USA - engelsk - NLM (National Library of Medicine)

slate run pharmaceuticals - arformoterol tartrate (unii: 5p8vj2i235) (arformoterol - unii:f91h02ebwt) - arformoterol tartrate inhalation solution is indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and emphysema. arformoterol tartrate inhalation solution is for use by nebulization only. arformoterol tartrate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see warnings and precautions(5.2) ]. arformoterol tartrate inhalation solution is not indicated to treat asthma. the safety and effectiveness of arformoterol tartrate inhalation solution in asthma have not been established. arformoterol tartrate inhalation solution is contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any other components of this product. use of a laba, including arformoterol tartrate inhalation solution, without an inhaled cortisteroid is contraindicated in patients with asthma [se

USA - engelsk - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - formoterol fumarate inhalation solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and emphysema. formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see warnings and precautions (5.2)]. formoterol fumarate inhalation solution is not indicated to treat asthma. the safety and effectiveness of formoterol fumarate inhalation solution in asthma have not been established. use of a laba, including formoterol fumarate inhalation solution, without an inhaled corticosteroid is contraindicated in patients with asthma [see warnings and precautions (5.1)].  formoterol fumarate inhalation solution is not indicated for the treatment of asthma. there are limited available data with formoterol fumarate inhalation solution use in pregnant women to inform a drug-associated

USA - engelsk - NLM (National Library of Medicine)

bryant ranch prepack - formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - formoterol fumarate inhalation solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and emphysema. formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see warnings and precautions (5.2)] . formoterol fumarate inhalation solution is not indicated to treat asthma. the safety and effectiveness of formoterol fumarate inhalation solution in asthma have not been established. use of a long-acting beta2 -adrenergic agonists (laba), including formoterol fumarate inhalation solution, without an inhaled corticosteroid is contraindicated in patients with asthma [see warnings and precautions (5.1)] . formoterol fumarate inhalation solution is not indicated for the treatment of asthma. risk summary there are limited available data with formoterol fumarate inhalation solution use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. beta-agonists may interfere with uterine contractility (see clinical considerations) . in animal reproduction studies, oral administration of formoterol fumarate to pregnant rats and rabbits caused increased fetal malformations (rats and rabbits), decreased fetal weight (rats), and increased neonatal mortality (rats) following administration of doses that produced exposures approximately 730 to 29,000 times the mrhd on a mg/m2 or auc basis. these adverse effects generally occurred at large multiples of the mrhd when formoterol fumarate was administered by the oral route to achieve high systemic exposures. no effects were observed in a study with rats that received formoterol fumarate by the inhalation route at an exposure approximately 300 times the mrhd (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. 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. clinical considerations labor or delivery there are no adequate and well-controlled human studies that have studied the effects of formoterol fumarate inhalation solution during labor and delivery. because of the potential for beta-agonists interference with uterine contractility, use of formoterol fumarate inhalation solution during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. data animal data in embryofetal development studies with pregnant rats and rabbits dosed throughout the period of organogenesis, formoterol fumarate did not cause malformations in either species. however, for pregnant rats dosed throughout organogenesis, formoterol fumarate caused delayed fetal ossification at an exposure approximately 50 times the mrhd (on a mcg/m2 basis with maternal oral doses of 200 mcg/kg and higher) and decreased fetal weight at an exposure approximately 1,500 times the mrhd (on a mcg/m2 basis with maternal oral doses of 6,000 mcg/kg and above). in a pre- and post-natal development study with rats dosed during the late stage of pregnancy, formoterol fumarate caused stillbirth and neonatal mortality at an exposure approximately 1,500 times the mrhd (on a mcg/m2 basis with maternal oral doses of 6,000 mcg/kg and above). however, no effects were observed in this study at an exposure approximately 50 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 200 mcg/kg). in embryofetal development studies, conducted by another testing laboratory, with pregnant rats and rabbits dosed throughout the period of organogenesis, formoterol