Land: Canada
Språk: engelsk
Kilde: Health Canada
CLOBAZAM
PRO DOC LIMITEE
N05BA09
CLOBAZAM
10MG
TABLET
CLOBAZAM 10MG
ORAL
30
Targeted (CDSA IV)
BENZODIAZEPINES
Active ingredient group (AIG) number: 0114637001; AHFS:
CANCELLED POST MARKET
2017-05-05
PRODUCT MONOGRAPH CLOBAZAM - 10 Clobazam Tablets Pro Doc Standard 10 mg Anticonvulsant For Adjunctive Therapy PRO DOC LTÉE DATE OF REVISION: 2925, boul. Industriel June 14, 2016 Laval, Quebec H7L 3W9 Control #: 194850 2 NAME OF DRUG CLOBAZAM - 10 Clobazam Tablets 10 mg THERAPEUTIC CLASSIFICATION Anticonvulsant for adjunctive therapy PART I: HEALTH PROFESSIONAL INFORMATION ACTIONS Clobazam is a 1,5-benzodiazepine with anticonvulsant properties. In general, the mode of antiepileptic action of clobazam is probably largely analogous to that of the 1,4-benzodiazepines. The differences between clobazam (a 1,5-benzodiazepine) and the 1,4-benzodiazepines in terms of therapeutic efficacy and neurotoxicity are possibly due to the variation in degree of the agonist action at the high affinity benzodiazepine receptor or to differing relative action at the high and low affinity benzodiazepine receptors. Regarding the mechanism of action, it is likely that modifications to the function of gamma- aminobutyric acid (GABA) as an important inhibitory neurotransmitter underlie the pharmacological effects of the benzodiazepines. Electrophysiological studies have shown that benzodiazepines potentiate GABA-ergic transmission at all levels of the neuroaxis, including the spinal cord, hypothalamus, hippocampus, substantia nigra, cerebellar cortex and cerebral cortex. The changes induced by the interaction of GABA with its receptors is enhanced by benzodiazepines, resulting in a decrease in the firing rate of critical neurons in many regions of the brain. The oral absorption of clobazam, like that of all benzodiazepines, is fast and complete and amounts to at least 87%. Relative bioavailability of clobazam tablets or solution (in propylene glycol) is not significantly different. After a single dose of 20 mg clobazam, marked interindividual variability in maximum plasma concentrations (222 to 709 ng/mL) was observed after 0.25 to 4 hours. The administration of food with the drug has variable effects on the rate of absorption. 3 Clobazam read_full_document