Nootropil (Pyracetam)

YUSB Pharma S.A., Belgium

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Product Overview

Composition

Active substance: 

piracetam 800 or 1200 mg;

Excipients:

macrogol 6000, 

silicon colloidal anhydride (Aerosil R972), 

magnesium stearate,

croscarmellose sodium, 

titanium dioxide (E171),

macrogol 400, 

hydroxypropyl methyl cellulose

pharmachologic effect

Nootropil improves cognitive (cognitive) processes, such as learning ability, memory, attention, and mental performance.

Nootropil has an effect on the central nervous system in various ways: it changes the speed of excitation in the brain, improves metabolic processes in nerve cells, improves microcirculation, affecting the rheological characteristics of the blood and not causing a vasodilating effect. \

It improves connections between the hemispheres of the brain and synaptic conduction in neocortical structures, increases mental performance, improves cerebral blood flow.

It inhibits platelet aggregation and restores the elasticity of the erythrocyte membrane, reduces the adhesion of red blood cells. At a dose of 9.6 g, it reduces the level of fibrinogen and Willibrand factors by 30% -40% and prolongs the bleeding time.

Nootropil has a protective and restorative effect in case of impaired brain function due to hypoxia and intoxication.

Reduces the severity and duration of vestibular nystagmus.

Indications

  • Treatment of the consequences of ischemic stroke, such as speech disorders, disorders of the emotional sphere, to increase motor and mental activity;
  • symptomatic treatment of the psycho-organic syndrome (including in elderly patients with decreased memory, dizziness, decreased ability to concentrate, mood changes, behavior disorders, impaired gait, as well as in patients with Alzheimer's disease and senile dementia of the Alzheimer's type);
  • for the treatment of withdrawal syndrome and psycho-organic syndrome in chronic alcoholism;
  • coma (and during the recovery period), including after injuries and intoxications of the brain;
  • for the treatment of dizziness and related equilibrium disorders (except in cases of dizziness of vasomotor and psychogenic origin); 
  • as part of complex therapy of low learning in children with psycho-organic syndrome;
  • treatment of cortical myoclonia (both as monotherapy and as part of combination therapy);
  • sickle cell anemia (as part of combination therapy).

Contraindications

  • Children's age up to 1 year;
  • hemorrhagic stroke;
  • severe renal dysfunction (CC less than 20 ml / min);
  • hypersensitivity to piracetam, pyrrolidone derivatives and other components of the drug.

Side effects

From the side of the central nervous system: hyperkinesia (1.72%), nervousness (1.13%), drowsiness (0.96%), depression (0.83%), asthenia (0.23%). These side effects often occur in elderly patients who received the drug at a dose of more than 2.4 g / day. 

In some cases - dizziness, headache, ataxia, imbalance, exacerbation of the course of epilepsy, insomnia, confusion, agitation, anxiety, hallucinations, increased sexuality.

From the side of metabolism: increase in body weight (1.29%).

From the digestive system: in some cases - nausea, vomiting, diarrhea, abdominal pain.

Dermatological reactions: dermatitis, itching, rash, edema.

How to take, course of administration and dosage

Daily doses vary in the range of 30-160 mg / kg body weight. Multiplicity of reception 2-4 times a day.

In the treatment of chronic psycho-organic syndrome, the drug is prescribed at a dose of 4.8 g / day for the first week, and then they switch to a maintenance dose of 1.2-2.4 g / day.

In the treatment of the effects of ischemic stroke, Nootropil should be prescribed at a dose of 4.8 g / day.

In the treatment of coma, as well as difficulties in perception in persons with brain injuries, the initial dose is 9-12 g / day, the maintenance dose is 2.4 g / day. Treatment should be continued for at least 3 weeks.

With abstinence in chronic alcoholism, the dose reaches 12 g / day during the period of manifestation of alcohol withdrawal syndrome. The maintenance dose is 2.4 g / day.

In the treatment of dizziness and related imbalances, the dose is 2.4-4.8 g / day.

With the correction of reduced learning, Nootropil is prescribed in a daily dose of 3.3 g (approximately 8 ml of a 20% oral solution 2 times a day). Treatment should continue throughout the school year.

With cortical myoclonia, treatment begins with a dose of 7.2 g / day, every 3-4 days the dose is increased by 4.8 g / day until the maximum dose of 24 g / day is reached. Nootropil treatment is continued throughout the entire period of the illness. 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. In the absence of effect or insignificant therapeutic effect, treatment is stopped.

In sickle cell anemia, the daily prophylactic dose is 160 mg / kg body weight, divided into 4 doses. During the crisis - up to 300 mg / kg iv. This dose may be given to children over the age of 1 year.

Inside, the drug is prescribed during meals or on an empty stomach; tablets and capsules should be washed down with liquid (water, juice). Parenteral administration in case of impossibility of ingestion, in the same daily dose.

Special instructions

Caution should be exercised when prescribing the drug to patients with impaired hemostasis, during major surgeries, or to patients with symptoms of severe bleeding.

In the treatment of patients with cortical myoclonia, abrupt cancellation of the therapy should be avoided, because this can cause renewed seizures.

With prolonged therapy of elderly patients, regular monitoring of renal function indicators is recommended, if necessary, dose adjustment is carried out depending on the results of the study of creatinine clearance.

Nootropil penetrates the filter membranes of hemodialysis machines.

Influence on the ability to drive vehicles and control mechanisms

Taking into account possible undesirable effects, the patient should be careful when working with mechanisms and driving a car.

Release form

 

Storage conditions

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

Shelf life

4 years

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