Roflumilast Dosage

Medically reviewed by Drugs.com. Last updated on Mar 31, 2025.

Applies to the following strengths: 250 mcg; 500 mcg

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.

No adjustment recommended.

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).

CONTRAINDICATIONS:

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Data not available

Monitoring:

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.