Država: Kanada
Jezik: engleski
Izvor: Health Canada
BUSPIRONE HYDROCHLORIDE
BRISTOL-MYERS SQUIBB CANADA
N05BE01
BUSPIRONE
10MG
TABLET
BUSPIRONE HYDROCHLORIDE 10MG
ORAL
100
Prescription
MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS
Active ingredient group (AIG) number: 0116263001; AHFS:
CANCELLED POST MARKET
2010-11-12
PRODUCT MONOGRAPH PR BUSPAR* (BUSPIRONE HYDROCHLORIDE) TABLETS, 5 AND 10 MG ANXIOLYTIC Bristol-Myers Squibb Canada 2365 Cote de Liesse Date of Preparation: Montreal, Canada October 29, 2004 H4N 2M7 Date of Revision: * TM of Mead Johnson & Company used under licence by Bristol-Myers Squibb Canada Control No.: 094863 1 PRODUCT MONOGRAPH BUSPAR* (BUSPIRONE HYDROCHLORIDE) Tablets, 5 and 10 mg THERAPEUTIC CLASSIFICATION Anxiolytic ACTION 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. Pročitajte cijeli dokument