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

sandoz pty ltd - riluzole, quantity: 50 mg - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; croscarmellose sodium; titanium dioxide; hypromellose; macrogol 6000 - riluzole is indicated for the treatment of patients with amyotrophic lateral sclerosis (als).

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

glenmark pharmaceuticals inc., usa - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole 50 mg - riluzole tablets are indicated for the treatment of amyotrophic lateral sclerosis (als). riluzole tablets are 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 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 associated with use of riluzole during pregnancy. data risk summary it is not known if riluzole is excreted in human milk. riluzole or its metabolites have been detected in milk of lactating rats. 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 in pediatric patients have not been established. in clinical studies of riluzole, 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 risk of adverse reactions. the impact of severe hepatic impairment on riluzole exposure is unknown. use of riluzole is not recommended in patients with baseline 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)].

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

sanofi-aventis australia pty ltd - riluzole -

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

rising pharmaceuticals, inc. - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole 50 mg - riluzole is indicated for the treatment of amyotrophic lateral sclerosis (als) riluzole 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 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 associated wit

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

sun pharmaceutical industries, inc. - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole 50 mg - riluzole tablets, usp are indicated for the treatment of amyotrophic lateral sclerosis (als). riluzole tablets are 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 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 th

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

ascend laboratories, llc - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole 50 mg - riluzole is indicated for the treatment of amyotrophic lateral sclerosis (als).  riluzole 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 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 associated wi

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

american health packaging - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole 50 mg - riluzole tablets are indicated for the treatment of amyotrophic lateral sclerosis (als). riluzole tablets are 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 tablets 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 pos

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

apotex corp - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole 50 mg - riluzole tablets are indicated for the treatment of amyotrophic lateral sclerosis (als). riluzole tablets are 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 tablets 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

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

mylan pharmaceuticals inc. - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole 50 mg - riluzole tablets are indicated for the treatment of amyotrophic lateral sclerosis (als). riluzole tablets are contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of their components (anaphylaxis has occurred) [see adverse reactions (6.1)]. there are no studies of riluzole tablets 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 associa

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

pharmacor pty ltd - riluzole, quantity: 50 mg - tablet, film coated - excipient ingredients: magnesium stearate; hypromellose; microcrystalline cellulose; calcium phosphate; croscarmellose sodium; colloidal anhydrous silica; purified water; titanium dioxide; macrogol 400 - riluzole is indicated for the treatment of patients with amyotrophic lateral sclerosis (als)