Comparative analysis of the use of high and regular doses of Lucetam (piracetam) in patients with residual schizophrenia

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Nootropil tablets 1200 mg 20 pcs. in Petropavlovka

Latin name

NOOTROPIL

International nonproprietary name

piracetam

Release form

Film-coated tablets

Package

10 pieces. - blisters (2) - cardboard packs.

Description

Tablets, coated, white or almost white, oblong, with a dividing transverse score on both sides; on one side of the tablet to the right and left of the mark there is an engraving “N”.

pharmachologic effect

Nootropic drug, cyclic derivative of gamma-aminobutyric acid (GABA). Available evidence suggests that the primary mechanism of action of piracetam is not cell-specific or organ-specific. Piracetam binds to the polar heads of phospholipids and forms mobile piracetam-phospholipid complexes. As a result, the two-layer structure of the cell membrane and its stability are restored, which in turn leads to the restoration of the three-dimensional structure of membrane and transmembrane proteins and the restoration of their function. At the neuronal level, piracetam facilitates various types of synaptic transmission, having a predominant effect on the density and activity of postsynaptic receptors (data obtained from animal studies). Piracetam improves functions such as learning, memory, attention and consciousness without causing sedation or psychostimulant effects. The hemorheological effects of piracetam are associated with its effect on red blood cells, platelets and the vascular wall. In patients with sickle cell anemia, piracetam increases the ability of red blood cells to deform, reduces blood viscosity and prevents the formation of coin columns. In addition, it reduces platelet aggregation without significantly affecting platelet count. Animal studies have shown that piracetam prevents vasospasm and counteracts various vasospastic substances. In studies in healthy volunteers, piracetam reduced the adhesion of red blood cells to the vascular endothelium and stimulated the production of prostacyclins by healthy endothelium.

Indications

Adults - symptomatic treatment of psychoorganic syndrome, in particular in elderly patients, accompanied by memory loss, dizziness, decreased concentration and decreased activity, mood changes, behavior disorder, gait disturbance (these symptoms may be early signs of age-related diseases such as Alzheimer's disease and senile dementia of the Alzheimer's type); - treatment of dizziness and associated imbalance, with the exception of vasomotor and psychogenic dizziness; — treatment of cortical myoclonus (as monotherapy or as part of complex therapy); - prevention of sickle cell vaso-occlusive crisis. Children - treatment of dyslexia (as part of complex therapy); - prevention of sickle cell vaso-occlusive crisis.

Directions for use and doses

The drug is prescribed orally, during meals or on an empty stomach, with 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 divided doses. Treatment of cortical myoclonus 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 in 2-3 doses. Treatment is continued throughout the entire period of the disease. Every 6 months, attempts should be made to reduce the dose or discontinue the drug, gradually reducing the dose by 1.2 g/day every 2 days. Prevention of sickle cell vaso-occlusive crisis: the daily dose is 160 mg/kg body weight, divided into 4 equal doses. Treatment of dyslexia in children (as part of complex therapy): the recommended daily dose for children from 8 years of age and adolescents is 3.2 g, divided into 2 doses. For patients with impaired renal function, the dose should be adjusted depending on the value of CC. CC can be calculated based on serum creatinine concentration using the following formula: For men CC (ml/min) = [140 - age (years)] x body weight (kg)/72 x serum creatinine (mg/dl); CC for women can be calculated by multiplying the resulting value by a coefficient of 0.85. Patients with renal failure require dose adjustment of the drug in accordance with the following regimen. Renal failure KK (ml/min) Dose and frequency of use Norm > 80 Usual dose Mild degree 50 - 79 2/3 of the usual dose in 2 - 3 doses Average degree 30 - 49 1/3 of the usual dose in 2 doses Severe <30 1 /6 usual dose, once End stage <20 Contraindicated In elderly patients, the dose is adjusted in the presence of renal failure; with long-term therapy, monitoring of the functional state of the kidneys is necessary. Patients with impaired liver function do not require dose adjustment. For patients with impaired renal and liver function, the drug is prescribed in the same way as for patients with only impaired renal function.

Compound

1 tab. piracetam 1200 mg Excipients: silicon dioxide, magnesium stearate, macrogol 6000, croscarmellose sodium; opadry Y-1-7000 (titanium dioxide (E171), macrogol 400, hypromellose 2910 5cP (E464)), opadry OY-S-29019 (hypromellose 2910 50cP, macrogol 6000).

Contraindications

— Acute cerebrovascular accident (hemorrhagic stroke). — End-stage renal failure (with creatinine clearance (CC)) — Children under 1 year of age (for oral solution). — Children under 3 years of age (for tablets and capsules). — Hypersensitivity to the components of the drug.

