Instructions Piracetam tablets 400 mg blister No. 60
Composition
active ingredient: piracetam;
1 tablet contains piracetam 200 mg or 400 mg;
excipients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, magnesium stearate, colloidal anhydrous silicon dioxide, talc.
Dosage form
Pills.
Main physicochemical properties: tablets are white with a creamy tint, flat-cylindrical in shape with a bevel and a score; marbling is allowed on the surface of the tablets.
Pharmacotherapeutic group
Psychostimulants and nootropics.
ATX code N06B X03.
Pharmacological properties
Pharmacodynamics.
The active ingredient of the drug is piracetam, a cyclic derivative of gamma-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, while there is no vasodilator effect. Improves connections between the cerebral hemispheres and synaptic conduction in neocortical structures. Piracetam inhibits platelet aggregation and restores the elasticity of the erythrocyte membrane, reduces erythrocyte adhesion. At a dose of 9.6 g, it reduces the level of fibrinogen and von Willebrand factors by 30-40% and prolongs bleeding time. Piracetam has a protective and restorative effect in impaired brain function due to hypoxia and intoxication, electroconvulsive therapy. Piracetam reduces the severity and duration of vestibular nystagmus, and as a monotherapy is effective in the treatment of cortical myoclonus.
Pharmacokinetics.
It is rapidly absorbed from the digestive tract and reaches maximum concentration in the blood after 30-40 minutes. It penetrates well through the blood-brain and placental barriers. It accumulates in the brain tissue after 1-4 hours. The half-life is approximately 4 hours. It is excreted from the cerebrospinal fluid much more slowly, which indicates a high tropism to the brain tissue. It is practically not metabolized. 90% is excreted by the kidneys unchanged.
Indication
Adults.
Symptomatic treatment of pathological conditions accompanied by memory impairment and cognitive disorders, with the exception of diagnosed dementia.
Treatment of cortical myoclonus, as a monotherapy or as part of complex therapy.
Contraindication
Individual intolerance to piracetam or pyrrolidone derivatives, as well as other components of the drug.
End-stage renal failure (creatinine clearance less than 20 ml/min).
Acute cerebrovascular accident (hemorrhagic stroke).
Huntington's cholera.
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.
High doses (9.6 g/day) of piracetam increased the effectiveness of acenocoumarol in patients with venous thrombosis: a significant decrease in the level of platelet aggregation, fibrinogen levels, von Willebrand factors, blood and plasma viscosity was observed.
Pharmacokinetic interactions.
The likelihood of changes in the pharmacodynamics of piracetam under the influence of other drugs is low, since 90% of the drug is excreted unchanged in the urine.
In vitro, piracetam does not inhibit 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%) was observed. However, the Ki of these two CYP isomers is sufficient above 1422 μg/ml. Therefore, metabolic interactions with drugs that are biotransformed by these enzymes are unlikely.
Antiepileptic drugs.
The use of piracetam at a dose of 20 mg/day did not change the peak and curve of serum concentrations of antiepileptic drugs (carbamazepine, phenytoin, phenobarbital, valproate) in patients with epilepsy.
Alcohol.
Co-administration with alcohol did not affect the serum concentration of piracetam, and serum alcohol concentration did not change when 1.6 g of piracetam was administered.
Application features
Effect on platelet aggregation.
Due to the fact that piracetam reduces platelet aggregation (see section "Pharmacodynamic properties"), it is necessary to prescribe the drug 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. The drug is excreted by the kidneys, therefore special attention should be paid to patients with renal failure.
During long-term therapy in elderly patients, regular monitoring of renal function is recommended, and if necessary, the dose is adjusted depending on the results of the creatinine clearance study (see section "Method of administration and dosage").
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.
Warnings related to the content of excipients.
The drug contains lactose. Therefore, patients with rare hereditary forms of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Use during pregnancy or breastfeeding
Do not use the drug during pregnancy. Piracetam passes into breast milk, so if necessary, breastfeeding should be discontinued.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug should be used with caution when driving vehicles and working with other mechanisms, given the possibility of adverse reactions from the central nervous system.
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 g per day in 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 from the day of achieving a stable improvement, 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 g 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 4.2). During long-term treatment, creatinine clearance should be monitored in such patients to ensure adequate dose adjustment.
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 patient's creatinine clearance using the formula:
[140 – age (in years)] × body weight (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, adhering to the following recommendations:
| Degree of renal failure | Creatinine clearance (ml/min) | Dosage |
| Normal kidney function | > 80 | Usual dose divided into 2 or 4 doses |
| Light | 50 – 79 | 2/3 of the usual dose in 2 – 3 doses |
| 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 in patients with impaired liver function
No dose adjustment is required except in cases of hepatic impairment. In cases of diagnosed or suspected hepatic and renal impairment, dose adjustment should be made as described in the section “Dosage in patients with renal impairment”.
Children.
Do not apply.
Overdose
Symptoms: increased side effects of the drug. Symptoms of overdose were observed with oral administration of the drug in 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).
Side effects
The frequency is defined as follows: very common (≥ 1/10), common (≥ 1/100 <1/10), uncommon (≥ 1/1000 <1/100), rare (≥ 1/10000 <1/1000), very rare (<1/10000), isolated cases (frequency cannot be estimated from the available data).
From the blood and lymph system.
Isolated cases: hemorrhagic disorders.
From the immune system.
Isolated cases: hypersensitivity, anaphylactoid reactions.
Mental disorders.
Common: nervousness.
Uncommon: depression.
Isolated cases: increased excitability, anxiety, confusion, hallucinations.
From the nervous system.
Common: hyperkinesia.
Uncommon: drowsiness.
Isolated cases: ataxia, balance disorders, increased frequency of epileptic seizures, headache, insomnia, tremor.
From the hearing organs.
Isolated cases: dizziness.
From the digestive system.
Isolated cases: abdominal pain, upper abdominal pain, diarrhea, nausea, vomiting.
On the skin and subcutaneous tissue.
Isolated cases: angioedema, dermatitis, rash, urticaria, itching.
From the reproductive system.
Isolated cases: increased sexual activity.
Research.
Common: weight gain.
Others.
Uncommon: asthenia.
Expiration date
2 years.
Do not use after the expiry date stated on the packaging.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister, 6 blisters in a cardboard pack.
Vacation category
According to the recipe.
Producer
PJSC "Chempharmaceutical Plant "Chervona Zirka".
Location of the manufacturer and its business address.
61010, Ukraine, Kharkiv, 1 Hordienkivska St.