fumarate was teratogenic in both species. umbilical hernia, a malformation, was observed in rat fetuses at exposures approximately 730 times the mrhd (on a mcg/m2 basis with maternal oral doses of 3,000 mcg/kg/day and above). brachygnathia, a skeletal malformation, was observed in rat fetuses at an exposure approximately 3,600 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 15,000 mcg/kg/day). in another study with rats, no teratogenic effects were observed with exposures up to approximately 300 times the mrhd (on a mcg/m2 basis with a maternal inhalation dose of 1,200 mcg/kg/day). subcapsular cysts on the liver were observed in rabbit fetuses at an exposure approximately 29,000 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 60,000 mcg/kg/day). no teratogenic effects were observed with exposures up to approximately 1,700 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 3,500 mcg/kg). risk summary there are no well-controlled human studies of the use of formoterol fumarate inhalation solution in nursing mothers. it is not known whether formoterol fumarate is excreted in human milk, or whether there are effects on the breastfed infant or on the milk production. in reproductive studies in rats formoterol was excreted in the milk (see data) . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for formoterol fumarate inhalation solution and any potential adverse effects on the breastfed child from formoterol fumarate inhalation solution or from the underlying maternal condition. data in a pharmacokinetic study in rats formoterol was excreted in the milk. the amount of radioactive labelled 3 h-formoterol fumarate was less than 2% of that in the maternal plasma. formoterol fumarate inhalation solution is not indicated for use in children. the safety and effectiveness of formoterol fumarate inhalation solution in pediatric patients have not been established. the pharmacokinetics of formoterol fumarate has not been studied in pediatric patients. of the 586 subjects who received formoterol fumarate inhalation solution in clinical studies, 284 were 65 years and over, while 89 were 75 years and over. of the 123 subjects who received formoterol fumarate inhalation solution in the 12-week safety and efficacy trial, 48 (39%) were 65 years of age or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. the pharmacokinetics of formoterol fumarate inhalation solution has not been studied in elderly subjects. formoterol fumarate (for moe' ter ol fue' ma rate) inhalation solution using formoterol fumarate inhalation solution formoterol fumarate inhalation solution is used only in a standard jet nebulizer machine connected to an air compressor. make sure you know how to use your nebulizer machine before you use it to breathe in formoterol fumarate inhalation solution or other medicines. do not mix formoterol fumarate inhalation solution with other medicines in your nebulizer machine. formoterol fumarate inhalation solution comes sealed in a foil pouch. do not open a sealed pouch until you are ready to use a dose of formoterol fumarate inhalation solution. - remove vial from the foil pouch. - twist the cap completely off the vial and squeeze all the medicine into the nebulizer medicine cup (reservoir) (figure 1 ). - connect the nebulizer reservoir to the mouthpiece or facemask (figure 2 ). - connect the nebulizer to the compressor. - sit in a comfortable, upright position. place the mouthpiece in your mouth (figure 3 ) or put on the facemask (figure 4 ); and turn on the compressor. - breathe as calmly, deeply and evenly as possible through your mouth until no more mist is formed in the nebulizer reservoir. the average nebulization time is 9 minutes. at this point, the treatment is finished. - discard the formoterol fumarate inhalation solution container and top after use. - clean the nebulizer (see manufacturer’s instructions). this instructions for use has been approved by the u.s. food and drug administration. manufactured in england by: norton healthcare limited t/a ivax pharmaceuticals uk runcorn, cheshire wa7 3fa england manufactured for: teva pharmaceuticals usa, inc. parsippany, nj 07054 iss. 10/2020

USA - engelsk - NLM (National Library of Medicine)

bryant ranch prepack - formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - formoterol fumarate inhalation solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and emphysema. formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see warnings and precautions (5.2)] . formoterol fumarate inhalation solution is not indicated to treat asthma. the safety and effectiveness of formoterol fumarate inhalation solution in asthma have not been established. use of a long-acting beta2 -adrenergic agonists (laba), including formoterol fumarate inhalation solution, without an inhaled corticosteroid is contraindicated in patients with asthma [see warnings and precautions (5.1)] . formoterol fumarate inhalation solution is not indicated for the treatment of asthma. risk summary there are limited available data with formoterol fumarate inhalation solution use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. beta-agonists may