Instructions Aminalon film-coated tablets 0.25 g No. 50
Composition
active ingredient: aminalon (gamma-aminobutyric acid);
1 tablet contains aminalone (gamma-aminobutyric acid) (calculated as 100% substance) 250 mg;
excipients: microcrystalline cellulose, povidone 25, colloidal anhydrous silica, magnesium stearate, Opadry II white 85F18422 (mixture of substances: polyethylene glycol, talc, titanium dioxide (E 171), polyvinyl alcohol).
Dosage form
Film-coated tablets.
Main physicochemical properties: round tablets with a biconvex surface, coated with a white or white with a creamy tint.
Pharmacotherapeutic group
Psychoanaleptics. Other psychostimulants and nootropics.
ATX code N06B X.
Pharmacological properties
Pharmacodynamics.
Gamma-aminobutyric acid (GABA) is the main mediator of the central nervous system, which participates in the processes of central inhibition. Under its influence, the energy processes of the brain are activated, the utilization of glucose by the latter is improved, the respiratory activity of tissues increases, and the blood supply improves. The drug improves the dynamics of nervous processes in the brain, thinking, memory, attention, promotes the restoration of movements and speech after cerebral circulation disorders, exhibits a mild psychostimulating effect. Helps reduce and stabilize high blood pressure (BP) and reduce subjective symptoms of arterial hypertension (dizziness, sleep disturbances). Has a moderate antihypotoxic and anticonvulsant effect. In patients with diabetes mellitus, it reduces glucose levels, and with normal blood glucose levels, it has the opposite effect (due to glycogenolysis). The nature of the drug's action is similar to nootropics.
Pharmacokinetics.
It is rapidly absorbed from the digestive tract. The maximum concentration is found in blood plasma. The final product of GABA metabolism in tissues is succinic acid, which is included in the Krebs cycle. Part of the drug is subject to transamination with the formation of g-guanidinebutyric acid, which in the liver and kidneys partially decomposes into GABA and urea. Also synthesized is g-aminobutyrylcholine, GABA-pantoyl, homocarnosine, and to a lesser extent - oxybutyric acid.
acid. The products of GABA conversion and the unchanged drug are excreted in the urine,
partly with carbon dioxide from exhaled air.
Indication
As part of the complex treatment of diseases of the central nervous system:
vascular diseases of the brain (atherosclerosis, damage to cerebral vessels in arterial hypertension);
chronic cerebral circulatory insufficiency with impaired memory, concentration, speech, dizziness, headache;
encephalopathy (alcoholic, post-stroke, post-traumatic);
cerebral palsy;
mental retardation in children (age 5 and older);
senile dementia (early stages of dementia);
sea and air sickness (for prevention and treatment of the symptom complex of motion sickness).
Contraindication
Hypersensitivity to any of the components of the drug. Acute renal failure.
Interaction with other medicinal products and other types of interactions
When used together with benzodiazepine drugs (tranquilizers, anticonvulsants), as well as with sedatives (barbiturates), mutual potentiation of the effect is observed. Pyridoxine hydrochloride (vitamin B6) can also enhance the effect of gamma-aminobutyric acid.
When used in combination with benzodiazepine drugs, each drug should be administered in the minimum or average effective doses.
Application features
At the beginning of treatment, blood pressure monitoring is necessary due to the possibility of its fluctuations.
It is not recommended to use the drug in the evening and before bedtime due to possible sleep disturbance.
It is not recommended to drink alcohol during treatment with the drug.
Use during pregnancy or breastfeeding
It is not recommended to prescribe the drug to women during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
With prolonged use of the drug, caution should be exercised by persons engaged in potentially hazardous activities that require increased attention and high speed of psychomotor reactions when driving vehicles and working with other mechanisms. In the first days of using the drug, you should refrain from driving vehicles and working with potentially dangerous mechanisms.
Method of administration and doses
The drug is taken orally before meals. Adults are prescribed 2-5 tablets (500-1250 mg) per dose, depending on the course and severity of the disease. The daily dose is usually 6-12 tablets (1500-3000 mg) in 3 doses.
For the treatment of the symptom complex of motion sickness, adults are prescribed 2 tablets (500 mg) and children over 5 years of age are prescribed 1 tablet (250 mg) 3 times a day for 3-4 days. For preventive purposes, adults are prescribed 2 tablets (500 mg) 3 times a day for 3 days preceding a trip or possible motion sickness.
The duration of the course of treatment is determined by the doctor individually.
Children
It is not recommended to prescribe the drug to children under 5 years of age.
Overdose
If the therapeutic doses of the drug are significantly exceeded and the recommended treatment regimens are not followed, nausea, vomiting, intestinal disorders, headache, fever, fluctuations in blood pressure, and sleep disturbances may develop. In such cases, the drug should be discontinued. Treatment is symptomatic.
Adverse reactions
Gamma-aminobutyric acid is very slightly toxic. In some cases, reactions may occur:
- from the gastrointestinal tract: dyspeptic phenomena; nausea, vomiting;
- from the central nervous system: insomnia, feeling of heat, increased body temperature, sleep disturbances;
- from the cardiovascular system: fluctuations in blood pressure;
- on the skin: allergic reactions, including skin rashes, itching.
When the dosage is reduced, these phenomena usually disappear quickly.
If any adverse reactions occur, discontinue use of the drug and consult a doctor.
Expiration date
2 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
10 tablets in a blister, 1 or 5, or 10 blisters in a cardboard pack.
Vacation category
Without a prescription.
Producer
PJSC "VITAMINS".
Location of the manufacturer and its business address
Ukraine, 20300, Cherkasy region, Uman city, Leninskaya Iskra st., 31.
Applicant
PJSC "VITAMINS".
Location of the applicant and/or applicant's representative
Ukraine, 20300, Cherkasy region, Uman city, Leninskaya Iskra st., 31.
