Generic Name and Formulations:
Roflumilast 250mcg, 500mcg; tabs.
Indications for DALIRESP:
To reduce risk of COPD exacerbations in severe COPD patients with chronic bronchitis and a history of exacerbations.
Limitations Of use:
Not for the relief of acute bronchospasm. Daliresp 250mcg is a starting dose only and is not the effective dose.
Maintenance: 500mcg once daily. Initiating 250mcg once daily for 4 weeks, then increasing to 500mcg once daily thereafter may reduce the rate of discontinuation in some patients.
Moderate-to-severe liver impairment (Child-Pugh B or C).
History of depression. Suicidal ideation. Monitor for new or worsening insomnia, anxiety, depression, suicidal thoughts, other mood changes; reevaluate if occur. Mild liver impairment (Child-Pugh A). Monitor weight regularly; consider discontinuing if unexplained or significant weight loss occurs. Pregnancy. Labor & delivery, nursing mothers: not recommended.
Selective phosphodiesterase 4 (PDE4) inhibitor.
Concomitant strong CYP450 inducers (eg, rifampicin, phenobarbital, carbamazepine, phenytoin): not recommended. Potentiated by CYP3A4 and CYP1A2 inhibitors (eg, erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine), and by oral contraceptives containing gestodene + ethinyl estradiol (possible increased adverse effects).
Diarrhea, weight loss, nausea, headache, back pain, influenza, dizziness, decreased appetite; psychiatric effects (eg, insomnia, anxiety, depression).
Tabs 250mcg—28; 500mcg—30, 90