Enerion® (Sulbutiamine) Instruction
International Non-Proprietary Name (INN): sulbutiamine
Dosage form: tablets
Structure
1 tablet contains:
Active ingredient: sulbutiamine 200 mg;
Excipients: corn starch, dried starch paste, anhydrous glucose (dextrose), lactose monohydrate, magnesium stearate, talc;
Capsule shell composition: sodium hydrocarbonate, sodium carboxymethylcellulose, white beeswax, titanium dioxide (E171), ethylcellulose, “Sunset” yellow FCF, E110, glycerol monooleate, polysorbate 80, povidone, sucrose, colloidal anhydrous silicon dioxide (Aerosil 130), talc.
Description
Double-radius, round tablets with an orange shell; a slight surface (the level of glossiness) or color inhomogeneity is permitted, insignificant impregnations are allowed.
Pharmacological classification: medicine, regulating metabolic processes in the central nervous system
ATC code: A11DA02
Pharmacological action: regulation of metabolic processes in the central nervous system
Pharmacodynamics
Enerion is a synthetic substance; its structure is close to thiamine, compared to which the molecule has an open thiazole cycle, an additional disulfide bond, and a lipophilic ether. Due to this modification, Sulbutiamine is well soluble in fat; it is quickly absorbed from the digestive tract and easily penetrates into the blood-brain barrier (BBB). In contrast to thiamine, it can accumulate in the cells of the reticular formation, in the hippocampus and the dentate gyrus, as well as in the Purkinje cells and in the glomeruli of the granular layer of the cerebellar cortex. Enerion improves the coordination of movement and resistance to physical exercise, the stability of the cerebral cortex structures becomes more resistant to repeated anoxia. The medicine is effective for the symptomatic treatment of functional asthenia.
Pharmacokinetics
Sulbutiamine is quickly absorbed from the gastrointestinal tract. The maximum concentration in blood plasma is reached 1-2 hours after an intake. The half-life is about 5 hours. The medicine is excreted in the urine.
Intended uses
- Symptomatic treatment of functional asthenia.
Contraindications
- Hypersensitivity to Enerion ingredients;
- The medicine is not recommended for patients under 18 years old (due to the lack of clinical data);
- Lactose monohydrate is one of Enerion’s excipients. Hence, the medicine is not recommended for patients with lactose insufficiency, galactosemia or glucose/galactose malabsorption syndrome.
Dosage and administration
Per os. Enerion is recommended for adult patients only.
The daily dose is 2-3 tablets (400–600 mg) divided into 2 intakes (during breakfast and lunch). Duration of treatment should not exceed 4 weeks.
Side effects
Allergic reactions (presence of “Sunset” yellow in the composition of the medication), digestive disorders, psychoneurological reactions (tremor, headache, agitation, general malaise).
Overdose
Excitement with symptoms of euphoria and tremor of extremities. These symptoms are transient and do not require special treatment.
Interaction with other drugs
There is no reported interaction with other medicines.
Pregnancy and lactation
According to the results of clinical studies, the medicine does not affect the foetation. However, due to the lack of sufficient clinical data, Enerion is not recommended during pregnancy and lactation.
Influence on the ability to drive vehicles and operate mechanisms
The medicine has no effect on the ability to drive vehicles and mechanisms.
Terms of release from pharmacy
On prescription.
Storage conditions
At a temperature of no higher than 25°C. Keep out of the reach of children.
Shelf life
3 years. Do not use beyond the expiration date printed on the package.
Manufacturer
Servier, France. https://servier.com/en/