Fenotropil

General characteristics. Structure:

Active agent: fenotropit (N-karbamoilmetil-4-phenyl-2-пирролидон) 100 mg.

Excipients: lactoses monohydrate (sugar milk) — 51,52 mg; potato starch — 46,48 mg; calcium stearate — 2 mg.

Pharmacological properties:

Pharmacodynamics. Fenotropil – nootropic drug, possesses the expressed anti-anamnestic action, exerts the direct activating impact on integrative activity of a brain, promotes memory consolidation, improves concentration of attention and cerebration, facilitates training process, increases information transfer speed between cerebral hemispheres, increases resistance of tissues of brain to a hypoxia and toxic influences, possesses anticonvulsant action and anxiolytic activity, regulates processes of activation and braking of TsNS, improves mood.

Fenotropil exerts positive impact on exchange processes and blood circulation of a brain, stimulates oxidation-reduction processes, increases energy potential of an organism due to glucose utilization, improves a regional blood stream in ischemic sites of a brain. Increases the maintenance of noradrenaline, dopamine and serotonin in a brain, does not influence the level of maintenance of GAMK, does not contact neither GAMKA, nor GAMKV receptors, does not exert noticeable impact on spontaneous bioelectric activity of a brain.

Fenotropil does not exert impact on breath and cardiovascular system, shows not expressed diuretic effect, has anorexigenic activity at course use.

The promoting effect of Fenotropil is shown in his ability to render moderately expressed effect concerning motor reactions, in increase in physical effeciency, in the expressed antagonism to cataleptic action of neuroleptics, and also in easing of expressiveness of somnolent effect of ethanol and hexenal.

Psychogogic action of Fenotropil prevails in the ideatorny sphere. The moderate psychogogic effect of drug is combined with anxiolytic activity, improves mood, renders some analgeziruyushchy effect, raising a threshold of painful sensitivity.

Adaptogenny action of Fenotropil is shown in increase in resistance of an organism to a stress in the conditions of excessive mental and exercise stresses, at exhaustion, a hypokinesia and an immobilization, at low temperatures.

Against the background of Fenotropil's reception improvement of sight which is shown in increase in sharpness, brightness and fields of vision is noted.

Fenotropil improves blood supply of the lower extremities.

Fenotropil stimulates development of antibodies in response to administration of antigen that indicates its immunostimulating properties, but at the same time it does not promote development of immediate hypersensitivity and does not change the allergic inflammatory reaction of skin caused by introduction of a foreign protein.

At course use of Fenotropil medicinal dependence, tolerance, "withdrawal" does not develop.

Fenotropil's action is shown from a single dose that is important at use of drug in extreme conditions.

Fenotropil has no teratogenic, mutagen, cancerogenic and embriotoksichny properties. Toxicity - is low, the lethal dose in an acute experiment makes 800 mg/kg.

Pharmacokinetics. Fenotropil is quickly soaked up, gets into various bodies and fabrics, easily passes through a blood-brain barrier. Absolute bioavailability of drug at oral administration makes 100%. The maximum concentration in blood is reached in 1 hour, the elimination half-life makes 3-5 hours. Fenotropil is not metabolized in an organism and brought from an organism in an invariable look. About 40% of drug are removed with urine and 60% of drug are removed with bile and then.

Indications to use:

The diseases of the central nervous system of various genesis which are especially connected with vascular diseases and disturbances of exchange processes in a brain, intoxication, (in particular at posttraumatic conditions and the phenomena of chronic cerebrovascular insufficiency), followed by deterioration intellectual мнестических functions, decrease in a physical activity;

The neurotic states which are shown the slackness increased by an exhaustion, decrease in psychomotor activity, disturbance of attention, a memory impairment;

Disturbances of processes of training;

Depressions easy and moderate severity;

The Psikhorganichesky syndromes which are shown intellectual мнестическими disturbances and the apatiko-abulichesky phenomena and also vyaloapatichesky states at schizophrenia;

Convulsive states;

Obesity (alimentary and constitutional genesis);

Prevention of a hypoxia, increase in resistance to a stress, correction of a functional condition of an organism in extreme conditions of professional activity for the purpose of the prevention of development of exhaustion and increase in intellectual and physical effeciency, correction of a daily biorhythm, inversion of the cycle "dream wakefulness";

Alcoholism (for the purpose of reduction of the phenomena of an adynamy, a depression, intellectual мнестических disturbances).

Route of administration and doses:

Fenotropil apply inside, right after food. The dose of drug and duration of treatment have to be defined by the doctor. Doses vary depending on features of a condition of the patient. The average single dose makes 150 mg (from 100 mg to 250 mg); the average daily dose makes 250 mg (from 200 mg to 300 mg). The maximum admissible dose makes – 750 mg a day. It is recommended to divide a daily dose into 2 receptions. To accept a daily dose to 100 mg once in the morning, and over 100 mg to divide a daily dose into two receptions. Duration of treatment can vary from 2 weeks to 3 months. The average duration of treatment makes 30 days. If necessary the course can be repeated in a month.

For increase in working capacity - 100-200 mg single in the morning, within 2 weeks (for athletes – 3 days).

The recommended treatment duration for patients with alimentary and constitutional obesity makes 30-60 days in a dose of 100-200 mg once a day (in the morning).

Fenotropil after 15 hours is not recommended to accept.

Features of use:

At excessive psychoemotional exhaustion against the background of a chronic stress and exhaustion, chronic sleeplessness, the single dose of Fenotropil in the first days can cause the sharp need for a dream. Such patients in out-patient conditions should recommend to begin course administration of drug in the days off.

Side effects:

Sleeplessness (in case of administration of drug 15 hours are later). Some patients in the first 1-3 days of administration of drug can have a psychomotor excitement, a hyperemia of integuments, a caumesthesia, increase in arterial pressure.

Interaction with other medicines:

Fenotropil can strengthen effect of the drugs stimulating the central nervous system, antidepressants and nootropic drugs.

Contraindications:

Individual intolerance.

PRECAUTIONARY MEASURES
Fenotropil apply with care at patients with crushing organic lesions of a liver and kidneys, severe forms of an arterial hypertension, at patients with atherosclerosis, also at the patients who transferred earlier panic attacks, alarming raptoidny states or acute psychotic states, especially with psychomotor excitement owing to a possibility of an aggravation of alarm, panic, hallucinations and nonsense, and also at the patients inclined to allergic reactions to nootropic drugs of group of a pirrolidon.

USE AT PREGNANCY AND THE LACTATION
Fenotropil it is not necessary to appoint at pregnancy and feeding a breast due to the lack of these clinical trials.

USE IN PEDIATRICS
Fenotropil's appointment is not recommended to children, due to the lack of data of use of drug for children.

Overdose:

Cases of overdose were not noted. Treatment: symptomatic therapy.

Storage conditions:

List B. In dry, protected from light and the place, unavailable to children, at a temperature not above 30 °C.

Issue conditions:

According to the recipe

Packaging:

The tablets containing 50 or 100 mg of Fenotropil. On 10 tablets in a blister strip packaging from a film of polyvinyl chloride and aluminum foil.
Each can, 1, 2 or 3 blister strip packagings together with the application instruction in a pack from a cardboard.