Piracetam-OBL coated pills 800mg N30
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Active ingredients
Piracetam
Release form
Pills
Composition
Piracetam - 800.0 mg. Excipients (core): croscarmellose sodium - 12.0 mg, pregelatinized starch - 12.0 mg, povidone (polyvinylpyrrolidone) - 20.0 mg, magnesium stearate - 8.0 mg.
Pharmacological effect
Nootropic agent. It has a positive effect on metabolic processes and blood circulation in the brain. Increases glucose utilization, improves the course of metabolic processes, improves microcirculation in the ischemic zones, inhibits the aggregation of activated platelets. It has a protective effect in brain damage caused by hypoxia, intoxication, electroshock. Improves the integrative activity of the brain. Does not have a sedative and psychostimulating action.
Pharmacokinetics
When ingestion quickly and almost completely absorbed from the gastrointestinal tract. Cmax in plasma is reached in approximately 30 minutes, in liquor - in 2-8 hours. The apparent Vd is 0.6 l / kg. Does not bind to plasma proteins. Distributed in all organs and tissues, penetrates through the BBB and placental barrier. Selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal ganglia. T1 / 2 from plasma is 4-5 hours, from liquor - 6-8 hours. It is excreted by the kidneys in unchanged form. With renal failure, T1 / 2 increases.
Indications
In adults: Symptomatic treatment of psychoorganic syndrome, in particular, in elderly patients, accompanied by decreased memory, dizziness, decreased concentration and decreased activity, mood changes, behavioral disorders, gait disturbance (these symptoms may be early signs of age-related diseases such as Alzheimer's and senile dementia of Alzheimer's type). Treatment of vertigo and associated imbalance, with the exception of vascular and psychogenic cephalus complex therapy and monotherapy of cortical myoclonia. Complex therapy of sickle cell anemia (for the prevention of sickle cell vasocclusal crisis). In children: Treatment of dyslexia (in combination with other methods). Combined therapy of sickle cell anemia (for the prevention of sickle cell vasocclusal crisis).
Contraindications
Individual intolerance to piracetam or pyrrolidone derivatives, as well as other components of the drug. Psychomotor agitation at the time of appointment of the drug. Chorea Huntington. Acute violation of cerebral circulation (hemorrhagic stroke). The final stage of renal failure (with creatinine clearance less than 20 ml / min). Children age up to 3 years. With care: violation of hemostasis. extensive surgical interventions. heavy bleeding. chronic renal failure (with creatinine clearance 20-80 ml / min).
Precautionary measures
On the part of the digestive system: rarely - dyspeptic symptoms, abdominal pain. From the side of the central nervous system: rarely - nervousness, agitation, irritability, anxiety, sleep disorders, dizziness, headache, tremor; in some cases - weakness, drowsiness.
Use during pregnancy and lactation
Adequate and strictly controlled studies of the safety of using piracetam during pregnancy have not been conducted. Application is possible only in cases where the intended benefit to the mother outweighs the possible risk to the fetus. Piracetam, apparently, gets into breast milk. If necessary, use during lactation should decide on the termination of breastfeeding. In experimental animal studies, no negative effects of piracetam on the fetus were identified.
Dosage and administration
Inside During a meal or on an empty stomach with a liquid. Symptomatic treatment of psychoorganic syndrome: 2.4 - 4.8 g / day in 2-3 doses. Treatment of dizziness and associated imbalance: 2.4 - 4.8 g / day in 2-3 doses. Treatment of cortical myoclonus: start with a dose of 7.2 g / day, every 3-4 days, increase the dose by 4.8 g / day until the maximum dose of 24 g / day is reached in 2-3 doses. Treatment continues throughout the entire period of the disease. Every 6 months, attempts should be made to reduce the dose or cancel the drug, gradually reducing the dose by 1.2 g / day every 2 days. Treatment of sickle cell anemia: the daily prophylactic dose is 160 mg / kg body weight, divided into 4 equal doses. Treatment of dyslexia in children (in combination with other methods of treatment): the recommended daily dose for children from 8 years old and adolescents - 3.2 g,divided into 2 doses. Dosing for patients with impaired renal function: the dose should be adjusted depending on the amount of creatinine clearance (CK): Creatinine clearance for men can be calculated based on the concentration of serum creatinine, using the following formula. Creatinine clearance for women can be calculated by multiplying the resulting value per coefficient Renal failure QC (ml / min) Dosage regimen Norm> 80 usual dose Light 50-79 2/3 usual dose in 2-3 doses Average 30-49 1/3 usual dose in 2 doses Heavy less than 30 1/6 usual doses The final step once - contraindicated Older patients the dose is adjusted in the presence of renal disease, long-term therapy is necessary to monitor the functional state pochek.Dozirovanie patients with impaired liver function: patients with impaired liver function dose not need correction. Patients with impaired function and kidney and liver dosing is carried out according to the scheme.
Side effects
On the part of the nervous system, motor disinhibition, irritability, drowsiness, depression, asthenia, headache, insomnia, agitation, imbalance, ataxia, exacerbation of epilepsy, anxiety, hallucinations, confusion. From the alimentary system nausea, vomiting, diarrhea, pain in stomach (including gastralgia). On the part of the metabolism, an increase in body weight. On the part of the ear organs, vertigo. On the side of the skin, dermatitis, itching, urticaria. Allergic reactions: angioedema, hypersens anaphylactic reactions.
Interaction with other drugs
A case of interaction of piracetam with simultaneous use with an extract of the thyroid gland containing triiodothyronine and tetraiodothyronine is described, when anxiety, irritability and sleep disorders are noted in the patient. With simultaneous use of thyroid hormones with drugs, central effects may develop - tremor, anxiety, irritability, sleep disturbances, confusion. With the simultaneous use of stimulants of the central nervous system may enhance the stimulating effect. With simultaneous use with neuroleptics, there is an increase in extrapyramidal disorders.
special instructions
With caution used in patients with severe hemostasis, with large surgical operations and heavy bleeding; with renal insufficiency. Continuous monitoring of renal function indicators is recommended. In the case of sleep disorders, it is recommended to cancel the evening intake of piracetam by adding this dose to the daily intake.