interfere with uterine contractility (see clinical considerations) . in animal reproduction studies, oral administration of formoterol fumarate to pregnant rats and rabbits caused increased fetal malformations (rats and rabbits), decreased fetal weight (rats), and increased neonatal mortality (rats) following administration of doses that produced exposures approximately 730 to 29,000 times the mrhd on a mg/m2 or auc basis. these adverse effects generally occurred at large multiples of the mrhd when formoterol fumarate was administered by the oral route to achieve high systemic exposures. no effects were observed in a study with rats that received formoterol fumarate by the inhalation route at an exposure approximately 300 times the mrhd (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. 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. clinical considerations labor or delivery there are no adequate and well-controlled human studies that have studied the effects of formoterol fumarate inhalation solution during labor and delivery. because of the potential for beta-agonists interference with uterine contractility, use of formoterol fumarate inhalation solution during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. data animal data in embryofetal development studies with pregnant rats and rabbits dosed throughout the period of organogenesis, formoterol fumarate did not cause malformations in either species. however, for pregnant rats dosed throughout organogenesis, formoterol fumarate caused delayed fetal ossification at an exposure approximately 50 times the mrhd (on a mcg/m2 basis with maternal oral doses of 200 mcg/kg and higher) and decreased fetal weight at an exposure approximately 1,500 times the mrhd (on a mcg/m2 basis with maternal oral doses of 6,000 mcg/kg and above). in a pre- and post-natal development study with rats dosed during the late stage of pregnancy, formoterol fumarate caused stillbirth and neonatal mortality at an exposure approximately 1,500 times the mrhd (on a mcg/m2 basis with maternal oral doses of 6,000 mcg/kg and above). however, no effects were observed in this study at an exposure approximately 50 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 200 mcg/kg). in embryofetal development studies, conducted by another testing laboratory, with pregnant rats and rabbits dosed throughout the period of organogenesis, formoterol fumarate was teratogenic in both species. umbilical hernia, a malformation, was observed in rat fetuses at exposures approximately 730 times the mrhd (on a mcg/m2 basis with maternal oral doses of 3,000 mcg/kg/day and above). brachygnathia, a skeletal malformation, was observed in rat fetuses at an exposure approximately 3,600 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 15,000 mcg/kg/day). in another study with rats, no teratogenic effects were observed with exposures up to approximately 300 times the mrhd (on a mcg/m2 basis with a maternal inhalation dose of 1,200 mcg/kg/day). subcapsular cysts on the liver were observed in rabbit fetuses at an exposure approximately 29,000 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 60,000 mcg/kg/day). no teratogenic effects were observed with exposures up to approximately 1,700 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 3,500 mcg/kg). risk summary there are no well-controlled human studies of the use of formoterol fumarate inhalation solution in nursing mothers. it is not known whether formoterol fumarate is excreted in human milk, or whether there are effects on the breastfed infant or on the milk production. in reproductive studies in rats formoterol was excreted in the milk (see data) . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for formoterol fumarate inhalation solution and any potential adverse effects on the breastfed child from formoterol fumarate inhalation solution or from the underlying maternal condition. data in a pharmacokinetic study in rats formoterol was excreted in the milk. the amount of radioactive labelled 3 h-formoterol fumarate was less than 2% of that in the maternal plasma. formoterol fumarate inhalation solution is not indicated for use in children. the safety and effectiveness of formoterol fumarate inhalation solution in pediatric patients have not been established. the pharmacokinetics of formoterol fumarate has not been studied in pediatric patients. of the 586 subjects who received formoterol fumarate inhalation solution in clinical studies, 284 were 65 years and over, while 89 were 75 years and over. of the 123 subjects who received formoterol fumarate inhalation solution in the 12-week safety and efficacy trial, 48 (39%) were 65 years of age or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. the pharmacokinetics of formoterol fumarate inhalation solution has not been studied in elderly subjects. formoterol fumarate (for moe' ter ol fue' ma rate) inhalation solution using formoterol fumarate inhalation solution formoterol fumarate inhalation solution is used only in a standard jet nebulizer machine connected to an air compressor. make sure you know how to use your nebulizer machine before you use it