roflumilast
Drug Details
- Generic Name
- roflumilast
- Brand Names
- ZORYVE, Roflumilast, Daliresp, ROFLUMILAST
- Application Number
- NDA215985
- Sponsor
- Takeda GmbH
- NDC Codes
- 11
- Dosage Forms
- TABLET, CREAM, AEROSOL, FOAM
- Routes
- TOPICAL, ORAL
- Active Ingredients
- ROFLUMILAST
Indications and Usage
1 INDICATIONS AND USAGE 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. Roflumilast is a selective phosphodiesterase 4 inhibitor 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. ( 1 , 14 ) Limitations of Use: Roflumilast tablets are not a bronchodilator and is not indicated for the relief of acute bronchospasm. ( 1 , 14 ) Roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose. ( 2 , 14 )