Aminalon tablets 0.25 (Tablets) Instructions for Use
ATC Code
N03AG03 (Gamma-aminobutyric acid)
Active Substance
Gamma-aminobutyric acid (Grouping name)
Clinical-Pharmacological Group
Nootropic drug
Pharmacotherapeutic Group
Antiepileptic agents; fatty acid derivatives
Pharmacological Action
Gamma-aminobutyric acid (GABA) is a biogenic amine that restores metabolic processes in the brain, promotes glucose utilization by the brain and the removal of toxic metabolic products from it, and ensures the normalization of the dynamics of nervous processes in the brain.
It increases thinking productivity, improves memory, has a mild psychostimulating effect, and has a beneficial effect on the recovery of movements and speech after cerebrovascular accident.
It contributes to the reduction and stabilization of elevated blood pressure and reduces the subjective symptoms of arterial hypertension (dizziness, sleep disturbance).
It has a moderate antihypoxic and anticonvulsant effect. In patients with diabetes mellitus, it reduces glucose levels; with normal blood glucose levels, it has the opposite effect (due to glycogenolysis).
Pharmacokinetics
Absorption is rapid and sufficiently complete. Cmax in blood plasma is reached within 60 minutes, then the concentration rapidly decreases. After 24 hours, GABA is not detected in blood plasma.
Indications
Conditions after cerebrovascular accidents; after traumatic brain injuries. Cerebral atherosclerosis with manifestations of brain softening. Alcoholic encephalopathy and polyneuritis. Headache, dizziness, sleep disorders in arterial hypertension. Cerebral palsy in children; consequences of birth traumatic brain injury in children over 3 years of age; mental retardation in children. Motion sickness.
ICD codes
| ICD-10 code | Indication |
| F51.2 | Nonorganic disorders of the sleep-wake schedule |
| F79 | Unspecified intellectual disabilities |
| G31.2 | Degeneration of nervous system caused by alcohol (including alcoholic encephalopathy) |
| G62.1 | Alcoholic polyneuropathy |
| G80 | Cerebral palsy |
| G93.4 | Unspecified encephalopathy |
| I67.2 | Cerebral atherosclerosis |
| I69 | Sequelae of cerebrovascular diseases |
| R42 | Dizziness and giddiness |
| R51 | Headache |
| T75.3 | Motion sickness |
| T90 | Sequelae of injuries of head |
| ICD-11 code | Indication |
| 6A00.Z | Disorders of intellectual development, unspecified |
| 7B2Z | Sleep-wake cycle disorders, unspecified |
| 8A8Z | Headache disorders, unspecified |
| 8B25.Z | Sequelae of cerebrovascular disease, unspecified |
| 8D2Z | Cerebral palsy, unspecified |
| 8D44.0 | Alcoholic polyneuropathy |
| 8D44.Z | Neurological disorders associated with alcohol, unspecified |
| 8E47 | Encephalopathy, not elsewhere classified |
| 8E4A.0 | Paraneoplastic or autoimmune disorders of the central nervous system, including brain and spinal cord |
| 8E63 | Post-cardiopulmonary bypass encephalopathy |
| BD55 | Asymptomatic stenosis of intracranial or extracranial artery |
| MB48.Z | Dizziness and giddiness, unspecified |
| NA0Z | Head injury, unspecified |
| NF08.3 | Motion sickness |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Tablets
The daily dose for adults is 3-3.75 g. For children aged from 1 to 3 years – 1-2 g/day; from 4 to 6 years – 2-3 g/day; over 7 years – 3 g/day. The daily dose for children and adults is divided into 3 doses and taken before meals. The course of treatment lasts from 2-3 weeks to 2-4 months.
For the prevention and treatment of motion sickness, adults – 500 mg 3 times/day for 3-4 days, children – 250 mg 3 times/day for 3-4 days.
Adverse Reactions
Possible nausea, vomiting, blood pressure lability, dyspepsia, increased body temperature, sleep disturbance.
Contraindications
Hypersensitivity to GABA.
