. The total clearance is 80 - 90 ml / min. The pharmacokinetics of pyracetam does not change in patients with hepatic insufficiency.

Indications:

Symptomatic treatment of psycho-organic syndrome, in particular in elderly patients suffering from memory loss, dizziness, reduced concentration of attention and general activity,lability of mood, behavioral disorder, Alzheimer's disease and senile dementia of the Alzheimer's type.

Dizziness (vertigo) and associated disorders of equilibrium (with the exception of vertigo of the vasomotor and psychogenic origin).

Cortical myoclonia (monotherapy or as part of complex therapy). Prevention of sickle-cell vaso-occlusive crisis.

Treatment of dyslexia in children from the age of 8, in combination with other methods, including speech therapy.

Contraindications:

Individual intolerance to piracetam or pyrrolidone derivatives, as well as other components of the drug.
Psychomotor agitation at the time of prescribing.
Horea Huntington.
Acute disturbance of cerebral circulation (hemorrhagic stroke).
Severe stage of chronic renal failure (with creatinine clearance less than 20 ml / min).
Pregnancy and the period of breastfeeding.
Children up to 3 years.

Carefully:

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

Pregnancy and lactation:

Contraindicated in pregnancy and during breastfeeding.

Dosing and Administration:

Inside (during meals or on an empty stomach, squeezed with liquid).

The last dose is taken no later than 17 hours (to prevent sleep disturbance). The daily dose is divided into 2-4 admission.

Symptomatic treatment of psycho-organic syndrome: 4.8 g / day during the first week, then pass to a maintenance dose of 1.2-2.4 g / day.

Treatment of dizziness and related imbalances: 2.4-4.8 g / day. Treatment of cortical myoclonus: I start with a dose of 7.2 g / day every 3-4 days, increase the dose of 4.8 g / day to a maximum dose of 24 g / day. Treatment continues throughout the period of the disease. Every 6 months, you should try to reduce the dose or cancel the drug, gradually reducing the dose by 1.2 g / day every 2 days. With little or no therapeutic effect, treatment is discontinued.

In the sickle-cell vaso-occlusive crisis (in adults and children): prophylaxis - inside at 160 mg / kg / day, divided into 4 equal doses. Dose less than 160 mg / kg / day or irregular intake of the drug may cause an exacerbation of the disease.

Treatment of dyslexia in children older than 8 years (in conjunction with other methods of treatment) - 3.2 grams, divided into 2 equal doses.

Dosing to patients with impaired renal function

Because the Pyracetam is excreted from the body by the kidneys, care should be taken when treating patients with chronic renal insufficiency in accordance with this dosing regimen.

Chronic Renal Failure	Creatinine clearance (ml / min)	Dosing
Norm	>80	Usual Dose
Lightweight	50-79	2/3 of the usual dose in 2 to 3 doses
Average	30-49	1/3 of the usual dose in 2 divided doses
Heavy	<30	1/6 of the usual dose, once
The final stage	-	contraindicated

Elderly, the dose is corrected in the presence of renal failure and with prolonged therapy requires monitoring of the functional state of the kidneys.

Dosing to patients with impaired liver function

Patients with a dysfunction of the liver do not need a dose adjustment. Patients with impaired functions and kidneys, and liver, dosing is carried out according to the scheme (see Section "Dosing to patients with impaired renal function").

Side effects:

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

From the sense organs: vertigo.

From the cardiovascular system: rarely - a decrease or increase in blood pressure.

From the digestive system: in isolated cases - nausea, vomiting, diarrhea, abdominal pain (including gastralgia).

From the side of metabolism: an increase in body weight - often occurs in elderly patients who received the drug at a dose of more than 2.4 g / day.

From the skin: dermatitis, itching, rashes.

Allergic reactions: angioedema, hypersensitivity, anaphylactic reactions.

Overdose:

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

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

Interaction:

The possibility of changing the pharmacokinetics of piracetam under the influence of other drugs is low, since 90% of the drug is excreted unchanged in urine.

Special instructions:

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

In the treatment of patients with cortical myoclonia, sudden interruption in treatment should be avoided, which can lead to the resumption of seizures.

When treating a veno-occlusive crisis with sickle-cell anemia, a dose of less than 160 mg / kg or an irregular intake of the drug may cause a recurrence of the crisis.

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.

It penetrates the hemodialysis apparatus through the filter membranes.

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

Piracetam should be used with caution during work drivers of vehicles and people whose profession is associated with increased concentration of attention.

Form release / dosage:

Capsules 400 mg.

Packaging:

For 10 capsules in a contour squad package, 6 contour packs with instructions for use in a pack of cardboard box.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N015177 / 01-2003

Date of registration:31.07.2008

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

Manufacturer: & nbsp

MINSKINTERKAPS, UP Republic of Belarus

Information update date: & nbsp22.09.2015

Illustrated instructions

Instructions

Pyracetam (Piracetam)