Piracetam capsules 400mg №10×6

Name:
Pyracetam caps.400 in a cell. pack No. 10×6
Description:
Capsules hard gelatin No. 0 cylindrical shape with hemispherical ends, white. Composition One capsule contains: active substance – piracetam 400 mg; excipients – stearic acid, sodium lauryl sulfate, basic magnesium carbonate. Capsule composition: gelatin, titanium dioxide E 171, methyl parahydroxybenzoate E 218, propyl parahydroxybenzoate E 216. Pharmacotherapeutic group Other psychostimulant and nootropic agents. ATX code – N06BX03. Pharmacological propertiesPharmacodynamics Piracetam is a nootropic agent that improves cognitive functions. It has an effect on the central nervous system in various ways: it changes the rate of propagation of excitation in the brain, improves metabolic conditions for neuronal plasticity. It improves microcirculation by affecting the rheological characteristics of the blood and does not cause a vasodilating effect. It inhibits increased aggregation of activated platelets and restores the elasticity of the erythrocyte membrane, as well as the ability of the latter to pass through the microvasculature. The appointment of piracetam to patients with cognitive impairment causes changes in the EEG, indicating an increase in functional activity (increase in α and β activity, decrease in α activity). Piracetam helps to restore cognitive abilities after cerebral dysfunction due to hypoxia, intoxication or trauma. Reduces the severity and duration of vestibular nystagmus. Piracetam is used in the treatment of cortical myoclonus as monotherapy or in combination with antimyoclonic agents. Pharmacokinetics Absorption After taking the drug inside, piracetam is rapidly and almost completely absorbed from the gastrointestinal tract, Cmax in blood plasma is reached after 1 hour. The bioavailability of the drug is about 100%. After a single dose of the drug at a dose of 3.2 g, the maximum concentration (Cmax) is 84 μg / ml, after repeated administration of 3.2 g 3 times a day – 115 μg / ml and is achieved after 1 hour in the blood serum and after 5 hours in cerebrospinal fluid. Eating reduces Cmax by 17% and increases the time to reach it (Tmax) up to 1.5 hours. In women, when taking piracetam at a dose of 2.4 g, Cmax and the area under the concentration-time curve (AUC) are 30% higher than in men. Distribution and metabolism Vd is about 0.6 l/kg. Animal studies have found that piracetam is concentrated in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal ganglia. Does not bind to plasma proteins. Piracetam crosses the blood-brain barrier and the placenta. Not metabolized in the body. Removal of T1 / 2 from blood plasma is 4-5 hours, T1 / 2 from cerebrospinal fluid – 6-8 hours. 80-100% of piracetam is excreted by the kidneys unchanged by glomerular filtration. The total clearance of piracetam in healthy volunteers is 80–90 ml/min. Pharmacokinetics in special clinical situations In renal failure, T1 / 2 increases (with terminal chronic renal failure – up to 59 hours). The pharmacokinetics of piracetam does not change in patients with hepatic insufficiency. Piracetam crosses the membranes used in hemodialysis. Indications Piracetam is indicated for the symptomatic treatment of memory disorders, intellectual impairment in the absence of a diagnosis of dementia. Piracetam may reduce the manifestations of cortical myoclonus. To determine the effect of piracetam in a patient with cortical myoclonus, a trial course of treatment is necessary. Contraindications Acute cerebrovascular accident (hemorrhagic stroke); severe renal failure (with creatinine clearance (CC) less than 20 ml / min); pregnancy; lactation; Huntington’s chorea; hypersensitivity to piracetam or pyrrolidone derivatives, as well as to other components of the drug; psychomotor arousal at the time of prescribing the drug. With caution Use with caution in patients with impaired hemostasis, surgical intervention (including dental), risk factors for bleeding (for example, peptic ulcer of the stomach and duodenum), previous hemorrhagic stroke or intracerebral hemorrhage, in patients taking anticoagulants or antiplatelet agents, including low doses of acetylsalicylic acid. Dosage and administration Inside for adults (during meals or on an empty stomach, drinking liquid). The last dose is taken no later than 1700 hours (to prevent sleep disturbance). In the symptomatic treatment of memory disorders, intellectual impairment in the absence of a diagnosis of dementia, depending on the severity of symptoms, the daily dose is 2.4-4.8 g, divided into two or three doses. With cortical myoclonus, treatment begins with a dose of 7.2 g / day, every 3–4 days the dose is increased by 4.8 g / day until a maximum dose of 24 g / day is reached. Treatment is continued throughout the entire period of the disease. Every 6 months, an attempt should be made to reduce the dose or discontinue the drug, gradually reducing the dose by 1.2 g every 2 days in order to prevent an attack. In the absence of effect or with a slight therapeutic effect, treatment is stopped. In patients with impaired renal function, a correction of the dosing regimen is required depending on the CC indicator. In elderly patients, the dose is adjusted in the presence of renal failure and with prolonged therapy, monitoring of the functional state of the kidneys is necessary. In patients with impaired liver function, correction of the dosing regimen is not required. In