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

Active substance: Pyracetam - 200 mg; auxiliary substances: sodium acetate trihydrate - 1 mg, acetic acid diluted 30% - to pH 5.8, water for injection - up to 1 ml.

Description:

Transparent colorless or slightly colored liquid.

Pharmacotherapeutic group:Nootropic agent.

ATX: & nbsp

N.06.B.X.03 Pyracetam

Pharmacodynamics:

Cyclic derivative of gamma-aminobutyric acid, 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 in various ways: it changes the rate of spread of excitation in the brain, improves metabolic processes in nerve cells, improves microcirculation, affects the rheological characteristics of the blood, without providing a vasodilating effect.

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.

Pharmacokinetics:

The volume of distribution is about 0.6 l / kg. Penetrates through blood-brain and placental barriers; is removed during hemodialysis. In experiments, animals selectively accumulate in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal nuclei.

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

The half-life is 4-5 hours from the blood plasma and 8.5 hours from the cerebrospinal fluid. 80-100% of pyracetam is excreted by the kidneys unchanged by glomerular filtration. The total clearance is 80-90 ml / min. The half-life period is prolonged for chronic renal failure (CRF) (with terminal CRF up to 59 hours). Hepatic insufficiency does not affect the pharmacokinetics of piracetam.

Indications:

Symptomatic treatment of intellectual-mnestic disorders in the absence of an established diagnosis of dementia.

Reduction of the manifestations of cortical myoclonia in piracetam sensitive patients both as monotherapy and as part of complex therapy. (In order to determine sensitivity to pyracetam in a particular case, a trial treatment course can be performed).

Contraindications:

Hypersensitivity to the components of the drug, severe chronic renal failure (CRF) (creatinine clearance less than 20 ml / min), hemorrhagic stroke, psychomotor agitation, Huntington's chorea, pregnancy, lactation.

Carefully:

Violation of hemostasis, extensive surgical interventions, severe bleeding, CRF (KK 20-80 ml / min) l.

Pregnancy and lactation:

Contraindicated in pregnancy, at the time of treatment should stop breastfeeding.

Dosing and Administration:

Intravenous (only with cortical myoclonus).

Intravenous administration is carried out within a few minutes; with intravenous infusion, the daily dose is administered for 24 hours through the catheter at a constant rate.

Treatment of cortical myoclonia

Treatment begins with a dose of 7.2 g-24 g per day, with little therapeutic effect or its absence, treatment is stopped on the 7th day, in case of a positive response to treatment, a dose of 24 g is reduced by 1.2 g every 2 days, until the emergence of myoclonus. This allows you to know the average effective dose. The daily dose of piracetam should be divided into 2-3 doses. The dose of other drugs for the treatment of myoclonus does not change. Then, later on the results of treatment, it is allowed to review the dose of other drugs for the treatment of myoclonus.

After initiation of piracetam treatment, treatment is continued as long as the symptoms of the disease persist.

However, every 6 months, attempts should be made to reduce the dose or cancel the drug. To avoid sudden relapse, the dose is reduced by 1.2 g every 2 days.

Elderly patients

Elderly patients with renal insufficiency should be corrected for the dose (see below "Renal failure").

With long-term treatment to assess the need for dose adjustment, creatinine clearance should be assessed regularly.

Renal insufficiency

Piracetam is excreted almost exclusively by the kidneys, care should be taken when treating patients with renal insufficiency or requiring renal function control. The elimination half-life increases in direct proportion to the impairment of kidney function and creatinine clearance; this is also true for the elderly, in whom the excretion of creatinine depends on age.

In this regard, the dose is adjusted in accordance with the table below:

Kidney function	CK (ml / min)	Dosing regimen
Norm	>80	The standard dose of 2-4 admission
Mild renal insufficiency	50-79	2/3 of the standard dose in 2-3 doses
Mean renal insufficiency	30-49	1/3 of the standard dose in 2 divided doses
Severe renal insufficiency	<30	1/6 of the standard dose once
Terminal Renal Failure		Contraindicated

Liver failure

Patients with isolated dysfunction of the liver do not need correction of the dose. Patients with impaired function and kidneys, and liver dosing is carried out according to the scheme (see above "Renal failure.")

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, consciousness.

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

From the side of metabolism: weight gain.

From the sense organs: Vertigo.

From the skin: dermatitis, itching, urticaria.

Allergic reactions: hypersensitivity, anaphylactic reactions angioedema.

Local reactions: pain together, thrombophlebitis.

Other (for parenteral administration): fever, lowering blood pressure.

Overdose:

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

Treatment: symptomatic therapy, hemodialysis (efficacy 50-60%). There is no specific antidote.

Interaction:

When used simultaneously with iodine-containing hormones of the thyroid gland, confusion, irritability and sleep disturbance may occur. In high doses (9.6 g / day) in patients with venous thrombosis increases the anticoagulant effect of indirect anticoagulants (more pronounced decrease in platelet aggregation, fibrinogen content, von Willebrand factor, viscosity of blood and plasma).

Pharmaceutically compatible with dextrose solutions (5%, 10%, 20%), fructose (5%, 10%, 20%), 0.9% sodium chloride solution, Ringer's solution, 20% mannitol solution, hydroxyethyl starch (6%, 10% %).

Special instructions:

Be wary appoint patients with hemostasis, before the forthcoming extensive surgical interventions or in patients with symptoms of severe bleeding.

In the treatment of cortical myoclonia, sudden cessation of treatment should be avoided, this can cause a resumption of seizures.

With prolonged therapy in elderly patients, regular monitoring of kidney function is recommended,if necessary, dose adjustment is performed depending on the QC. It penetrates the hemodialysis apparatus through the filter membranes.

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

During the treatment period, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Solution for intravenous and intramuscular injection 200 mg / ml.

Packaging:

5 ml of the drug into neutral glass ampoules.

5 ampoules are placed in a contiguous cell pack of a polyvinylchloride film without coating.

1 or 2 contour mesh packages are placed in a pack of cardboard for consumer containers.

5.10 ampoules are placed in a pack of cardboard for consumer containers with partitions or grilles, or a paperboard separator for consumer packaging or sack paper.

10 ampoules are placed in a box of cardboard for consumer packaging with a pile of paper paste. The box is pasted with a label-parcel of paper label or coated.

Each instruction pack or box is supplied with instructions for use, an ampoule knife or ampoule scarifier.

When using ampoules with incisions, break rings or break points, the ampoule knife or the ampoule scapegrator is not inserted.

Storage conditions:

In a place protected from light, inaccessible to children, at a temperature not exceeding 25 ° С.

Shelf life:

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

Terms of leave from pharmacies:On prescription

Registration number:LS-001231

Date of registration:25.08.2011

The owner of the registration certificate:BIOCHEMIST, OJSC BIOCHEMIST, OJSC Russia

Manufacturer: & nbsp

BIOCHEMIST, OJSC Russia

Information update date: & nbsp17.09.2015

Illustrated instructions

Instructions

Pyracetam (Piracetam)