Roflumilast

Aka: Roflumilast, Daliresp, Phosphodiesterase-4 Inhibitor, PDE4 Inhibitor

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II. Mechanism

  1. Phosphodiesterase-4 Inhibitor increases lung, intracellular cAMP
  2. Bronchodilates and reduces inflammation

III. Indications

  1. Severe, refractory COPD with Chronic Bronchitis and frequent exacerbations

IV. Medications

  1. Roflumilast Tablets: 250 mcg 500 mcg

V. Dosing

  1. Roflumilast 500 mcg orally daily

VI. Adverse Effects

  1. Gastrointestinal (common, intolerable in 5%)
    1. Diarrhea
    2. Nausea
    3. Weight loss (may be >10%)
  2. Other common symptoms
    1. Headache
    2. Insomnia
  3. Psychiatric (3%)
    1. Suicidality
    2. Depression
    3. Anxiety

VII. Safety

  1. Unknown safety in pregnancy
  2. Unknown safety in Lactation
    1. Avoid in Lactation (is excreted in Breast Milk)

VIII. Drug Interactions

  1. Cytochrome P450 3A4 Inhibitors
  2. Cytochrome P450 3A4 and Cytochrome P450 1A2 Inducers

IX. Efficacy

  1. NNT: 24 severe COPD patients to prevent 1 hospitalization per year
  2. Does not reduce mortality

X. Resources

  1. Roflumilast (DailyMed)
    1. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4d25f69c-58b7-4e2a-b835-4d0c76a83c7c

XI. References

  1. (2015) Presc Lett 22(5): 27
  2. Field (2011) Circ Respir Pulm Med 5: 57–70 [PubMed]

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