Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
RILUZOLE
SANOFI-AVENTIS SINGAPORE PTE. LTD.
N07XX02
50 mg
TABLET, FILM COATED
RILUZOLE 50 mg
ORAL
Prescription Only
Opella Healthcare International SAS
ACTIVE
1997-07-31
RILUTEK _® _ (RILUZOLE)_ _TABLETS [sanofi-aventis logo] RILUTEK _® _ (RILUZOLE)TABLETS RX ONLY DESCRIPTION RILUTEK _® _ (riluzole) is a member of the benzonthiazole class. Chemically riluzole is 2-amino-6- (trifluoromethoxy) benzonthiazole. Its molecular formula is C 8 H 5 F 3 N 2 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 dimethyformamide, dimethysolfuxide and methanol, freely soluble in dichloromethane, sparingly soluble in 0.1N HCl and very slightly soluble in water and 0.1N NaOH. RILUTEK is available as a capsule shaped, white, film coated tablet for oral administration containing 50mg of riluzole. Each tablet is engraved with “RPR 202” on one side. INACTIVE INGREDIENTS: CORE : anhydrous dibasic calcium phosphate, USP; microcrystalline cellulose, NF; anhydrous colloidal silica, NF; magnesium stearate, NF; croscarmellose sodium, NF. FILM COATING: Hydroxypropyl methylcellulose, USP; polyethylene glycol 6000; titanium dioxide, USP. CLINICAL PHARMACOLOGY MECHANISM OF ACTION The etiology and pathogenesis of amyotropic 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 RILUTEK 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 Read the complete document
RILUTEK _® _ ( RILUZOLE)_ _TABLETS [sanofi-aventis logo] RILUTEK _® _ ( RILUZOLE)TABLETS RX ONLY DESCRIPTION RILUTEK _® _ ( riluzole) is a member of the benzonthiazole class. Chemically riluzole is 2-amino-6- (trifluoromethoxy) benzonthiazole. Its molecular formula is C 8 H 5 F 3 N 2 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 dimethyformamide, dimethysolfuxide and methanol, freely soluble in dichloromethane, sparingly soluble in 0.1N HCl and very slightly soluble in water and 0.1N NaOH. RILUTEK is available as a capsule shaped, white, film coated tablet for oral administration containing 50mg of riluzole. Each tablet is engraved with “RPR 202” on one side. INACTIVE INGREDIENTS: CORE : anhydrous dibasic calcium phosphate, USP; microcrystalline cellulose, NF; anhydrous colloidal silica, NF; magnesium stearate, NF; croscarmellose sodium, NF. FILM COATING: Hydroxypropyl methylcellulose, USP; polyethylene glycol 6000; titanium dioxide, USP. CLINICAL PHARMACOLOGY MECHANISM OF ACTION The etiology and pathogenesis of amyotropic 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 RILUTEK 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. 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 Read the complete document