Nootropil, 200 mg/ml 125 ml

Pharmacotherapeutic group:

Notropic agent.

ATC code: N06BX03.

Pharmacological properties

Pharmacodynamics.

The active component of Nootropil is piracetam, a cyclic derivative of gamma-aminobutyric acid (GABA). Piracetam is a nootropic which directly affects the brain, improving cognitive processes such as learning, memory, attention and mental performance.

Notropil affects the central nervous system in different ways: by changing the speed of excitation distribution in the brain, improving metabolic processes in nerve cells; improving microcirculation, affecting blood rheological characteristics and causing no vasodilator effect. It improves connections between cerebral hemispheres and synaptic conduction in neocortical structures, increases mental performance, improves cerebral blood flow.

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

Piracetam has a protective effect, improves brain functions impaired due to hypoxia and intoxication.

Piracetam reduces the severity and duration of vestibular nystagmus.

Pharmacokinetics.

In oral administration piracetam is quickly and almost completely absorbed, the peak concentration is reached 1 hour after administration. Bioavailability of the drug is approximately 100%. After a single dose of 2 g, the maximum concentration is 40-60 mcg/ml, which is reached in the blood after 30 minutes and in cerebrospinal fluid after 5 hours after intravenous injection. The apparent volume of distribution of piracetam is about 0.6 l/kg.

Half-life of the drug from plasma is 4-5 hours and 8.5 hours from cerebrospinal fluid, which is prolonged in renal insufficiency. Pharmacokinetics of piracetam does not change in patients with hepatic insufficiency. It penetrates through the blood-brain and placental barrier and membranes used in hemodialysis.

In animal studies piracetam selectively accumulates in tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal ganglia. It does not bind with blood plasma proteins, is not metabolized in the body and is excreted unchanged by the kidneys. 80-100% of piracetam is excreted unchanged by the kidneys through renal filtration. Renal clearance of piracetam in healthy volunteers is 86 ml/min.

Indications

Alcoholism, Tinnitus, Concussion and other brain injuries, Impaired attention and memory, Headache, Dizziness, Mental disorders, Impaired cerebral circulation-Symptomatic treatment of psychoorganic syndrome, Particularly in elderly patients suffering from memory impairment, dizziness, decreased concentration and general activity, mood changes, behavior disorders, gait disturbances, as well as in patients with Alzheimer’s disease and senile dementia of Alzheimer’s type.

– Treatment of the effects of stroke, such as speech disorders, emotional disturbances, to increase motor and mental activity.

– Chronic alcoholism – for treatment of psychoorganic and withdrawal syndromes.

– Recovery period after comatose states, including after injuries and intoxications of the brain.

– Treatment of dizziness and related balance disorders, except for dizziness of vascular and mental origin.

– As a part of complex therapy of learning disability in children with psychorganic syndrome.

– For treatment of cortical myoclonias as a mono- or complex therapy.

– As a part of complex therapy of sickle cell anemia.

Active ingredient

Piracetam

Composition

Active ingredient:

Piracetam – 200 mg/mL.

Auxiliary substances: glycerol 85%, sodium saccharin, sodium acetate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, 52247/A apricot (flavor), 52939/A caramel (flavor), glacial acetic acid, purified water.

How to take, the dosage

Daily doses range from 30-160 mg/kg body weight. The frequency of administration is 2-4 times a day.

In the treatment of chronic psychoorganic syndrome the drug is prescribed at a dose of 4.8 g/day for the first week, and then a maintenance dose of 1.2-2.4 g/day is given.

In the treatment of ischemic stroke, Nootropil should be given in a dose of 4.8 g/day.

When treating comatose states as well as perceptual difficulties in persons with brain injuries the initial dose is 9-12 g/day, maintenance dose is 2.4 g/day. Treatment should be continued for at least 3 weeks.

In case of withdrawal in chronic alcoholism the dose of the drug reaches 12 g/day during the manifestation of alcohol withdrawal syndrome. Maintenance dose is 2.4 g/day.

In treatment of dizziness and associated balance disorders the dose is 2.4-4.8 g/day.

In the correction of learning disabilities Nootropil is prescribed in a daily dose of 3.3 g (about 8 ml of 20% solution for oral administration 2 times a day). The treatment must continue throughout the school year.

In case of cortical myoclonias treatment is started 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. Treatment with Nootropil is continued for the entire period of the disease. Every 6 months an attempt should be made to reduce the dose or cancel the drug, gradually reducing the dose by 1.2 g/day every 2 days. If there is no effect or little therapeutic effect, treatment should be discontinued.

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

The drug is administered orally with meals or on an empty stomach; tablets and capsules should be washed down with fluids (water, juice). Parenterally if oral administration is not possible, in the same daily dose.

Special Instructions

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

When treating patients with cortical myoclonias, abrupt withdrawal of current therapy should be avoided, as this may cause a recurrence of seizures.

In long-term therapy of elderly patients, regular monitoring of renal function parameters is recommended; if necessary, the dose should be adjusted depending on the results of creatinine clearance study.

Notropil passes through the filter membranes of hemodialysis machines.

Impact on driving and operating machinery

With due regard to possible adverse effects, the patient should use caution when operating machinery and driving.

Contraindications

– Individual intolerance to piracetam or pyrrolidone derivatives, as well as other components of the drug.

– Acute impairment of cerebral circulation (hemorrhagic stroke).

– End-stage renal failure (with creatinine clearance less than 20 ml/min).

– Children under 1 year of age (for oral solution, 200 mg/ml) and under 3 years (for capsules and tablets).

Side effects

CNS side effects: hyperkinesia (1.72%), nervousness (1.13%), drowsiness (0.96%), depression (0.83%), asthenia (0.23%). These side effects occur more frequently in elderly patients who received the drug in a dose greater than 2.4 g/day.

In some cases – dizziness, headache, ataxia, loss of balance, worsening of epilepsy, insomnia, confusion, agitation, anxiety, hallucinations, increased sexuality.

Metabolism: weight gain (1.29%).

Digestive system disorders: in some cases – nausea, vomiting, diarrhea, abdominal pain.

Dermatological reactions: dermatitis, itching, rash, edema.

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Overdose

When taking 75 g of piracetam in the dosage form of oral solution, dyspeptic phenomena such as diarrhea, with blood and abdominal pain have been noted, which are most likely related to the high content of sorbitol. No other specific symptoms of piracetam overdose have been noted.

Immediately after a significant oral overdose, gastric lavage or induced artificial vomiting may be performed.

Treatment is symptomatic, which may include hemodialysis. There is no specific antidote. The effectiveness of hemodialysis is 50%-60% for piracetam.

Pregnancy use

The animal studies showed no damaging effects on the embryo and its development, including in the postnatal period, and did not alter the course of pregnancy and childbirth.

There have been no studies on pregnant women.

Piracetam passes through the placental barrier and into the breast milk.

The concentration of the drug in the infant reaches 70-90% of its concentration in the blood of the mother. Except in special circumstances, Nootropil should not be prescribed during pregnancy.

Breastfeeding should be refrained from when a woman is prescribed Piracetam.

Similarities

Nootropil, Piracetam, Piracetam bufus, Notrocetam