Composition
1 tablet contains:
Active ingredient: fonturacetam-50.00 mg or 100.00 mg;
excipients: povidone K-17, microcrystalline cellulose, sodium carboxy-methyl starch, magnesium stearate.
Pharmacological action
A nootropic drug with a pronounced anti-amnesic effect has a direct activating effect on the integrative activity of the brain, promotes memory consolidation, improves concentration and mental activity, facilitates the learning process, increases the speed of information transfer between the cerebral hemispheres and the resistance of brain tissues to toxic effects, has an anticonvulsant effect and anxiolytic activity. It has a positive effect on metabolic processes, stimulates redox processes, increases the energy potential of the body due to the utilization of glucose. Increases the content of norepinephrine, dopamine, and serotonin in the brain, does not affect the level of GABA, does not bind to GABA and GABA receptors, and does not significantly affect the spontaneous bioelectric activity of the brain. It has no effect on respiration and the cardiovascular system, shows an unexpressed diuretic effect, and has anorexic activity when used in a course. The stimulating effect is manifested in the ability to have a moderate effect, manifested in relation to motor reactions, increasing physical performance, as well as reducing the severity of the hypnotic effect of ethanol and hexobarbital. Psychostimulating action prevails in the ideatory sphere. Moderate psychostimulating effect of the drug is combined with anxiolytic activity. It has some analgesic effect, increasing the threshold of pain sensitivity. Adaptogenic effect is manifested in increasing the body’s resistance to stress in conditions of excessive mental and physical exertion, fatigue, hypokinesia and immobilization, at low temperatures. Against the background of taking the drug, there was an improvement in vision, which is manifested in an increase in acuity, brightness and visual fields. Improves blood supply to the lower extremities. It stimulates the production of antibodies in response to the introduction of an antigen, which indicates immunostimulating properties, but at the same time does not contribute to the development of immediate hypersensitivity and does not change the allergic inflammatory reaction of the skin caused by the introduction of a foreign protein. Drug dependence, tolerance, and “withdrawal syndrome”do not develop during the course of use. The effect is manifested at a single dose, which is important when using the drug in extreme conditions.
Absorption rate: Quickly absorbed. Absolute oral bioavailability is 100%.
Distribution: Penetrates various organs and tissues, easily passes through the blood-brain barrier. The maximum concentration in the blood (Tmax) is reached after 1 h.
Metabolism: Not metabolized in the body.
Elimination: Half – life (T 1/2) – 3-5 hours. It is excreted unchanged: approximately 40% – by the kidneys and 60% – with bile and sweat.
Clinical pharmacology
Individual intolerance; Children under 18 years of age (safety and efficacy of the drug have not been established). With caution, patients with severe organic liver and kidney damage, severe hypertension, severe atherosclerosis, who have previously suffered panic attacks, acute psychotic states that occur with psychomotor agitation-due to the possibility of exacerbation of anxiety, panic, hallucinations and delusions, as well as patients prone to allergic reactions to nootropic drugs of the pyrrolidone group. Use during pregnancy and lactation should not be prescribed during pregnancy and lactation due to the lack of data from clinical studies.
Indications
* Diseases of the central nervous system of various origins, especially associated with metabolic disorders in the brain, intoxication (in particular, in post-traumatic conditions), accompanied by a deterioration in intellectual and mnestic functions, a decrease in motor activity;• Neurotic states that are manifested by lethargy, increased exhaustion, decreased psychomotor activity, impaired attention, and memory impairment;• Learning disabilities;• Psychoorganic syndromes manifested by intellectual-mnestic disorders and apathetic-abulic phenomena, as well as sluggish-apathetic states in schizophrenia;• Convulsive states;• Obesity (alimentary and constitutional origin);• Prevention of hypoxia, increasing resistance to stress, correction of the functional state of the body in extreme conditions of professional activity in order to prevent the development of fatigue and to increase mental and physical performance, correction of the daily biorhythm, inversion of the sleep-wake cycle• * Chronic alcoholism (in order to reduce intellectual and mnestic disorders).
Use during pregnancy and lactation
There are no data on randomized clinical trials of fonturacetam in pregnant women, and therefore, the use of Nanotropil® novo during pregnancy and lactation is contraindicated.
Contraindications
Hypersensitivity to fonturacetam or any excipient in the preparation.
Pregnancy and breast-feeding period.
Age up to 18 years (due to the lack of clinical data on the efficacy and safety of fonturacetam in this age population).
Side effects
Insomnia (if the drug is taken later than 15 hours). In some patients, psychomotor agitation, hyperemia of the skin, a feeling of warmth, and an increase in blood pressure are possible in the first 1-3 days of admission.
Interaction
Fonturacetam may enhance the effects of CNS-stimulating drugs and nootropic drugs. The drug shows a pronounced antagonism to the cataleptic action of neuroleptics, and also weakens the severity of the hypnotic effect of ethanol and hexobarbital.
How to take, course of use and dosage
Inside. Take immediately after meals. The dose and duration of treatment should be determined by the doctor. Doses vary depending on the patient’s condition. The average single dose is 150 mg (100 to 250 mg); the average daily dose is 250 mg (200 to 300 mg). The maximum daily dose of Nanotropil ® novo is 750 mg. It is recommended to take a daily dose of up to 100 mg once in the morning, and divide more than 100 mg into 2 doses. The duration of treatment can vary from 2 weeks to 3 months, with an average of 30 days. If necessary, the course can be repeated in 1 month.
To improve performance – 100-200 mg once in the morning, for 2 weeks (for athletes-3 days).
The recommended duration of drug therapy in patients with alimentary-constitutional obesity is 30-60 days at a dose of 100-200 mg once a day (in the morning). It is not recommended to take the drug later than 15 hours.
Overdose
No cases of overdose were reported. Treatment: symptomatic therapy.
Description
Round flat-cylindrical tablets from white to white with a yellowish tinge of color with a chamfer for a dosage of 50 mg, with a chamfer and a risk for a dosage of 100 mg.
Special instructions
With excessive psychoemotional exhaustion against the background of stress and fatigue, chronic insomnia, a single dose of the drug in the first day can cause a sharp need for sleep. Such patients on an outpatient basis should be recommended to start a course of taking the drug on non-working days.
Form of production
Tablets,50 mg,100 mg.
10 tablets in a contour cell package made of polyvinyl chloride film and aluminum foil printed varnished.
1,2,3,4 or 5 contour cell packs together with instructions for use in a cardboard pack.
Storage conditions
In a dark place at a temperature not exceeding 30 °C. Keep out of reach of children.
Shelf
life is 3 years.
Active ingredient
Fonturacetam
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
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