to breathe in formoterol fumarate inhalation solution or other medicines. do not mix formoterol fumarate inhalation solution with other medicines in your nebulizer machine. formoterol fumarate inhalation solution comes sealed in a foil pouch. do not open a sealed pouch until you are ready to use a dose of formoterol fumarate inhalation solution. - remove vial from the foil pouch. - twist the cap completely off the vial and squeeze all the medicine into the nebulizer medicine cup (reservoir) (figure 1 ). - connect the nebulizer reservoir to the mouthpiece or facemask (figure 2 ). - connect the nebulizer to the compressor. - sit in a comfortable, upright position. place the mouthpiece in your mouth (figure 3 ) or put on the facemask (figure 4 ); and turn on the compressor. - breathe as calmly, deeply and evenly as possible through your mouth until no more mist is formed in the nebulizer reservoir. the average nebulization time is 9 minutes. at this point, the treatment is finished. - discard the formoterol fumarate inhalation solution container and top after use. - clean the nebulizer (see manufacturer’s instructions). this instructions for use has been approved by the u.s. food and drug administration. manufactured in england by: norton healthcare limited t/a ivax pharmaceuticals uk runcorn, cheshire wa7 3fa england manufactured for: teva pharmaceuticals usa, inc. parsippany, nj 07054 iss. 10/2020

USA - engelsk - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - arformoterol tartrate (unii: 5p8vj2i235) (arformoterol - unii:f91h02ebwt) - arformoterol tartrate inhalation solution is indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and emphysema. arformoterol tartrate inhalation solution is for use by nebulization only. arformoterol tartrate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see warnings and precautions (5.2)] . arformoterol tartrate inhalation solution is not indicated to treat asthma. the safety and effectiveness of arformoterol tartrate inhalation solution in asthma have not been established. arformoterol tartrate inhalation solution is contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any other components of this product. use of a laba, including arformoterol tartrate inhalation solution, without an inhaled cortisteroid is contraindicated in patients with asthma [s

USA - engelsk - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - arformoterol tartrate (unii: 5p8vj2i235) (arformoterol - unii:f91h02ebwt) - arformoterol tartrate inhalation solution is indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and emphysema. arformoterol tartrate inhalation solution is for use by nebulization only. arformoterol tartrate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see warnings and precautions (5.2) ]. arformoterol tartrate inhalation solution is not indicated to treat asthma. the safety and effectiveness of arformoterol tartrate inhalation solution in asthma have not been established. arformoterol tartrate inhalation solution is contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any other components of this product. use of a laba, including arformoterol tartrate inhalation solution, without an inhaled cortisteroid is contraindicated in patients with asthma [see warnings and precautions (5) ]. arformoterol tartrate inhalation solution is not indicated for the treatment of asthma. risk summary there are no adequate and well-controlled studies in pregnant women. arformoterol tartrate 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 arformoterol tartrate. in animal reproduction studies with arformoterol administered by the oral route to rats and rabbits at exposures approximately 370 and 8,400 times the adult exposure at the maximum recommended human daily inhalation dose (mrhdid) of 15 mcg every 12 hours, respectively, there were findings of structural abnormalities, embryofetal and infant mortality, and alterations of growth. these adverse effects generally occurred at large multiples of the mrhdid when arformoterol was administered by the oral route to achieve high systemic exposures. no evidence of fetal harm was observed in rabbits at an exposure approximately 4,900 times the mrhdid. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations labor or delivery : the potential effect of arformoterol tartrate on labor and delivery is unknown. because of the potential for beta-agonists interference with uterine contractility, use of arformoterol tartrate inhalation solution during labor should be restricted to whom the benefits clearly outweigh the risk. data animal data in an embryofetal development study in which pregnant rats received doses of 1,000, 5,000 or 10,000 mcg/kg/day from gestation days 6 to 17, arformoterol was shown to be teratogenic based upon findings of omphalocele (umbilical hernia), a malformation, in rat fetuses at exposures approximately 370 times adult exposure at the mrhdid (on an auc basis with maternal oral doses of 1,000 mcg/kg/day and higher. maternal toxicity was not observed in rats with exposures up to 2,400 times the mrhdid (on an auc basis with maternal oral doses up to 10,000 mcg/kg/day). a