Anvifen^® (Capsules, Powder) Instructions for Use

ATC Code

N06BX22 (Phenibut)

Active Substance

Aminophenylbutyric acid (Grouping name)

Clinical-Pharmacological Group

Nootropic drug

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 cerebral vascular tone, improves microcirculation, has an antiplatelet effect). It helps reduce or eliminate feelings of anxiety, tension, restlessness, and fear, normalizes sleep, and has some anticonvulsant action.

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, feeling of heaviness in the head, sleep disorders, irritability, emotional lability), 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 sedative effects or agitation. 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 lethargy or excessive lethargy; a relaxing aftereffect is most often absent. It improves microcirculation in eye tissues and 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 BBB (about 0.1% of the administered dose penetrates into 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 brain tissue does not decrease and it is detected in the brain for up to 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 due to myelodysplasia. Insomnia and nightmares in elderly individuals. Prevention of anxiety states arising before surgical interventions and painful diagnostic examinations (premedication).

Meniere’s disease, dizziness associated with dysfunctions of the vestibular analyzer of various origins (including 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

Dosage Regimen

Capsules

Orally after meals.

Asthenic and anxiety-neurotic states

Adults are prescribed 250-500 mg 3 times/day. The maximum single dose is 750 mg, for patients over 60 years – 500 mg. The course of treatment is 2-3 weeks. If necessary, the course of treatment can be extended to 4-6 weeks.

Children aged 3 to 8 years – 125 mg up to 3 times/day; from 8 to 14 years – 250 mg 3 times/day; children over 14 years – adult doses.

Stuttering, tics and enuresis

Children aged 3 to 8 years – 125 mg up to 3 times/day; from 8 to 14 years – 250 mg 3 times/day; children over 14 years – adult doses.

Attention deficit hyperactivity disorder in children as part of complex therapy

Children aged 5 to 8 years are prescribed 100 mg 3 times/day; children aged 9 to 13 years – 250 mg 3 times/day.

Insomnia and nocturnal anxiety in the elderly

Prescribe 250-500 mg 3 times/day.

Meniere’s disease, dizziness associated with dysfunctions of the vestibular analyzer of various origins during exacerbation

Adults are prescribed 750 mg 3-4 times/day for 5-7 days, then 250-500 mg 3 times/day for 5-7 days and then – 250 mg once/day for 5 days. For treatment of dizziness in dysfunctions of the vestibular analyzer of vascular and traumatic origin – 250 mg 3 times/day for 12 days.

Prevention of motion sickness in kinetoses

Prescribe 250-500 mg once 1 hour before the expected journey or when the first symptoms of motion sickness appear.

The anti-motion sickness effect of Anvifen^® is enhanced with increasing dose. When pronounced manifestations of motion sickness occur (uncontrollable vomiting and others), the drug is not very effective.

As part of complex therapy for alcohol withdrawal syndrome to relieve psychopathological and somatovegetative disorders

At the beginning of treatment, prescribe 250-500 mg 3 times during the day and 750 mg at night, with a gradual reduction of the daily dose to the usual for adults.

Powder

Orally, regardless of food intake. The dose, frequency of administration, and duration of treatment depend on the indications, patient’s age, and tolerance. The single dose for adults varies from 20 mg to 750 mg, for children – from 20 mg to 250 mg.

Adverse Reactions

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

From the digestive system nausea (upon 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-ulcerative lesions of the gastrointestinal tract, hepatic insufficiency.

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

Not very effective in pronounced manifestations 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

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.