Phenibut (Tablets) Instructions for Use

Instructions
Dosage forms

ATC Code

N05BX (Other anxiolytics)

Active Substance

Aminophenylbutyric acid (Grouping name)

Clinical-Pharmacological Group

Nootropic drug with anxiolytic activity

Pharmacotherapeutic Group

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

Pharmacological Action

A nootropic agent, it is the hydrochloride of gamma-amino-beta-phenylbutyric acid. It facilitates GABA-mediated transmission of nerve impulses in the CNS (direct effect on GABA receptors), and also has tranquilizing, psychostimulant, antiplatelet, and antioxidant effects.

It improves the functional state of the brain by normalizing tissue metabolism and influencing cerebral circulation (increases volumetric and linear velocity of cerebral blood flow, reduces vascular tone of the brain, improves microcirculation, has an antiplatelet effect). It helps reduce or eliminate feelings of anxiety, tension, restlessness, and fear, normalizes sleep, and has some anticonvulsant effect.

It does not affect cholinergic and adrenergic receptors.

It lengthens the latent period and shortens the duration and severity of nystagmus.

It reduces manifestations of asthenia and vasovegetative symptoms (including headache, a feeling of heaviness in the head, sleep disorders, irritability, emotional lability), and increases mental performance.

It improves psychological indicators (attention, memory, speed and accuracy of sensorimotor reactions).

With course administration, it increases physical and mental performance, improves memory, normalizes sleep; improves the condition of patients with motor and speech disorders. In patients with asthenia, well-being improves from the first days of therapy; it increases interest and initiative (motivation for activity) without a sedative effect or excitation. When used after severe traumatic brain injury, it increases the number of mitochondria in perifocal areas and improves the course of bioenergetic processes in the brain.

In neurogenic lesions of the heart and stomach, it normalizes lipid peroxidation processes. In elderly people, it does not cause confusion and excessive lethargy; a relaxing aftereffect is most often absent. It improves microcirculation in the tissues of the eye, reduces the depressant effect of ethanol on the CNS. It has low toxicity.

Pharmacokinetics

Absorption is high, it penetrates well into all body tissues and through the blood-brain barrier (about 0.1% of the administered dose of the drug penetrates into the brain tissue, and to a significantly greater extent in young and elderly individuals). It is evenly distributed in the liver and kidneys. It is metabolized in the liver – 80-95%, metabolites are pharmacologically inactive. It does not accumulate. After 3 hours, it begins to be excreted by the kidneys, while the concentration in the brain tissue does not decrease and it is still detected in the brain for another 6 hours. About 5% is excreted by the kidneys unchanged, partially with bile.

Indications

Asthenic and anxiety-neurotic states, anxiety, fear, obsessive-compulsive neurosis, psychopathy. Stuttering and tics in children, enuresis. Urinary retention against the background of myelodysplasia. Insomnia and nightmares in elderly individuals. Prevention of anxiety states arising before surgical interventions and painful diagnostic studies (premedication).

Ménière’s disease, dizziness associated with dysfunctions of the vestibular analyzer of various origins (including in otogenic labyrinthitis, vascular and traumatic disorders); prevention of motion sickness in kinetoses.

Primary open-angle glaucoma (as part of combination therapy).

As an auxiliary therapy in the treatment of alcoholism (to relieve psychopathological and somatovegetative disorders in withdrawal syndrome).

Treatment of predelirious and delirious states in alcoholism (in combination with conventional detoxification agents).

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
F10.2	Chronic alcoholism
F10.3	Withdrawal state
F10.4	Withdrawal state with delirium
F40	Phobic anxiety disorders (including agoraphobia, social phobias)
F41.0	Panic disorder [episodic paroxysmal anxiety]
F41.1	Generalized anxiety disorder
F41.2	Mixed anxiety and depressive disorder
F42	Obsessive-compulsive disorder
F48.0	Neurasthenia
F51.0	Nonorganic insomnia
F51.5	Nightmares
F60.9	Personality disorder, unspecified
F95	Tics
F98.0	Nonorganic enuresis
F98.5	Stuttering [stammering]
H40.1	Primary open-angle glaucoma
H81.0	Ménière's disease
H81.1	Benign paroxysmal vertigo
H81.3	Other peripheral vertigo
H93.0	Degenerative and vascular disorders of ear
R33	Retention of urine
T75.3	Motion sickness
Z51.4	Preparatory procedures for subsequent treatment or examination, not elsewhere classified

