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

alvogen, inc. - rasagiline mesylate (unii: lh8c2ji290) (rasagiline - unii:003n66ts6t) - rasagiline 0.5 mg - rasagiline mesylate tablets are indicated for the treatment of parkinson’s disease (pd). rasagiline is contraindicated for use with meperidine, tramadol, methadone, propoxyphene and mao inhibitors (maois), including other selective mao-b inhibitors, because of risk of serotonin syndrome [see warnings and precautions (5.2)]. at least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with these medications. rasagiline is contraindicated for use with st. john’s wort and with cyclobenzaprine. rasagiline is contraindicated for use with dextromethorphan because of risk of episode of psychosis or bizarre behavior. pregnancy category c there are no adequate and well-controlled studies of rasagiline in pregnant women. rasagiline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in a combined mating/fertility and embryo-fetal development study in pregnant rats, no effect on embryo-fetal development was observed at oral doses

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

teva pharmaceuticals usa, inc. - rasagiline mesylate (unii: lh8c2ji290) (rasagiline - unii:003n66ts6t) - rasagiline 0.5 mg - rasagiline tablets are indicated for the treatment of parkinson’s disease (pd). rasagiline is contraindicated for use with meperidine, tramadol, methadone, propoxyphene, and mao inhibitors (maois), including other selective mao-b inhibitors, because of risk of serotonin syndrome [see warnings and precautions (5.2)] . at least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with these medications. rasagiline is contraindicated for use with st. john’s wort and with cyclobenzaprine. rasagiline is contraindicated for use with dextromethorphan because of risk of episode of psychosis or bizarre behavior. risk summary there are no adequate data on the developmental risks associated with the use of rasagiline in pregnant women. in animal studies, oral administration of rasagiline to rats during gestation and lactation resulted in decreased survival and reduced body weight in the offspring at doses similar to those used clinically. when administered to pregnant animals in combin

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

ascend laboratories, llc - rasagiline mesylate (unii: lh8c2ji290) (rasagiline - unii:003n66ts6t) - rasagiline 0.5 mg - rasagiline tablets are indicated for the treatment of parkinson's disease (pd) rasagiline is contraindicated for use with meperidine, tramadol, methadone, propoxyphene and mao inhibitors (maois), including other selective mao-b inhibitors, because of risk of serotonin syndrome [see warnings and precautions ( 5.2 )]. at least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with these medications. rasagiline is contraindicated for use with st. john’s wort and with cyclobenzaprine. rasagiline is contraindicated for use with dextromethorphan because of risk of episode of psychosis or bizarre behavior. risk summary there are no adequate data on the developmental risks associated with the use of rasagiline in pregnant women. in animal studies, oral administration of rasagiline to rats during gestation and lactation resulted in decreased survival and reduced body weight in the offspring at doses similar to those used clinically. when administered to pregnant animals in comb