Use during pregnancy and breastfeeding

Adequate and strictly controlled studies of the safety of Nootropil during pregnancy have not been conducted. The drug should not be prescribed during pregnancy unless absolutely necessary. Piracetam penetrates the placental barrier and is excreted in breast milk. The concentration of piracetam in newborns reaches 70-90% of its concentration in the mother’s blood. If it is necessary to use the drug during lactation, you should refrain from breastfeeding. Experimental studies on animals did not reveal any damaging effects on the embryo and its development, incl. in the postnatal period, as well as changes in the course of pregnancy and childbirth.

special instructions

Caution should be exercised when prescribing the drug to patients with impaired hemostasis, during major surgery, or to patients with symptoms of severe bleeding. When treating patients with cortical myoclonus, abrupt discontinuation of therapy should be avoided, because this may cause the attacks to recur. During long-term therapy in elderly patients, regular monitoring of renal function indicators is recommended; if necessary, dose adjustment is carried out depending on the results of a creatinine clearance study. Nootropil penetrates through the filter membranes of hemodialysis machines. Impact on the ability to drive vehicles and operate machinery Taking into account possible undesirable effects, the patient should be careful when working with machinery and driving a car.

Side effects

From the central nervous system: hyperkinesia (1.72%), nervousness (1.13%), drowsiness (0.96%), depression (0.83%), asthenia (0.23%). These side effects occur more often in elderly patients receiving the drug at a dose of more than 2.4 g/day. In some cases - dizziness, headache, ataxia, imbalance, exacerbation of epilepsy, insomnia, confusion, agitation, anxiety, hallucinations, increased sexuality. From the metabolic side: increase in body weight (1.29%). From the digestive system: in some cases - nausea, vomiting, diarrhea, abdominal pain. Dermatological reactions: dermatitis, itching, rash, swelling.

Drug interactions

The possibility of changes in the pharmacokinetics of piracetam under the influence of other drugs is low, because 90% of the drug is excreted unchanged in the urine. When used concomitantly with thyroid hormones, there have been reports of confusion, irritability, and sleep disturbances. According to a published study of patients with recurrent venous thrombosis, piracetam at a dose of 9.6 g/day increases the effectiveness of indirect anticoagulants (there was a more pronounced decrease in platelet aggregation, fibrinogen concentration, von Willebrand factors, blood and plasma viscosity compared with the use of indirect anticoagulants only). Piracetam does not inhibit cytochrome P450 isoenzymes. Metabolic interaction with other drugs is unlikely. Taking piracetam at a dose of 20 g/day for 4 weeks did not change the serum Cmax and AUC of antiepileptic drugs (carbamazepine, phenytoin, phenobarbital, valproate). Co-administration with alcohol did not affect serum concentrations of piracetam; The concentration of ethanol in the blood serum did not change when taking 1.6 g of piracetam.

Storage conditions

The drug should be stored in a dry place at a temperature not exceeding 25C.

Compound

Piracetam is the active ingredient of the drug.
The tablets contain 800 or 1200 mg of this substance. Additional elements: macrogol 6000, silicon dioxide, croscarmellose sodium, magnesium stearate.

Capsules of 400 mg of active ingredient. Additional substances: macrogol 6000, silicon dioxide, lactose monohydrate, magnesium stearate.

The oral solution contains 200 or 330 mg of active substance per 1 ml. Additional elements of the composition are: sodium saccharinate, pure water, glycerol , sodium acetate, acetic acid, methyl parahydroxybenzoate, flavorings, propyl parahydroxybenzoate.

Nootropil solution IV and IM contains 200 mg of active substance per 1 ml. Auxiliary elements are: sodium acetate trihydrate, water for injection, glacial acetic acid.

Indications for use

The drug is used to treat psychiatric, neurological, and drug-related diseases. It is prescribed in the presence of such pathologies and disorders:

  • Alzheimer's disease;
  • deterioration of memory and other intellectual functions;
  • intoxication;
  • various brain injuries;
  • headaches;
  • dizziness;
  • speech problems;
  • comatose states;
  • pathology of cerebral vessels;
  • period of convalescence;
  • defective conditions, including schizophrenia;
  • nephrotic syndrome;
  • lethargy;
  • hypochondria;
  • depressive states;
  • withdrawal syndrome due to alcoholism;
  • acute poisoning with certain drugs (including when using barbiturates, morphine);
  • sickle cell anemia (as an additional therapy);
  • perinatal brain damage (including mental retardation in children, cerebral palsy).

Nootropil is often used in cases of intolerance to antipsychotic drugs. It is used to overcome side effects associated with somatovegetative and neurological complications.

Reviews about Nootropil

According to reviews of Nootropil on the forums, memory pills are very useful. They improve brain activity, help memorize large amounts of information, add energy and invigorate.

The drug also helps for its intended purpose, but does not act immediately. Based on reviews for children who used this medication, Nootropil is also useful for delayed speech development in a child.

The disadvantages include a bitter taste, individual intolerance to the drug, as well as side effects, for example, headaches.

Side effects

There are the following side effects during treatment: vomiting, nausea, disturbances in concentration, imbalance, motor disinhibition, mental agitation, gastralgia , sleep disturbances, anxiety, appetite disturbances, stool disturbances, increased sexual activity, convulsive syndrome , extrapyramidal disorders, headache, dizziness, tremors of extremities. When angina is diagnosed, the course of the disease worsens. Most often, side effects are recorded when the recommended dose of 5 g per day is exceeded.

Contraindications

The medication is not used for hemorrhagic stroke , with severe pathology of the renal system, or with intolerance to the main substance piracetam. During pregnancy, severe bleeding , after extensive surgical interventions, with pathology of hemostasis and during breastfeeding, Nootropil is prescribed with caution, assessing the possible risks.

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