ICD-11 code	Indication
6A01.1	Developmental speech fluency disorder
6A73	Mixed depressive and anxiety disorder
6A8Z	Affective disorders, unspecified
6B00	Generalized anxiety disorder
6B01	Panic disorder
6B0Z	Anxiety or fear-related disorders, unspecified
6B20.Z	Obsessive-compulsive disorder, unspecified
6C00.Z	Enuresis, unspecified
6C40.2Z	Alcohol dependence, unspecified
6C40.4Z	Alcohol withdrawal syndrome, unspecified
6C40.5	Alcohol-induced delirium
6C40.Z	Disorders due to alcohol use, unspecified
6C9Z	Disruptive behavior or dissocial disorders, unspecified
6D10.Z	Personality disorder, unspecified severity
7A00	Chronic insomnia
7A01	Acute insomnia
7A0Z	Insomnia disorders, unspecified
7B01.2	Nightmares
8A05.Z	Tic disorders, unspecified
8D44.Y	Other specified alcohol-related neurological disorders
9C61.0Z	Primary open-angle glaucoma, unspecified
AB31.0	Ménière's disease
AB31.2	Benign paroxysmal positional vertigo
AB34.1	Other peripheral vestibular vertigo
AB71	Degenerative or vascular disorders of the ear
MF50.3	Retention of urine
NF08.3	Motion sickness
QB9A	Preparatory procedures for subsequent treatment

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally, regardless of meals.

For adults, a single dose ranges from 20 mg to 750 mg.

For children, a single dose ranges from 20 mg to 250 mg.

Adjust the dose, frequency, and duration based on the specific indication, patient age, and individual tolerance.

For anxiety-neurotic and asthenic conditions in adults, administer 250-500 mg three times daily. The maximum daily dose is 2500 mg. For severe conditions, increase the single dose to 750 mg.

For elderly patients, the dosage regimen is similar to that for adults.

The duration of treatment is typically 2-3 weeks.

For insomnia and nightmares, take a single dose of 250-500 mg at bedtime.

For premedication before surgical procedures or diagnostic studies, administer 250-500 mg 20-30 minutes prior to the event.

For dizziness in vestibular disorders and Ménière’s disease, administer 250 mg three times daily for 5-7 days. For prevention of motion sickness, take a single dose of 250-500 mg one hour before the anticipated motion.

For alcohol withdrawal syndrome, administer 250-500 mg three times daily and an additional 750 mg at bedtime. Gradually reduce the dose over the subsequent treatment days.

For predelirious and delirious states in alcoholism, administer 250-500 mg three times daily and 750 mg at night for 5-7 days, in combination with standard detoxification therapy.

For children aged 3-8 years, administer 50-100 mg three times daily.

For children aged 9-12 years, administer 250 mg three times daily.

The duration of treatment for children is typically 2-4 weeks.

For stuttering in children aged 3-8 years, administer 250 mg daily for 10-14 days, then reduce to a maintenance dose of 125 mg daily for 5-7 days.

For stuttering in children aged 9-12 years, administer 250-500 mg daily for 10-14 days, then reduce to a maintenance dose of 125-250 mg daily for 5-7 days.

For primary open-angle glaucoma as part of combination therapy, administer 250 mg three times daily for at least 4 weeks.

Do not exceed the prescribed dose or duration of treatment.

Adverse Reactions

From the CNS increased irritability, agitation, anxiety, dizziness, headache, drowsiness.

From the digestive system nausea (during the first doses).

Allergic reactions skin rash, itching.

Contraindications

Hypersensitivity to phenibut.

Use in Pregnancy and Lactation

Use with caution during pregnancy and lactation.

Use in Hepatic Impairment

Use with caution in hepatic insufficiency.

Special Precautions

Use with caution in erosive and ulcerative lesions of the gastrointestinal tract, hepatic insufficiency.

With long-term use, it is necessary to monitor liver function indicators and the peripheral blood picture.

It is not very effective for severe symptoms of motion sickness (including uncontrollable vomiting, dizziness).

Influence on the ability to drive vehicles and mechanisms

During the treatment period, it is necessary to refrain from potentially hazardous activities requiring increased attention and high speed of psychomotor reactions.

Drug Interactions

It prolongs and enhances the effect of hypnotics, narcotic analgesics, antiepileptic, antipsychotic, and antiparkinsonian 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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Phenibut [Belmedpreparaty RUP (Republic of Belarus)]
Tablets 250 mg: 10 or 20 pcs.

Marketing Authorization Holder

Belmedpreparaty RUP (Republic of Belarus)

Dosage Form

Phenibut

Tablets 250 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
γ-amino-β-phenylbutyric acid hydrochloride	250 mg

10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (1) – cardboard packs.

