Lucetam solution 200mg / ml, No. 10

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BIDL3179802
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Expiration Date: 05/2027

Russian Pharmacy name:

Луцетам раствор 200мг/мл, №10

Lucetam solution 200mg / ml, No. 10

Common to all dosage forms

In adults

symptomatic treatment of psychoorganic syndrome, in particular in elderly patients, accompanied by memory loss, dizziness, decreased concentration and decreased general activity, mood changes, behavioral disorders, gait disturbance, as well as in patients with Alzheimer's disease and senile dementia of the Alzheimer's type;

treatment of dizziness and related balance disorders, with the exception of dizziness of a vascular and mental origin;

treatment of cortical myoclonus as mono- or complex therapy;

For solution for intravenous and intramuscular administration additionally

Treatment of sickle cell vaso-occlusive crisis in adults and children.

For tablets additionally

treatment of the consequences of ischemic stroke, such as speech impairment, emotional impairment, decreased motor and mental activity;

chronic alcoholism - for the treatment of psychoorganic and withdrawal symptoms;

as part of complex therapy for learning disabilities in children with psychoorganic syndrome;

recovery period after coma, incl. after trauma and intoxication of the brain;

as part of the complex therapy of sickle cell anemia.

For oral solution additionally:

In adults

prevention of sickle cell vaso-occlusive crisis.

In children

dyslexia treatment (in combination with other methods);

prevention of sickle cell vaso-occlusive crisis.

In / in, in / m, inside during meals or on an empty stomach; the tablets should be taken with a liquid (water, juice).

Parenteral administration of piracetam is prescribed when it is impossible to use oral forms of the drug (unconsciousness, difficulty swallowing). IV administration is preferred.

The intravenous infusion of a daily dose is performed through a catheter at a constant rate for 24 hours a day (for example, in the initial stage of treatment of severe myoclonus).

The drug is preliminarily diluted in one of the compatible infusion solutions: dextrose 5, 10 or 20%; fructose 5, 10, 20%; sodium chloride 0.9%; dextran 40 10% (in sodium chloride solution 0.9%); Ringer's solution; mannitol solution 20%.

The total volume of the solution intended for administration is determined taking into account the clinical indications and the patient's condition.

A bolus intravenous injection (for example, emergency treatment of a crisis in sickle cell anemia) is performed for at least 2 minutes, the daily dose is distributed over several injections (2-4) at regular intervals so that the dose per injection does not exceed 3 g.

The intramuscular drug is administered if the introduction through a vein is difficult. The volume of the solution injected intramuscularly cannot exceed 5 ml. The frequency of administration of the drug is similar to that when it is administered intravenously or orally. When the opportunity arises, they switch to oral administration of the drug. The duration of treatment is determined by the doctor, depending on the disease and taking into account the dynamics of symptoms.

Symptomatic treatment of chronic psychoorganic syndrome: - 2.4-4.8 g / day (capsules, oral solution - 2-3 doses).

Treatment of dizziness and associated imbalance - 2.4-4.8 g / day (capsules, oral solution - in 2-3 doses).

Cortical myoclonus. 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 (24 g / day) is reached; capsules, oral solution - in 2-3 doses. Treatment continues 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.

Sickle cell anemia. During a crisis - 300 mg / kg IV, divided into 4 equal doses.

Dosing for patients with impaired renal function. The dose should be adjusted depending on the amount of creatinine clearance (see table below).

The creatinine clearance for men can be calculated from the serum creatinine concentration using the following formula:

Cl creatinine, ml / min

The creatinine clearance for women can be calculated by multiplying the resulting value by a factor of 0.85.

Film-coated tablets

The daily dose is 30Ц160 mg / kg of body weight, the frequency of administration is 2Ц4 times a day.

In the treatment of chronic psychoorganic syndrome, depending on the severity of symptoms, NootropilЃ 4.8 g / day is prescribed for the first week, and then they switch to a maintenance dose of 1.2Ц2.4 g / day.

In the treatment of the consequences of a stroke - 4.8 g / day.

With alcohol withdrawal syndrome - 12 g / day in 2-3 doses. The maintenance dose is 2.4 g / day.

In the treatment of dizziness and related balance disorders - 2.4-4.8 g / day.

In the treatment of coma, as well as perception difficulties in persons with brain injuries, the initial dose is 9Ц12 g / day, and the maintenance dose is 2.4 g / day. Treatment continues for at least 3 weeks.

For the correction of learning disabilities, NootropilЃ is prescribed for children at a dose of 3.3 g / day (approximately 8 ml of oral solution 2 times a day). Treatment continues throughout the school year.

