STRESAM Capsule Ref.[27562] Active ingredients: Etifoxine

Revision Year: 2010  Publisher: BIOCODEX, 7 avenue Gallieni, 94250 GENTILLY, FRANCE

5.1. Pharmacodynamic properties

ANTIANXIETY AGENT
(N : central nervous system)

Etifoxine hydrochloride belongs to the benzoxazines chemical group. As antianxiety agent, it has an autonomic regulatory action.

Animal and human studies have failed to establish any rebound effect, nor dependency potential (physical or psychological).

5.2. Pharmacokinetic properties

Etifoxine hydrochloride is well absorbed by oral route, it does not bind to blood cells, its plasma levels fall slowly in three phases and it is mainly eliminated in urine. Etifoxine hydrochloride crosses the placenta barrier.

5.3. Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, toxicity to reproduction.

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