RATIO-BACLOFEN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BACLOFEN

Available from:

TEVA CANADA LIMITED

ATC code:

M03BX01

INN (International Name):

BACLOFEN

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

BACLOFEN 10MG

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: 0113246001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-04-30

Summary of Product characteristics

ratio-BACLOFEN Product Monograph
Page 1 of 21
PRODUCT MONOGRAPH
PR
RATIO-
BACLOFEN
Baclofen Tablets, USP
10 mg and 20 mg
Antispastic Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Date of revision:
May 13, 2016
Control: 193957
ratio-BACLOFEN Product Monograph
Page 2 of 21
PRODUCT MONOGRAPH
PR
RATIO-
BACLOFEN
Baclofen Tablets USP
10mg and 20mg
THERAPEUTIC CLASSIFICATION
Antispastic Agent
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 compensated
renal failure indicate sig