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Active ingredients
Aminophenylbutyric acid
Release form
Capsules
Composition
The active ingredient of the drug or its auxiliary components. The concentration of the active substance (mg): 250 mg
Pharmacological effect
Nootropic drug, a derivative of gamma-aminobutyric acid and phenylethylamine. It has tranquilizing properties, stimulates memory and learning, increases physical ability to work, eliminates psycho-emotional tension, anxiety, fear and improves sleep. It does not affect cholino and adrenoreceptors. The drug prolongs the latent period and shortens the duration and severity of nystagmus. Visibly reduces the manifestations of asthenia and vasovegetative symptoms, incl. headache, feeling of heaviness in the head, sleep disturbance, irritability, emotional lability, increases mental performance, improves well-being, increases interest and initiative, motivates you to be active without a sedative effect or arousal. In contrast to tranquilizers, psychological indicators improve attention, memory, speed and accuracy of sensory-motor reactions). The formation of addiction and dependence to the drug, withdrawal syndrome is not marked.
Pharmacokinetics
Absorption and distribution; After ingestion, the drug is well absorbed and penetrates into all tissues of the body. About 0.1% of γ-amino-β-phenylbutyric acid hydrochloride penetrates the brain tissue from the accepted dose of the drug; in patients in young and old age, an increase in BBB penetration is possible. After 3 hours, γ-amino-β-phenylbutyric acid hydrochloride is found in the urine, at the same time the concentration in the brain tissues does not decrease, it is found in the brain after another 6 hours; With repeated use, the drug does not accumulate in the body.; γ-amino-β-phenylbutyric acid hydrochloride occurs in the liver (80%), it is not specific.; Metabolism and excretion; 80-95% of the drug is metabolized in the liver to pharmacologically inactive metabolites. 5% excreted by the kidneys unchanged. The next day after taking the drug γ-amino-β-phenylbutyric acid, hydrochloride can only be detected in the urine; it is determined in the urine even 2 days after administration, but the detectable amount is 5% of the injected dose.
Indications
- asthenia; ; - anxiety and neurotic states; - neurosis; - psychopathy; - nervous disorders in children: enuresis, stuttering, tics; - senile disorders: insomnia in the elderly, anxiety syndromes; - before surgery or complex diagnostic procedures, to reduce the severity of anxiety and stress; - alcoholism and withdrawal states (including delirium and pre-delirious states); - Meniere's disease; - pathology of the vestibular apparatus; - pathological menopause; - in the treatment of treatment of osteochondrosis in women; ; - TBI; - cognitive disorders, memory disorders.
Contraindications
Allergy to the active ingredient of the drug or its auxiliary components.
Use during pregnancy and lactation
Use during pregnancy and during breastfeeding is not recommended, because there are not enough clinical observations.; In experimental animal studies, the mutagenic, teratogenic and embryotoxic effects of the drug have not been established.
Dosage and administration
The average therapeutic dosage for adults is 0. 25-0. 5 g three times a day, if necessary, the dose can be increased to 2. 5 g. The highest dose per dose is not more than 0. 75 g, for patients over 60, not more than 0. 5 g; For children, the drug is prescribed depending on age: · from 3 to 4 years old at 0. 1 g twice a day, the highest dose per dose is 0. 1 g; ; · From 5 to 6 years old at 0. 1 g 2-3 times per day, the highest dose per administration is 0. 1 g; ; · From 7 to 10 years old at 0. 1 g 3–4 times a day, the highest dose per administration is 0. 2 g; ; · From 11 to 14 years old at 0. 2 g 2 -3 times a day, the highest dose per administration is 0. 3 g; ; · After 14 years, the drug is prescribed in dosage, as for adults. ; With the simultaneous appointment of Noofen with other psychotropic drugs, the dose of the drug can be reduced, since there is a mutual potentiation of effects. ; For the treatment of alcoholism and withdrawal symptoms, Noofen is prescribed as follows: 0. 25 - 0. 5 g 3 times during the day and 0. 75 g per night, this scheme is applied for several days, then the patient is gradually transferred to the usual for adults dosage. To reduce the severity or eliminate vertigo (Meniere's syndrome, otogenic labyrinthitis, other pathologies of the vestibular apparatus), Noofen is prescribed 0. 75 g three times a day, during the week, then 0. 25 - 0.5 three times a day, during the week, then at 0. 25 once a day, for 5 days. If the symptoms of the disease are mild and the disease is quite easy, it is possible to prescribe a drug of 0. 25 g twice a day, for a week, then 0. 25 g once, for 7-10 days. ; If vestibular disorders have a vascular or traumatic genesis, Noofen is prescribed at 0. 25 g three times a day, for 12 days. ; For the prevention of motion sickness, Noofen is prescribed at 0. 25 g -0. 5 g, 1 hour before sea voyage. With the onset of symptoms of seasickness: vomiting, drooling, the use of the drug is ineffective. ; To prevent air sickness, Noofen prescribed in a dose of 0. 25-0. 5 g, 1 hour before the flight. ; For the treatment of pathological menopause and osteochondrosis of the cervico-thoracic spine in women, Noofen is prescribed at a dose of 0. 75 g per day, divided into 3 doses, within 14 days; then at 0. 5 g per day, divided into 2 doses, for 14 days. With a weak severity of pain, it is possible to appoint Noofen at a dose of 0. 5 g per day, divided into 2 doses.
Side effects
Very rarely, drowsiness and nausea, which usually occur after the first dose of the drug and pass on their own.
Overdose
Noofen; low toxicity. Data on cases of overdose have been reported. Symptoms: drowsiness, nausea, vomiting, dizziness. With long-term use in high doses, eosinophilia, arterial hypotension, impaired renal activity, fatty degeneration of the liver (intake of more than 7 g) can develop; Treatment: gastric lavage, symptomatic treatment, maintenance of vital functions. There is no specific antidote.
Interaction with other drugs
In order to mutual potentiation, Noofen; can be combined with other nootropic drugs, reducing the dose of Noofen and combined drugs.; Extends and enhances the effect of hypnotic, neuroleptic and anti-Parkinsonian drugs.
special instructions
With long-term use, it is necessary to monitor the cellular composition of blood, liver functions.; Influence on the ability to drive vehicles and control mechanisms; During treatment, patients need to be careful when driving and doing other potentially dangerous activities that require increased concentration and psychomotor speed reactions, as in some patients there may be disorders of the central nervous system, such as drowsiness and dizziness.