With cortical myoclonus, treatment begins 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 continues 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. In the absence of effect or insignificant therapeutic effect, treatment is discontinued.

In sickle cell anemia, the daily prophylactic dose is 160 mg / kg body weight, divided into 4 doses.

Oral solution

Prevention of sickle cell vaso-occlusive crisis. The daily prophylactic dose is 160 mg / kg, divided into 4 equal doses.

Treatment of dyslexia in children (in combination with other methods of treatment): the recommended daily dose for children from 8 years of age and adolescents is 3.2 g, divided into 2 doses.

For elderly patients, the dose is adjusted in the presence of renal failure; with prolonged therapy, it is necessary to monitor the functional state of the kidneys. Dosing for patients with impaired liver function: patients with impaired liver function do not need dose adjustment. For patients with impaired renal and liver function, dosing is carried out according to the scheme (see section 'Dosing for patients with impaired renal function').

Since NootropilЃ is excreted from the body by the kidneys, when prescribing the drug to patients with renal insufficiency and elderly patients, the dose should be adjusted depending on the value of Cl creatinine.

Dosing for patients with impaired renal function

Renal failureCl creatinine, ml / minDosage regimen
Absent (norm)> 80The usual dose
Easy50-792/3 of the usual dose in 2-3 divided doses
Average30Ц491/3 of the usual dose in 2 divided doses
Heavy<301/6 of the usual dose once
Terminal stage<20Contraindicated

For elderly patients, the dose is adjusted in the presence of renal failure; with prolonged therapy, it is necessary to monitor the functional state of the kidneys.

No dose adjustment is required in patients with impaired liver function.

For patients with impaired renal and hepatic function, dosing is carried out according to the table above.

Precautions

When treating cortical myoclonus, abrupt interruption of treatment should be avoided. this can cause seizures to recur.

In the treatment of sickle cell anemia, a dose of less than 160 mg / kg or irregular administration of the drug may exacerbate the disease.

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

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

Penetrates through the filter membranes of hemodialysis machines.

Solution for i / v and i / m administration1 amp.
active substance:
piracetam1 g / 5 ml or 3 g / 15 ml
excipients: sodium acetate trihydrate - 0.005 / 0.015 g; glacial acetic acid - 0.000245 / 0.000735 g; water for injection - 4.194 / 12.585 g

in ampoules of 5 or 15 ml; in contoured plastic packages (in pallets) 4 (15 ml) or 6 (5 ml) pcs.; in a pack of cardboard 1 (4 amp.) or 2 (6 amp.) packaging.

Film-coated tablets1 tab.
active substance:
piracetam800 mg
1200 mg
excipients: silicon dioxide - 14.7 / 22.05 mg; magnesium stearate - 2/3 mg; macrogol 6000 - 20/30 mg; sodium croscarmellose - 16.7 / 25.05 mg;
shell: Opadry Y-1-7000 (titanium dioxide (E171) - 8/12 mg, macrogol 400 - 1.6 / 2.4 mg, hypromellose 2910 5cP (E464) - 16/24 mg) - 25.6 / 38 .4 mg; Opadry OY-S-29019 (hypromellose 2910 50cP0.95 / 1.425 mg, macrogol 6000 - 0.05 / 0.075 mg) - 1 / 1.5 mg

in a blister 15 pcs.; in a box 2 blisters (800 mg) or in a blister 10 pcs.; 2 blisters in a box (1200 mg).

Oral solution100 ml
piracetam20 g
excipients: glycerol 85% - 27.0 g; sodium saccharin - 0.300 g; sodium acetate - 0.200 g; methyl parahydroxybenzoate - 0.135 g; propyl parahydroxybenzoate - 0.015 g; 52247 / A apricot (flavoring) - 0.03 g; 52939 / A caramel (flavoring) - 0.015 g; glacial acetic acid - 0.016 ± 5% g; purified water - 62.10 g ± 5%

in dark glass bottles of 125 ml; in the box 1 bottle complete with a measuring cup.

hypersensitivity to piracetam or pyrrolidone derivatives, as well as other components of the drug;

psychomotor agitation at the time of prescribing the drug;

chorea of ??Huntington;

acute violation of cerebral circulation (hemorrhagic stroke);

end stage renal failure (Cl creatinine <20 ml / min);

children under 1 year of age (oral solution) and up to 3 years (solution for intravenous and intramuscular administration, capsules and coated tablets).

With care: impaired hemostasis, extensive surgical interventions. heavy bleeding, chronic renal failure (with Cl creatinine 20Ц80 ml / min).

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