Instructions Piracetam film-coated tablets 200 mg blister No. 60
Composition
active ingredient: piracetam;
1 tablet contains piracetam 200 mg;
excipients: potato starch, povidone, heavy magnesium carbonate, calcium stearate;
shell composition: refined sugar, silicon dioxide, povidone, heavy magnesium carbonate, titanium dioxide (E 171), tartrazine (E 102), beeswax, sunflower oil.
Dosage form
Film-coated tablets.
Main physicochemical properties: film-coated tablets, yellow, biconvex. Two layers are visible on cross-section.
Pharmacotherapeutic group
Psychostimulants and nootropics. Piracetam. ATX code N06B X03.
Pharmacological properties
Pharmacodynamics.
The active ingredient of the drug is piracetam, a cyclic derivative of γ-aminobutyric acid.
Piracetam is a nootropic that acts on the brain, improving cognitive functions such as learning ability, memory, attention, and mental performance. There are probably several mechanisms of action of the drug on the central nervous system: changing the speed of propagation of excitation in the brain; enhancing metabolic processes in nerve cells; improving microcirculation by affecting the rheological characteristics of the blood, without causing a vasodilator effect. Improves connections between the cerebral hemispheres and synaptic conduction in neocortical structures, inhibits platelet aggregation and restores the elasticity of the erythrocyte membrane, reduces erythrocyte adhesion. Piracetam has a protective and restorative effect in impaired brain function due to hypoxia, intoxication, and electroconvulsive therapy. Piracetam reduces the strength and duration of vestibular nystagmus.
Piracetam is used as a monotherapy or as part of a complex treatment for cortical myoclonus to reduce the severity of the provoking factor, vestibular neuronitis.
Pharmacokinetics.
After oral administration, it is rapidly and completely absorbed in the digestive tract. Bioavailability is almost 100%. Cmax after administration of 2 g of the drug is achieved in blood plasma after 30 minutes, and in cerebrospinal fluid - within 2-8 hours and is 40-60 μg / ml. The volume of distribution of piracetam is almost 0.6 l / kg. The half-life of the drug from blood plasma is 4-5 hours and 6-8 hours from cerebrospinal fluid. This period may be prolonged in renal failure. It does not bind to blood plasma proteins, is not metabolized in the body. 80-100% of piracetam is excreted by the kidneys unchanged by glomerular filtration.
Renal clearance of piracetam in healthy volunteers is 86 ml/min. The pharmacokinetics of piracetam does not change in patients with hepatic insufficiency. Piracetam penetrates the blood-brain barrier, placental barrier and membranes used in hemodialysis. In animal studies, it was found that piracetam selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital zones, the cerebellum and basal ganglia.
Indication
Adults:
– symptomatic treatment of pathological conditions accompanied by memory impairment, cognitive disorders (except for diagnosed dementia);
– treatment of cortical myoclonus: as a monodrug or as part of complex therapy.
Contraindication
– Hypersensitivity to piracetam or pyrrolidone derivatives, as well as to other components of the drug;
– acute cerebral circulation disorder (hemorrhagic stroke);
– terminal stage of renal failure;
– Huntington's chorea.
Interaction with other medicinal products and other types of interactions
Thyroid hormones.
When used together with thyroid hormones (T3+T4), increased irritability, disorientation, and sleep disturbances are possible.
Acenocoumarol.
Clinical studies have shown that in patients with severe recurrent thrombosis, the use of piracetam at doses of 9.6 g/day did not cause the need to change the dosage of acenocoumarol to achieve an international normalized ratio (INR) of 2.5–3.5, but with its simultaneous use, a significant decrease in the level of platelet aggregation, β-thromboglobulin release, fibrinogen levels, von Willebrand factors (VIII: C; VIII: vW: Ag; VIII: vW: Rco), and viscosity of whole blood and plasma was observed.
Pharmacokinetic interactions.
The likelihood of changes in the pharmacokinetics of piracetam under the influence of other drugs is low, since approximately 90% of the drug is excreted unchanged in the urine.
In vitro, piracetam does not inhibit the major human liver cytochrome P450 isoforms CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 4A9/11 at concentrations of 142, 426, 1422 μg/ml.
At a concentration of 1422 μg/ml, a slight inhibition of CYP2A6 (21%) and ZA4/5 (11%). However, the CI for inhibition of these two CYP isomers is sufficient above 1422 μg/ml. Therefore, metabolic interactions with drugs that are biotransformed by these enzymes are unlikely.
The use of piracetam at a dose of 20 g/day daily for 4 weeks or more did not change the concentration curve and maximum concentration (Cmax) of antiepileptic drugs in serum (carbamazepine, phenytoin, phenobarbital, sodium valproate) in patients with epilepsy receiving stable doses.
Alcohol
Co-administration with alcohol did not affect the level of piracetam concentration in blood plasma, and alcohol concentration did not change when using 1.6 g of piracetam.
Application features
Effect on platelet aggregation.
Due to the fact that piracetam reduces platelet aggregation, the drug should be prescribed with caution to patients with impaired hemostasis, conditions that may be accompanied by bleeding (gastrointestinal ulcer), during major surgical operations (including dental interventions), patients with symptoms of severe bleeding or patients with a history of hemorrhagic stroke; patients using anticoagulants, platelet antiaggregants, including low doses of acetylsalicylic acid.
Kidney dysfunction.
The drug is excreted by the kidneys, so special attention should be paid to patients with renal failure.
Interruption of application.