Use in Pregnancy and Lactation
Contraindicated for use in the first trimester of pregnancy and during breastfeeding.
The possibility of use in the second and third trimesters of pregnancy is decided by the doctor individually.
Pediatric Use
Use is possible according to the dosing regimen.
Geriatric Use
Use is possible according to the dosing regimen.
Special Precautions
Blood pressure fluctuations are possible in the first days of treatment.
Drug Interactions
With simultaneous use, it is possible to enhance the effect of benzodiazepine derivatives, many hypnotics and antiepileptic 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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Coated tablets, 250 mg: 100 pcs.
Marketing Authorization Holder
Biopharma, CJS (Russia)
Dosage Form
 |
Aminalon tablets 0.25 | Coated tablets, 250 mg: 100 pcs. |
Dosage Form, Packaging, and Composition
| Coated tablets | 1 tab. |
| Gamma-aminobutyric acid | 250 mg |
100 pcs. – dark glass jars (1) – cardboard packs.
Coated tablets, 250 mg: 100 pcs.
Marketing Authorization Holder
Severnaya Zvezda, CJSC (Russia)
Dosage Form
|
Aminalon tablets 0.25 | Coated tablets, 250 mg: 100 pcs. |
Dosage Form, Packaging, and Composition
| Coated tablets | 1 tab. |
| Gamma-aminobutyric acid | 250 mg |
100 pcs. – dark glass jars (1) – cardboard packs.
Coated tablets, 250 mg: 100 pcs.
Marketing Authorization Holder
STI-Med-Sorb, PJSC (Russia)
Dosage Form
|
Aminalon tablets 0.25 | Coated tablets, 250 mg: 100 pcs. |
Dosage Form, Packaging, and Composition
| Coated tablets | 1 tab. |
| Gamma-aminobutyric acid | 250 mg |
100 pcs. – dark glass jars (1) – cardboard packs.
Coated tablets, 250 mg: 100 pcs.
Marketing Authorization Holder
Central European Pharmaceutical Company CJS (Russia)
Dosage Form
|
Aminalon tablets 0.25 | Coated tablets, 250 mg: 100 pcs. |
Dosage Form, Packaging, and Composition
| Coated tablets | 1 tab. |
| Gamma-aminobutyric acid | 250 mg |
100 pcs. – dark glass jars (1) – cardboard packs.
Sugar-coated tablets, 250 mg: 20, 50, or 100 pcs.
Marketing Authorization Holder
Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)
Dosage Form
|
Aminalon | Sugar-coated tablets, 250 mg: 20, 50, or 100 pcs. |
Dosage Form, Packaging, and Composition
| Coated tablets | 1 tab. |
| Gamma-aminobutyric acid | 250 mg |
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
Film-coated tablets, 250 mg: 50 or 100 pcs.
Marketing Authorization Holder
Organika, JSC (Russia)
Dosage Form
|
Aminalon | Film-coated tablets, 250 mg: 50 or 100 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex; on cross-section, the core is white or almost white.
| 1 tab. | |
| Gamma-aminobutyric acid | 250 mg |
Excipients: sucrose (white sugar) – 27.2 mg, magnesium stearate – 2.8 mg, coating: Opadry 200 white, series 200F280000 or another film-forming system with the specified composition (polyvinyl alcohol – 4.9 mg, titanium dioxide – 3.5 mg, macrogol (polyethylene glycol) – 1.68 mg, talc – 3.343 mg, methacrylic acid copolymer type C – 0.56 mg, sodium bicarbonate – 0.017 mg) – 14 mg.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.
Film-coated tablets, 250 mg: 10, 20, 30, 40, 50, or 100 pcs.
Marketing Authorization Holder
Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)
Dosage Form
|
Aminalon | Film-coated tablets, 250 mg: 10, 20, 30, 40, 50, or 100 pcs. |
Dosage Form, Packaging, and Composition
| Film-coated tablets | 1 tab. |
| Gamma-aminobutyric acid | 250 mg |
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
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