Roflumilast

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Roflumilast
Drug monograph · NCLEX study reference
Trade namesDaliresp
Therapeutic classAnti-inflammatory (respiratory)
Pharmacologic classPhosphodiesterase-4 inhibitor
Onset / peak / durationEffect over weeks; once-daily dosing.
Half-life / levelLong active-metabolite half-life; no routine level.
RoutesPO (oral)
High-alert (ISMP)No
Black box warningNone
Antidote / reversalNot applicable.
Pregnancy / lactationNot recommended.

Nursing pharmacology study reference (NCLEX-style monograph). Numeric values are standard teaching ranges for study and must be verified against current manufacturer labeling before clinical use. This is educational content, not prescribing guidance.

Roflumilast (brand name Daliresp) — Anti-inflammatory (respiratory); Phosphodiesterase-4 inhibitor.

Identification

  • Therapeutic class: Anti-inflammatory (respiratory).
  • Pharmacologic class: Phosphodiesterase-4 inhibitor.

Pharmacology

  • Mechanism of action: Inhibits PDE-4 to reduce airway inflammation in severe COPD.
  • Onset / peak / duration: Effect over weeks; once-daily dosing.
  • Half-life / therapeutic level: Long active-metabolite half-life; no routine level.

Clinical use

  • Indications: Severe COPD with chronic bronchitis and exacerbation history.
  • Usual dose, route, frequency: 500 mcg PO once daily.
  • Maximum dose / adjustments: Avoid in moderate to severe hepatic impairment.

Safety

  • Contraindications: Moderate to severe hepatic impairment.
  • Black box warning: None.
  • Interactions: Strong CYP inducers reduce effect; CYP inhibitors raise exposure.
  • Pregnancy / lactation: Not recommended.
  • High-alert: No.

Adverse effects

  • Common side effects: Weight loss, diarrhea, nausea, headache, insomnia.
  • Serious effects to report: Significant weight loss, mood changes, depression or suicidal thoughts.
  • Antidote / reversal: Not applicable.

Nursing process

  • Assessment before administration: Weight, mood history, hepatic function.
  • Interventions during therapy: Track weight; screen mood.
  • Monitor: Weight, mood, GI tolerance.
  • Evaluation / expected outcome: Fewer COPD exacerbations.

Patient teaching

  • Patient teaching: Report mood changes or marked weight loss.
  • Notify provider if: Depression, weight loss, persistent diarrhea.
  • Administration tips: Once daily; not a bronchodilator and not for acute symptoms.