no-observed-adverse-effect-level (noael) for rat fetuses was not identified. in an embryofetal development study in which pregnant rabbits received doses of 20,000, 40,000 or 80,000 mcg/kg/day from gestation days 7 to 20, arformoterol was shown to be teratogenic based upon findings of malpositioned right kidney, a malformation, in rabbit fetuses at exposures approximately 8400 times and higher than the adult exposure at the mrhdid (on an auc basis with maternal oral doses of 20,000 mcg/kg/day and higher). malformations including brachydactyly, bulbous aorta, and liver cysts as well as decreased body weights were observed in rabbit fetuses at doses approximately 26,000 times and higher than the mrhdid in adults (on a mcg/m2 basis with maternal oral doses of 40,000 mcg/kg/day and higher). malformations including adactyly, lobular dysgenesis of the lung, and interventricular septal defect as well as embryolethality were observed in rabbit fetuses at a dose approximately 52,000 times the mrhdid in adults (on a mcg/m2 basis with a maternal oral dose of 80,000 mcg/kg/day). maternal toxicity was observed at doses approximately 26,000 times and higher than the mrhdid in adults (on a mcg/m2 basis with maternal oral doses of 40,000 mcg/kg/day and higher). there was no evidence of fetal harm in rabbits at exposures approximately 4,900 times and lower than the adult exposure at the mrhdid (on an auc basis with maternal oral doses of 10,000 mcg/kg/day and lower). in a pre-and post-natal development study, female rats received arformoterol at oral doses of 0, 1,000, 5,000, and 10,000 mcg/kg/day from gestation day 6 through lactation day 20. lengths of gestation for female rats receiving doses 325 times and higher than the mrhdid (on a mcg/m2 basis with maternal oral doses of 1,000 mcg/kg/day and higher) were slightly prolonged, which was attributed to prolonged parturition or dystocia due to the pharmacological action of β-adrenergic agonists such as arformoterol to relax uterine musculature. one female that had received a dose 3,200 times the mrhdid (on a mcg/m2 basis with a maternal oral dose of 10,000 mcg/kg/day) was euthanized due to complications during parturition. pup survival and body weights were decreased at doses 1,600 times and higher than the mrhdid (on a mcg/m2 basis with maternal oral doses of 5,000 mcg/kg/day and higher) at birth and during lactation. umbilical hernia, a malformation, was observed for 1 pup at a dose 3,200 times the mrhdid (on a mcg/m2 basis with a maternal oral dose of 10,000 mcg/kg/day). potential developmental delays of rat pups were observed at a dose 3,200 times the mrhdid (on a mcg/m2 basis with a maternal oral dose of 10,000 mcg/kg/day); however, no developmental delays were evident with doses 1,600 times the mrhdid (on a mcg/m2 basis with a maternal oral dose of 5,000 mcg/kg/day). risk summary there are no data on the presence of arformoterol or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. however, arformoterol was excreted in the milk of lactating rats. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for arformoterol tartrate and any potential adverse effects on the breastfed infant from arformoterol tartrate or from the underlying maternal condition. data arformoterol and its metabolites were detected in the milk of lactating rats following oral administration of a 10,000 mcg/kg dose of radiolabeled arformoterol tartrate. arformoterol tartrate inhalation solution is approved for use in the long-term maintenance treatment of bronchoconstriction associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. this disease does not occur in children. the safety and efficacy of arformoterol tartrate inhalation solution in pediatric patients have not been established. of the 873 patients who received arformoterol tartrate inhalation solutionin two placebo-controlled clinical studies in adults with copd, 391 (45%) were 65 years of age or older while 96 (11%) were 75 years of age or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. among subjects age 65 years and older, 129 (33%) received arformoterol tartrate inhalation solution at the recommended dose of 15 mcg twice daily, while the remainder received higher doses. ecg alerts for ventricular ectopy in patients 65 to ≤75 years of age were comparable among patients receiving 15 mcg twice daily, 25 mcg twice daily, and placebo (3.9%, 5.2%, and 7.1%, respectively). a higher frequency (12.4%) was observed when arformoterol tartrate inhalation solution was dosed at 50 mcg once daily. the clinical significance of this finding is not known. 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. arformoterol tartrate inhalation solution should be used cautiously in patients with hepatic impairment due to increased systemic exposure in these patients [see clinical pharmacology (12.3) ]. the systemic exposure to arformoterol was similar to renally impaired patients compared with demographically matched healthy control subjects [see clinical pharmacology (12.3) ]. there were no reported cases of abuse or evidence of drug dependence with the use of arformoterol tartrate inhalation solution in the clinical trials.

