MYLAN-BACLOFEN TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

BACLOFEN

から入手可能:

MYLAN PHARMACEUTICALS ULC

ATCコード:

M03BX01

INN（国際名）:

BACLOFEN

投薬量:

10MG

医薬品形態:

TABLET

構図:

BACLOFEN 10MG

投与経路:

ORAL

パッケージ内のユニット:

100/500

処方タイプ:

Prescription

治療領域:

GABA-DERIVATIVE SKELETAL MUSCLE RELAXANTS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2009-07-10

製品の特徴

1
PRODUCT MONOGRAPH
PR
MYLAN-BACLOFEN
BACLOFEN
TABLETS 10 MG AND 20 MG
MUSCLE RELAXANT/ANTISPASTIC AGENT
MYLAN PHARMACEUTICALS ULC Date of Revision: April 26, 2021
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Control Number: 250562
2
NAME OF DRUG
PR
MYLAN-BACLOFEN
(BACLOFEN)
TABLETS 10 MG AND 20 MG
THERAPEUTIC CLASSIFICATION
Muscle Relaxant/Antispastic Agent
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION (MOA)
The precise mechanisms of action of MYLAN-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 MYLAN-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 MYLAN-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
MYLAN-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 MYLAN-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