aclidinium bromide
Drug Details
- Generic Name
- aclidinium bromide
- Brand Names
- Tudorza Pressair
- Application Number
- NDA202450
- Sponsor
- Covis Pharma US, Inc
- NDC Codes
- 1
- Dosage Forms
- POWDER, METERED
- Routes
- RESPIRATORY (INHALATION)
- Active Ingredients
- ACLIDINIUM BROMIDE
Indications and Usage
1 INDICATIONS AND USAGE DUAKLIR PRESSAIR is a combination of aclidinium bromide (an anticholinergic) and formoterol fumarate (a LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: DUAKLIR PRESSAIR is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions ( 5.1 , 5.4 )] . DUAKLIR PRESSAIR is a combination of aclidinium bromide an anticholinergic, and formoterol fumarate, a long-acting beta 2 -adrenergic agonist (LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1 ) Limitations of Use: Not indicated for the relief of acute bronchospasm or for the treatment of asthma. ( 1 , 5.4 )