USA - engelsk - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - arformoterol tartrate (unii: 5p8vj2i235) (arformoterol - unii:f91h02ebwt) - arformoterol tartrate inhalation solution is indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and emphysema. arformoterol tartrate inhalation solution is for use by nebulization only. arformoterol tartrate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see warnings and precautions (5.2) ]. arformoterol tartrate inhalation solution is not indicated to treat asthma. the safety and effectiveness of arformoterol tartrate inhalation solution in asthma have not been established. arformoterol tartrate inhalation solution is contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any other components of this product. use of a laba, including arformoterol tartrate inhalation solution, without an inhaled cortisteroid is contraindicated in patients with asthma [see warnings and precautions (5) ]. arformoterol tartrate inhalation solution is not indicated for the treatment of asthma. risk summary there are no adequate and well-controlled studies in pregnant women. arformoterol tartrate inhalation solution 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 arformoterol tartrate inhalation solution. in animal reproduction studies with arformoterol administered by the oral route to rats and rabbits at exposures approximately 370 and 8,400 times the adult exposure at the maximum recommended human daily inhalation dose (mrhdid) of 15 mcg every 12 hours, respectively, there were findings of structural abnormalities, embryofetal and infant mortality, and alterations of growth. these adverse effects generally occurred at large multiples of the mrhdid when arformoterol was administered by the oral route to achieve high systemic exposures. no evidence of fetal harm was observed in rabbits at an exposure approximately 4,900 times the mrhdid. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. 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. clinical considerations labor or delivery : the potential effect of arformoterol tartrate inhalation solution on labor and delivery is unknown. because of the potential for beta-agonists interference with uterine contractility, use of arformoterol tartrate inhalation solution during labor should be restricted to whom the benefits clearly outweigh the risk. data animal data in an embryofetal development study in which pregnant rats received doses of 1,000, 5,000 or 10,000 mcg/kg/day from gestation days 6 to 17, arformoterol was shown to be teratogenic based upon findings of omphalocele (umbilical hernia), a malformation, in rat fetuses at exposures approximately 370 times adult exposure at the mrhdid (on an auc basis with maternal oral doses of 1,000 mcg/kg/day and higher. maternal toxicity was not observed in rats with exposures up to 2,400 times the mrhdid (on an auc basis with maternal oral doses up to 10,000 mcg/kg/day). a no-observed-adverse-effect-level (noael) for rat fetuses was not identified. in an embryofetal development study in which pregnant rabbits received doses of 20,000, 40,000 or 80,000 mcg/kg/day from gestation days 7 to 20, arformoterol was shown to be teratogenic based upon findings of malpositioned right kidney, a malformation, in rabbit fetuses at exposures approximately 8400 times and higher than the adult exposure at the mrhdid (on an auc basis with maternal oral doses of 20,000 mcg/kg/day and higher). malformations including brachydactyly, bulbous aorta, and liver cysts as well as decreased body weights were observed in rabbit fetuses at doses approximately 26,000 times and higher than the mrhdid in adults (on a mcg/m2 basis with maternal oral doses of 40,000 mcg/kg/day and higher). malformations including adactyly, lobular dysgenesis of the lung, and interventricular septal defect as well as embryolethality were observed in rabbit fetuses at a dose approximately 52,000 times the mrhdid in adults (on a mcg/m2 basis with a maternal oral dose of 80,000 mcg/kg/day). maternal toxicity was observed at doses approximately 26,000 times and higher than the mrhdid in adults (on a mcg/m2 basis with maternal oral doses of 40,000 mcg/kg/day and higher). there was no evidence of fetal harm in rabbits at exposures approximately 4,900 times and lower than the adult exposure at the mrhdid (on an auc basis with maternal oral doses of 10,000 mcg/kg/day and lower). in a pre-and post-natal development study, female rats received arformoterol at oral doses of 0, 1,000, 5,000, and 10,000 mcg/kg/day from gestation day 6 through lactation day 20. lengths of gestation for female rats receiving doses 325 times and higher than the mrhdid (on a mcg/m2 basis with maternal oral doses of 1,000 mcg/kg/day and higher) were slightly prolonged, which was attributed to prolonged parturition or dystocia due to the pharmacological action of β-adrenergic agonists such as arformoterol to relax uterine musculature. one female that had received a dose 3,200 times the mrhdid (on a mcg/m2 basis with a maternal oral dose of 10,000 mcg/kg/day) was euthanized due to complications during parturition. pup survival and body weights were decreased at doses 1,600 times and higher than the mrhdid (on a mcg/m2 basis with maternal oral doses of 5,000 mcg/kg/day and higher) at birth and during lactation. umbilical hernia, a malformation, was observed for 1 pup at a dose 3,200 times the mrhdid (on a mcg/m2 basis with a maternal oral dose of 10,000 mcg/kg/day). potential developmental delays of rat pups were observed at a dose 3,200 times the mrhdid (on a mcg/m2 basis with a maternal oral dose of 10,000 mcg/kg/day); however, no developmental delays were evident with doses 1,600 times the mrhdid (on a mcg/m2 basis with a maternal oral dose of 5,000 mcg/kg/day). risk summary there are no data on the presence of arformoterol or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. however, arformoterol was excreted in the milk of lactating rats. