roflumilast (Daliresp)

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Indications

Contraindications

Pregnancy category: C

Safety in lactation: -

Dosage

Pharmacokinetics

Adverse effects

Drug interactions

Mechanism of action

Notes

  • the FDA approved roflumilast in March 2011 with a medication guide informing patients of the potential risks of mental health problems, including changes in mood, thinking, or behavior, or unexplained weight loss

More general terms

More specific terms

References

  1. Rabe KF et al Roflumilast - An oral anti-inflammatory treatment for chronic obstructive pulmonary disease: A randomised controlled trial. Lancet 2005 Aug 13; 366:563-71. PMID: https://www.ncbi.nlm.nih.gov/pubmed/16099292
  2. FDA NEWS RELEASE, March 1, 2011 FDA approves new drug to treat chronic obstructive pulmonary disease http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm244989.htm
  3. 3.0 3.1 Prescriber's Letter 18(7): 2011 New Drug: Daliresp (Roflumilast) Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=270709&pb=PRL (subscription needed) http://www.prescribersletter.com
  4. 4.0 4.1 Wedzicha JA, Rabe KF, Martinez FJ et al Efficacy of roflumilast in the COPD frequent exacerbator phenotype. Chest. 2013 May;143(5):1302-11 PMID: https://www.ncbi.nlm.nih.gov/pubmed/23117188
  5. Medical Knowledge Self Assessment Program (MKSAP) 18, American College of Physicians, Philadelphia 2018
  6. Fabbri LM, Calverley PM, Izquierdo-Alonso JL et al Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):695-703. PMID: https://www.ncbi.nlm.nih.gov/pubmed/19716961 Clinical Trial.
  7. Martinez FJ, Calverley PM, Goehring UM et al Effect of roflumilast on exacerbations in patients with severe chronic obstructive pulmonary disease uncontrolled by combination therapy (REACT): a multicentre randomised controlled trial. Lancet. 2015 Mar 7;385(9971):857-66. PMID: https://www.ncbi.nlm.nih.gov/pubmed/25684586 Clinical Trial.
  8. 8.0 8.1 Bankhead C Rapid Improvement in Atopic Dermatitis With Topical PDE4 Inhibitor. Disease status, itch improved significantly within 1 to 2 weeks with roflumilast cream. MedPage Today March 20, 2023 https://www.medpagetoday.com/meetingcoverage/aad/103615
    Bunk D Roflumilast Cream 0.15% Approved for Eczema in Patients Aged 6 or Older. Medscape. July 10, 2024 https://www.medscape.com/viewarticle/roflumilast-cream-approved-eczema-patients-2024a1000cpx

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