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Pharmacotherapeutic Group: Vitamin B1, plain. ATC Code: A11DA02.
Pharmacology: Pharmacodynamics: In humans: This medicine has been studied in controlled clinical trials versus placebo or reference products, by using psychometric evaluation scales and tests. These trials demonstrate the psychoactive effect of this drug, with a predominant action on psychological and physical inhibition.
Pharmacokinetics: Sulbutiamine is rapidly absorbed and peak blood concentration is reached between 1 and 2 hours after administration.
The half-life is approximately 5 hours. Elimination is by the urinary route.
Toxicology: Preclinical safety data: No special hazards have been identified for use in humans on the basis of preclinical studies of acute, subchronic and chronic toxicity and reproduction toxicity (studies conducted in pregnant mice, rats and rabbits haven't shown any teratogenic potential). Sulbutiamine was not mutagenic in the Ames test. No studies of carcinogenicity have been performed.
