Fonturacetam (Tablets) Instructions for Use

ATC Code

N06BX (Other psychostimulants and nootropic drugs)

Active Substance

Fonturacetam (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Psychoanaleptics; psychostimulants, agents used in attention deficit hyperactivity disorder, and nootropic agents; other psychostimulants and nootropic agents

Pharmacological Action

Nootropic agent. It has a pronounced anti-amnesic 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 an anticonvulsant effect and anxiolytic activity, regulates the processes of activation and inhibition of the central nervous system, and improves mood.

It has a positive effect on the metabolic processes and blood circulation of the brain, stimulates redox processes, increases the body’s energy potential through glucose utilization, and improves regional blood flow in ischemic areas of the brain. It increases the content of norepinephrine, dopamine, and serotonin in the brain.

It does not affect the GABA level, does not bind to GABA_A and GABA_B receptors, and does not have a noticeable effect on the spontaneous bioelectrical activity of the brain.

It does not affect the respiratory and cardiovascular systems. It has a mild diuretic effect. It has anorexigenic activity with course use.

It has a moderately activating effect on motor reactions, increases physical performance, has a pronounced antagonism to the cataleptic effect of neuroleptics, and reduces the severity of the hypnotic effect of ethanol and hexenal.

The psychostimulant effect predominates in the ideational sphere. The moderate psychoactivating effect of the drug is combined with anxiolytic activity; it improves mood, has an analgesic effect by increasing the pain threshold.

It has an adaptogenic effect, increasing the body’s resistance to stress under conditions of increased mental and physical stress, fatigue, hypokinesia and immobilization, and at low temperatures.

Against the background of the drug use, an improvement in vision is noted (increase in acuity, brightness, and visual fields); blood supply to the lower extremities improves.

It stimulates the production of antibodies in response to antigen administration, indicating its immunostimulating properties, but at the same time, it does not cause the development of immediate hypersensitivity reactions and does not alter the allergic inflammatory skin reaction caused by the introduction of a foreign protein.

The effect manifests itself after a single dose, which is important for use in extreme conditions.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract, distributed in various organs and tissues, and easily penetrates the blood-brain barrier. The absolute bioavailability of the drug when taken orally is 100%. C_max in the blood is reached after 1 hour. It is not metabolized in the body and is excreted unchanged. About 40% is excreted in the urine, 60% – in bile and sweat. T_1/2 is 3-5 hours.

Indications

Diseases of the central nervous system of various origins, especially vascular diseases or those associated with disorders of metabolic processes in the brain and intoxication (in particular, in post-traumatic conditions and phenomena of chronic cerebrovascular insufficiency), accompanied by deterioration of intellectual and mnestic functions, decreased motor activity; neurotic conditions manifested by lethargy, increased exhaustion, decreased psychomotor activity, impaired attention, memory deterioration; learning disorders; mild and moderate depression; psycho-organic syndromes manifested by intellectual and mnestic disorders and apathetic-abulic symptoms, as well as lethargic and apathetic states in schizophrenia; convulsive conditions; obesity (alimentary-constitutional origin); prevention of hypoxia, increasing resistance to stress; correction of the functional state of the body in extreme conditions of professional activity to prevent the development of fatigue and increase mental and physical performance; correction of the daily biorhythm, regulation of the “sleep-wakefulness” cycle; chronic alcoholism (to reduce the symptoms of asthenia, depression, intellectual and mnestic disorders).

ICD codes

Dosage Regimen

Take tablets orally. The dosage regimen is individual and must be strictly determined by a physician based on the indication, patient age, and clinical situation.

For adults, the typical single dose ranges from 100 mg to 200 mg. The typical daily dose ranges from 200 mg to 600 mg, divided into two or three administrations.

For conditions requiring increased mental performance and stress resistance, use a dose of 100 mg to 200 mg once or twice daily.

For asthenic and depressive conditions, the daily dose may be increased to 400 mg to 600 mg in divided doses. The maximum daily dose should not exceed 800 mg.

Administer the last dose no later than 3 PM to prevent insomnia. The duration of treatment is typically 2 to 4 weeks and can be extended to 3 months based on physician recommendation.

For elderly patients, initiate treatment with lower doses and titrate cautiously to avoid exacerbation of concomitant diseases. Monitor for potential adverse reactions.

Do not use in children or adolescents under 18 years of age. The drug is contraindicated during pregnancy and breastfeeding.

In patients with severe hepatic or renal impairment, use with extreme caution and under close medical supervision. Adjust dosage if necessary.

Adverse Reactions

From the central nervous system insomnia (when taking the drug after 3 PM).

In some patients during the first 3 days of administration – psychomotor agitation, skin hyperemia, feeling of heat, increased blood pressure.

Contraindications

Childhood, pregnancy, lactation (breastfeeding), hypersensitivity to fonturacetam.

Use in Pregnancy and Lactation

Should not be prescribed during pregnancy and lactation (breastfeeding) due to the lack of clinical research data; it does not have teratogenic, mutagenic, or embryotoxic effects.

Use in Hepatic Impairment

With caution in patients with severe organic liver lesions.

Use in Renal Impairment

With caution in patients with severe organic kidney lesions.

Pediatric Use

The drug is contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

Use with caution in elderly patients to avoid exacerbation of concomitant diseases.

Special Precautions

Should be used with caution in patients with severe organic lesions of the liver and kidneys, severe arterial hypertension, with pronounced atherosclerosis; in patients who have previously experienced panic attacks, acute psychotic conditions accompanied by psychomotor agitation (since exacerbation of anxiety, panic, hallucinations, and delusions is possible); in patients prone to allergic reactions to nootropic drugs of the pyrrolidone group.

It should be taken into account that in cases of excessive psycho-emotional exhaustion against the background of chronic stress and fatigue, chronic insomnia, a single dose of fonturacetam on the first day may cause a sharp need for sleep.

Drug Interactions

May enhance the effect of drugs stimulating the central nervous system, antidepressants, and nootropic drugs.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.