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Roflumilast

Medication

Medication

FieldValue
Verifiedfieldschanged
Watchedfieldschanged
verifiedrevid464383196
imageRoflumilast structure.svg
image_classskin-invert-image
width240
image2Roflumilast ball-and-stick model.png
image_class2bg-transparent
width2240
tradenameDaxas, Daliresp, Zoryve, others
Drugs.com
MedlinePlusa611034
DailyMedIDRoflumilast
pregnancy_AUB3
routes_of_administrationBy mouth, topical
classPDE4 inhibitor
ATC_prefixR03
ATC_suffixDX07
ATC_supplemental
legal_AUS4
legal_BR
legal_CARx-only
legal_CA_comment
legal_DE
legal_NZ
legal_UKPOM
legal_UK_comment
legal_USRx-only
legal_US_comment
legal_EURx-only
legal_EU_comment
legal_UN
legal_status
bioavailability79%
protein_bound99%
metabolismHepatic via CYP1A2 & CYP3A4
elimination_half-life17 hours (30 hours [active metabolite])
excretionUrine (70%)
CAS_number_Ref
CAS_number162401-32-3
PubChem449193
IUPHAR_ligand6962
DrugBank_Ref
DrugBankDB01656
ChemSpiderID_Ref
ChemSpiderID395793
UNII_Ref
UNII0P6C6ZOP5U
KEGGD05744
ChEBI_Ref
ChEBI47657
ChEMBL_Ref
ChEMBL193240
PDB_ligandROF
IUPAC_name3-(Cyclopropylmethoxy)-N-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide
C17H=14Cl=2F=2N=2O=3
SMILESC1CC1COC2=C(C=CC(=C2)C(=O)NC3=C(C=NC=C3Cl)Cl)OC(F)F
StdInChI_Ref
StdInChI1S/C17H14Cl2F2N2O3/c18-11-6-22-7-12(19)15(11)23-16(24)10-3-4-13(26-17(20)21)14(5-10)25-8-9-1-2-9/h3-7,9,17H,1-2,8H2,(H,22,23,24)
StdInChIKey_Ref
StdInChIKeyMNDBXUUTURYVHR-UHFFFAOYSA-N

| Drugs.com =

| elimination_half-life = 17 hours (30 hours [active metabolite])

Roflumilast, sold under the brand name Daxas among others, is a medication used for the treatment of chronic obstructive pulmonary disease, plaque psoriasis, seborrheic dermatitis, and atopic dermatitis. It acts as a selective, long-acting inhibitor of the enzyme phosphodiesterase-4 (PDE-4). It has anti-inflammatory effects.

It was approved for medical use in the European Union in 2010, in the United States in 2011, and in Canada in 2017. It is available as a generic medication.

Medical uses

Roflumilast is indicated for the treatment of severe chronic obstructive pulmonary disease (COPD), plaque psoriasis, seborrheic dermatitis, and atopic dermatitis,

It is used in the prevention of exacerbations (lung attacks) in severe chronic obstructive pulmonary disease (COPD).

Adverse effects

Common (1–10% incidence) adverse effects include diarrhea, weight loss, nausea, headache, insomnia, decreased appetite, abdominal pain, rhinitis, sinusitis, urinary tract infection, and depression.

Society and culture

In June 2010, it was approved in the European Union for severe COPD associated with chronic bronchitis. In February 2011, it gained FDA approval in the United States for reducing COPD exacerbations.

References

References

  1. (7 November 2023). "Zoryve Product information".
  2. (2007). "PDE4 inhibitors as potential therapeutic agents in the treatment of COPD-focus on roflumilast". International Journal of Chronic Obstructive Pulmonary Disease.
  3. (May 2008). "Suppression of cytokine expression by roflumilast and dexamethasone in a model of chronic asthma". Clinical and Experimental Allergy.
  4. (May 2008). "Roflumilast: an oral, once-daily selective PDE-4 inhibitor for the management of COPD and asthma". Expert Opinion on Investigational Drugs.
  5. (17 September 2018). "Daxas EPAR".
  6. (12 March 2020). "Daliresp- roflumilast tablet".
  7. (20 July 2017). "Daxas Product information".
  8. (3 March 2023). "2022 First Generic Drug Approvals".
  9. (16 August 2022). "Zoryve- roflumilast cream".
  10. (29 July 2022). "FDA Approves Arcutis' Zoryve (Roflumilast) Cream 0.3% For the Treatment of Plaque Psoriasis in Individuals Age 12 and Older". Arcutis Biotherapeutics.
  11. (20 December 2023). "Zoryve- roflumilast aerosol, foam".
  12. (10 July 2024). "FDA Approves Atopic Dermatitis Label Expansion for Arcutis' Zoryve Cream".
  13. (11 June 2020). "Daxas 250 micrograms tablets - Summary of Product Characteristics (SmPC)".
  14. (26 September 2013). "Daliresp : EPAR - Product Information". Takeda GmbH.
  15. "roflumilast (Rx) - Daliresp". WebMD.
  16. (October 2008). "PDE4 inhibitors: current status". British Journal of Pharmacology.
  17. ""Nycomed's Anti-Inflammatory Gains Approval in EU for COPD"".
  18. (24 December 1999). "Drug Approval Package: Daliresp Tablets (roflumilast) NDA #022522".
  19. (1 March 2011). "FDA approves new drug to treat chronic obstructive pulmonary disease". U.S. [[Food and Drug Administration]] (FDA).
Info: Wikipedia Source

This article was imported from Wikipedia and is available under the Creative Commons Attribution-ShareAlike 4.0 License. Content has been adapted to SurfDoc format. Original contributors can be found on the article history page.

drugs-developed-by-abbvie drugs-developed-by-astrazeneca benzamides chloropyridines cyclopropyl-compounds organofluorides pde4-inhibitors phenol-ethers drugs-developed-by-takeda-pharmaceutical-company
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