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Lucetam tablets p/o 800mg per vial. No. 30 in the pack. No. 1
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Film-coated tablets, white or almost white, oval, biconvex, chamfered, scored on both sides, engraved “E 242” on one side, odorless. The main active ingredient Piracetam Release formtext Dosage 800 mg per bottle. No. 30 in the pack. No. 1 Special instructions In connection with the effect of piracetam on platelet aggregation, the drug should be prescribed with caution to patients with hemorrhagic disorders, the risk of bleeding (for example, with stomach ulcers), impaired hemostasis, in patients taking anticoagulants and antiplatelet agents, incl. acetylsalicylic acid in low doses. In the treatment of cortical myoclonus, abrupt interruption of treatment should be avoided, because. this may cause seizures to recur. 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. Influence on the ability to drive vehicles and work with mechanisms During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. Pharmacological action Nootropic drug. It has an effect on the central nervous system in various ways: it modifies neurotransmission in the brain, improves the conditions conducive to neuronal plasticity, improves microcirculation by affecting the rheological characteristics of the blood and does not cause vasodilation. The use of piracetam in patients with cerebral dysfunction increases concentration and improves cognitive functions, which is manifested by significant changes in the EEG (increase in α and β activity, decrease in α activity). Promotes the recovery of cognitive functions due to various disorders, such as hypoxia, intoxication or electroconvulsive therapy. Reduces the duration of vestibular neuronitis. Piracetam inhibits increased aggregation of activated platelets and, in the case of pathological rigidity of erythrocytes, improves their deformability and filtration capacity. Pharmacokinetics Absorption After oral administration, piracetam is rapidly and almost completely absorbed from the gastrointestinal tract. The bioavailability of the drug is about 100%. After a single dose at a dose of 2 g, Cmax is achieved in blood plasma after 30 minutes and is 40-60 mcg / ml, after 2-8 hours – in the cerebrospinal fluid. Distribution and metabolism Vd is about 0.6 l/kg. Piracetam selectively accumulates 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. Piracetam crosses the BBB and the placental barrier. Not metabolized in the body. Removal of T1 / 2 from the blood plasma is 4-5 hours, T1 / 2 from the cerebrospinal fluid – 8.5 hours. Excreted by the kidneys unchanged. Excretion by the kidneys is almost complete (> 95%) within 30 hours. The total clearance of piracetam in healthy volunteers is 86 ml / min. Pharmacokinetics in special clinical situations In renal failure, T1 / 2 increases. Indications for use – symptomatic treatment of intellectual-mnestic disorders in the absence of an established diagnosis of dementia; – in order to reduce the manifestations of cortical myoclonus in patients sensitive to piracetam, both as monotherapy and as part of a lump. The daily dose is divided into 2-4 doses. The last dose should be taken no later than 17 hours (to prevent sleep disturbances). In the symptomatic treatment of intellectual-mnestic disorders, depending on the severity of the symptoms, 2.4-4.8 g / day is prescribed, distributing the dose into 2-3 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. To prevent worsening of the patient’s condition, do not abruptly stop the use of the drug. It is necessary to gradually lower the dose of the drug – by 1.2 g / day every 2 days. In the absence of effect or the presence of an insignificant therapeutic effect, treatment is stopped. Since piracetam is excreted by the kidneys, care should be taken when treating patients with renal insufficiency. The calculation of the dose should be based on the assessment of CC in a patient, which is calculated by the formula: CC = 140 – age (years) x body weight (kg) / 72 – serum creatinine (mg%) For women, the resulting figure is multiplied by 0.85. Treatment of such patients is prescribed depending on the severity of renal failure. In elderly patients, the dose should be adjusted in the presence of renal insufficiency. With prolonged therapy, monitoring of kidney function is necessary. Patients with impaired liver function do not require dose adjustment. For patients with impaired renal and hepatic function, dosing is carried out according to the scheme described for patients with impaired renal