TRADE NAME
Phenotropil®
INTERNATIONAL NON-PROPRIETARY NAME (INN)
Phenylpiracetam
ACTIVE INGREDIENT
Fontouracetam (Phenylpiracetam) [N-carbamoylmethyl-4-phenyl-2-pyrrolidone]
ATC CODE
N06BX – Other Psychostimulants and Nootropic Drugs
PHARMACOLOGICAL GROUP
Nootropic Agent [Nootropics]
DOSAGE FORM
Tablets
COMPOSITION PER TABLET
Active ingredient: Fonturacetam – 50.00 mg / 100.00 mg
Excipients: Povidone K-25, Potato starch, Sodium croscarmellose, Lactose monohydrate, Calcium stearate.
DESCRIPTION
Round, flat-cylindrical tablets ranging in color from white to white with a yellowish tint. Tablets with a beveled edge for 50 mg dosage; with a beveled edge and score line for 100 mg dosage.
PHARMACOLOGICAL PROPERTIES
Pharmacological Action
Phenotropil is a nootropic drug with pronounced antiamnestic effects. It directly activates integrative brain functions, enhances memory consolidation, improves focus and cognitive performance, facilitates learning, and accelerates interhemispheric information transfer. The drug increases brain tissue resistance to hypoxia and toxic influences, exhibits anticonvulsant and anxiolytic activities, and regulates CNS activation and inhibition processes to improve mood.
Phenotropil positively influences brain metabolism and circulation, stimulating redox reactions, increasing energy potential through glucose utilization, and improving regional blood flow in ischemic brain areas. It raises norepinephrine, dopamine, and serotonin levels in the brain without affecting GABA content or receptor interaction.
It does not impact respiration or cardiovascular function, exhibits mild diuretic effects, and demonstrates appetite-suppressing activity with prolonged use.
Stimulant Effects: Phenotropil moderately enhances motor reactions, physical performance, and antagonism to neuroleptic-induced catalepsy. It also reduces the hypnotic effects of ethanol and hexenal.
Psychostimulant Effects: Predominantly ideational, it is accompanied by anxiolytic activity and mood improvement, with mild analgesic effects by raising pain tolerance thresholds.
Adaptogenic Effects: Phenotropil increases stress resilience under mental and physical overload, fatigue, hypokinesia, immobilization, and low temperatures. It improves visual function, increasing acuity, brightness, and field of vision.
Phenotropil stimulates antibody production in response to antigens, indicating immunostimulating properties, but does not trigger immediate hypersensitivity or modify skin allergic inflammatory reactions.
The drug’s effects occur after a single dose, crucial for extreme conditions. It does not cause dependency, tolerance, or withdrawal syndrome.
Safety Profile: Phenotropil is non-teratogenic, non-mutagenic, non-carcinogenic, and non-embryotoxic. Its acute toxicity is low, with a lethal dose exceeding 800 mg/kg in experimental studies.
Pharmacokinetics
Phenotropil is rapidly absorbed and distributed across organs and tissues, easily crossing the blood-brain barrier. Oral bioavailability is 100%. Maximum plasma concentration (Cmax) is reached within 1 hour, with a half-life (T½) of 3-5 hours. The drug is excreted unchanged: approximately 40% in urine and 60% in bile and sweat.
INDICATIONS
- Central nervous system disorders of various etiologies, particularly vascular and metabolic brain dysfunctions and intoxications (e.g., post-traumatic conditions, chronic cerebrovascular insufficiency).
- Intellectual and memory impairments.
- Learning disorders.
- Mild-to-moderate depression.
- Psychorganic syndromes with intellectual and motivational deficits, including apathetic states in schizophrenia.
- Seizures.
- Obesity (of alimentary-constitutional origin).
- Hypoxia prevention, stress resistance enhancement, functional state correction under extreme conditions, including professional activities to prevent fatigue and increase cognitive and physical performance.
- Chronic alcoholism to alleviate asthenia, depression, and cognitive impairments.
CONTRAINDICATIONS
Hypersensitivity to the drug.
With caution
- Severe hepatic or renal impairments.
- Severe hypertension.
- Atherosclerosis.
- History of panic attacks or acute psychotic conditions with psychomotor agitation.
- Allergic reactions to pyrrolidone-based nootropics.
PREGNANCY AND LACTATION
Phenotropil is contraindicated due to insufficient clinical data. Not recommended for children due to limited usage information.
DOSAGE AND ADMINISTRATION
Oral use, immediately after meals. Dosages and treatment duration should be determined by a physician.
Dosage Guidelines:
| Parameter | Dose | Range |
|---|---|---|
| Average single dose | 150 mg | 100–250 mg |
| Average daily dose | 250 mg | 200–300 mg |
| Maximum daily dose | 750 mg | Not applicable |
Divide daily doses into two administrations. For doses up to 100 mg, take once in the morning; for doses exceeding 100 mg, split into two doses.
Treatment Duration: Ranges from 2 weeks to 3 months, with an average of 30 days. Repeat courses may be initiated after 1 month if needed.
For enhanced performance: 100-200 mg once in the morning for 2 weeks (3 days for athletes).
For obesity: 100-200 mg daily in the morning for 30-60 days. Avoid taking Phenotropil after 3 PM.
SIDE EFFECTS
- Insomnia (if taken after 3 PM).
- Initial psychomotor agitation, skin flushing, warmth, or increased blood pressure during the first 1-3 days of use.
OVERDOSE
No reported cases. Symptomatic therapy if needed.
DRUG INTERACTIONS
Phenotropil may enhance CNS stimulants, antidepressants, and other nootropics.
SPECIAL INSTRUCTIONS
Under conditions of chronic stress, fatigue, or insomnia, Phenotropil may initially induce drowsiness. Start treatment on non-working days in outpatient settings.
FORM OF RELEASE
Tablets, 50 or 100 mg. Blister packs of 10 tablets in PVC film and aluminum foil.
PACKAGING
1 or 3 blister packs for 50 mg dosage, or 1, 2, 3, 6, or 10 blister packs for 100 mg dosage, with instructions, in a cardboard box.
STORAGE CONDITIONS
Store in a dry, dark place at a temperature not exceeding 30°C. Keep out of reach of children.
SHELF LIFE
3 years. Do not use beyond the expiration date printed on the package.
DISPENSING CONDITIONS
Prescription only.
MANUFACTURER
Valenta Pharmaceuticals JSC 141108, Shchelkovo, Moscow Region, Russia, Fabrichnaya St., 2. https://www.valentapharm.com/