Phenibut [Vertex, JSC (Russia)]
Tablets 250 mg: 10, 20, 30, 40, or 60 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Phenibut

Tablets 250 mg: 10, 20, 30, 40, or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets from white to white with a slightly yellowish tint, round, flat-cylindrical, with a bevel and a score line.

	1 tab.
Aminophenylbutyric acid hydrochloride (phenibut)	250 mg

Excipients : lactose monohydrate – 90 mg, microcrystalline cellulose – 90 mg, potato starch – 65 mg, calcium stearate – 5 mg.

Phenibut [West, LLC (Russia)]
Tablets 250 mg: 10, 20, 30, 40, 50, 60, 75, 80, 100, or 125 pcs.

Marketing Authorization Holder

West, LLC (Russia)

Manufactured By

Samaramedprom, OJSC (Russia)

Technopark-Center LLC (Russia)

Dosage Form

Phenibut

Tablets 250 mg: 10, 20, 30, 40, 50, 60, 75, 80, 100, or 125 pcs.

Dosage Form, Packaging, and Composition

Tablets white or yellowish-white, round, flat-cylindrical, with a bevel and a score line.

	1 tab.
Aminophenylbutyric acid hydrochloride	250 mg

Excipients : lactose monohydrate – 180 mg, potato starch – 65 mg, calcium stearate – 5 mg.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
20 pcs. – blister packs (1) – cardboard packs.
20 pcs. – blister packs (2) – cardboard packs.
20 pcs. – blister packs (3) – cardboard packs.
20 pcs. – blister packs (4) – cardboard packs.
20 pcs. – blister packs (5) – cardboard packs.
25 pcs. – blister packs (1) – cardboard packs.
25 pcs. – blister packs (2) – cardboard packs.
25 pcs. – blister packs (3) – cardboard packs.
25 pcs. – blister packs (4) – cardboard packs.
25 pcs. – blister packs (5) – cardboard packs.
10 pcs. – bottles (1) – cardboard packs.
20 pcs. – bottles (1) – cardboard packs.
25 pcs. – bottles (1) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
25 pcs. – jars (1) – cardboard packs.

Phenibut [Moscow Endocrine Plant FSUE (Russia)]
Tablets 250 mg: 20, 30, or 50 pcs.

Marketing Authorization Holder

Moscow Endocrine Plant FSUE (Russia)

Dosage Form

Phenibut

Tablets 250 mg: 20, 30, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a slightly yellowish tint, flat-cylindrical in shape, with a bevel and a score line.

	1 tab.
γ-amino-β-phenylbutyric acid hydrochloride	250 mg

Excipients : lactose monohydrate 180 mg, potato starch 56 mg, povidone 9 mg, calcium stearate monohydrate 5 mg.

10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.

Phenibut [Ozon, LLC (Russia)]
Tablets 250 mg: 10, 20, 30, 40, 50, 60, 80, 100, or 200 pcs.

Marketing Authorization Holder

Ozon, LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Ozon Pharm, LLC (Russia)

Dosage Form

Phenibut

Tablets 250 mg: 10, 20, 30, 40, 50, 60, 80, 100, or 200 pcs.

Dosage Form, Packaging, and Composition

Tablets from white to white with a slightly yellowish tint, flat-cylindrical in shape, with a bevel on both sides and a score line on one side.

	1 tab.
Aminophenylbutyric acid hydrochloride	250 mg

Excipients : microcrystalline cellulose (MCC-101 Premium) – 60 mg, corn starch – 24 mg, povidone K25 – 15 mg, croscarmellose sodium – 8 mg, calcium stearate – 3 mg.

Phenibut [Onlinepharm, JSC (Latvia)]
Tablets 250 mg: 20 pcs.

Marketing Authorization Holder

Onlinepharm, JSC (Latvia)

Dosage Form

Phenibut

Tablets 250 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets from white to white with a slightly yellowish tint, round, flat-cylindrical, with a bevel and a score line on one side of the tablet.

	1 tab.
Aminophenylbutyric acid hydrochloride	250 mg

Excipients : lactose monohydrate – 180 mg, pregelatinized corn starch – 57.7 mg, corn starch – 7.3 mg, stearic acid – 5 mg.

10 pcs. – blister packs (2) – cardboard packs.

Phenibut [Organika, JSC (Russia)]
Tablets 250 mg: 10, 20, 30, or 50 pcs.

Marketing Authorization Holder

Organika, JSC (Russia)

Dosage Form

Phenibut

Tablets 250 mg: 10, 20, 30, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
γ-amino-β-phenylbutyric acid hydrochloride	250 mg

Phenibut [OHFK, JSC (Russia)]
Tablets 250 mg: 10, 20, 30, 40, 50, or 100 pcs.

