NOOTROPIL 3G/15ML AESICA injection solution treats symptoms of memory disorders (1 blister x 4 tubes x 15ml)

Dosage form Box of 1 blister x 4 tubes x 15ml
Specifications Piracetam

Ingredient

Composition informationContent
Piracetam3G

Uses

Indications

Nootropil 3g/15ml drug are indicated in the following cases:

Adults

Piracetam is assigned to:

  • Treatment of symptoms of mental syndrome - entity with improved characteristics by treatment such as memory loss, attention disorder and lack of motivation.
  • Single or coordination in muscle vibration due to cerebral cortex.

    Dizziness and the accompanying balance disorders, except dizziness from vascular or mental origin.

  • Prevention and reduction of exacerbations in sickle cell disease.
  • Children

    Piracetam is assigned to:

  • Treatment of difficult to read, combined with appropriate measures such as language therapy.
  • Prevention and reduction of exacerbations in sickle cell disease.
  • Pharmacology

    Mechanism of action

    The available data suggests that the basic mechanism of Piracetam is not specialized in cells and organs. Piracetam is physically connected to the polar head of phospholipids in the dose -based cell membrane model, creating a thin restoration of the cell membrane characterized by the formation of flexible drug complexes - phospholipids. This can lead to improved cell membrane stability, which allows membrane proteins and piercing proteins to maintain or restore three -dimensional or folded structure to perform their function. Piracetam works on nerves and blood vessels.

    Pharmacological effects

  • Effects on the nerves.
  • Act on red blood cells.
  • Effects on platelets.

  • Effects on blood vessels.
  • Dynamic pharmacokinetics

    Piracetam's dynamic characteristics are linear and dependent on time with a small difference between individuals on a wide doses. This is consistent with high membrane permeability, high solubility and minimum metabolism of Piracetam. The semi -cancellation time in the plasma of Piracetam is 5 hours. The half -life is equivalent to healthy adults and patients. Hal increasing half -life time in the elderly reduces the clearance of the kidneys and is in the subject of renal failure. Plasma concentrations in a stable state are achieved within 3 days of drug use.

    Distribution

    Piracetam does not bind plasma proteins and has an integral distribution of approximately 0.6L/kg. Piracetam passed through the micro -blood barrier that had been found in cerebrospinal fluid after using intravenous tract. At the cerebrospinal fluid, the time to reach the peak is 5 hours after the drug and the half -life cancel about 8.5 hours. In animals, Piracetam concentration is the highest in the brain is at the cerebral cortex (frontal lobe, peak and occipital lobe), in the cerebellum shell and background lymph nodes. Piracetam diffuses to all tissues except adipose tissue, through the placenta fence and absorbed into the isolated red blood cell membrane.

    Metabolism

    It is unclear whether Piracetam is metabolic in the human body. This non -metabolic is shown by the half -life of the drug in plasma lasting at the patient and the original drug is found in the urine.

    Elimination

    Semi -cancellation time in Piracetam's plasma in adults is about 5 hours after intravenous or after drinking. The total apparay is 80 - 90ml/min. The main excretion path is through urine, accounting for 80 - 100% of the dose. Piracetam is eliminated through glomerular filtration.

    linear

    The pharmacokinetics of linear piracetam in the dose of 0.8 - 12g. Pharmacokinetic variables such as the half -life and clearance time does not change according to the dose and treatment period.

    Before taking NOOTROPIL 3G/15ML AESICA injection solution treats symptoms of memory disorders (1 blister x 4 tubes x 15ml)

    How to use

    drugs used intravenously.

    Dosage

    When the infusion is needed (such as difficulty swallowing, coma), Piracetam can be used by intravenous lines at the same daily dose level.

    In the case of an infusion piracetam, the doctor first prescribes the appropriate dose of piracetam. This dose will determine the amount of drug solution to be injected. In many cases, the amount of drug solution to be injected will exceed one of the injection tubes and rarely some multiplying the exact amount of the amount of injection tubes available. For example, in case of a 4.8g piracetam infusion dose, the amount of piracetam injection solution needs to be used is 24ml. At that time, medical staff need to withdraw into a 15ml injection cylinder and add 9ml of the second tube.

    Injectable solution will be injected with intravenously for a few minutes.

    Adults

    Symptomatic treatment of mental syndrome - entity

    The daily dose range is recommended from 2.4g to 4.8g, divided into 2-3 times.

    Treatment with muscle vibration medications Causes Causes

    Start the daily dose of 7.2g, then increase 4.8g every 3-4 days to a maximum of 20g, divided into 2-3 times.

    Treatment with other anti -vibration medications should be maintained at the same dose. Depending on the clinical benefits achieved, the dose of these drugs should be reduced, if possible. Right and by trying treatment.

