Roflumilast Dosage

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

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.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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