Marketing Authorization Holder

OHFK, JSC (Russia)

Dosage Form

Phenibut

Tablets 250 mg: 10, 20, 30, 40, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a slight yellowish tint, round, flat-cylindrical, with a bevel on both sides and a score on one side.

	1 tab.
Aminophenylbutyric acid	250 mg

Excipients: microcrystalline cellulose, sodium carboxymethyl starch, colloidal anhydrous silicon dioxide, povidone K17, calcium stearate.

Phenibut [Salvus, LLC (Russia)]
Tablets 250 mg: 20 or 50 pcs.

Marketing Authorization Holder

Salvus, LLC (Russia)

Manufactured By

V-MIN, LLC (Russia)

Biopharmkombinat, LLC (Russia)

Dosage Form

Phenibut

Tablets 250 mg: 20 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or yellowish-white, round, flat-cylindrical, with a bevel and a score.

	1 tab.
Aminophenylbutyric acid hydrochloride	250 mg

Excipients: lactose – 180 mg, potato starch – 49.25 mg, povidone K25 – 15.75 mg, magnesium stearate – 5 mg.

10 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.

Phenibut [Sorbent, LLC (Russia)]
Tablets 250 mg: 10, 20, 30, or 50 pcs.

Marketing Authorization Holder

Sorbent, LLC (Russia)

Manufactured By

PharmVILAR NPO, LLC (Russia)

Dosage Form

Phenibut

Tablets 250 mg: 10, 20, 30, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a slight yellowish tint, round, biconvex, with a score.

	1 tab.
Aminophenylbutyric acid hydrochloride (phenibut)	250 mg

Excipients: lactose monohydrate – 180 mg, potato starch – 56 mg, povidone K30 – 9 mg, calcium stearate monohydrate – 5 mg.

Phenibut [Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)]
Tablets 250 mg: 10, 20, 30, 40, or 50 pcs.

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Phenibut

Tablets 250 mg: 10, 20, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a yellowish tint, round, flat-cylindrical, with a bevel and a score.

	1 tab.
Aminophenylbutyric acid hydrochloride	250 mg

Excipients: lactose (milk sugar) – 181.4 mg, potato starch – 63.6 mg, calcium stearate – 5 mg.

Phenibut [YUGPHARM, LLC (Russia)]
Tablets 250 mg: 10, 20, 25, 30, 40, 50, 60, 75, 80, 100, 125, 200, or 250 pcs.

Marketing Authorization Holder

YUGPHARM, LLC (Russia)

Dosage Form

Phenibut

Tablets 250 mg: 10, 20, 25, 30, 40, 50, 60, 75, 80, 100, 125, 200, or 250 pcs.

Dosage Form, Packaging, and Composition

Tablets white or yellowish-white, round, flat-cylindrical, with a bevel and a score.

	1 tab.
Aminophenylbutyric acid hydrochloride	250 mg

Excipients: microcrystalline cellulose – 60 mg, potato starch – 24 mg, povidone (low molecular weight medical polyvinylpyrrolidone 12600±2700) – 15 mg, croscarmellose sodium – 8 mg, calcium stearate – 3 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (10) – cardboard packs.
25 pcs. – contour cell packs (1) – cardboard packs.
25 pcs. – contour cell packs (2) – cardboard packs.
25 pcs. – contour cell packs (3) – cardboard packs.
25 pcs. – contour cell packs (4) – cardboard packs.
25 pcs. – contour cell packs (5) – cardboard packs.
25 pcs. – contour cell packs (10) – cardboard packs.
50 pcs. – polyethylene jars (1) – cardboard packs.
100 pcs. – polyethylene jars (1) – cardboard packs.

Phenibut Avexima [Avexima JSC (Russia)]
Tablets 250 mg: 10, 20, 30, 40, or 50 pcs.

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Avexima Siberia LLC (Russia)

Dosage Form

Phenibut Avexima

Tablets 250 mg: 10, 20, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a yellowish tint, round, flat-cylindrical in shape, with a double-sided bevel and a score on one side.

	1 tab.
Aminophenylbutyric acid hydrochloride (phenibut)	250 mg

Excipients: lactose monohydrate, potato starch, povidone K-30, calcium stearate.

10 pcs. – contour cell packs – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – jars – cardboard packs.

Phenibut-LekT [Patent-Pharm, JSC (Russia)]
Tablets 250 mg: 10, 20, 30, or 50 pcs.