Each tablet contains the following excipients: Maize starch, sodium carboxymethylcellulose, white beeswax, titanium dioxide, pregelatinized maize starch, ethylcellulose, anhydrous glucose, lactose, sunset yellow FCF, glyceryl mono-oleate, polysorbate 80, polyvidone excipient, saccharose, anhydrous colloidal silica, magnesium stearate and talc.
Pharmacotherepeutic Group: Antiasthenic drug.
Pharmacology: In Animals: Pharmacological studies carried out in animals, either with acute or chronic administration, have evidenced the following actions: Sulbutiamine increases physical resistance to fatigue, neuromuscular efficiency and learning and memory; and improves the metabolic functions of the cerebral cortex.
In Man: The activity of sulbutiamine has been studied in functional asthenia in the course of controlled clinical studies (against placebo or reference products) using psychometric scales (Middlesex Hospital Questionnaire, Crocq Scale for the evaluation of nonpsychotic depressive conditions, Lipman auto-evaluation scale), with statistical analysis of the results. These studies showed the activity of sulbutiamine in the symptomatic treatment of functional asthenia.
Pharmacokinetics: Sulbutiamine is rapidly absorbed and the blood concentration is maximum in 1-2 hrs after oral administration. The molecule is rapidly distributed in the whole organism and is eliminated with a biological half-life of 5 hrs.
The urinary excretion is maximal 2-3 hrs after administration.
Symptomatic treatment of functional asthenia.
Only a history of hypersensitivity to sulbutiamine constitutes a contraindication.
Use in pregnancy: No fetal toxicity or malformation has been reported. However, follow-up of women exposed to sulbutiamine during pregnancy is insufficient to exclude such a risk. Therefore, as a precautionary measure, it is preferable not to use this drug during pregnancy.
Use in lactation: In the absence of data concerning the diffusion into breast milk, breastfeeding is not recommended during treatment.
Use in pregnancy: No fetal toxicity or malformation has been reported. However, follow-up of women exposed to sulbutiamine during pregnancy is insufficient to exclude such a risk. Therefore, as a precautionary measure, it is preferable not to use this drug during pregnancy.
Use in lactation: In the absence of data concerning the diffusion into breast milk, breastfeeding is not recommended during treatment.
Possibility of neuro-physic side effects (tremor, malaise, headache, agitation), skin allergy and digestive disorders.
No drug interactions have been reported.
A11DA02 - sulbutiamine ; Belongs to the class of vitamin B1. Used as dietary supplements.
Arcalion 200 sugar-coated tab 200 mg
60's (Rp655,557/pak)
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