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Roflumilast

    Brands

    DEA Class; Rx

    Common Brand Names; Daliresp, Zoryve

    • Phosphodiesterase-4 Enzyme Inhibitors

    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

    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

    Hypersensitivity

    Moderate-to-severe liver impairment (Child-Pugh class B or C)

    • 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%)

    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

    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

    Adults

    500 mcg/day PO; 1 application per day topically.

    Geriatric

    500 mcg/day PO; 1 application per day topically.

    Adolescents

    1 application per day topically; safety and efficacy have not been established for the oral tablet.

    Children

    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.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Roflumilast

    tablet

    • 250mcg
    • 500mcg

    topical cream

    • 0.3%