European Union - English - EMA (European Medicines Agency)

zentiva k.s. - riluzole - amyotrophic lateral sclerosis - other nervous system drugs - riluzole zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (als).clinical trials have demonstrated that riluzole zentiva extends survival for patients with als. survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.there is no evidence that riluzole zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. riluzole zentiva has not been shown to be effective in the late stages of als.safety and efficacy of riluzole zentiva has only been studied in als. therefore, riluzole zentiva should not be used in patients with any other form of motor-neurone disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - riluzole -

United States - English - NLM (National Library of Medicine)

avkare - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole tablets is indicated for the treatment of amyotrophic lateral sclerosis (als). riluzole tablets is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see adverse reactions ( 6.1)] . risk summary there are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data] . based on these results, women should be advised of a possible risk to the fetus associated with use of riluzole during pregnancy. data animal data oral administration of riluzole (3, 9, or 27 mg/kg/day) to pregnant rats during the period of organogenesis resulted in decreases in fetal growth (body weight and length) at the high dose. the mid dose, a no-effect dose for embryofetal developmental toxicity, is approximately equal to the recommended human daily dose (rhdd, 100 mg) on a mg/m 2 basis. when riluzole was administered orally (3, 10, or 60 mg/kg/day) to pregnant rabbits during the period of organogenesis, embryofetal mortality was increased at the high dose and fetal body weight was decreased and morphological variations increased at all but the lowest dose tested. the no-effect dose (3 mg/kg/day) for embryofetal developmental toxicity is less than the rhdd on a mg/m 2 basis. maternal toxicity was observed at the highest dose tested in rat and rabbit. when riluzole was orally administered (3, 8, or 15 mg/kg/day) to male and female rats prior to and during mating and to female rats throughout gestation and lactation, increased embryofetal mortality and decreased postnatal offspring viability, growth, and functional development were observed at the high dose. the mid dose, a no-effect dose for pre-and postnatal developmental toxicity, is approximately equal to the rhdd on a mg/m 2 basis. risk summary it is not known if riluzole is excreted in human milk. riluzole or its metabolites have been detected in milk of lactating rat. women should be advised that many drugs are excreted in human milk and that the potential for serious adverse reactions in nursing infants from riluzole is unknown. in rats, oral administration of riluzole resulted in decreased fertility indices and increases in embryolethality [see nonclinical toxicology ( 13.1)] . safety and effectiveness of riluzole tablets in pediatric patients have not been established. in clinical studies of riluzole tablets, 30% of patients were 65 years and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. patients with mild [child-pugh's (cp) score a] or moderate (cp score b) hepatic impairment had increases in auc compared to patients with normal hepatic function. thus, patients with mild or moderate hepatic impairment may be at increased of adverse reactions. the impact of severe hepatic impairment on riluzole exposure is unknown. use of riluzole tablets is not recommended in patients with baseline elevation of elevations of serum aminotransferases greater than 5 times upper limit of normal or evidence of liver dysfunction (e.g., elevated bilirubin) [clinical pharmacology ( 12.3)] . japanese patients are more likely to have higher riluzole concentrations. consequently, the risk of adverse reactions may be greater in japanese patients [see clinical pharmacology ( 12.3)] .

United States - English - NLM (National Library of Medicine)

quinn pharmaceuticals, llc - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole tablets, usp is indicated for the treatment of amyotrophic lateral sclerosis (als). riluzole tablets is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see adverse reactions (6.1)] . there are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data] . based on these results, women should be advised of a possible risk to the fetus associ

United States - English - NLM (National Library of Medicine)

kaiser foundation hospitals - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole 50 mg

United States - English - NLM (National Library of Medicine)

quinn pharmaceuticals - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole tablets is indicated for the treatment of amyotrophic lateral sclerosis (als). riluzole tablets is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see adverse reactions ( 6.1)] . risk summary there are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data] . based on these results, wome

United States - English - NLM (National Library of Medicine)

kaiser foundation hospitals - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole 50 mg

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - riluzole, quantity: 50 mg - tablet, film coated - excipient ingredients: macrogol 8000; croscarmellose sodium; titanium dioxide; hypromellose; microcrystalline cellulose; magnesium stearate; purified talc; calcium hydrogen phosphate dihydrate - for treatment of patients with amyotrophic lateral sclerosis (als)

New Zealand - English - Medsafe (Medicines Safety Authority)

apotex nz ltd - riluzole 50mg - film coated tablet - 50 mg - active: riluzole 50mg excipient: calcium hydrogen phosphate dihydrate croscarmellose sodium hypromellose macrogol 8000 magnesium stearate microcrystalline cellulose purified talc purified water titanium dioxide - riluzole is indicated for the treatment of patients with amyotrophic lateral sclerosis (als).

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

actavis uk ltd - riluzole - tablet - 50mg