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

mylan pharmaceuticals inc. - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol inhalation solution, usp is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol inhalation solution, usp is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions (5.6) ]. there are no adequate and well-controlled studies of levalbuterol inhalation solution, usp in pregnant women. there are clinical considerations with the use of levalbuterol inhalation solution, usp in pregnant women [see clinical considerations] . following oral administration of levalbuterol hcl to pregnant rabbits, there was no evidence of teratogenicity at doses up to 25 mg/kg/day [approximately 108 times the maximum recommended human daily inhalation dose (mrhdid) of levalbuterol hcl for adults on a mg/m2 basis]; however,

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

cipla usa inc. - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e), ipratropium bromide (unii: j697uz2a9j) (ipratropium - unii:gr88g0i6ul) - albuterol 2.5 mg in 3 ml - ipratropium bromide and albuterol sulfate inhalation solution is indicated for the treatment of bronchospasm associated with copd in patients requiring more than one bronchodilator. ipratropium bromide and albuterol sulfate inhalation solution is contraindicated in patients with a history of hypersensitivity to any of its components, or to atropine and its derivatives.

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

ritedose pharmaceuticals, llc - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e), ipratropium bromide (unii: j697uz2a9j) (ipratropium - unii:gr88g0i6ul) - albuterol 2.5 mg in 3 ml - ipratropium bromide and albuterol sulfate inhalation solution is indicated for the treatment of bronchospasm associated with copd in patients requiring more than one bronchodilator. ipratropium bromide and albuterol sulfate inhalation solution is contraindicated in patients with a history of hypersensitivity to any of its components, or to atropine and its derivatives.

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

sun pharmaceutical industries, inc. - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions (5.6) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medication, including levalbuterol inhalation solution, during pregnancy. to enroll in mothertobaby pregnancy studies’ asthma & pregnancy study or for more information about the registry, call 1-877-311-8972 or visit www.mothertobaby.org/ongoing-study/asthma. risk summary there are no adequate and well-controlled studies of levalbuterol inhalation solution in pregnant women. there are clinical considerations with

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

northstar rxllc - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions (5.6) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medication, including levalbuterol inhalation solution, during pregnancy. to enroll in mothertobaby pregnancy studies’ asthma & pregnancy study or for more information about the registry, call 1-877-311-8972 or visit www.mothertobaby.org/ongoing-study/asthma. risk summary there are no adequate and well-controlled studies of levalbuterol inhalation solution in pregnant women. there are clinical considerations with

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

remedyrepack inc. - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions ( 5.6) ]. risk summary there are no adequate and well-controlled studies of levalbuterol inhalation solution in pregnant women. there are clinical considerations with the use of levalbuterol inhalation solution in pregnant women [see clinical considerations]. following oral administration of levelbuterol hcl to pregnant rabbits, there was no evidence of teratogenicity at doses up to 25 mg/kg/day [approximately 108 times the maximum recommended human daily inhalation dose (mrhdid) of levalbute

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

nucare pharmaceuticals,inc. - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions ( 5.6) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medication, including levalbuterol inhalation solution, during pregnancy. to enroll in mothertobaby pregnancy studies’ asthma & pregnancy study or for more information about the registry, call 1-877-311-8972 or visit www.mothertobaby.org/ongoing-study/asthma. risk summary there are no adequate and well-controlled studies of levalbuterol inhalation solution in pregnant wome

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

impax generics - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol 1.25 mg in 3 ml

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

actavis pharma, inc. - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol 0.31 mg in 3 ml

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

cardinal health - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol 1.25 mg in 0.5 ml