PMS-BACLOFEN TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

BACLOFEN

Dostopno od:

PHARMASCIENCE INC

Koda artikla:

M03BX01

INN (mednarodno ime):

BACLOFEN

Odmerek:

10MG

Farmacevtska oblika:

TABLET

Sestava:

BACLOFEN 10MG

Pot uporabe:

ORAL

Enote v paketu:

100/500

Tip zastaranja:

Prescription

Terapevtsko območje:

GABA-DERIVATIVE SKELETAL MUSCLE RELAXANTS

Povzetek izdelek:

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

Status dovoljenje:

MARKETED

Datum dovoljenje:

1994-12-31

Lastnosti izdelka

PRODUCT MONOGRAPH
PR
PMS-BACLOFEN
Baclofen Tablets, USP
10 mg and 20 mg
ANTISPASTIC AGENT
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
December 11, 2020
SUBMISSION CONTROL NO.: 245244
_pms-BACLOFEN Product Monograph _
_ _
_Page 2 of 23 _
PR
PMS-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
compensated renal failure indicate significantly