    Once you have started, it is advisable to continue treating with piracetam as long as you still exist. In patients with an acute attack, the patient can progress well after a period of time and so every 6 months should try reducing the dose or stopping treatment.

    Should reduce the dose or stop treatment. It is advisable to reduce 1.2g of Piracetam every 2 days (every 3 or 4 days in the event of a Lance - Adams syndrome to prevent convulsions due to suspension or sudden recurrence.

    Dizziness treatment

    Daily dose is recommended between 2.4g to 4.8g divided into 2-3 times.

    Preventing and reducing the exacerbations in sickle cell disease

    Daily dosage is recommended to prevent exacerbations of 160mg/kg, orally, divided into 4 times.

    Daily dose is recommended to reduce exit of 300mg/kg of intravenously, divided into 4 times.

    When taking a dose of less than 160mg/kg/day or uneven use, it can lead to recurrence of acute attacks.

    Children

    Demonstrate treatment for readers in combination with appropriate measures such as language therapy

    recommended dose for children in school age (from 8 years old) and teenagers is 3.2g/day, divided into 2 times.

    Preventing and reducing the exacerbations in sickle cell disease

    In children 3 years of age and older, the prevention of exacerbations is 160mg/kg/day, divided into 4 times. In case of reducing exacerbations, using a dose of 300mg/kg/day intravenously, divided into 4 times.

    When taking a dose of less than 160mg/kg/day or uneven use can lead to recurrence. Piracetam can be used for children with sickle cell anemia at the recommended daily dose (mg/kg - see above). Piracetam has been used in a few children aged 1-3 years old.

    Elderly

    Should adjust the dose in the elderly with kidney function damage.

    When long -term treatment in the elderly, regular evaluation of creatinine is needed to adjust the appropriate dose when necessary.

    Patients with renal failure

    Contraindicated to use piracetam for patients with severe renal impairment (renal creatinine clearance below 20m/minute).

    Daily dose is calculated for each patient by kidney function. Please refer to the Bang below and adjust the dose as directed. To use this dose table, the patient's creatinine clearance is estimated (CLCR) is calculated by ml/min. It is possible to estimate creatinine clearance (ml/min) from serum creatinine (mg/dl) through the following formula:

    CLCR = 140 - Age X is weight (kg) 72 x Creatinine serum (mg/dl) (x 0.85 in women).

    group

    Creatinine clearance (ml/minute)

    dose and number of times

    Normal

    80

    Common daily dose, divided 2-4 times.

    50 - 79

    2/3 of the daily dose daily, divided 2-3 times.

    Average

    30 - 49

    1/3 is often used daily, divided 2 times.

    1/6 is often used daily, 1 time.

    No dose adjustment in patients only has liver failure. Recommendations for dosage adjustments in patients with liver and renal failure (see the correction for patients with renal failure above).

    Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?

    Symptoms and signs

    There are no additional adverse reactions related to overdose reported to Piracetam.

    The highest overdose is reported by taking Piraceteeam dose of 75g, appearing bloody diarrhea with abdominal pain, most likely related to very high sorbitol content in the composition of the drug.

    Overdose

    In case of significant, acute overdose, the stomach drum may be drowned by vomiting. There is no specific antidote for Piracetam overdose. Overdose treatment is mainly symptomatic treatment and may include hemorrhage. The efficiency of the splitting machine is 50 to 60% for piracetam.

    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. Note that it should not be used double the prescribed dose.

    Side Effects

    When using 3G/15ml Nootropil , you may experience unwanted effects (ADR).

    Double clinical, verified clinical studies with placebo or clinical pharmacological studies, including data on safety, including more than 3,000 subjects using Piracetam, regardless of treatment indications, dosage, daily dosage or characteristics of the research population.

    Unwanted effects are classified according to the following frequency of use:

    very popular

    1/10

    ≥ 1/100 to

    ≥ 1/1000 to

    rare

    ≥ 1/10000 to

    Not estimated from the available data

  • Unknown: bleeding disorders.
  • immune system disorders

  • Unknown: Anaphylactic reaction, hypersensitivity.
  • Mental disorders

  • Popular: restlessness.
  • Unsatisfactory: depression .
  • Unknown: excited, worried, confused, hallucinations.
  • Nervous system disorders

  • Popular: hyperactivity.
  • Not common: drowsiness.
  • Unknown: loss of movement air conditioning, balance disorders, severe epilepsy, headache , insomnia.
  • Disorders of ears and mesmerizing

  • Unknown: dizziness.
  • Vascular disorders

  • Rare: thrombosis, hypotension.
  • Gastrointestinal disorders

  • Unknown: abdominal pain, upper abdominal pain, diarrhea , nausea, vomiting.
  • Skin and subcutaneous skin disorders

  • Unknown: Neuritis, dermatitis, itching, urticaria.
  • Systemic disorders and medication on the spot.
  • Not common: weakness. rare: fever, pain at the injection site.

