Piracetam - Egis 800mg tablets treat symptoms of physical mental syndrome (30 tablets)

Dosage form Box of 30 tablets
Specifications Piracetam

Ingredient

Composition informationContent
Piracetam800mg

Uses

indications

Piracetam - Egis 800 mg is indicated in the following cases:

  • Treatment of symptoms of physical mental syndrome (cognitive disability, [memory disorder; lack of attention], reducing vigilance due to local or spreading brain damage, functional disorders).
  • Treatment of dizziness and balance disorders (except when in combination with vascular and mental disorders).

    Pharmacology

    Classification of Pharmacological Therapy: Intellectual Drug (Nootropic).

    ATCC code: N06b x03

    Mechanism of action:

    Active ingredient Piracetam is an intellectual orientation with a complex mechanism of action. Piracetam works by increasing nucleotid metabolism in nerve cells, increasing glucose and oxygen consumption in the brain and increasing acetylcholine and dopamine details in nerve cells. Piracetam level is attached to the dual layer of phospholipids of the cell membrane depending on the dosage, the drug restores the integrity of the structure, which is thought to increase the liquid and function of the membranes.

    Piracetam works well on microcirculation and metabolism in the brain of patients with ischemia because the drug increases blood supply to areas with ischemic anemia without increasing the osical osical areas of intact brain areas.

    Piracetam has a positive blood flow effect, an increase in the deformation of red blood cells, reducing platelet aggregation, as well as reducing the adhesion of red blood cells into the blood vessel wall and reducing capillary spasms.

    In addition, Piracetam has a direct stimulating effect on the synthesis of prostacycline in the intact blood vessel wall.

    The results of animal tests showing piracetam protect the central nervous system against oxygen deficiency, brain injury, toxic effects and electric seizures, or reducing damage caused by these factors.

    On the basis of the results of clinical and clinical pharmacological studies, Piracetam improves cognitive functions (study, memory, attention, consciousness) both in healthy people and in people with a reduced cognitive activity. These effects are not accompanied by sedative or stimulating activities. Piracetam can protect or restore cognitive functions during and after the brain lesions (lack of oxygen, poisoning, electric convulsions). The drug reduces the effect of oxygen deficiency on the function and brain activity.

    pharmacokinetics

    piracetam with linear pharmacokinetics with a dose of 0.8 - 12 g. After drinking, Piracetam is quickly absorbed in the form of unchanged. Birth is almost 100%. Achieving peak concentration in plasma 30-60 minutes after taking the drug and within 2 - 8 hours in cerebrospinal fluid. Use at the same time with food does not affect the absorption, but the value of CMAX decreases and TMAX increases.

    The semi -destructive time of Piracetam is 4-5 hours in plasma and 6-8 hours in cerebrospinal fluid. 15% of the drug is attached to the protein of plasma. Piracetam focuses on cerebral cortex, cerebellum, tail core, hippocampus, outer pillow and vein puppet.

    The drug is discharged into the urine in the form of unchanged. After a single dose, 90 - 100% of the drug is discharged within 24 - 30 hours. Piracetam passes through blood - brain partitions, enters the placenta (the concentration of the drug in the fetus accounts for 70-90% of the mother concentration) and appears in breast milk. Piracetam can be appraised (the separation efficiency is 50 - 60%).

  • Before taking Piracetam - Egis 800mg tablets treat symptoms of physical mental syndrome (30 tablets)

    How to use

    Drugs for oral, drink before meals with 100-200 ml of water, divided evenly twice a day or 3-4 times.

    Dosage

    Dosage must be determined for each case based on the severity of the disease and clinical response.

    Adults:

    Normal starting dose for adults is 2400 mg daily.

    Maintenance dose is 1200 - 2400 mg daily.

    Maximum daily dose is 4800 mg.

    Treatment time must be determined based on the patient's clinical condition.

    In chronic diseases, usually treated for about 6 - 12 weeks for maximum effectiveness. After three months of treatment, the use of drugs must be reviewed and decided to see if it continues.

    If you have to treat longer, you should reduce the dose or stop the drug completely for a period of 6 months. Depending on the cause of the disease - if you see a good clinical response, the treatment may last for months or the case of Alzheimer sometimes has to be treated for many years.

    Dose for the day depending on indications:

    Treatment of symptoms of physical mental syndrome:

    Use 2.4 - 4.8 g/ day divided into two to three times.

    Treatment of sequelae of stroke:

    In acute and chronic diseases (lasting more than 15 days) the recommended daily dose is 4.8 - 6 g.

    muscle shock due to cerebral cortex:

    The starting dose of the day is 7.2 g when necessary, can increase each time 4.8 g 3-4 days to 20 g per day. After that, depending on the clinical improvement, it is advisable to gradually reduce the dose of 1.2 g a day, about 2 days away (about 34 days in the Lance and Adam syndrome) to avoid unexpected recurrence or convulsions due to quitting drugs.

    It is also advisable to use other drugs with the usual doses to treat muscle vibration caused by the cerebral cortex, then depending on the clinical improvement that can reduce this dose.

    Dizziness:

    Use 2.4 - 4.8 g/ day divided into 2-3 times.

    alcohol:

    12 g per day, then 2.4 g for maintenance.

    Children read difficult:

    Children from 8-13 years old, the maximum dose of the day is 3.2 g divided into two times, in collaboration with the method of teaching linguistic disability.

