Source: Υπουργείο Υγείας (CY) Revision Year: 2018 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Pharmacotherapeutic group: Benzodiazepines derivates, Anxiolitycs
ATC code: N05BA12
Alprazolam, like other benzodiazepines, has a high affinity for the benzodiazepine binding site in the brain. It facilitates the inhibitory neurotransmitter action of gamma-aminobutyric acid, which mediates both pre- and post-synaptic inhibition in the central nervous system (CNS).
Alprazolam is readily absorbed. Following oral administration peak concentration in the plasma occurs after 1-2 hours.
The mean half-life is 12-15 hours. Repeated dosage may lead to accumulation and this should be borne in mind in elderly patients and those with impaired renal or hepatic function. Alprazolam and its metabolites are excreted primarily in the urine.
In vitro alprazolam is bound (80%) to human serum protein.
Non-clinical data reveal no special hazard for humans based on conventional studies of genotoxicity and carcinogenic potential.
When rats were treated orally with alprazolam for 2 years, a tendency for a dose related increase in the number of cataracts (females) and corneal vascularization (males) was observed. These lesions did not appear until after 11 months of treatment.
In reproductive toxicity studies administration of alprazolam in rats and rabbits is associated at very high doses with developmental delay and an increased incidence of fetal death and skeletal malformations. In fertility studies, treatment of male rats at high doses prior to mating resulted in a decrease in the percentage of dams conceiving.
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