RIVA-BACLOFEN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BACLOFEN

Available from:

LABORATOIRE RIVA INC.

ATC code:

M03BX01

INN (International Name):

BACLOFEN

Dosage:

20MG

Pharmaceutical form:

TABLET

Composition:

BACLOFEN 20MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

GABA-DERIVATIVE SKELETAL MUSCLE RELAXANTS

Product summary:

Active ingredient group (AIG) number: 0113246002; AHFS:

Authorization status:

APPROVED

Authorization date:

2000-04-20

Summary of Product characteristics

_RIVA-BACLOFEN - Product Monograph _
_Page 1 of 23 _
PRODUCT MONOGRAPH
PR
RIVA-BACLOFEN
Baclofen Tablets, USP
10 mg and 20 mg
ANTISPASTIC AGENT
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville,
Quebec
J7C 3V4
www.labriva.com
DATE OF REVISION:
February 5, 2021
Submission
Control No.: 248258
_RIVA-BACLOFEN - Product Monograph _
_Page 2 of 23 _
PR
RIVA-BACLOFEN
Baclofen Tablets, USP
10 mg and 20 mg
THERAPEUTIC CLASSIFICATION
Antispastic Agent
ACTION AND CLINICAL PHARMACOLOGY
MECHANISM OF ACTION (MOA)
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
2 – 4 hours.
_SPECIAL POPULATIONS _
GERIATRICS (AGED 65 YEARS OR ABOVE)
Following a single oral dose, elderly patients have a slower rate of
absorption and elimination, a
slightly
prolonged elimination half-life, but a similar systemic exposure of
baclofen compared to
young adults.
HEPATIC IMPAIRMENT
No pharmacokinetic data is available in patients with hepatic
impairment after administration
of
baclofen. However, as the liver does not play a significant role in
the disposition
of baclofen, it is
unlikely
that baclofen pharmacokinetics would be altered to a clinically
significant level in
patients with hepatic impairment.
RENAL IMPAIRMENT
No controlled clinical pharmacokinetic study is available in patients
with renal impairment after
administration of baclofen. Baclofen is predominantly
eliminated unchanged in urine. Sparse
plasma concentration data collected in female patients under chronic
hemodialysis or
compensat