DOM-BACLOFEN-TAB 10MG TABLET

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

BACLOFEN

Доступно од:

DOMINION PHARMACAL

АТЦ код:

M03BX01

INN (Међународно име):

BACLOFEN

Дозирање:

10MG

Фармацеутски облик:

TABLET

Састав:

BACLOFEN 10MG

Пут администрације:

ORAL

Јединице у пакету:

100/500/1000

Тип рецептора:

Prescription

Терапеутска област:

GABA-DERIVATIVE SKELETAL MUSCLE RELAXANTS

Резиме производа:

Active ingredient group (AIG) number: 0113246001; AHFS:

Статус ауторизације:

MARKETED

Датум одобрења:

1995-12-31

Карактеристике производа

PRODUCT MONOGRAPH
PR
DOM-BACLOFEN
(Baclofen tablets, USP 10 mg & 20 mg)
Muscle Relaxant / Antispastic Agent
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
Date of revision:
February 6, 2013
Control No. 161862
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_Dom-BACLOFEN Product Monograph _
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_Page 2 of 23 _
PRODUCT MONOGRAPH
NAME OF DRUG
Pr
Dom-BACLOFEN
(Baclofen Tablets, USP 10mg & 20mg)
THERAPEUTIC CLASSIFICATION
Muscle Relaxant and Antispastic Agent
ACTION
The precise mechanisms of action of baclofen are not fully known. It
inhibits both monosynaptic
and polysynaptic reflexes at the spinal level, probably by
hyperpolarization of afferent terminals,
although actions at supraspinal sites may also occur and contribute to
its clinical effect. Although
baclofen is an analog of the putative inhibitory neurotransmitter
gamma-aminobutyric acid
(GABA), there is no conclusive evidence that actions on GABA systems
are involved in the
production of its clinical effects.
Peak plasma concentrations of baclofen are achieved within 2 hours and
the plasma half-life is
approximately 2-4 hours.
INDICATIONS
Dom-BACLOFEN is useful for the alleviation of signs and symptoms of
spasticity resulting
from multiple sclerosis.
Dom-BACLOFEN may also be of some value in patients with spinal cord
injuries and other
spinal cord diseases.
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_Dom-BACLOFEN Product Monograph _
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_Page 3 of 23 _
CONTRAINDICATIONS
Hypersensitivity to Dom-BACLOFEN or to any of the excipients.
WARNINGS
ABRUPT DRUG WITHDRAWAL:
Following abrupt withdrawal of baclofen, visual and auditory
hallucinations, convulsions (status
epilepticus), dyskinesia, confusion, psychotic, manic or paranoid
states, anxiety with tachycardia
and sweating, insomnia, and worsening of spasticity have occurred.
Therefore, except for serious
adverse reactions, the dose should be reduced slowly when the drug is
discontinued (over a
period of approximately 1-2 weeks).
For the intrathecal formulation of baclofen, it has been reported that
clinical characteristics of
withdrawal may resemble autonomic dysref