Composition, form of production and packaging
Tablets from white to white with a yellowish or kremovatym color shade, flat-cylindrical.
1 tab.
phenotropyl (N-carbamoylmethyl-4-phenyl-2-pyrrolidone) 50 mg
Excipients: lactose monohydrate - 80.5 mg, potato starch - 18 mg, calcium stearate - 1.5 mg.
10 pieces. - packings of cellular contour (1) - packs cardboard.
10 pieces. - packings cellular planimetric (3) - packs cardboard.
Tablets from white to white with a yellowish or kremovatym color shade, flat-cylindrical.
1 tab.
phenotropyl (N-carbamoylmethyl-4-phenyl-2-pyrrolidone) 100 mg
Excipients: lactose monohydrate - 51.52 mg, potato starch - 46.48 mg, calcium stearate - 2 mg.
10 pieces. - packings of cellular contour (1) - packs cardboard.
10 pieces. - packings cellular planimetric (3) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Nootropic preparation. Has a pronounced antiamnestic effect, activates the integrative activity of the brain, promotes memory consolidation, improves concentration and mental activity, facilitates learning processes, accelerates the transfer of information between the cerebral hemispheres, increases the resistance of brain tissue to hypoxia and toxic effects, has anticonvulsant action and anxiolytic activity , regulates the processes of activation and inhibition of the central nervous system, improves mood.
Fenotropil В® has a positive effect on the metabolic processes and blood circulation of the brain, stimulates redox processes, increases the energy potential of the body through the utilization of glucose, improves regional blood flow in the ischemic areas of the brain. Increases the content of norepinephrine, dopamine and serotonin in the brain.
Does not affect the level of GABA, does not bind to GABA A - and GABA B receptors, does not have a significant effect on spontaneous bioelectrical activity of the brain.
Phenotropil В® does not affect the respiratory and cardiovascular systems. Has a weakly diuretic effect. Possesses anorexigenic activity in course use.
Fenotropil В® has a moderately activating effect on motor reactions, improves physical performance, has a pronounced antagonism with respect to the catalepsy effect of neuroleptics, reduces the severity of the hypnotics of ethanol and hexenal.
Psycho-stimulating effect of phenothyrosine prevails in the ideator sphere. Moderate psychoactivating effect of the drug is combined with anxiolytic activity.Fenotropil В® improves mood, analgesic effect, raising the threshold of pain sensitivity.
Fenotropil В® has an adaptogenic effect, increasing the body's resistance to stress in conditions of increased mental and physical stress, fatigue, hypokinesia and immobilization, at low temperatures.
Against the background of the use of Fenotropil noted improvement in vision (increased acuity, brightness and fields of vision).
Phenotropil В® improves the blood supply of the lower extremities.
Phenotropil В® stimulates the production of antibodies in response to the administration of the antigen, which indicates its immunostimulating properties, but at the same time does not cause the development of immediate-type hypersensitivity reactions and does not change the allergic skin inflammatory reaction caused by the introduction of a foreign protein.
In the course of the use of Fenotropil, drug dependence and tolerance do not develop. When the drug was withdrawn, there was no development of withdrawal syndrome.
The action of Fenotropil appears after a single dose, which is important when using the drug in extreme conditions.
PHARMACOKINETICS
Suction and distribution
After oral administration, it is rapidly absorbed from the digestive tract, distributed in various organs and tissues, easily penetrates the GEB. Absolute bioavailability of the drug when taken inside is 100%. C max in the blood is reached after 1 h.
Metabolism and excretion
Phenylpyracetam is not metabolized in the body and is excreted unchanged. About 40% is excreted in the urine, 60% - with bile and then. T 1/2 is 3-5 hours.
