CLOBAZAM-10 TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

CLOBAZAM

Dostępny od:

PRO DOC LIMITEE

Kod ATC:

N05BA09

INN (International Nazwa):

CLOBAZAM

Dawkowanie:

10MG

Forma farmaceutyczna:

TABLET

Skład:

CLOBAZAM 10MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30

Typ recepty:

Targeted (CDSA IV)

Dziedzina terapeutyczna:

BENZODIAZEPINES

Podsumowanie produktu:

Active ingredient group (AIG) number: 0114637001; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2017-05-05

Charakterystyka produktu

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