    Dosage for patients with impaired renal function:

    Creatine clearance

    Creatinin in serum

    Dosage

    40 - 60 ml/minute

    1.25 - 1.7 mg %

    ½ normal dose

    20 - 40 ml/minute

    1.7 - 3.0 mg %

    Normal dose

    Piracetam is not toxic even at very high doses. In a case, there is diarrhea and abdominal pain after taking the dose of Piracetam 75 g/ day, possibly due to the high content of the sorbit in the tablet.

    How to handle

    There is no specific antidote for Piracetam. Handling the possibility of overdose by treating symptoms. Piracetam can be removed with a separation efficiency with 50 - 60%.

    What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

    Side Effects

    When using Piracetam - Egis 800 mg, you may experience unwanted effects (ADR).

    Clinical studies

    Clinical or clinical pharmacological trials with placebo -controlled pharmaceutical control are conducted on 3000 patients using Piracetam.

    When the unwanted effect is grouped in groups of WHO (Medra), the following unwanted effects are thought to occur with significantly higher frequency in patients treated with piracetam nutritional disorders and metabolism, mental disorders, nervous system disorders, systemic disorders and at the position of drug use.

    The following unwanted effects are reported at significantly higher frequency than placebo. The rate of occurrence is calculated in the patient treated with piracetam compared to the placebo (n = 3016 and n = 2850)

    Agency system

    (According to Meddra)

    Common

    (≥ 1/100

    Not common
    (≥ 1/1000> 1/100)

    weight gain

    (1.29 compared to 0.39%)

    restless

    (1.13 compared to 0.25%)

    drowsy

    (0.96 compared to 0.25%)

    Depression

    (0.83 compared to 0.21%)

    Dynamic increase

    (1.72 compared to 0.42%)

    (0.23 compared to 0.00%)

    When circulating the drug, the following unwanted effects are reported (classified by side effects on the Meddra Agency).

    The existing data is not enough to estimate the frequency of occurrence.

  • Immune system disorders: severe allergic reactions, sensitive reactions.
  • Mental disorders: restlessness, anxiety, confusion, hallucinations.

    Nervous system disorders: balance disorders and coordination, more serious epilepsy.

  • Disorders of ears and mesmerizing: Dizziness.
  • Gastrointestinal disorders: abdominal pain, upper abdominal pain, diarrhea, nausea, vomiting.

    Skin and subcutaneous tissue disorders: edema, dermatitis, itching, urticaria.

    Instructions for handling ADR

    Notify the doctor with unwanted effects when using the drug.

    Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    Contraindicated

    Piracetam - Egis 800 mg contraindicated in the following cases:

  • Hypersensitivity to Piracetam, with other Pyrrolidon derivatives, or with any other component of the drug (excipients: Core core: Magnesium stearate, Povidone K-30; Park: Macrogol 6000, Dibutyl Sebacate, Titanium Dioxide C.I. 77891 E.E.11 Ethylcellulose, Hypromellose).
  • Hemorrhage.
  • Severe renal failure (clearing creatine below 20 ml/minute).

    General principle is contraindicated for pregnant and lactating women.

    Be cautious when used

    When kidney failure, the dose must be lower, in addition to regular monitoring of the kidney function regularly. Elderly patients must be tested for kidney function before taking the drug.

    Piracetam can lower the threshold of seizures in patients with epilepsy and patients with convulsions. The change of anti -seizure therapy is used for patients with epilepsy should be carefully considered by a specialist, although Piracetam has improved the condition of the patient.

    Because Piracetam has the effect of inhibiting platelet aggregation, especially when using Piracetam for patients with blood clotting, severe bleeding, or after major surgery.

    In patients treated for muscle shock due to cerebral cortex, sudden stopping of the drug can cause acute recurrent convulsions and convulsions due to quitting drugs.

    Special caution especially when using piracetam in the thyroid gland because the risk of increasing central effects, tremor, hyperactivity, sleep disorders, confusion.

    The ability to drive and operate machinery

    without clinical data shows that Piracetam affects the above capabilities. However, because Piracetam can cause side effects, this possibility cannot be excluded. Therefore, the application limits must be decided by the doctor for each case.

    Pregnancy

    Clinical data in clinical studies on toxicity on reproductive reproduction does not see piracetams that are harmful to the fetus. Data in humans without clinical research performed in pregnant women. In general, do not use piracetam during pregnancy. Except for special cases on the basis of careful evaluation/ harm.

    The period of breastfeeding

    piracetam is secreted into the mother's milk. In general, do not use piracetam when breastfeeding. Except for special cases on the basis of careful evaluation/ harm.

    Drug interaction

    used with central nervous system stimulants can increase the stimulating effect.

    Used with sedatives can lead to increased dysplasia.

    Used with hormonal hormones (T3 + T4) can increase the central effect, tremor, hyperactivity, sleep disorders, confusing.

    According to the results in patients with severe and recurrent blood tolerance, the dose of piracetams 9.6 g during the day has no effect but the drug significantly reduces platelet accumulation, liberation of P - Thromboglobulin, fibrinogen levels and volume elements Von Wilebrand, and viscosity of whole blood and plasma.

    In patients being treated with anti -epilepsy (carbamazepin, phenytoin, phenobarbiton, sodium valproate), the dose of piracetam per day for 4 g in 4 weeks does not change the concentration at the lowest stage in the plasma of anti -epileptic drugs.

    Simultaneous use of 1.6 g piracetam with alcohol does not see the concentration in plasma of both substances.

    In in vitro, Piracetam concentration 142, 426 and 1422 mcg/ ml does not inhibit cytochrome P450 liver enzymes in humans (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4/ 5, 4A9/ 11). Therefore there is no interaction in metabolism between piracetam and other drugs.

    Storage

    Store at temperatures below 300C.

    To be out of reach of children.

    Other drugs

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