Noophen^® (Capsules, Powder) Instructions for Use

ATC Code

N06BX22 (Phenibut)

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 agents; other psychostimulants and nootropic agents

Pharmacological Action

A nootropic agent, a derivative of gamma-aminobutyric acid and phenylethylamine. It has tranquilizing properties, stimulates memory and learning, increases physical performance, relieves psycho-emotional stress, anxiety, fear, and improves sleep. It does not affect cholinergic and adrenergic receptors.

It lengthens the latent period and shortens the duration and severity of nystagmus. It noticeably reduces the manifestations of asthenia and vasovegetative symptoms, including headache, a feeling of heaviness in the head, sleep disturbance, irritability, emotional lability, increases mental performance, improves well-being, increases interest and initiative, motivation for active activity without a sedative effect or excitation.

Unlike tranquilizers, under the influence of this agent, psychological indicators (attention, memory, speed and accuracy of sensorimotor reactions) improve. No development of habituation, dependence, or withdrawal syndrome has been noted.

Pharmacokinetics

Absorption and Distribution

After oral administration, it is well absorbed and penetrates all tissues of the body. About 0.1% of gamma-amino-beta-phenylbutyric acid hydrochloride from the administered dose penetrates into the brain tissue; in young and elderly patients, an increase in penetration through the blood-brain barrier is possible. After 3 hours, gamma-amino-beta-phenylbutyric acid hydrochloride is detected in the urine; at the same time, its concentration in brain tissues does not decrease; it is detected in the brain for another 6 hours.

With repeated use, the drug does not accumulate in the body.

The greatest binding of gamma-amino-beta-phenylbutyric acid hydrochloride occurs in the liver (80%); it is not specific.

Metabolism and Excretion

80-95% is metabolized in the liver to pharmacologically inactive metabolites. 5% is excreted from the body by the kidneys unchanged. The day after administration, gamma-amino-beta-phenylbutyric acid hydrochloride can be detected only in the urine; it is detected in the urine for another 2 days after administration, but the detectable amount is 5% of the administered dose.

Indications

• Asthenic and anxiety-neurotic states;
• Stuttering, tics, and enuresis in children;
• Insomnia and night anxiety in the elderly;
• Meniere’s disease, dizziness associated with dysfunction of the vestibular analyzer of various origins;
• Prevention of motion sickness in kinetoses;
• As part of complex therapy for alcohol withdrawal syndrome to relieve psychopathological and somatovegetative disorders.

ICD codes

Dosage Regimen

Powder

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

Capsules

Orally after meals, with water.

Asthenic and anxiety-neurotic statesadults – 250-500 mg 3 times/day. The maximum single dose for adults is 750 mg, for patients over 60 years – 500 mg. If necessary, the daily dose can be increased to 2.5 g. The course of treatment is 4-6 weeks.

Stuttering, tics, and enuresis in children aged 8 to 14 years – 250 mg 2-3 times/day; in children over 14 years – adult doses.

Insomnia and night anxiety in elderly patients – 250-500 mg 3 times/day.

To relieve dizziness in dysfunction of the vestibular analyzer of infectious origin (otogenic labyrinthitis) and Meniere’s disease during an exacerbation, 750 mg 3 times/day is prescribed for 5-7 days; with a decrease in the severity of vestibular disorders – 250-500 mg 3 times/day for 5-7 days, then – 250 mg once/day for 5 days. In a relatively mild course of the disease – 250 mg twice/day for 5-7 days, then 250 mg once/day for 7-10 days.

To relieve dizziness in dysfunctions of the vestibular analyzer of vascular and traumatic origin, 250 mg 3 times/day is prescribed for 12 days.

For the prevention of motion sickness in kinetoses: 250-500 mg once 1 hour before the expected journey or at the first symptoms of motion sickness. The anti-motion sickness effect of Noophen^® is enhanced with an increase in the dose of the drug. With the onset of severe manifestations of seasickness (including uncontrollable vomiting), oral administration of the drug is ineffective even at a dose of 750-1000 mg.

As part of complex therapy for alcohol withdrawal syndrome to relieve psychopathological and somatovegetative disorders, in the first days of treatment, 250-500 mg 3 times during the day and 750 mg at night are prescribed, with a gradual reduction of the daily dose to the usual for adults.

Do not take a double dose to make up for a missed dose.

In patients with renal and/or hepatic impairment with long-term use, it is necessary to monitor indicators of kidney and/or liver function.

In case of impaired liver function, the use of this agent in high doses can cause hepatotoxicity. In such cases, a dose reduction is required.

Adverse Reactions

Classification of adverse reactions by frequency of occurrence: very common (≥10%); common (≥1%, but <10%); uncommon (≥0.1%, but <1%); rare (≥0.01%, but <0.1%); very rare (<0.01%); unknown (cannot be estimated from the available data).

Nervous system disorders unknown – drowsiness and increased symptoms (at the beginning of treatment), dizziness, headache.

Gastrointestinal disorders: unknown – nausea (at the beginning of treatment).

Skin and subcutaneous tissue disorders: rare – allergic reactions (skin rash, itching).

Hepatobiliary disorders: unknown – with long-term use in high doses – hepatotoxicity.

Contraindications

• Hypersensitivity to this agent;
• Acute renal failure;
• Pregnancy;
• Breastfeeding period;
• Children under 8 years of age (for this dosage form);
• Rare congenital galactose intolerance, lactase deficiency or glucose-galactose malabsorption (because the dosage form contains lactose).

With caution

Patients with erosive and ulcerative diseases of the gastrointestinal tract (due to the irritating effect, it is recommended to use this agent in lower doses).

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is contraindicated.

Use in Hepatic Impairment

In patients with renal and/or hepatic impairment with long-term use, it is necessary to monitor indicators of kidney and/or liver function.

In case of impaired liver function, the use of this agent in high doses can cause hepatotoxicity. In such cases, a dose reduction is required.

Use in Renal Impairment

Contraindicated in acute renal failure.

In patients with renal and/or hepatic impairment with long-term use, it is necessary to monitor indicators of kidney and/or liver function.

Pediatric Use

Contraindicated in children under 8 years of age.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

With long-term use, it is necessary to monitor the cellular composition of the blood and indicators of liver function.

Influence on the ability to drive vehicles and operate machinery

During the treatment period, patients must be cautious when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, since some patients may experience CNS disorders, such as drowsiness and dizziness.

Drug Interactions

Prolongs and enhances the effect of hypnotics, neuroleptics, 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.