BUSPAR TAB 10MG TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BUSPIRONE HYDROCHLORIDE

Available from:

BRISTOL-MYERS SQUIBB CANADA

ATC code:

N05BE01

INN (International Name):

BUSPIRONE

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

BUSPIRONE HYDROCHLORIDE 10MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2010-11-12

Summary of Product characteristics

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.