BUSPAR TAB 10MG TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

BUSPIRONE HYDROCHLORIDE

Disponible depuis:

BRISTOL-MYERS SQUIBB CANADA

Code ATC:

N05BE01

DCI (Dénomination commune internationale):

BUSPIRONE

Dosage:

10MG

forme pharmaceutique:

TABLET

Composition:

BUSPIRONE HYDROCHLORIDE 10MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Descriptif du produit:

Active ingredient group (AIG) number: 0116263001; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2010-11-12

Résumé des caractéristiques du produit

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.