PMS-BUSPIRONE TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

BUSPIRONE HYDROCHLORIDE

Доступна з:

PHARMASCIENCE INC

Код атс:

N05BE01

ІПН (Міжнародна Ім'я):

BUSPIRONE

Дозування:

5MG

Фармацевтична форма:

TABLET

Склад:

BUSPIRONE HYDROCHLORIDE 5MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100

Тип рецепту:

Prescription

Терапевтична области:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Огляд продуктів:

Active ingredient group (AIG) number: 0116263002; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

1997-03-18

Характеристики продукта

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