RILUZOLE tablet film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

RILUZOLE (UNII: 7LJ087RS6F) (RILUZOLE - UNII:7LJ087RS6F)

Beschikbaar vanaf:

KAISER FOUNDATION HOSPITALS

INN (Algemene Internationale Benaming):

RILUZOLE

Samenstelling:

RILUZOLE 50 mg

Prescription-type:

PRESCRIPTION DRUG

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

RILUZOLE - RILUZOLE TABLET, FILM COATED
KAISER FOUNDATION HOSPITALS
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RILUZOLE TABLETS, USP
DESCRIPTION
Riluzole is a member of the benzothiazole class. Chemically, riluzole
is 2-amino-6-(trifluoromethoxy)
benzothiazole. Its molecular formula is C H F N OS and its molecular
weight is 234.2. Its structural
formula is as follows:
Riluzole is a white to slightly yellow powder that is very soluble in
dimethylformamide,
dimethylsulfoxide and methanol, freely soluble in dichloromethane,
sparingly soluble in 0.1 N HCl and
very slightly soluble in water and in 0.1 N NaOH. Riluzole tablets,
USP are available as round-shaped,
white to off white, biconvex, film-coated tablets for oral
administration containing 50 mg of riluzole
USP. Each tablet is debossed with “538” on one side.
INACTIVE INGREDIENTS
CORE: anhydrous dibasic calcium phosphate, microcrystalline cellulose,
povidone, croscarmellose
sodium, colloidal silicon dioxide, talc, magnesium stearate.
FILM COATING: hypromellose, polyethylene glycol 400, titanium dioxide,
talc.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The etiology and pathogenesis of amyotrophic lateral sclerosis (ALS)
are not known, although a
number of hypotheses have been advanced. One hypothesis is that motor
neurons, made vulnerable
through either genetic predisposition or environmental factors, are
injured by glutamate. In some cases
of familial ALS the enzyme superoxide dismutase has been found to be
defective.
The mode of action of riluzole is unknown. Its pharmacological
properties include the following, some
of which may be related to its effect: 1) an inhibitory effect on
glutamate release, 2) inactivation of
voltage-dependent sodium channels, and 3) ability to interfere with
intracellular events that follow
transmitter binding at excitatory amino acid receptors.
8
5
3
2
Riluzole has also been shown, in a single study, to delay median time
to death in a transgenic mouse
model of ALS. These mice express human superoxide dismutase bearing
one of the mutations found in
one of the fam