Enerion® [Sulbutiamine]
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Pharmacological properties
Sulbutiamine is an original molecule synthesized by thiamine modifications. thanks to these modifications, Sulbutiamine is able to penetrate through the BBB and accumulate in the structures of the brain, which causes such effects of the drug as:
- improved coordination of movements;
- increased resistance to muscle fatigue;
- improving the resistance of the cerebral cortex to chronic hypoxia (oxygen starvation);
- Improving concentration and memory.
The effectiveness of the drug Enerion has been proven in many clinical placebo-controlled and comparative studies involving patients with functional asthenia of various etiologies, namely:
- post-infectious asthenia developing after acute viral and infectious diseases of the respiratory tract (bronchitis, tonsillitis, flu), bacterial infections (Salmonella, Yersinia), tuberculosis, malaria, typhoid fever, infectious hepatitis;
- asthenia arising from somatic diseases;
- asthenia caused by depression;
- asthenia in elderly patients: clinical studies have proved the effectiveness of Enerion in cases of impaired mental function (decreased memory, attentiveness, vigilance and thinking) and in difficulties of social adaptation (fatigue, communication disorders, personality, behavior and sleep);
- asthenia in students (physical and mental fatigue);
- asthenia in athletes.
Pharmacokinetics Sulbutiamine is rapidly absorbed, Cmax in blood plasma is achieved 1–2 hours after administration. T½ is about 5 hours. Sulbutiamine is excreted in the urine.
Indications
Treatment for physical and mental asthenia, accompanied by apathy and a decrease in activity.
Application
The drug is prescribed only for adults. for oral use. the daily dose is 2-3 tablets, which should be taken in 2-3 doses during breakfast and at lunchtime, respectively. the duration of treatment should not exceed 4 weeks.
Contraindications
Hypersensitivity to the active substance or to any of the excipients of the drug.
Side effects
During treatment with the drug, the following side effects or events were reported, which are distributed in frequency as follows: very often (≥1 / 10), often (from ≥1 / 100 to 1/10), infrequently (from ≥1 / 1000 to 1 / 100), rarely (from ≥1 / 10,000 to 1/1000), very rarely (1/10 000), the frequency is unknown (cannot be determined according to available information).
| Organ System Classification | Frequency | Adverse reaction |
|---|---|---|
| From the psyche | Infrequently | Agitation |
| From the nervous system | Infrequently | Headache |
| Tremor | ||
| From the gastrointestinal tract | Infrequently | Nausea |
| Vomiting | ||
| Frequency unknown | Abdominal pain | |
| Diarrhea | ||
| On the part of the skin and subcutaneous tissue | Infrequently | Rash |
| General disorders and reactions at the injection site | Infrequently | Malaise |
Description of some adverse reactions. Due to the presence of the dye yellow FCF in the formulation, there is a risk of allergic reactions (see SPECIAL INSTRUCTIONS).
Report on suspected adverse reactions. Reporting suspected adverse reactions after drug registration is important. This will allow continuous monitoring of the benefit / risk ratio of the drug. Health professionals are required to report any suspected adverse reactions through the national reporting system.
special instructions
Excipients. the composition of the drug includes glucose, lactose, sucrose.
Patients with rare hereditary fructose or galactose intolerance, Lapp lactase deficiency or sucrose-isomaltase deficiency, or glucose-galactose malabsorption should not take this drug.
This medicine contains the dye "yellow sunset FCF (E110)", which can cause allergic reactions (see ADVERSE EFFECTS).
Use during pregnancy and lactation
Pregnancy. Data on the use of Sulbutiamine in pregnant women are absent or limited (300 cases).
Animal studies have not revealed a direct or indirect toxic effect on reproduction.
As a preventative measure, it is advisable to avoid the use of Sulbutiamine during pregnancy.
Lactation. It is not known whether Sulbutiamine and its metabolites pass into breast milk. The risk to newborns / infants cannot be excluded. Sulbutiamine should not be used during lactation.
Fertility. There are no data on fertility effects.
Children. The drug is not used in children.
The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Special studies on the effect of Sulbutiamine on the ability to drive vehicles or work with mechanisms have not been conducted.
Interactions
Special studies of the interaction of Sulbutiamine with other drugs have not been conducted.
Simultaneous use
1430 Items
2020-07-30
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