Drug Detail:Roflumilast (systemic) (monograph) (Daliresp)
Drug Class:
Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Maintenance
Initial dose: 250 mcg orally once a day for 4 weeks
Maintenance dose: 500 mcg orally once a day
Comments:
- Starting the dose at 250 mcg daily may reduce the rate of treatment discontinuation, but it is not the effective/therapeutic dose.
- This drug is not a bronchodilator and is not indicated for acute exacerbation treatment.
Use(s): To reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
Contraindicated in moderate to severe liver impairment (Child-Pugh B or C)
- Consider the risk to benefit of administering to patients with mild renal impairment (Child-Pugh A).
Precautions
CONTRAINDICATIONS:
- Moderate to severe liver impairment (Child-Pugh B or C)
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Monitoring:
- Monitor weight regularly.
Patient advice:
- Advise patients and caregivers to watch for emergence or worsening of insomnia, anxiety, depression, suicidal thoughts, or other mood changes and to contact their healthcare provider if such changes occur.
