BACLOFEN TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

BACLOFEN

Saatavilla:

SANIS HEALTH INC

ATC-koodi:

M03BX01

INN (Kansainvälinen yleisnimi):

BACLOFEN

Annos:

20MG

Lääkemuoto:

TABLET

Koostumus:

BACLOFEN 20MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

GABA-DERIVATIVE SKELETAL MUSCLE RELAXANTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2010-02-04

Valmisteyhteenveto

1
PRODUCT MONOGRAPH
PR
BACLOFEN
BACLOFEN TABLETS BP
10 MG AND 20 MG
MUSCLE RELAXANT/ANTISPASTIC AGENT
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Control Number: 253909
Date of Revision:
August 4, 2021
2
NAME OF DRUG
PR
BACLOFEN
(BACLOFEN TABLETS BP)
10 MG AND 20 MG
THERAPEUTIC CLASSIFICATION
Muscle Relaxant/Antispastic Agent
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION (MOA)
The precise mechanisms of action of BACLOFEN (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 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 significantly decreased clearance and increased
half-life of baclo