When treating patients with cortical myoclonus, abrupt discontinuation of treatment should be avoided due to the risk of generalization of myoclonus or the occurrence of seizures.
Elderly patients.
During long-term therapy in elderly patients, it is recommended to regularly monitor kidney function indicators and, if necessary, adjust the dose depending on the results of the creatinine clearance study.
Precautions related to excipients.
Due to the presence of refined sugar in the coating of the drug, patients with known intolerance to some sugars should consult their doctor before taking this medicine.
The medicine contains the azo dye tartrazine (E 102), which may cause allergic reactions.
Use during pregnancy or breastfeeding
Piracetam should not be used during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Given the adverse reactions observed with the use of this medicinal product, an impact on the ability to drive and use machines is possible and should be taken into account.
Method of administration and doses
The drug is administered orally, washed down with a small amount of water.
Adults.
Treatment of conditions accompanied by memory impairment and cognitive disorders.
The initial daily dose is 4.8 g during the first week of treatment. Usually the dose is divided into 2-3 doses. The maintenance dose is 2.4 mg per day, divided into 2-3 doses. Subsequently, a gradual dose reduction of 1.2 g per day is possible.
Treatment of cortical myoclonus.
The initial daily dose is 24 g for 3 days. If during this time the desired therapeutic effect is not achieved, the drug is continued at the same dosage (24 g/day) for up to 7 days. If the desired therapeutic effect is not achieved on the 7th day of treatment, the treatment is discontinued. If the therapeutic effect has been achieved, then starting from the day when a stable improvement is achieved, the dose of the drug is reduced by 1.2 g every 2 days until the manifestations of cortical myoclonus appear again. This will make it possible to establish the average effective dose.
The daily dose is divided into 2-3 doses. Treatment with other antimyoclonic agents is maintained in previously prescribed doses. Treatment is continued until the symptoms of the disease disappear. To prevent deterioration of the patient's condition, the drug should not be abruptly discontinued. The dose should be gradually reduced by 1.2 every 2-3 days. Repeated courses of treatment with the drug should be prescribed every 6 months, adjusting the dose depending on the patient's condition, until the symptoms of the disease disappear or decrease.
Use in elderly patients.
Dose adjustment is recommended for elderly patients with known or suspected renal impairment (see section "Dosage in patients with renal impairment"). During long-term treatment, if necessary, creatinine clearance should be monitored in such patients in order to adjust the dose appropriately.
Dosage for patients with renal impairment.
Since the drug is excreted from the body by the kidneys, caution should be exercised when treating patients with renal insufficiency.
The increase in half-life is directly related to the deterioration of renal function and creatinine clearance. This also applies to elderly patients, in whom creatinine clearance is age-dependent. The interval between doses should be adjusted based on renal function.
The dose is calculated based on the assessment of creatinine clearance using the formula:
[140-age (in years)]* m (in kg)
Kcr = (x 0.85 for women)
72 * Plasma creatinine C (mg/dL)
Treatment for such patients is prescribed depending on the severity of renal failure, following the following recommendations:
| Degree of renal failure | Creatinine clearance (ml/min) | Dosage |
| Normal | > 80 | Usual dose divided into 2 or 4 doses |
| Light | 50-79 |
| Moderate | 30-49 | 1/3 of the usual dose in 2 doses |
| Severe | < 30 | 1/6 of the usual dose once |
| Terminal stage | – | Contraindicated |
Dosage for patients with impaired liver function.
No dose adjustment is required for patients with hepatic impairment. In cases of known or suspected hepatic or renal impairment, dose adjustment should be made as described in the section “Dosage in patients with renal impairment”.
Children
Not used.
Overdose
Symptoms: increased side effects of the drug. Symptoms of overdose were observed with oral administration of the drug at a dose of 75 g.
Treatment is symptomatic, gastric lavage, induce vomiting. There is no specific antidote, hemodialysis can be used (removal of 50-60% of piracetam).
Adverse reactions
Adverse reactions observed during clinical trials and during post-marketing surveillance are listed by system organ class and frequency.
The frequency is defined as follows: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000), very rare (<1/10,000), frequency unknown (frequency cannot be estimated from the available data).
Postmarketing data are insufficient to calculate the frequency of adverse reactions in the treated population.
From the nervous system.
Common: hyperactivity.
Uncommon: drowsiness.
Frequency unknown: ataxia, balance disorders, increased frequency of epileptic seizures, headache, insomnia, tremor.
Mental disorders.
Common: nervousness.
Uncommon: depression.
Frequency unknown: increased excitability, anxiety, confusion, hallucinations.
From the blood and lymphatic system.
Frequency unknown: hemorrhagic disorders.
From the immune system.
Frequency unknown: hypersensitivity, anaphylactoid reactions.
From the side of the organs of hearing and labyrinth.
Frequency unknown: dizziness.
From the digestive system.
Frequency unknown: abdominal pain, upper abdominal pain, diarrhea, nausea, vomiting.
On the skin and subcutaneous tissue.
Frequency unknown: angioedema, dermatitis, urticaria, pruritus.
From the reproductive system and mammary glands.
Frequency unknown: increased sexual activity.
General disorders.
Uncommon: asthenia.
Research.
Common: weight gain.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions in the post-marketing period is an important measure. This allows for continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions as required by law.
Expiration date
3 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
10 tablets in a blister; 3 or 6 blisters in a pack.
Vacation category
According to the recipe.
Producer
PJSC "Halychpharm".
Location of the manufacturer and its business address
Ukraine, 79024, Lviv, Opryshkivska St., 6/8.