    Survey studies

  • Popular: weight gain.
  • Instructions on how to handle 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

    Nootropil 3G/15ML Contraindications in the following cases:

  • Hypersensitivity to piracetam, other derivatives of pyrrolidone or any excipients of the drug.
  • End -stage kidney disease (renal creatinine clearance below 20ml/minute).

    Brain hemorrhage.

  • Patients with dance dance Huntington (Huntington’s Chorea).
  • Be cautious when using

    impact on platelet gathering

    Due to the impact of Piracetam on platelet gathering, cautious recommendations in patients with severe bleeding, patients are at risk of bleeding such as gastrointestinal ulcers, potential hemostasis patients, patients with a history of hemorrhage due to hemorrhage, patients need to conduct surgery including dental surgery and patients using anticoagulants or anti -platelet aggregation including low -dose ASPIRIN.

    kidney failure

    Piracetam is eliminated through the kidneys, so be careful in the case of renal failure (see dosage and usage).

    Elderly

    When long -term treatment in the elderly, regular evaluation of creatinine is needed to adjust the appropriate dose when necessary (see dosage and usage).

    Stop drugs

    Should avoid sudden treatment of treatment because it can cause muscle seizures or totalization of totalization in some patients with muscle -shock.

    Exacerbation of sickle cell disease

    With indications in sickle blood cells, lower dose of 160mg/kg/day or non -regular use can lead to recurrence of acute attacks.

    excipients

    Sodium: The drug contains less than 1 mmol (23mg) sodium for every 24g of piracetam. This should be considered in patients who are in the diet that controls the amount of sodium.

    The ability to drive and operate machinery

    With adverse effects observed after use, the drug may affect driving and operating machinery, and this should be noted.

    Pregnancy

    should not use piracetam during pregnancy unless it is necessary, when the benefits are superior to the risk and clinical status of pregnant women require piracetam treatment.

    There is no enough data on the use of piracetam in pregnant women. Animal studies do not show direct or indirect effects on pregnancy, embryo or fetal development, birth or development after birth. Piracetam passed the placenta. Drug concentration in infants is about 70% to 90% of the drug concentration in the mother.

    breastfeeding period

    Do not use piracetam while breastfeeding or no breastfeeding during piracetam treatment. The benefits of breastfeeding should be taken into account and the benefits of treatment for mothers when deciding not to breastfeed or do not use piracetam. Piracetam is secreted into breast milk.

    Drug interaction

    pharmacological interaction

    Possed drug interactions lead to piracetam pharmacokinetic changes are expected to be low because about 90% of piracetam dose excreted in urine in constant form.

    In the laboratory (In vitro), Piracetam does not inhibit the isomers of Cytochrome P450 in the liver CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 4A9/11 at concentrations 142, 426 and 1422μg/ml. At concentration of 1422μg/ml, observing slightly inhibited effects on CYP 2A6 (21%) and 3A4/5 (11%). However, the ki values ​​to inhibit these two types of CYP isomers are good when the concentration exceeds 1422μg/ml.

    Therefore, the metabolic interaction of piracetam with other drugs is almost none.

    thyroid hormones

    Confusion, ease of stimulation and sleep disorders are a report when used simultaneously with the extract of the thyroid gland (T3+T4).

    acenocoumarol

    In a single blind study published in patients with severe recurrent venous thrombosis, piracetam dose of 9.6g/day does not change the dose acenocoumarol necessary to achieve Inr 2.5 to 3.5, but compared to the effect of acenocoumarol used alone, the addition of piracetam 9.6g/day is significantly reducing platelets, reducing the set of minor practice β-THROMBOGLOBULIN, Fibrinogen concentration and Von Willohrand elements (\/LLL: C; VIII: VW: AG: VIII: VW: RCO) and the viscosity of total blood and plasma.

    Anti -epileptic drugs

    daily dose of 20g piracetam for 4 weeks does not change the peak concentration and bottom concentration of serum of anti -epileptic drugs (carbamazepine, phenytoin, phenobarbitone, valproate) in patients with epilepsy are taking stable doses.

    alcohol

    Drinking alcohol at the same time does not affect the concentration of piracetam in serum and alcohol concentration is not changed by a 1.6g piracetam oral dose.

    taboo

    Unknown.

    Storage

    Store at a temperature of 30 ° C.

    Other drugs

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