FENOTROPYL

Active material: Fenilpiratsetam
When ATH: N06BX
CCF: Nootropics
ICD-10 codes (testimony): E66, F07, F10.2, F20, F31, F32, F33, F41.2, F43, F48.0, F51.2, F81, I69, R25.2, Z73.0, Z73.3
At KFU: 02.14.01
Manufacturer: OAO Valenta PHARMACEUTICS (Russia)

Pharmaceutical form, composition and packaging

Pills from white to white with yellowish or Valium a color shade, Valium.

Excipients: lactose, potato starch, calcium stearate.

10 PC. – packings Valium planimetric (1) – packs cardboard.
10 PC. – packings Valium planimetric (3) – packs cardboard.

Pharmacological action

Nootropics. According to the mechanism of action is a neuromodulator, It operates on most neurotransmitter systems of the brain. It has expressed antiamnesic action, activates the integrative activity of the brain, It contributes to memory consolidation, It improves concentration and mental performance, It facilitates the learning process, It speeds up the transfer of information between the hemispheres of the brain, increases the resistance of brain tissue hypoxia and toxic effects, It has an anticonvulsant effect and anxiolytic activity, regulates the activation and inhibition of the central nervous system, improves mood.

Fenotropyl^® It has a positive effect on the metabolism and blood circulation of the brain, stimulating redox processes, It increases energy potential due to the utilization of glucose, improving regional blood flow in the ischemic areas of the brain. Increases of noradrenaline, dopamine and serotonin in the brain.

It does not affect the levels of GABA, It does not bind to GABA_A– and GABA_IN-receptors, no appreciable effect on the spontaneous brain activity.

Fenotropyl^® It has no effect on the respiratory and cardiovascular systems. It has a weakly expressed diuretic effect. It has anoreksigennoy activity in exchange application.

Fenotropyl^® It has a moderate activating effect in respect of motor reactions, increases physical performance, It has a strong antagonism cataleptic action of neuroleptics, It reduces the severity of hypnotic action of ethanol and geksenala.

Stimulating effect Phenotropil^® prevails in the area ideatornoy. Moderate psychoactivating effect of the drug is combined with anxiolytic activity. Fenotropyl^® improves mood, It has analgesic effect, increasing the pain threshold.

Fenotropyl^® It has adaptogenic effect, increasing the body's resistance to stress in the face of increased mental and physical exertion, when fatigue, hypokinesia and immobilization, at low temperatures.

Against the background of Phenotropil^® marked improvement in vision (increase in severity, brightness and visual fields).

Fenotropyl^® It improves blood flow to the lower extremities.

Fenotropyl^® It stimulates the production of antibodies in response to antigen, indicating its immunostimulatory properties, but at the same time it does not cause the development of immediate hypersensitivity reactions or modify the allergic inflammatory reaction of the skin, caused by the introduction of a foreign protein.

In exchange application Phenotropil^® do not develop drug dependence and tolerance. When you remove the drug development not observed withdrawal.

Action Phenotropil^® It is seen after a single dose, which is important when using the drug in extreme conditions.

Pharmacokinetics

Absorption and distribution

After intake of rapidly absorbed from the gastrointestinal tract, distributed in various organs and tissues, easily penetrates through the BBB. The absolute bioavailability of the drug when taken orally makes 100%. FROM_max blood achieved through 1 no.

Metabolism and excretion

Fenilpiratsetam is not metabolized in the body and is excreted unchanged in. About 40% excreted in the urine, 60% – the bile and then. T_1/2 is 3-5 no.

Testimony

- CNS disorders of various origins, especially diseases of vascular origin or associated with disorders of metabolic processes in the brain and intoxication (in particular, post-traumatic states and phenomena of chronic cerebrovascular insufficiency), accompanied by a deterioration in intellectual-mental functions, reduction in motor activity;

- Neurotic state, manifested apathy, increased exhaustion, reduction of psychomotor activity, violation of attention, memory impairment;

- Breach of learning processes;

- Depression of mild to moderate severity;

- Psycho-organic syndromes, manifesting intellectual mnesticheskimi disorders and symptoms apatiko-abulicheskimi, and vyaloapaticheskih state in schizophrenia;

- Convulsive status;

- Obesity (alimentary-constitutional genesis);

- Prevention of hypoxia, increase resistance to stress;

- Correction of the functional state of the body in extreme conditions of professional activity with the aim of preventing the development of fatigue and enhance mental and physical performance;

- Correction daily biorhythms, regulation loop “sleep-wake”;

- Alcoholism (to reduce symptoms of asthenia, depression, intellectual-mental disorders).

Dosage regimen

The mode set individually.

Fenotropyl^® taken orally immediately after meals.

The average single dose is 100-200 mg, Average daily dose – 200-300 mg. The maximum daily dose – 750 mg. It is recommended to divide the daily dose in the 2 admission. The daily dose to 100 mg should be 1 time / day in the morning, the daily dose of a 100 mg should be divided into 2 admission. The duration of treatment may vary from 2 weeks before 3 months. The average duration of treatment is 30 days. If necessary, the course may be repeated a month.

To improve efficiency appointed 100-200 mg 1 times / day in the morning for 2 weeks (for athletes – 3 day).

At alimentary-constitutional obesity – 100-200 mg 1 times / day in the morning for 30-60 days.

Do not take Phenotropil^® after 15 no.

Side effect

CNS: insomnia (while taking the drug after 15 no).

Some patients in the first 3 Day reception – psychomotor agitation, flushing of the skin, feeling the heat, increased blood pressure.

Contraindications

- Hypersensitivity to the drug.

FROM caution should be prescribed to patients with severe organic lesions of the liver and kidneys, severe hypertension, with advanced atherosclerosis; patients, previously suffered a panic attack, acute psychotic state, accompanied by psychomotor agitation (tk. may increase anxiety, panic, hallucinations and delusions); patients, prone to allergic reactions to the group nootropics pyrrolidone.

Pregnancy and lactation

Fenotropyl^® should not be administered during pregnancy and lactation (breast-feeding) due to lack of clinical trial data.

Fenotropyl^® not teratogenic, mutagenic and embryotoxic action.

Cautions

It should be taken into account, that the excessive psycho-emotional exhaustion on the background of chronic stress and fatigue, chronic insomnia, single dose Phenotropil^® on the first day can cause a sharp need for sleep. Such patients on an outpatient basis is recommended to start taking the drug in non-working days.

Use in Pediatrics

Fenotropyl^® not recommended for children due to the lack of clinical data on the use of the drug in children.

The results of experimental studies

Fenotropyl^® characterized by low toxicity, the lethal dose is in acute experiment 800 mg / kg. Do not have a carcinogenic effect.

Overdose

Currently, cases of drug overdose Phenotropil^® not reported. If necessary spend symptomatic therapy.

Drug Interactions

Fenotropyl^® may increase the effects of drugs, stimulating the central nervous system, antidepressants and nootropics.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children, dry, protected from light, at a temperature no higher than 30 ° C. Shelf life – 5 years.