Nootropil 200 mg-ml 125 ml oral solution

Nosological classification (ICD-10)

• F03 Dementia, unspecified
• F06.6 Organic emotionally labile [asthenic] disorder
• F06.7 Mild cognitive impairment
• F10.2 Alcohol dependence syndrome
• F10.3 Withdrawal state
• F70-F79 Mental retardation
• G81 Hemiplegia
• H81.4 Dizziness of central origin
• I63 Cerebral infarction
• I67.2 Cerebral atherosclerosis
• I67.9 Cerebrovascular disease, unspecified
• I69 Consequences of cerebrovascular diseases
• R40.2 Coma, unspecified
• R41.8.0* Intellectual-mnestic disorders
• R63.0 Anorexia
• S06 Intracranial injury
• T90.5 Consequences of intracranial injury

Indications of the drug Nootropil®

Involution syndrome in the elderly (memory impairment, difficulty remembering and reproducing, adaptation disorders), asthenic syndrome, post-traumatic syndrome due to traumatic brain injury (headache and dizziness, motor disorders, asthenia), acute cerebrovascular accident, cerebral vascular sclerosis, hemiplegia, chronic alcoholism (preliminary states, delirium tremens, intellectual impairment, withdrawal syndrome, anorexia), impaired consciousness or coma of traumatic or toxic origin, mental retardation and learning disorders in children.

Nootropil fl 200mg/ml 125ml

Active substance

piracetam

ATX code

N06BX03 (Piracetam)

Dosage forms

for oral administration

Release form, packaging and composition of the drug

Film-coated tablets

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

[PRING] 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).

15 pcs. - blisters (2) - cardboard packs.

Film-coated tablets

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

[PRING] 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).

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

Oral solution

colorless, transparent.

[PRING] glycerol 85% 27 g, sodium saccharinate 300 mg, sodium acetate 200 mg, methyl parahydroxybenzoate 135 mg, propyl parahydroxybenzoate 15 mg, apricot flavor 30 mg, caramel flavor 15 mg, glacial acetic acid 16 mg±5%, purified water 62.1 g ±5%.

125 ml - dark glass bottles (1) complete with a measuring cup - cardboard packs.

Clinical and pharmacological group

Nootropic drug

Pharmacotherapeutic group

Nootropic drug

pharmachologic effect

Suction

After taking the drug orally, piracetam is quickly and almost completely absorbed from the gastrointestinal tract. After a single dose of the drug in a dose of 3.2 g, Cmax is 84 mcg/ml, after repeated doses of 3.2 mg 3 times a day - 115 mcg/ml and is achieved after 1 hour in the blood plasma and after 5 hours in the cerebrospinal fluid. Food intake reduces Cmax by 17% and increases Tmax by up to 1.5 hours. In women, when taking piracetam at a dose of 2.4 g, Cmax and AUC are 30% greater than in men.

Distribution and metabolism

Does not bind to blood plasma proteins.

Vd of piracetam is about 0.6 l/kg.

In animal studies, it was found that piracetam selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal ganglia.

Not metabolized in the body.

Penetrates the BBB and placental barrier.

Removal

T1/2 from blood plasma is 4-5 hours, from cerebrospinal fluid - 8.5 hours. T1/2 does not depend on the route of administration.

80-100% of piracetam is excreted unchanged by the kidneys by renal filtration. The total clearance of piracetam in healthy volunteers is 80-90 ml/min.

Pharmacokinetics in special clinical situations

T1/2 is prolonged in renal failure; for end-stage chronic renal failure - up to 59 hours.

The pharmacokinetics of piracetam does not change in patients with liver failure.

Penetrates through the filter membranes of hemodialysis machines.

Indications for use

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 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.

Dosage

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 divided doses.

Treatment of dizziness and associated imbalance:

2.4-4.8 g/day in 2-3 divided doses.

Treatment of cortical myoclonus

start 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 over 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 CC value.

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);

QC for women

can be calculated by multiplying the resulting value by a factor of 0.85.

Patients with renal failure

a dose adjustment of the drug is required in accordance with the following scheme.

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.

Contraindications

• psychomotor agitation at the time of drug prescription;
• Huntington's chorea;
• acute cerebrovascular accident (hemorrhagic stroke);
• end stage of chronic renal failure (with CC < 20 ml/min);
• children under 1 year of age (for oral solution);
• children under 3 years of age (for tablets);
• hypersensitivity to the components of the drug;
• hypersensitivity to pyrrolidone derivatives.

Carefully _

the drug should be used in cases of impaired hemostasis, extensive surgical interventions, severe bleeding, and chronic renal failure (creatinine clearance 20-80 ml/min).

Overdose

Symptoms:

a single case of the development of dyspeptic symptoms in the form of diarrhea with blood and pain in the abdominal area was registered when taking the drug orally at a daily dose of 75 g. Apparently, this was associated with the use of a large total dose of sorbitol, which was previously included in the dosage form oral solution .

Treatment:

immediately after a significant overdose when taken orally, you can rinse the stomach or induce artificial vomiting. There is no specific antidote. The effectiveness of hemodialysis is 50-60%.

Side effects

From the nervous system:

motor disinhibition (1.72%), irritability (1.13%), drowsiness (0.96%), depression (0.83%), asthenia (0.23%); in isolated cases - dizziness, headaches, ataxia, imbalance, exacerbation of epilepsy, insomnia, confusion, agitation, anxiety, hallucinations, increased sexuality. In post-marketing practice, the following side effects have been observed, the frequency of which has not been established (due to insufficient data): headache, insomnia, agitation, imbalance, ataxia, exacerbation of epilepsy, anxiety, hallucinations, confusion.

From the digestive system:

nausea, vomiting, diarrhea, abdominal pain (including gastralgia).

From the side of metabolism:

increase in body weight (1.29%).

From the organ of hearing and balance:

vertigo.

From the skin:

dermatitis, itching, urticaria.

Allergic reactions:

angioedema, hypersensitivity, anaphylactic reactions.

Other:

in rare cases - pain at the injection site, thrombophlebitis, hyperthermia, arterial hypotension (with intravenous administration).

In most cases, it is possible to achieve regression of such symptoms by reducing the dose of the drug.

Overdose

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 out of the reach of children, in a dry place at a temperature not exceeding 25°C. Shelf life: 4 years.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Special Instructions

Due to the effect of piracetam on platelet aggregation, the drug should be prescribed with caution to patients with impaired hemostasis, during extensive surgery, or to patients with symptoms of severe bleeding.

When treating cortical myoclonus, abrupt interruption of treatment should be avoided, because this may cause the attacks to recur.

When treating sickle cell anemia, a dose of less than 160 mg/kg or irregular use of the drug may cause an exacerbation of the disease.

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 the QC study.

When treating patients on a hyposodium diet, it is recommended to take into account that piracetam oral solution at a dose of 24 g contains 80.5 mg of sodium.

Piracetam penetrates through the filter membranes of hemodialysis machines.

Impact on the ability to drive vehicles and operate machinery

During the treatment period, care should be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.