Generic Name and Formulations:
Roflumilast 500mcg; tabs.

Company:
Forest Laboratories
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.

Adult:
500mcg once daily.

Children:
Not established.

Contraindications:
Moderate-to-severe liver impairment (Child-Pugh Class B or C).

Warnings/Precautions:
Depression. Suicidal ideation. Mild liver impairment (Child-Pugh Class A). Monitor for insomnia, anxiety, depression, suicidal ideation, other mood changes; reeva luate if occurs. Monitor weight regularly; consider discontinuing if unexplained or significant weight loss occurs. Pregnancy (Cat. C). Labor & delivery, nursing mothers: not recommended.

Interactions:
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).

Pharmacological Class:
Selective phosphodiesterase 4 (PDE4) inhibitor.

Adverse Reactions:
Diarrhea, weight decrease, nausea, headache, back pain, influenza, dizziness, decreased appetite; psychiatric effects (eg, insomnia, anxiety, depression).

How Supplied:
Tabs—30, 90