function. Use during pregnancy and lactation Adequate and strictly controlled clinical studies on the safety of the drug during pregnancy have not been conducted, so Lucetam® should not be used during pregnancy. Piracetam crosses the placental barrier and is excreted in breast milk. If necessary, the use of the drug during lactation, breastfeeding should be discontinued. Precautions In patients with impaired liver function, correction of the dosing regimen is not required. In patients with impaired renal function, dosage adjustment is required depending on the CC. In elderly patients, the dose is adjusted in the presence of renal failure. With prolonged therapy, it is necessary to monitor the functional state of the kidneys. Interaction with other drugs When used simultaneously with an extract of the thyroid gland (T3 + T4), increased irritability, disorientation and sleep disturbances are possible. There was no interaction with clonazepam, phenytoin, phenobarbital, valproic acid. Piracetam in high doses (9.6 g / day) increases the effectiveness of acenocoumarol in patients with venous thrombosis (there was a more pronounced decrease in platelet aggregation, fibrinogen levels, von Willebrand factors, blood and plasma viscosity compared with the use of acenocoumarol alone). The possibility of changing the pharmacodynamics 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 concentration of piracetam of 1422 µg/ml, a slight inhibition of CYP2A6 (21%) and 3A4/5 (11%) was noted. However, the Ki level probably goes far beyond the concentration of 1422 µg/ml. Therefore, metabolic interaction with other drugs is unlikely. Taking piracetam at a dose of 20 mg / day did not affect the Cmax and AUC of antiepileptic drugs in serum (carbamazepine, phenytoin, phenobarbital, valproate) in patients with epilepsy receiving the drug at a constant dose. Co-administration with ethanol did not affect the level of piracetam concentration in serum, the concentration of ethanol in the blood serum did not change when taking piracetam at a dose of 1.6 g. Contraindications – Huntington’s chorea; – hemorrhagic stroke; – severe chronic renal failure (with CC less than 20 ml / min); – pregnancy; – lactation period; – hypersensitivity to piracetam or pyrrolidone derivatives, as well as other components of the drug. With caution, the drug should be prescribed for violations of hemostasis, extensive surgical interventions, severe bleeding, chronic renal failure (CC 20-80 ml / min). Compositionpiracetam 800 mg Excipients: stearate – 6 mg, povidone K-30 – 50 mg. Shell composition: dibutyl sebacate – 1.4 mg, ethyl cellulose (in the form of an aqueous suspension) – 7 mg, white opadry (macrogol 6000 – 0.5 mg, titanium dioxide – 1.5 mg, talc – 2 mg, hypromellose – 7.6 mg). Overdose Piracetam is non-toxic even at high doses. A single case of the development of dyspeptic phenomena in the form of diarrhea with blood and pain in the lower abdomen was registered when taking the drug in the dosage form of an oral solution at a daily dose of 75 g. Treatment: induction of vomiting, gastric lavage, symptomatic therapy, hemodialysis (effectiveness 50-60%) . There is no specific antidote. Side effects From the side of the central nervous system: hyperkinesis, irritability, drowsiness, depression, asthenia, headache, dizziness, insomnia, mental agitation, anxiety, imbalance, tremor, ataxia, exacerbation of epilepsy, anxiety, hallucinations, confusion, increased libido. From the senses: dizziness (vertigo). From the side of the cardiovascular system: a decrease or increase in blood pressure. From the digestive system: nausea, vomiting, diarrhea, abdominal pain, epigastric pain. From the side of metabolism and nutrition: weight gain. From the skin: dermatitis, itching, urticaria. On the part of the immune system: hypersensitivity, anaphylactic reactions, angioedema. Storage conditions The drug should be stored out of the reach of children at a temperature of 15 ° to 30 ° C. Buy Lucetam pills p/o 800mg No. 30 No. 1 Price for Lucetam pills p/o 800 mg No. 30 No. 1
INN | PIRACETAM |
---|---|
The code | 1 854 |
Barcode | 5 995 327 154 756 |
Dosage | 800mg |
Active substance | Piracetam |
Manufacturer | Egis Pharmaceuticals PLC, Hungary |
Importer | LLC "GrandPharm", Minsk, 220004, Minsk, Timiryazeva st., 4, office 1H, office 7; "VitPharmMarket" LLC Vitebsk, Republic of Belarus, 210004 Vitebsk, 5th Kooperativnaya st., 8; Komfarm LLC, Minsk, 220131 Minsk, Sosnovy Bor st., 4, office 1; SOOO "Brititrade", 223021, Minsk district, Shchomyslitsky s / s, 18 |
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