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

sunovion pharmaceuticals inc. - indacaterol maleate (unii: 2jec1itx7r) (indacaterol - unii:8or09251mq), glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - indacaterol 27.5 ug - utibron® neohaler® is a combination of indacaterol and glycopyrrolate indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema. important limitations of use: utibron neohaler is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see warnings and precautions (5.1, 5.2)] . the safety and effectiveness of utibron in asthma have not been established. use of a laba, including utibron neohaler, without an inhaled corticosteroid is contraindicated in patients with asthma [see warnings and precautions (5.1)] . utibron neohaler is not indicated for the treatment of asthma. utibron neohaler is contraindicated in patients who have demonstrated hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients [see warnings and precautions (5.5)] . teratogenic effects: pregnancy category c there are no adequate and well-controlled studies with utibron

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

sunovion pharmaceuticals inc. - indacaterol maleate (unii: 2jec1itx7r) (indacaterol - unii:8or09251mq) - indacaterol 75 ug - arcapta neohaler is a long-acting beta2 -agonist indicated for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema. arcapta neohaler is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see warnings and precautions (5.2) ]. arcapta neohaler is not indicated to treat asthma. the safety and effectiveness of arcapta neohaler in asthma have not been established. use of a laba, including arcapta neohaler, without an inhaled corticosteroid is contraindicated in patients with asthma [see warnings and precautions (5.1) ]. arcapta neohaler is not indicated for the treatment of asthma. arcapta neohaler is contraindicated in patients with a history of hypersensitivity to indacaterol or to any of the ingredients [see warnings and precautions (5.4)]. teratogenic effects: pregnancy category c. there are no adequate and well-controlled studies with arc

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

sunovion pharmaceuticals inc. - ciclesonide (unii: s59502j185) (ciclesonide - unii:s59502j185) - ciclesonide 37 ug - zetonna® (ciclesonide) nasal aerosol is indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older. zetonna is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of zetonna [see warnings and precautions (5.3) ]. teratogenic effects : pregnancy category c. there are no adequate and well-controlled trials in pregnant women. zetonna should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. oral administration of ciclesonide in rats at approximately 120 times the maximum recommended human daily intranasal dose (mrhdid) in adults (on a mcg/m2 basis at a maternal dose of 900 mcg/kg/day) produced no teratogenicity or other fetal

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

sunovion pharmaceuticals inc. - ciclesonide (unii: s59502j185) (ciclesonide - unii:s59502j185) - ciclesonide 50 ug - omnaris nasal spray is indicated for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. omnaris nasal spray is indicated for the treatment of nasal symptoms associated with perennial allergic rhinitis in adults and adolescents 12 years of age and older. omnaris nasal spray is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of omnaris nasal spray [see warnings and precautions (5.3)] . teratogenic effects : pregnancy category c. there are no adequate and well-controlled studies in pregnant women. omnaris nasal spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. in addition, because there is a natural increase in corticosteroid p

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

physicians total care, inc. - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone 1 mg - lunesta is indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, lunesta administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). none known. lunesta is a schedule iv controlled substance under the controlled substances act. other substances under the same classification are benzodiazepines and the nonbenzodiazepine hypnotics zaleplon and zolpidem. while eszopiclone is a hypnotic agent with a chemical structure unrelated to benzodiazepines, it shares some of the pharmacologic properties of the benzodiazepines. abuse and addiction are separate and distinct from physical dependence and tolerance. abuse is characterized by misuse of the dru

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

dispensing solutions, inc. - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone 2 mg - lunesta is indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, lunesta administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). none known. lunesta is a schedule iv controlled substance under the controlled substances act. other substances under the same classification are benzodiazepines and the nonbenzodiazepine hypnotics zaleplon and zolpidem. while eszopiclone is a hypnotic agent with a chemical structure unrelated to benzodiazepines, it shares some of the pharmacologic properties of the benzodiazepines. abuse and addiction are separate and distinct from physical dependence and tolerance. abuse is characterized by misuse of the dru

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

h.j. harkins company, inc. - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone 2 mg - lunesta is indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, lunesta administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). none known. lunesta is a schedule iv controlled substance under the controlled substances act. other substances under the same classification are benzodiazepines and the nonbenzodiazepine hypnotics zaleplon and zolpidem. while eszopiclone is a hypnotic agent with a chemical structure unrelated to benzodiazepines, it shares some of the pharmacologic properties of the benzodiazepines. abuse and addiction are separate and distinct from physical dependence and tolerance. abuse is characterized by misuse of the dru

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

pd-rx pharmaceuticals, inc. - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone 3 mg - lunesta ® (eszopiclone) is indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, lunesta administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). lunesta is contraindicated in patients who have experienced complex sleep behaviors after taking lunesta lunesta is contraindicated in patients who have experienced complex sleep behaviors after taking lunesta [see warnings and precautions ( 5.1)]. lunesta is contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema . lunesta is contraindicated in patients w

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

sunovion pharmaceuticals inc. - apomorphine hydrochloride (unii: f39049y068) (apomorphine - unii:n21far7b4s) - kynmobi is indicated for the acute, intermittent treatment of “off” episodes in patients with parkinson's disease (pd). kynmobi is contraindicated in patients: - using concomitant 5ht3 antagonists, including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) and alosetron [see drug interactions (7.1)]. there have been reports of profound hypotension and loss of consciousness when subcutaneous apomorphine was administered with a 5ht3 antagonist. - with hypersensitivity/allergic reaction to apomorphine or to any of the ingredients of kynmobi. angioedema or anaphylaxis may occur [see warnings and precautions (5.3)]. risk summary there are no adequate data on the developmental risk associated with use of kynmobi in pregnant women. in animal reproduction studies, apomorphine had adverse developmental effects in rats (increased neonatal deaths) and rabbits (increased incidence of malformation) when administered during pregnancy at clinically relevant doses. these doses were also associated with

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

sunovion pharmaceuticals inc. - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - glycopyrrolate 25 ug in 1 ml - lonhala magnair is indicated for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema. lonhala magnair is contraindicated in patients with a hypersensitivity to glycopyrrolate or any of the ingredients [see warnings and precautions (5.3) ]. risk summary there are no adequate and well-controlled studies in pregnant women. lonhala magnair should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the fetus. women should be advised to contact their physician if they become pregnant while taking lonhala magnair. in animal reproduction studies, there were no teratogenic effects in wistar rats and new zealand white rabbits at inhaled doses approximating 1521 and 580 times, respectively, the maximum recommended human daily inhalation dose (mrhdid) based on an auc comparison [see data ]. the estimated background risk of major birth defects and miscarriage