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

Each tablet contains 200, 400 or 800 mg of piracetam as an active ingredient; auxiliary substances - polyethylene glycol 6000, sodium croscarmellose (impellose), magnesium stearate, aerosil (silicon dioxide colloid), hydroxypropyl cellulose, (USP 24), titanium dioxide, quinoline yellow.

Description:

The tablets covered with a cover of yellow color, with a dosage of 200 mg round, biconvex form, with a dosage of 400 mg and 800 mg - biconvex, oblong with rounded ends, with a risk. Two layers are visible on the cross-section.

Pharmacotherapeutic group:Nootropic agent.

ATX: & nbsp

N.06.B.X.03 Pyracetam

Pharmacodynamics:

Pyracetam is a cyclic derivative of gamma-aminobutyric acid (GABA), is a nootropic remedy that directly affects the brain, improves cognitive processes (learning ability, memory, attention, mental performance). It influences the central nervous system in various ways: it changes the rate of spread of excitation in the brain, improves metabolic processes in nerve cells, improves microcirculation, influences the rheological characteristics of the blood and does not cause vasodilation.

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, prolongs bleeding time.

Improves interhemispheric connections in the brain and synaptic conductivity in neocortical structures.

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

Reduces the severity and duration of the vestibular nystagmus.

Pharmacokinetics:

When taking the drug inside quickly and almost completely absorbed, peak concentration is achieved 1 hour after admission. Bioavailability of the drug is approximately 100%. After taking a single dose of 2 g the maximum concentration is 40-60 μg / ml, which is achieved in the blood after 30 minutes and after 5 hours in the cerebrospinal fluid after intravenous administration. The apparent volume of distribution of pyracetam is about 0.6 l / kg. The half-life of the drug from the blood plasma is 4-5 hours and 8.5 hours from the cerebrospinal fluid, which is prolonged with renal failure. The pharmacokinetics of pyracetam does not change in patients with hepatic insufficiency.

Penetrates through the blood-brain and placental barrier and membranes used in hemodialysis. When tested on animals piracetam selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, the cerebellum and basal ganglia. It does not bind to blood plasma proteins and is not metabolized in the body. 80-100% of piracetam is excreted by the kidneys unchanged by renal filtration.The renal clearance of piracetam in healthy volunteers is 86 ml / min.

Indications:

Symptomatic treatment of psycho-organic syndrome, in particular in elderly patients suffering from memory loss, dizziness, reduced concentration of attention and general activity, mood changes, behavioral disorders, gait disorders, as well as patients with Alzheimer's disease and senile dementia of Alzheimer's type.

The consequences of ischemic stroke - speech disturbances, emotional disorders, decreased motor and mental activity.

Chronic alcoholism - for the treatment of psycho-organic and abstinence syndromes.

The recovery period after injuries and intoxications of the brain.

Dizziness and related disorders of balance, with the exception of dizziness of the vasomotor and psychic origin.

In the complex therapy of low learning in children with psycho-organic syndrome.

For the treatment of cortical myoclonia as a mono- or complex therapy.

In the complex therapy of sickle-cell anemia.

Contraindications:

Individual intolerance to piracetam or pyrrolidone derivatives, as well as other components of the drug.
Acute disturbance of cerebral circulation (hemorrhagic stroke).
The final stage of renal failure (with creatinine clearance less than 20 ml / min).
Children up to 1 year.

Pregnancy and lactation:

Piracetam penetrates the placental barrier and into breast milk. The concentration of the drug in newborns reaches 70-90% of its concentration in the blood of the mother. Except in special circumstances piracetam should not be administered during pregnancy. It should be refrained from breastfeeding with the appointment of a woman piracetam.

Dosing and Administration:

Inside is prescribed during a meal or on an empty stomach, washed down with a liquid (water, juice). The daily dose is 30-160 mg / kg, the frequency of reception is 2-4 times a day.

With symptomatic treatment of chronic psychoorganic syndrome, depending on the severity of symptoms, 1.2-2.4 g is prescribed, and during the first week - 4.8 g per day.

When treating the consequences of stroke appoint 4.8 g / day.

With alcohol withdrawal syndrome - 12 g / day. Maintenance dose of 2.4 g / day.Treatment of dizziness and associated disorders of equilibrium 2.4-4.8 g per day. Children for correction of low learning capacity dose is 3.3 g / day. Treatment continues throughout the school year.

In cortical myoclonia, treatment starts at 7.2 g / day, every 3-4 days the dose increases by 4.8 g / day until a maximum dose of 24 g / day is reached. Treatment continues throughout the period of the disease. Every 6 months, attempts are made to reduce the dose or discontinue the drug, to prevent an attack gradually reducing the dose by 1.2 g every 2 days. In the absence of effect or a slight therapeutic effect, treatment is discontinued.

With sickle cell anemia, the daily prophylactic dose is 160 mg / kg body weight divided into four equal doses.

Dosing to patients with impaired renal function. Because the piracetam is excreted from the body by the kidneys, care should be taken when treating patients with renal insufficiency in accordance with this dosing regimen.

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	30-20	1/6 of the usual dose, once

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:

Hyperkinesis, weight gain, drowsiness, irritability, depression, asthenia.

Most often occur in elderly patients receiving doses above 2.4 g / day. In most cases, it is possible to regress such symptoms by lowering the dose of the drug. There are isolated reports of side effects from the gastrointestinal tract, such as nausea, vomiting, diarrhea, abdominal pain; nervous system - dizziness, headaches, ataxia, imbalance, exacerbation of epilepsy, insomnia; from the side of the psyche - confusion, agitation, anxiety, hallucinations, increased sexuality; from the skin - dermatitis, itching, rashes, swelling.

Overdose:

When 75 g of piracetam was taken, dyspeptic phenomena such as diarrhea with blood and abdominal pain were noted.

Treatment: gastric lavage, symptomatic therapy (may include hemodialysis). There is no specific antidote. The efficacy of hemodialysis is 50% - 60% for piracetam.

Interaction:

When combined with thyroid hormones (TZ + T4), there may be increased irritability, disorientation and sleep disturbances. No interaction with clonazepam, phenytoin, phenobarbital, sodium valproate has been observed.

High doses (9.6 g / day) of piracetam increased the efficacy of acenocoumarol in patients with venous thrombosis: there was a greater decrease in platelet aggregation, fibrinogen, von Willebrand factors, viscosity of blood and plasma than in the administration of acenocoumarol alone.

Changeable pharmacodynamics piracetam under the influence of other drugs is low, since 90% of the drug is excreted unchanged in the urine.

Joint reception with alcohol does not affect the level of concentration of pyracetam in the blood plasma.

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.

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:

Taking into account possible side effects, care should be taken when working with mechanisms and driving a car.

Form release / dosage:Tablets coated with a coating, 200 mg, 400 mg and 800 mg.

Packaging:

For 10, 15, 20, 30 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 12 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

In dry, dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N001564 / 01

Date of registration:07.08.2008

The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Manufacturer: & nbsp

OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Information update date: & nbsp23.09.2015

Illustrated instructions

Instructions

Pyracetam Obolenskoe (Pyracetam Obolenskoe)