国家: 加拿大
语言: 英文
来源: Health Canada
BUSPIRONE HYDROCHLORIDE
PHARMASCIENCE INC
N05BE01
BUSPIRONE
5MG
TABLET
BUSPIRONE HYDROCHLORIDE 5MG
ORAL
100
Prescription
MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS
Active ingredient group (AIG) number: 0116263002; AHFS:
APPROVED
1997-03-18
PRODUCT MONOGRAPH PR PMS-BUSPIRONE Buspirone Hydrochloride Tablets, USP 5 mg and 10 mg ANXIOLYTIC PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Québec H4P 2T4 www.pharmascience.com Date of revision: October 11, 2016 CONTROL NUMBER: 197779 PRODUCT MONOGRAPH NAME OF DRUG PR PMS-BUSPIRONE Buspirone Hydrochloride Tablets, USP 5 mg and l0 mg THERAPEUTIC CLASSIFICATION Anxiolytic ACTIONS AND CLINICAL PHARMACOLOGY Buspirone is a psychotropic drug with selective anxiolytic properties which belongs chemically to the class of compounds known as the azaspirodecanediones, not chemically or pharmacologically related to benzodiazepines, barbiturates, or other known psychotropic agents. Buspirone shares some of the properties of the benzodiazepines and the neuroleptics, as well as demonstrating other pharmacological action. Buspirone attenuates punishment suppressed behaviour in animals and exerts a taming effect, but is devoid of anticonvulsant and muscle relaxant properties and does not bind to the benzodiazepine/GABA receptor complex. Buspirone affects a variety of dopamine mediated biochemical and behavioural events, but is free of cataleptic activity. Buspirone has an affinity for brain D 2 -dopamine receptors, where it acts as an antagonist and agonist, and for the 5-HT 1A receptors, where it acts as an agonist. Buspirone does not block the neuronal reuptake of monoamines and, on chronic administration; it does not lead to changes in receptor density in the models investigated. However, the mechanism of action of buspirone in man remains to be elucidated. Buspirone is rapidly absorbed in man and undergoes extensive first pass metabolism. Following oral administration, low peak plasma levels of unchanged drug, of 1 to 6 ng/mL were observed 40 to 90 minutes after a single 20 mg dose. In a number of studies performed in healthy volunteers, the mean half-life of buspirone ranged from 2 to 3 hours up to approximately 11 hours with considerable variation in individual values. Multiple dose studies suggest that 阅读完整的文件