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

micro labs limited - roflumilast (unii: 0p6c6zop5u) (roflumilast - unii:0p6c6zop5u) - roflumilast tablets are indicated as a treatment to reduce the risk of copd exacerbations in patients with severe copd associated with chronic bronchitis and a history of exacerbations. limitations of use roflumilast tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm. roflumilast tablet 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose. the use of roflumilast tablet is contraindicated in the following condition: moderate to severe liver impairment (child-pugh b or c) [see clinical pharmacology ( 12.3) and use in specific populations ( 8.6)]. risk summary there are no randomized clinical studies of roflumilast in pregnant women. in animal reproductive toxicity studies, roflumilast administered to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities. the highest roflumilast dose in these studies was approximately 30 and

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

camber pharmaceuticals, inc. - roflumilast (unii: 0p6c6zop5u) (roflumilast - unii:0p6c6zop5u) - roflumilast tablet is indicated as a treatment to reduce the risk of copd exacerbations in patients with severe copd associated with chronic bronchitis and a history of exacerbations. limitations of use roflumilast tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm. roflumilast 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose. the use of roflumilast tablet is contraindicated in the following condition: moderate to severe liver impairment (child-pugh b or c) [see clinical pharmacology (12.3) and use in specific populations (8.6)]. risk summary there are no randomized clinical studies of roflumilast in pregnant women. in animal reproductive toxicity studies, roflumilast administered to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities. the highest roflumilast dose in these studies was approximately 30 and 26 ti

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

zydus pharmaceuticals usa inc. - roflumilast (unii: 0p6c6zop5u) (roflumilast - unii:0p6c6zop5u) - roflumilast tablets are indicated as a treatment to reduce the risk of copd exacerbations in patients with severe copd associated with chronic bronchitis and a history of exacerbations. limitations of use roflumilast is not a bronchodilator and is not indicated for the relief of acute bronchospasm. roflumilast tablet 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose. the use of roflumilast is contraindicated in the following condition: moderate to severe liver impairment (child-pugh b or c) [see clinical pharmacology (12.3) and use in specific populations (8.6)]. risk summary there are no randomized clinical studies of roflumilast in pregnant women. in animal reproductive toxicity studies, roflumilast administered to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities. the highest roflumilast dose in these studies was approximately 30 and 26 times, respectively, the maximum recommended human dose

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

torrent pharmaceuticals limited - roflumilast (unii: 0p6c6zop5u) (roflumilast - unii:0p6c6zop5u) - roflumilast tablets are indicated as a treatment to reduce the risk of copd exacerbations in patients with severe copd associated with chronic bronchitis and a history of exacerbations. limitations of use roflumilast tablets are not bronchodilators and are not indicated for the relief of acute bronchospasm. the use of roflumilast is contraindicated in the following condition: moderate to severe liver impairment (child-pugh b or c) [ see clinical pharmacology ( 12.3) and use in special populations ( 8.6) ] . risk summary there are no randomized clinical studies of roflumilast tablets in pregnant women. in animal reproductive toxicity studies, roflumilast tablets administered to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities. the highest roflumilast tablets dose in these studies was approximately 30 and 26 times, respectively,

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

strides pharma science limited - roflumilast (unii: 0p6c6zop5u) (roflumilast - unii:0p6c6zop5u) - roflumilast tablets are indicated as a treatment to reduce the risk of copd exacerbations in patients with severe copd associated with chronic bronchitis and a history of exacerbations. limitations of use roflumilast tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm. the use of roflumilast is contraindicated in the following condition: moderate to severe liver impairment (child-pugh b or c) [see clinical pharmacology (12.3) and use in specific populations (8.6)] . risk summary there are no randomized clinical studies of roflumilast in pregnant women. in animal reproductive toxicity studies, roflumilast administered to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities. the highest roflumilast dose in these studies was approximately 30 and 26 times, respectively, the maximum recommended human dose (mrhd). roflumilast induced post-implantation loss in rats at doses greater than or equal to approximately 10 times the mrhd