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for arformoterol tartrate inhalation solution and any potential adverse effects on the breastfed infant from arformoterol tartrate inhalation solution or from the underlying maternal condition. data arformoterol and its metabolites were detected in the milk of lactating rats following oral administration of a 10,000 mcg/kg dose of radiolabeled arformoterol tartrate. arformoterol tartrate inhalation solution is approved for use in the long-term maintenance treatment of bronchoconstriction associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.  this disease does not occur in children. the safety and efficacy of arformoterol tartrate inhalation solution in pediatric patients have not been established. of the 873 patients who received arformoterol tartrate inhalation solution in two placebo- controlled clinical studies in adults with copd, 391 (45%) were 65 years of age or older while 96 (11%) were 75 years of age or older.  no overall differences in safety or effectiveness were observed between these subjects and younger subjects.  among subjects age 65 years and older, 129 (33%) received arformoterol tartrate inhalation solution at the recommended dose of 15 mcg twice daily, while the remainder received higher doses.  ecg alerts for ventricular ectopy in patients 65 to ≤75 years of age were comparable among patients receiving 15 mcg twice daily, 25 mcg twice daily, and placebo (3.9%, 5.2%, and 7.1%, respectively).  a higher frequency (12.4%) was observed when arformoterol tartrate inhalation solution was dosed at 50 mcg once daily.  the clinical significance of this finding is not known.  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. arformoterol tartrate inhalation solution should be used cautiously in patients with hepatic impairment due to increased systemic exposure in these patients [see clinical pharmacology (12.3) ]. the systemic exposure to arformoterol was similar to renally impaired patients compared with demographically matched healthy control subjects [see clinical pharmacology (12.3) ]. there were no reported cases of abuse or evidence of drug dependence with the use of arformoterol tartrate inhalation solution in the clinical trials.

USA - engelsk - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - arformoterol tartrate (unii: 5p8vj2i235) (arformoterol - unii:f91h02ebwt) - arformoterol tartrate inhalation solution is indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and emphysema. arformoterol tartrate inhalation solution is for use by nebulization only. arformoterol tartrate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see warnings and precautions (5.2)]. arformoterol tartrate inhalation solution is not indicated to treat asthma. the safety and effectiveness of arformoterol tartrate inhalation solution in asthma have not been established. arformoterol tartrate inhalation solution is contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any other components of this product. use of a laba, including arformoterol tartrate inhalation solution, without an inhaled cortisteroid is contraindicated in patients with asthma [se

USA - engelsk - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - formoterol fumarate inhalation solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and emphysema. formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see warnings and precautions (5.2)]. formoterol fumarate inhalation solution is not indicated to treat asthma. the safety and effectiveness of formoterol fumarate inhalation solution in asthma have not been established. use of a laba, including formoterol fumarate inhalation solution, without an inhaled corticosteroid is contraindicated in patients with asthma [see warnings and precautions (5.1)]. formoterol fumarate inhalation solution is not indicated for the treatment of asthma. risk summary there are limited available data with formoterol fumarate inhalation solution use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. beta-agonists may interfere with uterine contractility (see clinical considerations) .  in animal reproduction studies, oral administration of formoterol fumarate to pregnant rats and rabbits caused increased fetal malformations (rats and rabbits), decreased fetal weight (rats), and increased neonatal mortality (rats) following administration of doses that produced exposures approximately 730 to 29,000 times the mrhd on a mg/m2 or auc basis. these adverse effects generally occurred at large multiples of the mrhd when formoterol fumarate was administered by the oral route to achieve high systemic exposures. no effects were observed in a study with rats that received formoterol fumarate by the inhalation route at an exposure approximately 300 times the mrhd (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. 