Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
BACLOFEN
SANIS HEALTH INC
M03BX01
BACLOFEN
20MG
TABLET
BACLOFEN 20MG
ORAL
100
Prescription
GABA-DERIVATIVE SKELETAL MUSCLE RELAXANTS
Active ingredient group (AIG) number: 0113246002; AHFS:
APPROVED
2010-02-04
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 Aqra d-dokument sħiħ