.Pharmacolibrary.Drugs.ATC.D.D05AX06 .Pharmacolibrary.Drugs.ATC.D.D05AX06| name: | Roflumilast |
| ATC code: | D05AX06 | route: | oral |
| n-compartments | 2 |
Roflumilast is a selective phosphodiesterase-4 (PDE4) inhibitor used primarily in the treatment of severe chronic obstructive pulmonary disease (COPD) to reduce the risk of exacerbations. It is an orally administered, anti-inflammatory agent approved in multiple jurisdictions including the US and EU for maintenance treatment of COPD.
Pharmacokinetic parameters in healthy adult subjects after oral administration of 500 micrograms roflumilast once daily.
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Han, M, et al., & Li, JT (2023). A Single-center, Open-label, Parallel Control Study Comparing the Pharmacokinetics and Safety of a Single Oral Dose of Roflumilast and Its Active Metabolite Roflumilast N-oxide in Healthy Chinese and Caucasian Volunteers. Clinical pharmacology in drug development 12(3) 314–323. DOI:10.1002/cpdd.1209 PUBMED:https://pubmed.ncbi.nlm.nih.gov/36484261
Lahu, G, et al., & Facius, A (2010). Population pharmacokinetic modelling of roflumilast and roflumilast N-oxide by total phosphodiesterase-4 inhibitory activity and development of a population pharmacodynamic-adverse event model. Clinical pharmacokinetics 49(9) 589–606. DOI:10.2165/11536600-000000000-00000 PUBMED:https://pubmed.ncbi.nlm.nih.gov/20690782