Selective phosphodiesterase-4 inhibitors
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Roflumilast Dosage

Drug Detail:Roflumilast (Roflumilast [ roe-floo-mi-last ])

Drug Class: Selective phosphodiesterase-4 inhibitors

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

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.
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