PHL-BACLOFEN TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

BACLOFEN

Tilgjengelig fra:

PHARMEL INC

ATC-kode:

M03BX01

INN (International Name):

BACLOFEN

Dosering :

10MG

Legemiddelform:

TABLET

Sammensetning:

BACLOFEN 10MG

Administreringsrute:

ORAL

Enheter i pakken:

100/500

Resept typen:

Prescription

Terapeutisk område:

GABA-DERIVATIVE SKELETAL MUSCLE RELAXANTS

Produkt oppsummering:

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

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2013-02-07

Preparatomtale

PRODUCT MONOGRAPH
PR
PHL-BACLOFEN
(Baclofen tablets, USP 10 mg & 20 mg)
Muscle Relaxant / Antispastic Agent
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
Date of revision:
February 6, 2013
Control No. 161863
phl-BACLOFEN Product Monograph
Page 2 of 24
PRODUCT MONOGRAPH
NAME OF DRUG
Pr
phl-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
phl-BACLOFEN is useful for the alleviation of signs and symptoms of
spasticity resulting from
multiple sclerosis.
phl-BACLOFEN may also be of some value in patients with spinal cord
injuries and other
spinal cord diseases.
phl-BACLOFEN Product Monograph
Page 3 of 24
CONTRAINDICATIONS
Hypersensitivity to phl-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
dysreflexia,
malignant
hyperthermia,
neu