tiotropium bromide and olodaterol
Drug Details
- Generic Name
- tiotropium bromide and olodaterol
- Brand Names
- Stiolto Respimat
- Application Number
- NDA206756
- Sponsor
- Boehringer Ingelheim Pharmaceuticals, Inc.
- NDC Codes
- 1
- Dosage Forms
- SPRAY, METERED
- Routes
- RESPIRATORY (INHALATION)
- Active Ingredients
- OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE MONOHYDRATE
Indications and Usage
1 INDICATIONS AND USAGE STIOLTO RESPIMAT is a combination of tiotropium bromide, an anticholinergic and olodaterol, a long-acting beta 2 -adrenergic agonist (LABA) indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1.1 ) Important limitations: STIOLTO RESPIMAT is NOT indicated to treat acute deterioration of COPD. ( 1.1 ) STIOLTO RESPIMAT is NOT indicated to treat asthma. ( 1.1 ) 1.1 Maintenance Treatment of COPD STIOLTO RESPIMAT is a combination of tiotropium bromide and olodaterol indicated for long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Important Limitations of Use STIOLTO RESPIMAT is not indicated to treat acute deteriorations of COPD [see Warnings and Precautions (5.2) ]. STIOLTO RESPIMAT is not indicated to treat asthma. The safety and effectiveness of STIOLTO RESPIMAT in asthma have not been established.