LIORESAL INTRATHECAL 2MG/ML SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BACLOFEN

Available from:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC code:

M03BX01

INN (International Name):

BACLOFEN

Dosage:

2MG

Pharmaceutical form:

SOLUTION

Composition:

BACLOFEN 2MG

Administration route:

INTRATHECAL

Units in package:

5ML

Prescription type:

Prescription

Therapeutic area:

GABA-DERIVATIVE SKELETAL MUSCLE RELAXANTS

Product summary:

Active ingredient group (AIG) number: 0113246003; AHFS:

Authorization status:

APPROVED

Authorization date:

1997-06-03

Summary of Product characteristics

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_Page 1 of 40_
PRODUCT MONOGRAPH
Pr
LIORESAL
® INTRATHECAL
(baclofen injection)
0.05 mg/mL, 0.5 mg/mL and 2 mg/mL
For intrathecal injection and infusion only
Antispastic Agent
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Novartis Pharmaceuticals Canada Inc.
DATE OF PREPARATION:
385 Bouchard Blvd.
September 13, 1994
Dorval, Quebec H9S 1A9
DATE OF REVISION:
May 5, 2020
Submission Control No: 235751
LIORESAL is a registered trademark.
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_Page 2 of 40_
PRODUCT MONOGRAPH
PR
LIORESAL
® INTRATHECAL
(baclofen injection)
0.05 mg/mL, 0.5 mg/mL and 2 mg/mL
For intrathecal injection and infusion only
THERAPEUTIC CLASSIFICATION
Antispastic Agent
CLINICAL PHARMACOLOGY
The precise mechanisms of action of LIORESAL (baclofen) as an
antispastic agent are not fully
understood. Baclofen inhibits both monosynaptic and polysynaptic
reflex transmission at the
spinal level, possibly by decreasing excitatory neurotransmitter
release from primary afferent
terminals. Actions at supraspinal sites may also contribute to its
clinical effect. Baclofen is an
analogue of the inhibitory neurotransmitter gamma-aminobutyric acid
(GABA), and may exert
its effects by stimulation of the GABA
B
receptor subtype. _ _
Baclofen has been shown to have general Central Nervous System (CNS)
depressant properties
as indicated by the production of sedation with tolerance, somnolence,
ataxia and respiratory and
cardiovascular depression. A dose-dependent inhibitory effect on
erectile function has been
shown in men through GABA
B
receptor stimulation.
In neurological diseases associated with spasm of the skeletal
muscles, LIORESAL Intrathecal
may
have
beneficial
action
on
reflex
muscle
contractions,
painful
spasm,
automatism,
hyperreflexia, trismus and clonus. Neuromuscular transmission is not
affected by baclofen.
Baclofen may also reduce pain associated with spasticity.
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_Page 3 of 40_
PHARMACODYNAMICS OF LIORESAL INTRATHECAL:
INTRATHECAL BOLUS:
The onset of action is generally half an hour to one hour after
administration of an intrathecal
bolus dose. Peak antispast