Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
BACLOFEN
DOMINION PHARMACAL
M03BX01
BACLOFEN
10MG
TABLET
BACLOFEN 10MG
ORAL
100/500/1000
Prescription
GABA-DERIVATIVE SKELETAL MUSCLE RELAXANTS
Active ingredient group (AIG) number: 0113246001; AHFS:
MARKETED
1995-12-31
PRODUCT MONOGRAPH PR DOM-BACLOFEN (Baclofen tablets, USP 10 mg & 20 mg) Muscle Relaxant / Antispastic Agent DOMINION PHARMACAL 6111 Royalmount Ave., Suite 100 Montreal, Quebec H4P 2T4 Date of revision: February 6, 2013 Control No. 161862 _ _ _Dom-BACLOFEN Product Monograph _ _ _ _Page 2 of 23 _ PRODUCT MONOGRAPH NAME OF DRUG Pr Dom-BACLOFEN (Baclofen Tablets, USP 10mg & 20mg) THERAPEUTIC CLASSIFICATION Muscle Relaxant and Antispastic Agent ACTION 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 approximately 2-4 hours. INDICATIONS Dom-BACLOFEN is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis. Dom-BACLOFEN may also be of some value in patients with spinal cord injuries and other spinal cord diseases. _ _ _Dom-BACLOFEN Product Monograph _ _ _ _Page 3 of 23 _ CONTRAINDICATIONS Hypersensitivity to Dom-BACLOFEN or to any of the excipients. WARNINGS ABRUPT DRUG WITHDRAWAL: Following abrupt withdrawal of baclofen, visual and auditory hallucinations, convulsions (status epilepticus), dyskinesia, confusion, psychotic, manic or paranoid states, anxiety with tachycardia and sweating, insomnia, and worsening of spasticity have occurred. Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued (over a period of approximately 1-2 weeks). For the intrathecal formulation of baclofen, it has been reported that clinical characteristics of withdrawal may resemble autonomic dysref Přečtěte si celý dokument