patients with impaired renal and hepatic function, the dose is adjusted depending on the CC, as indicated above. Piracetam capsules are taken with food or on an empty stomach with water. Adverse reactions are classified according to the frequency of their occurrence: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1 /10000, <1/1000), very rarely (<1/10000), the frequency is unknown (due to insufficient data). From the nervous system and psyche Often: nervousness, hyperkinesia. Uncommon: depression, drowsiness. Frequency unknown: dizziness, headache, ataxia, imbalance, exacerbation of epilepsy, insomnia, confusion, agitation, anxiety, hallucinations, tremor, confusion. On the part of the blood and lymphatic system Frequency unknown: hemorrhagic disorders. From the side of the immune system Frequency unknown: anaphylactoid reactions, hypersensitivity. From the digestive system Frequency is unknown: abdominal pain, pain in the upper abdomen, diarrhea, vomiting, nausea. On the part of the skin Frequency unknown: angioedema, dermatitis, itching, urticaria. Metabolic and nutritional disorders Common: weight gain. From the reproductive system Frequency unknown: sexual arousal. On the part of the organ of hearing Frequency unknown: vertigo. General disorders Uncommon: asthenia. Interaction with other medicinal products When used simultaneously with thyroid hormone preparations, increased irritability, disorientation and sleep disturbances are possible. According to the results of a study of patients with recurrent venous thrombosis, piracetam at a dose of 9.6 g / day does not change the dose of acenocoumarol required to achieve an MNR (international normalized ratio) of 2.5-3.5, but compared with the effects of acenocoumarol alone, the addition of piracetam to a dose of 9.6 g / day significantly reduces platelet aggregation, release of ?-thromboglobin, the concentration of fibrinogen and von Willebrand factor (VIII: C; VIII: vW: Ag; VIII: vW: RCo), as well as blood and serum viscosity. The possibility of changing the pharmacokinetics of piracetam under the influence of other drugs is low, because 90% of the drug is excreted unchanged in the urine. In vitro, piracetam does not inhibit CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 4A9/11 isoenzymes at concentrations of 142, 426 and 1422 µg/ml. At a piracetam concentration of 1422 µg/ml, there was a slight inhibition of CYP2A6 (21%) and 3A4/5 (11%). However, normal values of the inhibition constant (Ki) can probably be achieved at a higher concentration. Thus, the metabolic interaction of piracetam with other drugs is unlikely. Taking piracetam at a dose of 20 g / day for 4 weeks in patients with epilepsy who received stable doses of antiepileptic drugs did not change the maximum serum concentration and AUC (area under the curve) of antiepileptic drugs (carbamazepine, phenytoin, phenobarbital and valproate). Co-administration with ethanol does not affect the level of piracetam concentration in the blood serum, the concentration of ethanol in the blood serum did not change when taking 1.6 g of piracetam. Precautions Due to the effect of piracetam on platelet aggregation, caution should be exercised when prescribing the drug to patients with impaired hemostasis, surgical intervention (including dental), risk factors for bleeding (for example, peptic ulcer of the stomach and duodenum), previous hemorrhagic stroke or intracerebral hemorrhage, patients taking anticoagulants or antiplatelet agents, including low doses of acetylsalicylic acid. In the treatment of cortical myoclonus, abrupt interruption of treatment should be avoided, which may cause the resumption of attacks. With long-term therapy in elderly patients, regular monitoring of renal function is recommended, if necessary, dose adjustment is carried out depending on the results of the CC study. Penetrates through the filtering membranes of hemodialysis machines. Use in children The use of the drug in children under 18 years of age is not recommended. Influence on the ability to drive vehicles and work with mechanisms Taking into account possible side effects, the patient should be careful when driving a car and working with mechanisms. Pregnancy and lactation There have been no controlled studies of the use of the drug during pregnancy. Piracetam should not be used during pregnancy. Piracetam crosses the placenta and is excreted in breast milk. The concentration of piracetam in the blood of newborn animals reaches 70-90% of its concentration in the blood of the mother. If necessary, use during lactation, breastfeeding should be discontinued. Overdose In case of an overdose, it is possible to increase the severity of side effects, the appearance of abdominal pain, diarrhea mixed with blood. In case of symptoms of an overdose, you should consult a doctor. Treatment: induction of vomiting, gastric lavage, symptomatic therapy, hemodialysis (effectiveness 50-60%). There is no specific antidote. Upakovka10 capsules in a blister pack of PVC film and aluminum foil. 1 or 6 blister packs, together with the leaflet, are placed in a pack of cardboard. Storage conditions In a place protected from light and moisture, at a temperature not exceeding 25? Keep out of the reach of children. Shelf life 3 years. Do not use the medicine after the expiration date. Terms of dispensing from pharmacies By prescription. Buy Piracetam capsules 400mg No. 10x6 Price for Piracetam capsules 400mg No. 10x6