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ANTIANXIETY AGENT (N: Central nervous system).
PHARMACOLOGY: Pharmacodynamics: 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).
Pharmacokinetics: Etifoxine hydrochloride is well absorbed by oral route, it does not bind to blood cells. After etifoxine administration, the plasma concentration of the compound increases up to a maximal value, and then decreases in three phases, with elimination constants qualified of short (# 1 min), intermediate (4-5 hours) and long (40-60 hours) and it is mainly eliminated in urine. Etifoxine hydrochloride crosses the placenta barrier.
Toxicology: 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.
