Aminalon® [Gamma Aminobutyric Acid]

And n t r u to c and I

For medical use of the drug

Aminalon

(aminalon)

Structure:

Active ingredient: aminalon (gamma-aminobutyric acid);

1 tablet contains aminalon (gamma-aminobutyric acid) (in terms of 100%

substance) 250 mg;

excipients: microcrystalline cellulose, povidone 25, silicon

anhydrous colloidal dioxide, magnesium stearate, Opadry II white 85F18422 (mixture of substances: polyethylene glycol, talc, titanium dioxide (E 171), polyvinyl alcohol).

Dosage form.

Coated tablets.

Basic physical and chemical properties: round tablets with a biconvex surface, coated with a white or creamy-white color.

Pharmacotherapeutic group.

Psychoanaleptics. other psychostimulating and nootropic drugs.

ATX code N06B X.

Pharmacological properties.

Pharmacodynamics

Gamma-aminobutyric acid (GABA) is the main mediator of the central nervous system, participating in the processes of central inhibition. Under its influence, the energy processes of the brain are activated, the utilization of glucose by the latter improves, 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, helps to restore movement and speech after a violation of cerebral circulation, has a mild psychostimulating effect. Helps reduce and stabilize high blood pressure (BP) and reduce the subjective symptoms of hypertension (dizziness, sleep disturbance). It has a moderate antihypotoxic and anticonvulsant effect. In patients with diabetes mellitus, it reduces the glucose content, with a normal blood glucose content it has the opposite effect (due to glycogenolysis). The nature of the action of the drug is similar to nootropic drugs.

Pharmacokinetics

Quickly 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 undergoes transamination with the formation of g-guanidinobutyric acid, which in the liver and kidneys is partially decomposed into GABA and urea. It also synthesizes g-aminobutyrylcoline, GABA-pantoyl, homocarnosine, less oxybutyric acid. GABA conversion products and an unchanged drug are excreted in the urine, partly with carbon dioxide exhaled air.

Clinical characteristics.

Indications.

As part of a comprehensive treatment of diseases of the central nervous system:

• cerebrovascular diseases (atherosclerosis, cerebral vascular lesions with arterial hypertension);
• chronic cerebrovascular insufficiency with impaired memory, concentration of attention, speech, dizziness, headaches;
• encephalopathy (alcoholic, post-stroke, post-traumatic);
• cerebral palsy;
• mental retardation in children (over 5 years old);
• senile dementia (initial stages of dementia);
• sea ​​and air sickness (for the prevention and treatment of the symptoms of motion sickness).

Contraindications

Hypersensitivity to any components of the drug. acute renal failure.

Interaction with other drugs and other types

interactions.

When combined with benzodiazepine drugs (tranquilizers, anticonvulsants), as well as sedatives (barbiturates), mutual potentiation of the effect is noted. Pyridoxine Hydrochloride (Vitamin B₆) can also enhance the effect of gamma-aminobutyric acid.

When combined with benzodiazepine drugs, each of

prescribe drugs in minimal or medium effective doses.

Features of the application.

At the beginning of treatment, blood pressure control is necessary because of the possibility of it

fluctuations.

It is not recommended to use the drug in the evening and before bedtime because of the possible

sleep disturbances.

It is not recommended to drink alcohol during treatment with the drug.

Use during pregnancy or lactation.

It is not recommended to prescribe the drug to women during pregnancy or lactation.

The ability to influence the reaction rate when driving or

Other mechanisms.

With prolonged use of the drug, caution is required for persons involved in potentially hazardous activities that require increased attention and high speed of psychomotor reactions when driving vehicles and when working with other mechanisms. In the early days of the drug should refrain from driving and working with potentially dangerous mechanisms.

Dosage and administration.

The drug is taken orally before meals. adults should be 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 divided doses.

For children, prescribe the drug, from 5 years old, depending on the course and severity of the disease, 2-12 tablets (500-3000 mg) per day. Distribute the daily dose into 3 doses, the course of treatment from 2 weeks to 6 months. If necessary, conduct repeated courses.

For the treatment of the motion sickness symptom, appoint 2 tablets (500 mg) for adults and 1 tablet (250 mg) for children from 5 years old 3 times a day for 3-4 days. WITH

as a preventive goal, adults should be 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.

With a significant excess of therapeutic doses of the drug, non-compliance

recommended treatment regimens are possible nausea, vomiting, bowel disorders,

headache, fever, fluctuations in blood pressure, sleep disturbance. In such cases, it is necessary to stop the use of the drug. The treatment is symptomatic.

Adverse Reactions

Gamma-aminobutyric acid is very toxic. in some cases it is possible

occurrence of reactions:

• from the gastrointestinal tract: dyspeptic symptoms, nausea, vomiting;
• from the central nervous system: insomnia, feeling of heat, increase

  body temperature, sleep disturbance;

• from the cardiovascular system: fluctuations in blood pressure;
• on the part of the skin: allergic reactions, including skin rashes, itching.

With a decrease in dose, these phenomena usually pass quickly.

If any adverse reactions occur, discontinue use of the drug and be sure to consult a doctor.

Shelf life.

2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Packaging.

10 tablets in a blister, 1 or 5, or 10 blisters in a pack of cardboard.

Vacation category.

Over the counter.

Manufacturer.

Pao "vitamins."

The location of the manufacturer and his address of the place of business.

Ukraine, 20300, Cherkasy region, Uman, st. Lenin spark, 31.

Applicant

Pao "vitamins."

Location of the applicant and / or representative of the applicant.

Ukraine, 20300, Cherkasy region, Uman, st. Lenin spark, 31.