Lutsetam

Lutsetam – medicine with nootropic action.

Form of release and structure

Lutsetam release in two dosage forms:

• Tablets, film coated: biconvex, oval, almost white or white color, with a facet, with an engraving depending on a dosage (400/800/1200 mg) of "E241", "E242", "E243" on one of the parties, inodorous (on 10 or 15 pieces in blisters, on 2 or 4 blisters in a cardboard pack; on 20, 30 or 60 pieces in dark glass jars, after 1 bank in a cardboard pack);
• Solution for intravenous and intramuscular administration: transparent, with a subtle greenish shade or colourless, inodorous (in colourless glass ampoules on 5 ml, on 5 ampoules in plastic strip packagings, on 2 packagings in a cardboard pack; in colourless glass ampoules on 15 ml, on 4 ampoules in blister strip packagings, on 1 or 5 packagings in a cardboard pack).

Is a part of 1 tablet:

• Active agent: piracetam – 400, 800 or 1200 mg;
• Auxiliary components (tablets on 400/800/1200 mg respectively): K-30 povidone – 25/50/75 mg, magnesium stearate – 3/6/9 mg;
• Cover film (tablets on 400/800/1200 mg respectively): ethyl cellulose (in the form of water dispersion) – 3,5/7/9,1 mg, дибутилсебакат – 0,7/1,4/1,82 mg, white Opadry (talc – 1/2/2,6 mg, a macrogoal 6000 – 0,25/0,5/0,65 mg, a gipromelloza – 3,8/7,6/9,88 mg, titanium dioxide – 0,75/1,5/1,95 mg).

Is a part of 1 ml of injection solution:

• Active agent: piracetam – 200 mg;
• Auxiliary components: sodium acetate trihydrate – 1 mg, acetic ice acid – to pH 5,8, water for injections – to 1 ml.

Indications to use

• Effects of an ischemic stroke, including disturbances of a mental and physical activity, the speech and the emotional sphere (treatment);
• The psychoorganic syndrome (in particular at elderly patients) which is followed by dizziness, decrease in memory, disorder of behavior, changes of mood, reduced general activity and concentration of attention, gait disturbance and also at Alzheimer's disease and senile dementia of altsgeymerovsky type (symptomatic treatment);
• Dizzinesses and the related disturbances of balance, except dizzinesses of a mental origin (treatment);
• Alcoholism (treatment of abstinent and psychoorganic syndromes);
• The recovery period after intoxications and brain injuries;
• Cortical myoclonia (as monotherapy or along with other medicines);
• Low learnability at children, in particular during obtaining specific skills of reading, the account, the letter which cannot be explained with inadequate training, domestic surroundings or mental retardation (along with other medicines).

Contraindications

• Renal failure (the end-stage at clearance of creatinine is less than 20 ml in a minute);
• Hemorrhagic stroke;
• Age till 1 year;
• Pregnancy and period of breastfeeding (lactation);
• Hypersensitivity to components of drug or derivatives of a pirrolidon.

Route of administration and dosage

Lutsetam accept inside, washing down with liquid (water, juice), on an empty stomach or during meal. Injection solution is entered intravenously or intramusculary.

The average daily dose of Lutsetam irrespective of a dosage form makes 0,03-0,16 g/kg (from 3 to 12 g), frequency rate of use – 2-4 times a day.

The daily dose is defined by indications:

• Psychoorganic syndrome (at a chronic current): the first 7 days – 4,8 g, further – 1,2-2,4 g;
• Stroke effects: 4,8 g;
• Alcoholic abstinence syndrome: 12 g, the supporting daily dose – 2,4 g;
• Dizziness and related disorders of balance: 2,4-4,8 g;
• Cortical myoclonia: an initial dose – 7,2 g, increase a dose by 4,8 g each 3-4 days before achievement of the maximum daily dose – 24 g. Therapy needs to be carried out throughout the entire period of a disease. Each half a year it is necessary to make an attempt to lower a dose or to cancel Lutsetam, gradually reducing a dose (by 1,2 g each 2 days). In cases of lack of improvement or at insignificance of therapeutic effect use of drug is stopped;
• Comas, and also difficulties of perception at injuries: an initial dose – 9-12 g (injection solution), a maintenance dose – 2,4 g. Therapy duration – is not less than 3 weeks;
• The lowered learnability at children: 3,2 g (in). Lutsetam it is necessary to accept all academic year.

At functional disturbances of kidneys it is necessary to carry out correction of a daily dose depending on clearance of creatinine:

• > 80 ml a minute (norm): usual dose;
• 50-79 ml a minute (an easy form): 2/3 usual doses, frequency rate of use – 2-3 times a day;
• 30-49 ml a minute (an average form): 1/3 usual doses, frequency rate of use – 2 times a day;
• <30 мл в минуту (тяжелая форма): 1/6 обычной дозы, кратность применения – 1 раз в день.

At an end-stage of a renal failure it is contraindicated to carry out therapy.

Elderly patients need to adjust a dose in the presence of a renal failure, at long treatment it is necessary to control a functional condition of kidneys.

At functional disturbances of a liver correction of the mode of dosing is not required.

Injection solution of Lutsetam is compatible to such infusion solutions as: 5%, 10%, 20% of Dextrosum and fructose, 5% of a levuloz, 0,9% sodium chloride, Mannitolum dextran, Ringer's solution (with a lactate or without it), 6% hydroxyethylstarch, a dextran of 40 - 10% in 0,9% sodium chloride solution, a dextran of 100 - 6% in 0,9% sodium chloride solution.

Infusion solutions of piracetam keep stability not less than 24 hours.

Side effects

• Central and peripheral nervous system: hyperkinesia, drowsiness, nervousness, depression; in some cases – a headache, dizziness, an ataxy, an aggravation of a course of epilepsy, balance disturbance, confusion, sleeplessness, hallucinations, excitement, alarm, increase in sexuality;
• Alimentary system: in isolated cases – nausea, diarrhea, vomiting, pains in a stomach;
• Metabolism: increase in body weight;
• Dermatological reactions: hypostasis, itch, dermatitis, rashes;
• Others: adynamy.

Most often side effects arise at elderly patients at Lutsetam's use in a daily dose more than 2,4 g; in most cases these disturbances take place at reduction of a dose.

Special instructions

Because piracetam influences aggregation of thrombocytes, Lutsetam patients should apply with care with disturbances of a hemostasis, during big surgeries or in the presence of symptoms of heavy bleeding.

It is necessary to consider that piracetam gets through the filtering membranes of devices for a hemodialysis.

During treatment of a cortical myoclonia it is necessary to avoid sharp interruption of therapy as it can lead to resuming of attacks.

At long therapy elderly patients are regularly recommended to control indicators of function of kidneys, in need cases, based on results of a research of clearance of creatinine, it is necessary to carry out dose adjustment.

Considering possible side effects, patients need to show care at control of motor transport and performance of work with mechanisms.

Medicinal interaction

With Phenytoinum, clonazepam, Valproatum of sodium and phenobarbital of interaction it is noted.

At combined use of Lutsetam with some medicines there can be following effects:

• Extract of a thyroid gland: development of an acrimony, disorientation and sleep disorders;
• Atsenokumarol: increase in its efficiency at patients with venous thrombosis – is noted more expressed lowering of the level of aggregation of thrombocytes, Villebrand's factors, level of fibrinogen, viscosity of plasma and blood in comparison with performing monotherapy (at Lutsetam's use in high doses – 9,6 g a day).

Terms and storage conditions

To store in the place, unavailable to children, at a temperature of 15-30 °C.

Period of validity:

• Tablets – 5 years;
• Solution for injections – 2 years.