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

northstar rxllc - rasagiline mesylate (unii: lh8c2ji290) (rasagiline - unii:003n66ts6t) - rasagiline 0.5 mg - rasagiline tablets are indicated for the treatment of parkinson's disease (pd). rasagiline is contraindicated for use with meperidine, tramadol, methadone, propoxyphene and mao inhibitors (maois), including other selective mao-b inhibitors, because of risk of serotonin syndrome [see warnings and precautions (5.2)] . at least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with these medications. rasagiline is contraindicated for use with st. john’s wort and with cyclobenzaprine. rasagiline is contraindicated for use with dextromethorphan because of risk of episode of psychosis or bizarre behavior. risk summary there are no adequate data on the developmental risks associated with the use of rasagiline in pregnant women. in animal studies, oral administration of rasagiline to rats during gestation and lactation resulted in decreased survival and reduced body weight in the offspring at doses similar to those used clinically. when administered to pregnant animals in combination with levodopa/carbidopa, there were increased incidences of fetal skeletal variations in rats and increases in embryofetal death and cardiovascular abnormalities in rabbits [see data] . in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risks of major birth defects and miscarriage for the indicated population is unknown. data animal data in a combined mating/fertility and embryofetal development study in pregnant rats, no effect on embryofetal development was observed at oral doses up to 3 mg/kg/day (approximately 30 times the plasma exposure (auc) in humans at the maximum recommended human dose [mrhd, 1mg/day]). in pregnant rabbits administered rasagiline throughout the period of organogenesis at oral doses of up to 36 mg/kg/day, no developmental toxicity was observed. at the highest dose tested, the plasma auc was approximately 800 times that in humans at the mrhd. in pregnant rats administered rasagiline (0, 0.1, 0.3, 1 mg/kg/day) orally during gestation and lactation, offspring survival was decreased and offspring body weight was reduced at 0.3 mg/kg/day and 1 mg/kg/day (10 and 16 times the plasma auc in humans at the mrhd). the no-effect dose (0.1 mg/kg) for adverse developmental effects is similar to the mrhd on a body surface area (mg/m2) basis. the effect of rasagiline on physical and behavioral development was not adequately assessed in this study. rasagiline may be given as an adjunct therapy to levodopa/carbidopa treatment. in pregnant rats administered rasagiline (0, 0.1, 0.3, 1 mg/kg/day) and levodopa/carbidopa (80/20 mg/kg/day) (alone and in combination) orally throughout the period of organogenesis, there was an increased incidence of fetal skeletal variations in fetuses from rats treated with rasagiline in combination with levodopa/carbidopa at 1/80/20 mg/kg/day (approximately 8 times the rasagiline plasma auc in humans at the mrhd and similar to the mrhd of levodopa/carbidopa [800/200 mg/day] on a mg/m2 basis). in pregnant rabbits dosed orally throughout the period of organogenesis with rasagiline alone (3 mg/kg) or in combination with levodopa/carbidopa (rasagiline: 0.1, 0.6, 1.2 mg/kg, levodopa/carbidopa: 80/20 mg/kg/day), an increase in embryofetal death was noted at rasagiline doses of 0.6 and 1.2 mg/kg/day when administered in combination with levodopa/carbidopa (approximately 7 and 13 times, respectively, the rasagiline plasma auc in humans at the mrhd). there was an increase in cardiovascular abnormalities with levodopa/carbidopa alone (similar to the mrhd on a mg/m2 basis) and to a greater extent when rasagiline (at all doses; 1-13 times the rasagiline plasma auc in humans at the mrhd) was administered in combination with levodopa/carbidopa. risk summary there are no data on the presence of rasagiline in human milk or the effects on the breastfed infant. in rats, rasagiline was shown to inhibit prolactin secretion. the clinical relevance in humans is unknown, and there are no data on the effects of rasagiline on prolactin secretion or milk production in humans. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for rasagiline and any potential adverse effects on the breastfed infant from rasagiline or from the underlying maternal condition. the safety and effectiveness in pediatric patients have not been established. approximately half of patients in clinical trials were 65 years and over. there were no significant differences in the safety profile of the geriatric and nongeriatric patients. rasagiline plasma concentration may be increased in patients with mild (up to 2 fold, child-pugh score 5 to 6), moderate (up to 7 fold, child-pugh score 7 to 9), and severe (child-pugh score 10 to 15) hepatic impairment. patients with mild hepatic impairment should not exceed a dose of 0.5 mg/day. rasagiline should not be used in patients with moderate or severe hepatic impairment [see dosage and administration (2.3), warnings and precautions (5.5) and clinical pharmacology (12.3)]. dose adjustment of rasagiline is not required for patients with mild or moderate renal impairment because rasagiline plasma concentrations are not increased in patients with moderate renal impairment. rasagiline has not been studied in patients with severe renal impairment [see clinical pharmacology (12.3)]. rasagiline tablets are not a controlled substance. studies conducted in mice and rats did not reveal any potential for drug abuse and dependence. clinical trials have not revealed any evidence of the potential for abuse, tolerance or physical dependence; however, systematic studies in humans designed to evaluate these effects have not been performed. studies conducted in mice and rats did not reveal any potential for drug abuse and dependence. clinical trials have not revealed any evidence of the potential for abuse, tolerance or physical dependence; however, systematic studies in humans designed to evaluate these effects have not been performed.

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

mylan pharmaceuticals inc. - rasagiline mesylate (unii: lh8c2ji290) (rasagiline - unii:003n66ts6t) - rasagiline 0.5 mg - rasagiline tablets are indicated for the treatment of parkinson’s disease (pd). rasagiline tablets are contraindicated for use with meperidine, tramadol, methadone, propoxyphene, and mao inhibitors (maois), including other selective mao-b inhibitors, because of risk of serotonin syndrome [see warnings and precautions (5.2)] . at least 14 days should elapse between discontinuation of rasagiline tablets and initiation of treatment with these medications. rasagiline tablets are contraindicated for use with st. john’s wort and with cyclobenzaprine. rasagiline tablets are contraindicated for use with dextromethorphan because of risk of episode of psychosis or bizarre behavior. there are no adequate data on the developmental risks associated with the use of rasagiline in pregnant women. in animal studies, oral administration of rasagiline to rats during gestation and lactation resulted in decreased survival and reduced body weight in the offspring at doses similar to those used clinically. when administered to preg

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare limited - rasagiline tartrate - tablets - 1 milligram - rasagiline - anti-parkinson-drugs, monoamine oxidase -b inhibitors - rasagiline accord is indicated for the treatment of idiopathic parkinson’s disease (pd) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.

Israel - English - Ministry of Health

novartis israel ltd - rasagiline as tartrate - tablets - rasagiline as tartrate 1 mg - rasagiline - rasagiline sandoz® 1mg is indicated for the treatment of idiopathic parkinson's disease (pd) as monotherapy (without levodopa)or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.

Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - rasagiline - tablet - 1 milligram(s) - monoamine oxidase b inhibitors; rasagiline - anti-parkinson drugs, monoamine oxidase b inhibitors - rasagiline rowex is indicated for the treatment of idiopathic parkinson’s disease (pd) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations

Ireland - English - HPRA (Health Products Regulatory Authority)

teva b.v. - rasagiline - tablet - 1 milligram(s) - monoamine oxidase b inhibitors; rasagiline - anti-parkinson-drugs, monoamine oxidase -b inhibitors - rasagiline teva is indicated for the treatment of idiopathic parkinson’s disease (pd) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.

European Union - English - EMA (European Medicines Agency)

mylan s.a.s. - rasagiline tartrate - parkinson disease - anti-parkinson drugs - rasagiline mylan is indicated for the treatment of idiopathic parkinson’s disease (pd) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.