Classes
DEA Class; Rx
Common Brand Names; Daliresp, Zoryve
- Phosphodiesterase-4 Enzyme Inhibitors
Description
Phosphodiesterase-4 (PDE4) inhibitor that reduces inflammation via an intracellular action
Used orally to reduce COPD exacerbations in adults with severe COPD, chronic bronchitis, and history of COPD exacerbations; topically to treat plaque psoriasis, including intertriginous areas, in adults and children 12 years of age and older
GOLD guidelines recommend use with a long-acting bronchodilator
Indications
Indicated to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations
Indicated for plaque psoriasis, including intertriginous areas
Contraindications
Hypersensitivity
Moderate-to-severe liver impairment (Child-Pugh class B or C)
Adverse Effects
- Diarrhea (9.5%)
- Weight loss (7.5%)
- Nausea (4.7%)
- Headache (4.4%)
- Back pain (3.2%)
- Insomnia (2.4%)
- Decreased appetite (2.1%)
- Dizziness (2.1%)
- Abdominal pain (1-2%)
- Anxiety (1-2%)
- Depression (1-2%)
- Dyspepsia (1-2%)
- Gastritis (1-2%)
- Muscle spasms (1-2%)
- Rhinitis (1-2%)
- Sinusitis (1-2%)
- Tremor (1-2%)
- Urinary tract infection (1-2%)
- Vomiting (1-2%)
Warnings
Not indicated for relief of acute bronchospasm; drug is not bronchodilator
Psychiatric events, including suicidality, reported (monitor for emergence or worsening of insomnia, mood disturbance, or anxiety)
Monitor for clinically significant weight loss; this may be reversible upon discontinuance
Pregnancy and Lactation
Data are insufficient regarding drug-associated risk during pregnancy
Unknown if distributed in human breast milk; however, human IgG is known to be present in human milk
Maximum Dosage
500 mcg/day PO; 1 application per day topically.
500 mcg/day PO; 1 application per day topically.
1 application per day topically; safety and efficacy have not been established for the oral tablet.
12 years: 1 application per day topically; safety and efficacy have not been established for the oral tablet.
1 to 11 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Roflumilast
tablet
- 250mcg
- 500mcg
topical cream
- 0.3%