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. clinical considerations labor or delivery there are no adequate and well-controlled human studies that have studied the effects of formoterol fumarate inhalation solution during labor and delivery. because of the potential for beta-agonists interference with uterine contractility, use of formoterol fumarate inhalation solution during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. data animal data in embryofetal development studies with pregnant rats and rabbits dosed throughout the period of organogenesis, formoterol fumarate did not cause malformations in either species.  however, for pregnant rats dosed throughout organogenesis, formoterol fumarate caused delayed fetal ossification at an exposure approximately 50 times the mrhd (on a mcg/m2 basis with maternal oral doses of 200 mcg/kg and higher) and decreased fetal weight at an exposure approximately 1,500 times the mrhd (on a mcg/m2 basis with maternal oral doses of 6,000 mcg/kg and above).  in a pre- and post-natal development study with rats dosed during the late stage of pregnancy, formoterol fumarate caused stillbirth and neonatal mortality at an exposure approximately 1,500 times the mrhd (on a mcg/m2 basis with maternal oral doses of 6,000 mcg/kg and above). however, no effects were observed in this study at an exposure approximately 50 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 200 mcg/kg). in embryofetal development studies, conducted by another testing laboratory, with pregnant rats and rabbits dosed throughout the period of organogenesis, formoterol fumarate was teratogenic in both species. umbilical hernia, a malformation, was observed in rat fetuses at exposures approximately 730 times the mrhd (on a mcg/m2 basis with maternal oral doses of 3,000 mcg/kg/day and above). brachygnathia, a skeletal malformation, was observed in rat fetuses at an exposure approximately 3,600 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 15,000 mcg/kg/day). in another study with rats, no teratogenic effects were observed with exposures up to approximately 300 times the mrhd (on a mcg/m2 basis with a maternal inhalation dose of 1,200 mcg/kg/day). subcapsular cysts on the liver were observed in rabbit fetuses at an exposure approximately 29,000 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 60,000 mcg/kg/day). no teratogenic effects were observed with exposures up to approximately 1,700 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 3,500 mcg/kg). risk summary there are no well-controlled human studies of the use of formoterol fumarate inhalation solution in nursing mothers. it is not known whether formoterol fumarate is excreted in human milk, or whether there are effects on the breastfed infant or on the milk production. in reproductive studies in rats formoterol was excreted in the milk (see data) . the developmental and health benefits of breastfeeding should be considered along with the mother`s clinical need for formoterol fumarate inhalation solution and any potential adverse effects on the breastfed child from formoterol fumarate inhalation solution or from the underlying maternal condition. data in a pharmacokinetic study in rats formoterol was excreted in the milk. the amount of radioactive labeled 3 h  formoterol fumarate was less than 2% of that in the maternal plasma. formoterol fumarate inhalation solution is not indicated for use in children. the safety and effectiveness of formoterol fumarate inhalation solution in pediatric patients have not been established. the pharmacokinetics of formoterol fumarate has not been studied in pediatric patients. of the 586 subjects who received formoterol fumarate inhalation solution in clinical studies, 284 were 65 years and over, while 89 were 75 years and over. of the 123 subjects who received formoterol fumarate inhalation solution in the 12-week safety and efficacy trial, 48 (39%) were 65 years of age or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. the pharmacokinetics of formoterol fumarate inhalation solution has not been studied in elderly subjects.

USA - engelsk - NLM (National Library of Medicine)

lifestar pharma llc - arformoterol tartrate (unii: 5p8vj2i235) (arformoterol - unii:f91h02ebwt) - arformoterol tartrate inhalation solution is indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and emphysema. arformoterol tartrate inhalation solution is for use by nebulization only. arformoterol tartrate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see warnings and precautions (5.2)]. arformoterol tartrate inhalation solution is not indicated to treat asthma. the safety and effectiveness of arformoterol tartrate inhalation solution in asthma have not been established. arformoterol tartrate inhalation solution is contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any other components of this product. use of a laba, including arformoterol tartrate inhalation solution, without an inhaled cortisteroid is contraindicated in patients with asthma [se