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

oceanside pharmaceuticals - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide extended-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. budesonide extended-release tablets are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide extended-release tablets. anaphylactic reactions have occurred with other budesonide formulations [see adverse reactions (6.2)]. risk summary limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are clinical considerations (see clinical considerations). in animal reproduction studies with pregnant rats and rabbits, subcutaneous administration of budesonide during organogenesis at doses 0.5 times and 0.05 times, respectively, the maximum recommended human dose, resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities. maternal toxicity was observed in both rats a

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

padagis us llc - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide delayed-release capsules are indicated for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older. budesonide delayed-release capsules are indicated for the maintenance of clinical remission of mild to moderate crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults. budesonide delayed-release capsules are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide delayed-release capsules. serious hypersensitivity reactions, including anaphylaxis have occurred [see adverse reactions (6.2)] . risk summary limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are clinical considerations [see clinical considerations] . in animal reproduction studies with pregnant rats and rabbits, administration of sub

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

northstar rx llc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide delayed-release capsules (enteric coated) are indicated for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older. budesonide delayed-release capsules (enteric coated) are indicated for the maintenance of clinical remission of mild to moderate crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults. budesonide capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). serious hypersensitivity reactions, including anaphylaxis have occurred [see adverse reactions (6.2)]. risk summary limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are clinical considerations [see clinical considerations]. in animal reproduction studies with pregnant rats

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

golden state medical supply - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide extended-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. budesonide extended-release tablets are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide extended-release tablets. anaphylactic reactions have occurred with other budesonide formulations [see adverse reactions (6.2)]. risk summary limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are clinical considerations (see clinical  considerations). in animal reproduction studies with pregnant rats and rabbits, subcutaneous administration of budesonide during organogenesis at doses 0.5 times and 0.05 times, respectively, the maximum recommended human dose, resulted in increased fetal loss, decreased pup weights, and skele

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

astrazeneca pharmaceuticals lp - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - budesonide and formoterol fumarate dihydrate inhalation aerosol is indicated for the treatment of asthma in patients 6 years of age and older. budesonide and formoterol fumarate dihydrate inhalation aerosol should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (laba). important limitations of use: budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd) including chronic bronchitis and/or emphysema. budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is also indicated to reduce exacerbations of copd. budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is the only strength indicated for the treatment of copd. important limitat

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

mylan pharmaceuticals inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide extended-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. budesonide extended-release tablets are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide extended-release tablets. anaphylactic reactions have occurred with other budesonide formulations [see adverse reactions (6.2)] . limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are clinical considerations (see clinical considerations). in animal reproduction studies with pregnant rats and rabbits, subcutaneous administration of budesonide during organogenesis at doses 0.5 times and 0.05 times, respectively, the maximum recommended human dose, resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities. maternal toxicity was observed in both rats and rabbits at

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

american health packaging - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide delayed-release capsules (enteric coated) are indicated for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older. budesonide delayed-release capsules (enteric coated) are indicated for the maintenance of clinical remission of mild to moderate crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults. budesonide capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). serious hypersensitivity reactions, including anaphylaxis have occurred [see adverse reactions (6.2)]. risk summary limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are clinical considerations [see clinical considerations]. in animal re

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

remedyrepack inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - budesonide and formoterol fumarate dihydrate inhalation aerosol is indicated for the treatment of asthma in patients 6 years of age and older. budesonide and formoterol fumarate dihydrate inhalation aerosol should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (laba). important limitations of use: - budesonide and formoterol fumarate dihydrate inhalation aerosol is not indicated for the relief of acute bronchospasm. budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd) including chronic bronchitis and/or emphysema. budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is also indicated to reduce exacerbations of copd. budesonide and formoterol

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

golden state medical supply, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide extended-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. budesonide extended-release tablets are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide extended-release tablets. anaphylactic reactions have occurred with other budesonide formulations [see adverse reactions (6.2)] . limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are clinical considerations (see clinical considerations). in animal reproduction studies with pregnant rats and rabbits, subcutaneous administration of budesonide during organogenesis at doses 0.5 times and 0.05 times, respectively, the maximum recommended human dose, resulted in increased fetal loss, decreased pup

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

major pharmaceuticals - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide delayed-release capsules are indicated for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older.  budesonide delayed-release capsules are indicated for the maintenance of clinical remission of mild to moderate crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults.  budesonide delayed-release capsules are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide delayed-release capsules. serious hypersensitivity reactions, including anaphylaxis have occurred [see adverse reactions (6.2)] .  risk summary limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are clinical considerations [see clinical considerations] . in animal reproduction studies with pregnant rats and rabbits, administration of