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

novadoz pharmaceuticals llc - roflumilast (unii: 0p6c6zop5u) (roflumilast - unii:0p6c6zop5u) - roflumilast tablets are indicated as a treatment to reduce the risk of copd exacerbations in patients with severe copd associated with chronic bronchitis and a history of exacerbations. limitations of use  roflumilast tablets are not a bronchodilator and is not indicated for the relief of acute bronchospasm. roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose. the use of roflumilast tablets are contraindicated in the following condition: moderate to severe liver impairment (child-pugh b or c) [see clinical pharmacology (12.3 ) and use in specific populations (8.6) ]. risk summary there are no randomized clinical studies of roflumilast tablets in pregnant women. in animal reproductive toxicity studies, roflumilast tablets administered to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities. the highest roflumilast tablets dose in these studies was approximately 30 and 26

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

solco healthcare us, llc. - roflumilast (unii: 0p6c6zop5u) (roflumilast - unii:0p6c6zop5u) - roflumilast is indicated as a treatment to reduce the risk of copd exacerbations in patients with severe copd associated with chronic bronchitis and a history of exacerbations. limitations of use roflumilast is not a bronchodilator and is not indicated for the relief of acute bronchospasm. the use of roflumilast is contraindicated in the following condition: moderate to severe liver impairment (child-pugh b or c) [see clinical pharmacology (12.3) and use in specific populations (8.6)] . risk summary there are no randomized clinical studies of roflumilast in pregnant women. in animal reproductive toxicity studies, roflumilast administered to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities. the highest roflumilast dose in these studies was approximately 30 and 26 times, respectively, the maximum recommended human dose (mrhd). roflumilast induced post-implantation loss in rats at doses greater than or equal to approximately 10 times the mrhd. roflumilast in

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

aurobindo pharma limited - roflumilast (unii: 0p6c6zop5u) (roflumilast - unii:0p6c6zop5u) - roflumilast tablets are indicated as a treatment to reduce the risk of copd exacerbations in patients with severe copd associated with chronic bronchitis and a history of exacerbations. limitations of use roflumilast tablets are not a bronchodilator and is not indicated for the relief of acute bronchospasm. roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose. the use of roflumilast tablets are contraindicated in the following condition: moderate to severe liver impairment (child-pugh b or c) [see clinical pharmacology (12.3) and use in specific populations (8.6)] . risk summary there are no randomized clinical studies of roflumilast in pregnant women. in animal reproductive toxicity studies, roflumilast administered to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities. the highest roflumilast dose in these studies was approximately 30 and 26 times, respectively, the maximu

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

mylan pharmaceuticals inc. - roflumilast (unii: 0p6c6zop5u) (roflumilast - unii:0p6c6zop5u) - roflumilast tablets are indicated as a treatment to reduce the risk of copd exacerbations in patients with severe copd associated with chronic bronchitis and a history of exacerbations. limitations of use:  roflumilast tablets are not a bronchodilator and are not indicated for the relief of acute bronchospasm. roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose. the use of roflumilast tablets is contraindicated in the following condition: moderate to severe liver impairment (child-pugh b or c) [see clinical pharmacology (12.3) and use in specific populations (8.6)] . there are no randomized clinical studies of roflumilast tablets in pregnant women. in animal reproductive toxicity studies, roflumilast tablets administered to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities. the highest roflumilast tablets dose in these studies was approximately 30 and 26 times, respectively, th

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

cardinal health - roflumilast (unii: 0p6c6zop5u) (roflumilast - unii:0p6c6zop5u) - roflumilast 500 ug - daliresp® is indicated as a treatment to reduce the risk of copd exacerbations in patients with severe copd associated with chronic bronchitis and a history of exacerbations. limitations of use daliresp is not a bronchodilator and is not indicated for the relief of acute bronchospasm. the use of daliresp is contraindicated in the following condition: moderate to severe liver impairment (child-pugh b or c) [see clinical pharmacology (12.3) and use in special populations (8.6) ]. teratogenic effects: pregnancy category c: there are no adequate and well controlled studies of daliresp in pregnant women. daliresp was not teratogenic in mice, rats, or rabbits. daliresp should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. daliresp induced stillbirth and decreased pup viability in mice at doses corresponding to approximately 16 and 49 times, respectively, the maximum recommended human dose (mrhd) (on a mg/m2 basis at maternal doses > 2 mg/kg/day and 6 mg/kg/day, r