INDICATIONS
- Diseases of the central nervous system of various genesis, especially diseases of vascular genesis or associated with impaired metabolic processes in the brain and intoxication (in particular, in posttraumatic states and chronic cerebrovascular insufficiency), accompanied by impaired intellectual and mnestic functions, decreased motor activity;
- neurotic states, manifested by lethargy, increased exhaustion, decreased psychomotor activity, impaired attention, memory impairment;
- Violations of learning processes;
- Depression of mild and moderate severity;
- psycho-organic syndromes, manifested by intellectual-mnestic disorders and apatiko-abulic symptoms, as well as flaccid states in schizophrenia;
- convulsive conditions;
- obesity (alimentary-constitutional genesis);
- Prevention of hypoxia, increased resistance to stress;
- correction of the functional state of the organism in extreme conditions of professional activity with the purpose of preventing the development of fatigue and increasing mental and physical performance;
- correction of daily biorhythm, regulation of the "sleep-wake" cycle;
- chronic alcoholism (in order to reduce the symptoms of asthenia, depression, intellectual-mnestic disorders).
DOSING MODE
The dosage regimen is set individually.
Phenotropil В® is taken orally right after eating.
The average single dose is 100-200 mg, the average daily dose is 200-300 mg. The maximum daily dose is 750 mg. It is recommended to divide the daily dose into 2 doses. The daily dose to 100 mg should be taken 1 time / day in the morning, a daily dose of more than 100 mg should be divided into 2 divided doses. Duration of treatment can vary from 2 weeks to 3 months. The average duration of treatment is 30 days. If necessary, the course can be repeated in a month.
To improve performance, prescribe 100-200 mg 1 time / day in the morning for 2 weeks (for athletes - 3 days).
In case of alimentary-constitutional obesity , 100-200 mg 1 time / day in the morning for 30-60 days.
Do not take Phenotropil В® after 15 hours.
SIDE EFFECT
From the side of the central nervous system: insomnia (when taking the drug after 15 hours).
Some patients in the first 3 days of admission - psychomotor agitation, hyperemia of the skin, a feeling of warmth, an increase in blood pressure.
CONTRAINDICATIONS
- Hypersensitivity to the components of the drug.
Caution should be given to patients with severe organic lesions of the liver and kidneys, severe course of arterial hypertension, with severe atherosclerosis; patients who have experienced panic attacks earlier, acute psychotic conditions accompanied by psychomotor agitation (as possible aggravation of anxiety, panic, hallucinations and delusions); patients prone to allergic reactions to nootropic drugs of the pyrrolidone group.
PREGNANCY AND LACTATION
Fentotropil В® should not be prescribed during pregnancy and lactation (breastfeeding) because of the lack of clinical research data.
Fentotropil В® does not have a teratogenic, mutagenic and embryotoxic effect.
APPLICATION FOR FUNCTIONS OF THE LIVER
Caution should be given to the drug Fenotropil В® patients with severe organic kidney damage.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Caution should be given to the drug Fentotropil В® in patients with severe organic liver damage.
APPLICATION FOR CHILDREN
Fentotropil В® is not recommended for children due to the lack of clinical data on the use of the drug in children.
SPECIAL INSTRUCTIONS
It should be borne in mind that with excessive psychoemotional exhaustion on the background of chronic stress and fatigue, chronic insomnia, a single dose of Fentropil in the first day can cause a sharp need for sleep. Such patients in outpatient settings are advised to start taking the drug on non-working days.
Use in Pediatrics
Fentotropil В® is not recommended for children due to the lack of clinical data on the use of the drug in children.
Results of experimental studies
Fenotropil В® is characterized by low toxicity, the lethal dose in an acute experiment is 800 mg / kg. Does not have a carcinogenic effect.
OVERDOSE
At present, cases of an overdose of the drug Fentotropil В® have not been reported. If necessary, conduct symptomatic therapy.
DRUG INTERACTION
Phenotropil В® can enhance the effect of drugs that stimulate the central nervous system, antidepressants and nootropic drugs.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 30 В° C. Shelf life - 5 years.
